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2011: The Year of Building International Biosafety Communities Global Biosafety and Biosecurity: Taking Action February 15-17, 2011 Pullman Bangkok King Power Bangkok, Thailand International Federation of Biosafety Associations IFBA

IFBA - Adcell Group · IFBA, I wish to extend a warm welcome to our all delegates who have come to Bangkok to attend this important conference. I also with to thank our distinguished

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2011: The Year of Building International Biosafety Communities

Global Biosafety and Biosecurity: Taking ActionFebruary 15-17, 2011 Pullman Bangkok King Power Bangkok, Thailand

International Federation of Biosafety Associations

IFBA

International Federation of Biosafety Associations 403-445 Ellice Ave.

Winnipeg, Manitoba R3B 3P5 Canada

[email protected]

www.internationalbiosafety.org

Welcome to the 1st IFBA International Conference on ―Global

Biosafety and Biosecurity: Taking Action‖

Dear Colleagues,

It gives me great pleasure to welcome you to the IFBA‘s first international

conference on “Global Biosafety and Biosecurity: Taking Action”. On behalf of the

IFBA, I wish to extend a warm welcome to our all delegates who have come to

Bangkok to attend this important conference. I also with to thank our distinguished

speakers, Dr. Paijit Warachit, RADM Craig Vanderwagen and Dr. David Heymann.

We recognize that biosafety and biosecurity are important elements within the

greater framework of strengthening global health and security. Our goals this

week are to identify urgent gaps and priorities and recommend action to

advance global biosafety and biosecurity with particular attention to building

sustainable capacity in under-addressed regions of the world.

In order to improve and sustain capacity, the global biosafety and biosecurity

community must work collaboratively and in partnership with each other. To this

end, the IFBA and the Elizabeth Griffin Foundation are pleased to launch “2011 –

The Year of Building International Communities”. Our aim is to respond to an

explosion of global interest in biosafety by supporting the growth and sustainability

of new and emerging biosafety associations worldwide. Empowering these

associations with the knowledge and tools they need to develop in a focused,

meaningful and sustainable way will enable us to build significant and lasting

improvements to biosafety practices, while raising the profile and effectiveness of

biosafety and biosecurity at a crucial point in its global development.

The time for collective action is now. With your participation this week in Bangkok

we can turn biosafety and biosecurity challenges into opportunities for increased

capacity building. By increasing collaboration we can enhance policy and

program sustainability that will put our profession on a solid footing for decades to

come. This is what the Year of Building International Biosafety Communities is all

about. I look forward to hearing your thoughts over the next few days and to

working with you on this exciting initiative in the weeks and months ahead.

Sincerely,

Maureen Ellis

Co-Chair

International Federation of Biosafety Associations

Welcome to the 1st IFBA International Conference on ―Global

Biosafety and Biosecurity: Taking Action‖

Message from Co-Chair IFBA

I warmly welcome you to our 1st Annual International Biosafety Federation

Association‘s conference. I am excited and privileged to be part of this historical

conference. I wish to salute our colleagues who initiated IFBA in October 2001 and

who have worked very hard to bring this important global forum to where it is now.

Thank you!

This conference provides a unique opportunity for all of us in the International

Community to take stock of the achievements that we have made towards a

Healthier, Safer, and More Secure World and contribute to the worldwide fight

against emerging infectious disease.

The theme of this year‘s conference is “2011 The Year of Building International

Biosafety Communities”. In partnership with the Elizabeth R. Griffin Foundation, we

are all collectively undertaking a new initiative to strengthen global biosafety and

biosecurity. At the end of this conference I do hope that we will have identified

local, practical and sustainable solutions to close key gaps and commit to local

action.

We are grateful to our local biosafety community for hosting this important

conference in the beautiful city of Bangkok and to our sponsors who include the

US Biosecurity Engagement Programme (BEP), Biosafety Associations (A-PBA, EBSA,

ABSA), National Governments (Canada, US) and Private Industry Partners.

We thank Elizabeth R. Griffin Foundation and especially Jim Welch for giving us this

Year‘s theme. Indeed we are safer when we Work and Act together!

We wish to thank all our speakers and delegates who have contributed their time

and resources towards the success of this conference.

I wish you all a memorable and an enjoyable stay in this beautiful City of Bangkok,

Thailand.

Willy Kiprotich Tonui, PhD,

Co-Chair, IFBA

Remarks by Dr. Paijit Warachit, Permanent Secretary, Ministry of

Public Health, Thailand

At the Opening Ceremony of

The 1st IFBA International Conference on ―Global Biosafety and

Biosecurity: Taking Action‖

Bangkok, Feb 15, 2011

Rear Admiral Vanderwagen,

Distinguished Delegates,

Ladies and Gentleman,

On behalf of the Ministry of Public Health, Royal Thai Government, it gives me

great pleasure to welcome you to Bangkok and attend the opening ceremony of

the first international conference on “Global Biosafety and Biosecurity: Taking

Action”. I wish to extend a warm welcome to our all delegates who have come to

Bangkok to attend this important conference. I also wish to thank the International

Federation of Biosafety Associations, the Mahidol Oxford Tropical Medicine

Research Unit, and the Biosafety and Biosecurity Network of Thailand for jointly

organizing this event with us. Thailand is pleased to participate in this important

and ground-breaking international conference on biosafety and biosecurity.

Ladies and Gentlemen,

The international public health situation faces many urgent challenges and the threat of pandemics is a growing one in the 21st century. A fast spreading pandemic could produce many casualties, cripple economies and have national, regional and even global ramifications. I do not need to spend much time introducing biosafety and biosecurity: you are all familiar with their importance as key elements within the greater framework of strengthening global health and security. Yet sadly, many countries continue to suffer the burden of emerging infectious diseases despite the lack of resources to handle these diseases in a safe and secure manner. And this is what brings us here this week to Bangkok. Our goals this week are to identify urgent gaps and priorities and recommend action to advance global biosafety and biosecurity with particular attention to building sustainable capacity in under-addressed regions of the world. Ladies and gentlemen, in order to improve and sustain capacity, the global biosafety and biosecurity community must work collaboratively and in partnership with each other. Thailand promotes international cooperation in the biological field, appreciates the work of the International Federation of Biosafety Associations and has taken an active part in strengthening global biological safety and security. Ladies and gentlemen, under the theme of ―building international biosafety communities‖ this conference will provide a unique opportunity for in-depth discussions on the issues related to global public health security. I wish the workshop a complete success and each of you the best in your stay in Bangkok. Thank you.

Keynote Speaker: W. Craig Vanderwagen, M.D., RADM USPHS – Retired Dr. Craig Vanderwagen is a senior partner with Martin, Blanck, and Associates who joined the firm on November 1, 2009. His most recent assignment prior to joining MBA was the Assistant Secretary for Preparedness and Response for the US Department of Health and Human Services. He has special interests and experience in bio defense, domestic disaster preparedness and response, international humanitarian and disaster response, federal health delivery systems, innovative organization development and evaluation, and cross cultural health care. From August, 2006 until July, 2009, Dr. Vanderwagen was the founding Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services. In this role he was responsible for the leadership and development of a new organization whose mission was preparing the Nation for response and recovery from public health and other health disasters whether natural or manmade. The organization was initiated after hurricane Katrina and formalized after the passage of the Pandemic and All Hazards Preparedness Act. The Act empowered the ASPR as the lead for all federal public health and medical response in disasters. It also initiated the Biomedical Acquisition, Research, and Development Authority for the development and acquisition of medical countermeasures (preventives, treatments, and diagnostics) for the civilian population. Lastly the funding of grants for development of state and local hospital preparedness activities became a major element of the preparedness activities in ASPR. Dr. Vanderwagen had a distinguished 28 year career in public service as a commissioned officer in the United States Public Health Service (USPHS), Department of Health and Human Services (HHS). His assignments prior to becoming Assistant Secretary included many deployments in disaster environments. These included lead federal health official in Louisiana after Katrina from August-November, 2005; lead public health official and senior officer aboard the USNS Mercy in Indonesia after the tsunami in 2005; Director of Primary Care and Public Health for the Ministry of Health in Iraq from September 2003-March, 2004; consultant to the Pan American Health Organization in Honduras after Hurricane Mitch in 1999; and Medical Director for Project Provide Refuge (joint DOD-HHS Kosovar refugee assistance) in 1999.

These deployed assignments however were in addition to his regular duties in the

Indian Health Service where during his 25 years of service, he held a number of

responsible positions and was the agency‘s Chief Medical Officer as his last

assignment. During his career with Indian Health Service, Dr. Vanderwagen

provided leadership in the uses of electronic health records, implementation of the

use of best practices to combat chronic diseases, and was an early supporter of,

and the agency‘s lead negotiator for a majority of the early Self Governance

Compacts. Dr. Vanderwagen is a family physician who believes passionately in

the union of public health and clinical medicine. He and his wife of 38 years have

3 grown sons and one granddaughter.

Keynote Speaker (Dinner): Dr. David Heymann Dr David Heymann is currently Chair of the Health Protection Agency UK; Head and senior fellow of the Centre on Global Health Security at Chatham House, London and Professor of Infectious Disease Epidemiology at the London School of Hygiene and Tropical Medicine. Previously he was the World Health Organization's Assistant Director-General for Health Security and Environment and the representative of the Director-General for polio eradication. From 1998-2003 he was Executive Director of the WHO Communicable Diseases Cluster from where he led the global response to the outbreak of SARS, and from October 1995 to July 1998 he was Director of the WHO Programme on Emerging and other Communicable Diseases. Prior to that he was the Chief of research activities in the WHO Global Programme on AIDS. Before joining WHO, Dr Heymann worked for 13 years as a medical epidemiologist in sub-Saharan Africa on assignment from the US Centers for Disease Control and Prevention (CDC). In this capacity he supported ministries of health in designing and implementing programmes in infectious disease prevention and control, with emphasis on childhood diseases, malaria, ebola, and the African haemorrhagic fevers. Prior to that he worked in India for two years as a medical epidemiologist in the WHO Smallpox Eradication Programme. He is a member of the Institute of Medicine of the United States National Academies; and has been awarded the 2004 Award for Excellence of American Public Health Association, the 2005 Donald Mackay Award from the American Society for Tropical Medicine and Hygiene, and the 2007 Heinz Award on the Human Condition. In 2009 he was appointed an honorary Commander of the Most Excellent Order of the British Empire (CBE) for services to global public health and recently he was elected as a Fellow of the Academy of Medical Sciences in the UK. He is currently the editor of the 19th edition of the Control of Communicable Diseases Manual, a joint publication of the American Public Health Association and WHO, has over 140 publications in peer reviewed medical and public health journals, and has written numerous book chapters on infectious diseases.

Agenda

TUESDAY, February 15, 2011

7 : 0 0 a m – 8 : 3 0 a m

Cuisine Unplugged

Infinity I and II

Continental Breakfast and Registration

8 : 3 0 a m – 9 : 0 0 a m

Infinity I and II

Opening Remarks: Dr. Paijit Warachit Permanent Secretary

Ministry of Public Health, Thailand Introduced by: Maureen Ellis, Co-Chair, IFBA

9 : 0 0 a m – 9 : 3 0 a m

Keynote Address: RADM Craig Vanderwagen

9 : 3 0 a m . – 9 : 4 0 a m Overview of Agenda Maureen Ellis

9 : 4 0 a m – 1 0 : 1 0 a m

Infinity Room Foyer Break

Session I – Global Biological Risks: Defining the Problem Moderator: Maureen Ellis

1 0 : 1 0 a m – 1 1 : 5 0 a m

Infinity I and II

“Expanding the Landscape of Biological Threats: Public Health Security and Bio-Preparedness ”

Redi Center

”Title to be Confirmed” Alexandre Bouchet, OIE

“Roles of Biosafety and Biosecurity in Risk Reduction at Human-Animal Interface”

Pawin Padungtod, FAO

“Biosafety, Biosecurity and the Biological Weapons Convention” Piers Millett, BTWC ISU

Discussion/Questions

1 1 : 5 0 a m – 1 2 : 5 0 p m

Cuisine Unplugged Lunch

Session II – Regional Biosafety Gaps and Needs

Moderator: Sara Heninger

1 2 : 5 0 p m – 1 4 : 3 0 p m

Infinity I and II

“Progress and Challenges of Biosafety Management in Vietnam” Nguyen Thuy, Vietnam

Global Biosafety and Biosecurity:

Taking Action

February15-17, 2011 Pullman Bangkok King Power,

Bangkok, Thailand

”Implementation of Biosafety and Biosecurity in Africa: Gaps and Needs” Willy Tonui, AfBSA

“Biosafety in Pakistan: A Journey from Gaps and Needs Assessments to Recent

Achievements” Erum Khan, Pakistan

“Process for Establishment of a Caribbean Biological Safety Association”

Valerie Wilson, Trinidad

Discussion/Questions

1 4 : 3 0 p m - 1 5 : 0 0 p m

Infinity Room Foyer Break

1 5 : 0 0 p m – 1 6 : 4 0 p m

Infinity I and II

Session III – Addressing Biosafety Challenges

Moderator: Siripan Wongwanich

“Program Implementation and Event Management” Edgar Sevilla-Reyes, AMEXBIO

”Biosafety and Biosecurity Capacity Building Efforts in Afghanistan (In Contrast to

Similar Efforts Elsewhere)” Samuel Yingst, AFRIMS

“Five Years of Institutional Biosafety Capacity Building Through Cost Effective Training

Programs Initiated by Biosafety Association of Pakistan” Shahana Kazmi, BSAP

“Better Biosafety for Low Resource Settings”

Heather Sheeley, EBSA

Discussion/Questions

Open Discussion Moderator: Robert Heckert

16:40 pm – 17:30 pm Infinity I and II

Biosafety Gaps, Needs and Challenges Expectations from the Meeting

Summary of Day 1

Maureen Ellis, Co-Chair, IFBA

18:30pm – 20:00pm Infinity I and II

TBD

Reception: Pullman Bangkok King Power

WEDNESDAY, February 16, 2011

7 : 0 0 a m – 8 : 3 0 a m

Cuisine Unplugged Continental Breakfast

8 : 3 0 a m – 9 : 0 0 a m

Infinity I and II

Taking Stock…the Way Forward Jim Welch

Elizabeth R. Griffin Research Foundation Introduced by: Maureen Ellis, Co-Chair, IFBA

9 : 0 0 a m – 9 : 3 0 a m

Infinity I and II

WHO 5-Year Strategic Plan for Biosafety Nicoletta Previsani

Moderator: Sandra Fry

Discussion/Questions

9 : 3 0 a m – 1 0 : 0 0 a m

Infinity Room Foyer Break

Session IV – Biosafety Resources and Tools Moderator: Barbara Johnson

1 0 : 0 0 a m – 1 1 : 4 0 a m

Infinity I and II

“Implementing an Electronic IFBA Information Sharing and Collaboration Suite ” Brad Goble, IFBA

”Promoting Biosecurity Education: Resource and Programme”

Cathy Bollaert, Bradford

“Preliminary Activities and Considerations from the IFBA Working Group on Biosafety Professional Accreditation”

Michelle McKinney, ABSA/IFBA

“Laboratory Biorisk Management: Bringing Biosafety and Biosecurity to the Next Level” Stefan Wagener, DFAIT/PHAC

Discussion/Questions

1 1 : 4 0 a m – 1 2 : 4 0 p m

Cuisine Unplugged Lunch

Session V – Local and Regional Capacity Building Moderator: Stuart Blacksell

1 2 : 4 0 p m – 1 4 : 2 0 p m

Infinity I and II

“International Regulatory Cooperation: The Global Human Pathogens Biosafety and Biosecurity Group”

Marianne Heisz, GHPBG

”Title to be Confirmed” Saied Jaradat, Jordan

“AALAS Animal Biosafety Training Program”

Ann Turner, AALAS

“Enabling High Biosafety Containment Designers and Operators in Low Resource Countries”

Felix Gmuender, Singapore Sunee Korbsrisate, Thailand

Discussion/Questions

14:20pm - 14:50pm Infinity Room Foyer

Break

Session VI – National and Regional Biosafety Associations Moderator: Stefan Wagener

14:50pm – 16:10pm Infinity I and II

“National and Regional Biosafety Associations – What Role can Associations Play?” Teck Mean Chua, A-PBA

“Role of Egyptian Biosafety Association (EGBSA) in Promoting Biosafety and

Biosecurity” Mohammed Hassan, EGBSA

“Georgian Biosafety Association: Efforts Towards Partnership in the Region”

Lela Bakanidze, GeBSA

“The American Biological Safety Association (ABSA): Committed to Promoting Biosafety Worldwide”

Benjamin Fontes, ABSA

Discussion/Questions

Open Discussion Moderator: Hillary Carter

16:10 pm –17:30 pm Infinity I and II

What Resources/Capacity Building Programs are Missing – Locally, Regionally, Globally? What are our Priorities?

How can we Collectively Address the Problem?

Summary of Day 2/Introduction to Working Groups Maureen Ellis, Co-Chair, IFBA

THURSDAY, February 17, 2011

7:00 am – 8:30 am Cuisine Unplugged

Continental Breakfast

8 : 3 0 a m – 9 : 0 0 a m Infinity I and II

Action at the Regional Level – Forming Partnerships Terry Taylor, ICLS

Mohammed Hassar, MOBSA Introduced by: Maureen Ellis, Co-Chair, IFBA

9 : 0 0 a m – 9 : 1 0 a m Infinity I and II

Instructions to Working Groups Maureen Ellis, Co-Chair, IFBA

Group locations assigned during instructions

Break Out Sessions

9 :10am – 12:00pm Infinity I and II

Beta Room

Working Group 1: Raising International Biosafety Posture Moderator: Benjamin Fontes

Working Group 2: Moving the Agenda Forward

Moderator: Brad Goble

Working Group 3: Addressing Priority Gaps and Needs Moderator: Robert Heckert

12:00pm – 1:20pm Cuisine Unplugged

Lunch

Report from Working Groups

1 : 2 0 p m – 2 : 4 0 p m Infinity I and II

Conclusions and Recommendations Working Group Moderators

Conference Declaration

Terry Taylor/Rapporteurs

Discussion/Questions

2 : 4 0 p m - 3 : 0 0 p m Infinity Room Foyer

Break

3:00 pm – 3:10 pm Infinity I and II

Conference Summation Maureen Ellis, Co-Chair, IFBA

3:10 pm – 3:40 pm Infinity I and II

The Road Ahead: Taking Action Brad Goble, IFBA

Biosafety Heroes Award Michael Weaver, ISTC

Next Steps

Willy Tonui, AfBSA/IFBA

3:40 pm – 4:00 pm Infinity I and II

Closing Remarks: Dr. Sathaporn Wongjaroen

Director General, Department of Medical Sciences Ministry of Public Health, Thailand

6:30 pm – 8:30 pm Thai Puppet Show

6:45 p.m. Invited Speaker

7:30 p.m.

Dinner Keynote Speaker: Dr. David Heymann

Working Sessions

PLEASE NOMINATE ONE MEMBER OF YOUR TABLE TO COMPLETE THIS FORM AND

ANOTHER TO SHARE KEY RESPONSES WITH THE ROOM

IFBA Inaugural Conference

Global Biosafety and Biosecurity: Taking Action

Feb 15-17, 2011

Bangkok, Thailand

Group Discussion Day One

Gaps, needs, and challenges

Meeting Expectations

1. What did you learn today that you did not know before coming to this

conference?

?

?

?

2. Is there anything you would like to add that was not raised today with

respect to biosafety gaps and challenges?

?

?

?

3. What are your expectations from the rest of this meeting?

?

?

?

PLEASE NOMINATE ONE MEMBER OF YOUR TABLE TO COMPLETE THIS FORM AND

ANOTHER TO SHARE KEY RESPONSES WITH THE ROOM

IFBA Inaugural Conference

Global Biosafety and Biosecurity: Taking Action

Feb 15-17, 2011

Bangkok, Thailand

Group Discussion Day Two

What resources/capacity building programs are missing locally, regionally,

globally?

What are some of our priorities?

How can we build sustainable biosafety programs?

1. Are you aware of any other tools, resources and programs that can be

leveraged to build biosafety and biosecurity capacity?

?

?

?

2. What are some of the pressing biosafety needs/issues facing your region?

?

?

?

3. What can the biosafety community do to implement biosafety programs that

are sustainable?

?

?

?

IFBA Inaugural Conference

Global Biosafety and Biosecurity: Taking Action

Feb 15-17, 2011

Bangkok, Thailand

Working Group 1- Raising International Biosafety

Posture

Theme:

What are our common goals?

What are the benefits and added value of biosafety to global health,

agriculture, & security?

How can we garner more support at national, regional, international levels?

How can we better mobilize stakeholders and funding agencies into action?

STEP ONE

Develop a list of 4 common goals for IFBA and the international biosafety

community (e.g. awareness raising, capacity building, facilitate best practices

and sharing of expertise, outreach and advocacy, establish linkages and

partnerships, empowerment of an international biosafety advisory body)

Note: these 4 goals feed into the conference declaration

STEP TWO

Outline 3 ways in which biosafety/biosecurity adds value to each of the human

health, animal health and security sectors (e.g. enable diagnostic testing and

disease surveillance, enhanced laboratory capacity, strengthened preparedness

for disease outbreaks whether naturally occurring or deliberate, reduced risk of

laboratory-acquired infections and containment breaches, reduced risk of terrorist

acquisition of dangerous pathogens).

Note: these 3 benefits of biosafety (one for each sector) feed into the conference

declaration

STEP 3

Identify any major obstacles/challenges that must be overcome to raise the

international posture of biosafety among these sectors.

STEP 4

Given the above, what 2 activities will help “raise support” for biosafety and

biosecurity within each of these sectors? Who could carry out these activities and

how?

WORKING GROUP 1 Step One

Common Goals for IFBA and the international biosafety community

Goal

1

2

3

4

WORKING GROUP 1 Step Two

Added value of biosafety/biosecurity

Human Health

?

?

? Three Ideas

Animal Health

?

?

? Three Ideas

Security Sector

?

?

? Three Ideas

WORKING GROUP 1 Step Three

Major Obstacles to Raising the Posture of Biosafety

Human Health

?

Animal Health

?

Security Sector

?

WORKING GROUP 1 Step Four

How to Raise Support for Biosafety and Biosecurity

Action How?

Human Health

? Two Ideas

?

Animal Health

? Two Ideas

?

Security Sector

? Two Ideas

?

IFBA Inaugural Conference

Global Biosafety and Biosecurity: Taking Action

Feb 15-17, 2011

Bangkok, Thailand

Working Group 2- Moving the Agenda Forward

Theme:

What would a multi-stakeholder partnership to move forward in a

coordinated and focused manner look like?

What is IFBA‘s role in the partnership?

What initial steps could be taken to develop the partnership?

STEP ONE

Identify the major stakeholder groups/communities that should be engaged in a

partnership to advance global biosafety and biosecurity (e.g. international

agencies such as WHO/OIE/Interpol, biosafety associations, government, private

sector, donor agencies, academia, civil society).

Indicate with a ☼ which of these are ―must-haves‖.

Note: the makeup of the multi-stakeholder partnership ―must-haves‖ feeds into the

conference declaration

STEP TWO

For each “must-have‖, identify a lead organization/entity/contact to act as the

liaison for their group/community on the multi-stakeholder partnership.

STEP 3

What role should the IFBA play (e.g. coordinating body, secretariat, coordinating

future meetings)?

Note: a sentence on the structure feeds into the conference declaration

STEP 4

Identify the immediate next steps for further defining and establishing the

partnership (e.g. establish secretariat, structure, funding, draft terms of reference,

coordination of efforts to maximize resources, meetings).

Note: one or two next steps of the partnership feeds into the conference

declaration

WORKING GROUP 2 Step One

Major Stakeholders and ―Must Haves‖

?

?

?

?

?

?

?

?

?

?

Must

Have

WORKING GROUP 2 Step Two

Liaison Contact Points

―Must Have‖ Stakeholder

Group/Community

Lead/Contact

WORKING GROUP 2 Step Three & Four

Role of IFBA &Next Steps

Role of IBA

Next Steps

?

?

?

?

?

?

IFBA Inaugural Conference

Global Biosafety and Biosecurity: Taking Action

Feb 15-17, 2011

Bangkok, Thailand

Working Group 3- Addressing Priority Gaps and

Needs

Theme:

What are some accessible, practical and sustainable short-term projects

that can be implemented now?

How can we maximize scarce resources?

What long term biosafety issues and challenges do we face?

STEP ONE

Identify 4 short-term target biosafety projects for action over the next 1-2 years.

These could include projects that address a priority issue facing most of the

biosafety community (e.g. lack of accessible hands-on training), projects that are

easily doable and can demonstrate early success (e.g. translating

guidelines/training materials), and/or projects that address a critical issue in

particular region (e.g. lack of certified biosafety cabinets).

Note: these 4 projects feed into the conference declaration

STEP TWO

For each project above, provide suggestions for 2-3 practical and sustainable

activities to be taken in order to successfully carry out the project. Who could

undertake these activities?

STEP 3

How can existing resources and donor/partner efforts be leveraged and

coordinated in implementing these projects to maximize their impact and value?

STEP 4

Identify 4 biosafety needs/issues that require a longer-term (ie. 3-5 years)

approach to address (e.g. sustaining biocontainment laboratories, lack of

biocontainment engineering expertise). Provide any suggestions for how they

could be tackled.

Note: one or two long term action items feed into the conference declaration

WORKING GROUP 3 Step One and Two

Short Term (1-2 years) Projects and Activities

Project 1

Project 2

Project 3

Project 4

Actions Who?

Project 1

?

? 2-3 Actions

?

Project 2

?

?

?

Project 3

? 2-3 Actions

?

?

Project 4

? 2-3 Actions

?

?

WORKING GROUP 3 Step Three

Leveraging Existing Resources and ―Donor/Partner Efforts

?

?

?

WORKING GROUP 3 Step Four

Long-Term (3-5 years) Issues and Possible Approaches

Issue Suggestions for approach?

? ?

?

? ?

?

? ?

?

? ?

?

Abstracts

Expanding the landscape of biological threats: public health security and bio-

preparedness

The REDI Center, Singapore

In recent years the scope of biological threats and the risk they pose from a

security perspective has increasingly incorporated naturally occurring diseases1.

As illustrated in Figure 1, the recent emergence of infectious diseases as global

public health threats (e.g. HIV/AIDS, SARS and pandemic influenza) has pulled the

security and health sectors together. As a result the organizing frameworks of

health security and bio-preparedness are playing an increasing role in shaping

public health policies and responses aimed at managing this expanded

landscape. Health security, defined by WHO as ―activities required to minimize

vulnerability to acute public health events that endanger the collective health of

national populations‖2, is being promoted through the 2005 update of the

International Health Regulations (IHR 2005). IHR 2005 directs WHO member states

to achieve the necessary capacities that will enable them to detect, diagnose,

report, respond and recover from ―public health events of international concern‖.

Although IHR 2005 capacities are universal by design, there will remain

fundamental differences in the strategies for dealing with, for example, pandemic

threats compared to accidental exposure, negligence or suspected bioterrorism

events.

1 New approaches to biological risk assessment. The Royal Society Policy Document 08/09

2 The World Health Report 2007 - A safer future: global public health security in the 21st century. World

Health Organization 2007

Figure 1. Health, Security and the spectrum of biological risks

Naturall

y

occurrin

g

disease

s

Reemergi

ng

infectious

diseases

Unintended

consequen

ces of

research

Laborato

ry

accident

s

Lack of

awarene

ss

Negligen

ce

Delibera

te

misuse

Adapted from Terence Taylor, ―Safeguarding advances in Life Sciences, ― EMBO

Reports, Vol 7 (July 2006) pp S61-S64

HEALTH Health

Security

Our presentation will provide a perspective on building comprehensive capacity

for addressing global biological risks. In particular we will cover four areas of bio-

preparedness – reducing bio-risk (laboratory biosafety/biosecurity, infection

prevention and control), surveillance, planning and response, and access to

research, analysis and technologies and discuss how these are being addressed

through international and regional strategies and frameworks such as the IHR and

APSED. We will attempt to identify capabilities and capacities that are critical for

building and ensuring public health security and look at some of the approaches

that are being taken to manage and sustain the multiple components.

Roles of Biosafety and Biosecurity in Risk Reduction at Human-Animal Interface

Pawin Padungtod, FAO ECTAD- RAP, Thailand

Biosafety and biosecurity should not be applied only to the diagnostic laboratory,

but should be considered for livestock farming and other areas where human and

animal may come into contact. Organisms circulating in the domestic and wild

animal populations can potentially pose a threat to both animal and human

health. As humans increase contact with animal the risk of exposure to known

pathogen and unknown agent is increased.

In order to create a world that is capable of managing, and ideally, preventing

animal and public health risks, attributable to zoonoses and animal diseases, FAO-

OIE-WHO continue to collaborate and coordinate global activities to address

health risks at the animal-human-ecosystems interfaces particularly where a

disease has the potential to impact on a large numbers of people and animals.

This inter-sectoral and multi-disciplinary approach is considered crucial to

addressing the complex problem of zoonoses and other emerging infectious

diseases. One of the key expected outcomes under this tripartite collaboration is

to improve biosafety and biosecurity of the laboratories processing samples from

animals and producing biological products. This is necessary to ensure that

pathogens which may be presence in large amount are not transmitted to

laboratory workers or accidentally release and cause disease outbreaks in either

animals or human.

Apart from the laboratories, the concept and practice of biosecurity can be

applied to livestock farming as well although the objective may differ from

applying biosecurity in the laboratory. In livestock farming, biosecurity is a

cornerstone of herd health maintenance to reduce the risk of pathogens being

introduced and spread. There are three main elements of farm level biosecurity;

segregation, cleaning and disinfection. Reducing the incidence of high impact

diseases in domestic animals will lead to reducing the risk of outbreak of such

diseases in humans too.

Biosafety, Biosecurity and the Biological Weapons Convention

Piers Millett, BWC Implementation Support Unit, Biological Weapons Convention,

UN Office for Disarmament Affairs

The BWC balances the interests of states, with the needs of business and the

concerns of the general public. It is a regime, tailored to the specific needs of both

biology and biologists, which manages the risk that biology could be used to

cause harm. The BWC uses a layered approach to dealing with the threat posed

by biological weapons: the international legal framework; how treaties are turned

into action; the implementation of the obligations; and the work of the community

dedicated to ensuring biology continues only to be used to improve our lives.

By examining state actions, the presentation covers the different types of

commitments under the Convention. It uses the issue of biosafety and biosecurity

as a case study to illustrate the types of outputs produced and the nature of the

work programmes that produce them. The presentation also looks at the work of

the network of organizations, companies and individuals committed to ensuring

that biology is used safely, securely and solely for our collective benefit.

Progress and Challenges of Biosafety Management in Vietnam

Thuy Nguyen Thanh, National Institute of Hygiene and Epidemiology, Vietnam

In recent years, Vietnam has had to deal with life-threatening infectious diseases

such as SARS, avian influenza A/H5N1, H1N1 and others. Laboratory tests are

essential for the diagnosis and research of such dangerous diseases. For the

management of laboratory biosafety, in the Law of Communicable Diseases

Control and Prevention (taking effect from July 2008), laboratory biosafety has

been included (Article 24, 25, and 26). According to this Law a Decree on

biosafety should be issued by the Government, and Regulations should be issued

by the Ministry of Health.

In the Decree on Laboratory Biosafety issued by the Government (taking effect

from November 2010) the risk group classification of infectious microorganisms,

mandatory requirements of facilities, equipments and personnel of Biosafety Level

1 to 4 Laboratory was adapted mainly from the book ―Biosafety Manual‖

published by WHO.

As per the plan, by the end of 2011, the Ministry of Health will issue: (i) the detail list

of risk groups of microorganisms, (ii) the required biosafety level of a laboratory for

specific techniques of handling infectious pathogens, (iii) a national standard of

laboratory practice and biosafety, (iv)a procedure for certification and

recertification of biosafety levels of laboratories. When the above mentioned

regulations and standards take effect, only certified laboratories will have

permission to carry out tests.

For the management of biosafety, challenges faced by Vietnam are: lack of

experienced experts in developing biosafety regulations/ standards; laboratories

haven‘t met the needed biosafey interim requirements of facilities and equipment;

lack of detail and updated guidelines for laboratory design. Service of

maintanance and calibration of laboratory equipment is still difficult for

laboratories to access. Many laboratory personel and medical students have not

been trained on biosafety in a systematic manner.

Among activities needed for strengthening biosafety management in Vietnam

are, the development of regulations/standards and establishment of the National

Center for Biosafety Training should be considered as top priorities.

Implementation of Biosafety and Biosecurity in Africa: Gaps and Needs

Willy Tonui, African Biological Safety Association

Biosafety and Biosecurity as scientific disciplines are still at their formative stages in

most Institutions in Africa. Recent outbreaks of emerging infectious disease

awakened the African Governments, NGOs to threats to public and agricultural

health. Most threat mitigation strategies to emerging infectious diseases have

focused on outbreak management. This has encouraged initiation of measures

that include Laboratory biosafety and biosecurity to prevent outbreaks of highly

infectious disease.

The African Biological Safety Association (AfBSA) was formed on May 31, 2007.

AfBSA is a non-governmental, non-political, non-sectarian and non-profit making

association through which its members work, co-operate and collaborate with

one or each other, or with other associations, scientific or health organizations,

institutions or individuals throughout Africa or elsewhere in the world to promote

Biosafety and Biosecurity.

As a result of workshops and conferences sponsored by AfBSA we have been able

to identify gaps from our membership. In general, majority of laboratories in Africa

are the typical university research laboratory i.e. a BSL-1 facility. Most Research

Institutions have BSL-2 and mushrooming BSL-3 facilities (e.g. KEMRI 5 BSL-3 labs).

Enhanced BSL-3 facilities exist in Institutions that include the Naval Medical

Research Unit No. 3 Cairo, Egypt (NAMRU-3 (Cairo, Egypt) and the University of

Manitoba and Nairobi University joint laboratory in Nairobi, Kenya. There are only 2

BSL-4 facilities in Africa which based at the Centre International de Recherches

Médicales de Franceville, Franceville, Gabon) and the National Institute for

Communicable Diseases (NICD), Grahamstown, South Africa.

Most Institutions in Africa are still building up their occupational health and safety

programmes. This includes programmes aimed at addressing spill-management

and post-exposure management (e.g. for HBV/HIV), recording mechanism for

laboratory acquired infections and other safety errors, proper use of use of

personal protective equipment (PPE) and waste disposal. Institutions in most

countries also do not have adequate use, operation and maintenance of

biosafety equipment such as Biosafety cabinets.

Constitutions in several countries do not contain explicit Biosafety and Biosecurity

provisions. Biosafety and Biosecurity are addressed through sectoral regulatory

instruments that may have arisen in different historical contexts and because of

specific needs. At the institutional level studies show that coordination is often

lacking among government bodies involved in Biosafety and Biosecurity matters,

and inter-institutional conflicts are common. It is encouraging to note that

Biosafety awareness in the continent has been promoted through Biotechnology

innovations (Mainly GMOs) within the framework of the ―Cartagena Protocol‖ and

UN 1540 Convention. As a result of this, several countries have initiated steps

towards development of laws and regulations to domesticate these conventions.

Among the opportunities that AfBSA has to address the gaps include: promotion of

International partnerships towards reducing the risk of biological threats by

collaborating with governments to develop biosafety and biosecurity standards

that are consistent with national and international guidelines, norms and

requirements; Enhancing collaboration and networking between laboratories in

areas of biosafety and biosecurity, including risk assessment on implementation of

these principles among African laboratories; and ddesigning and implementing

training programmes that increase knowledge and skills towards biosafety and

biosecurity in Africa.

Already AfBSA has initiated awareness in several countries and Institutions through

its membership. This has been achieved through workshops held in various regions

of the continent. AfBSA has also developed a strategic plan (201-2013) that aims

at promoting Biosafety and Biosecurity in Africa. Specifically our strategic plan

aims at raising awareness on Biosafety and Biosecurity including Dual Use

Research to be done in countries and Institutions; Implementation of Biological

and Toxins Weapons Convention & UN 1540 Regulations in Countries and

Sensitization of policy makers and Institutional Management (to support lab

needs). AfBSA through its standing committees will initiate development of

guidelines and generic policies to support these Institutions. AfBSA is also

promoting appointment of Biorisk Officers and establishment of Institutional Biorisk

Committees in Institutions.

It is also important to note that International Partnerships is encouraging

Laboratory programmes to establishing and maintaining Laboratory quality

systems. Through WHO‘s International Health regulations and Quality

Implementation systems countries are now encouraged to develop biosafety and

biosecurity programmes. It is hoped that all these efforts will lead to a sustained

implementation of biosafety and biosecurity in Africa.

Biosafety in Pakistan: A Journey from Gaps and Needs Assessments to Recent

Achievements

Erum Khan, Pakistan Biological Safety Association

Pakistan is situated along the coast line of Arabian Sea and the Gulf of Oman. It is

boarded by Afghanistan and Iran in the West and India and China in the

Northeast. With the estimated population of 170 million it is world‘s sixth most

populous country. Due to other economical and military priorities, a very nominal

amount of GDP is invested on health and education (1.9% and 2.5% respectively).

Consequently there are challenges in terms of quality education and health care

provision at Public sector. Capitalizing on this situation private sector has emerged

extensively with mushrooming of diagnostic and educational laboratories in all

major cities in Pakistan. In the absence of national regulatory body and active

disease surveillance system these labs pose biosafety threat which is cause of

concern at national and international level.

Pakistan has been cognizant of challenges in view of biosafety issues at national

and international level. It is one of the countries signatory to the Cartagena

Protocols set in early 70;s. However due to political instability gaps remain.

My presentation will talk about Biosafety gaps in Pakistan such as: lack of biorisks

management as part of basic curriculum for scientists and technical staff to be

employed in the diagnostic, research and veterinarian labs, lack of national

guidelines, lack of legislative regulations for laboratory design and its

management. Disease surveillance and cross border transportation and control of

high risk GMO‘s and select agent.

It will also highlight the recent achievements that have been made with the

inception of non-governmental organization of scientists Pakistan Biological Safety

Association (PBSA) to advocate of Biosafety and Biosecurity concepts among

scientists, educationists, government agencies and public sector in general.

The focus will also be drawn to the recent activation and focused attention by

present government towards the Biosafety and Biosecurity gaps in Pakistan.

Government has taken new initiatives such as: formation of national Biosafety

taskforce which is composed of scientists, academicians and representatives from

different-ministries, is addressing key issues like development of legal regulatory

document, code of conduct and national Biosafety framework and regulatory

body for the transport and control of GMO‘s and selects agents.

With the help of international Biosafety community, this will be journey of Pakistan‘s

achievements in field of Biosafety.

Process for Establishment of a Caribbean Biological Safety Association

Valerie Wilson and Wendy Kitson-Piggott, Caribbean Med Labs Foundation

The Caribbean region is one of the most geographically complex and culturally

varied in the world, consisting of an economically diverse group of island and

mainland territories. Caribbean national populations range from > 8 million, for

example in Haiti and the Dominican Republic (French and Spanish-speaking

respectively) to approximately 9,000 and 4,000, respectively in English-speaking

dependent territories such as Anguilla and Montserrat. GDPs also vary widely from

Cayman Islands with a GDP of approximately $44,000US to Haiti with a GDP of

$600US per capita.

Caribbean medical, public health and trade laboratories have embarked on

quality standards implementation over the past decade but laboratory safety

standards implementation has received limited focus. The Caribbean Med Labs

Foundation (CMLF), a not-for-profit regional organization, tasked with the

strengthening of Caribbean medical laboratory services, collaborated with the

International Federation of Biosafety Associations (IFBA) to establish a Caribbean

Biological Safety Association (CABSA). Establishment of a Biological Safety

Association in 2010-2011 to meet the needs of the Caribbean region was timely,

dovetailed with the quality improvement initiatives and required a process that

took into account the needs of this diverse group of countries.

The process for establishing CABSA included the following:

Identification of an appropriate lead organization (CMLF)

Sensitisation of potential ‗biosafety champions‘

Development of a needs assessment tool and the conduct of biosafety

assessments within a representative group of Caribbean countries to ensure

that conclusions about overall needs could be drawn and to develop a

preliminary advocacy strategy

Analysis of the data collected to determine overall needs

Development of a business plan to guide the establishment and

sustainability of CABSA, utilizing data from the needs assessments

Establishment of a mentoring relationship with an established and successful

biosafety association.

In executing this initiative, funding was provided for the conduct of the needs

assessments and development of the business plan by IFBA.

PROGRAM IMPLEMENTATION AND EVENT MANAGEMENT

Edgar E. Sevilla-Reyes, Mexican Biosafety Association

Biosafety associations (BAs) foster the development of local biosafety communities

and are important hubs for training and expertise as well as stakeholders in the

development of technical standards and guidelines, among other areas. The

development of strategic plans (vision, mission, goals) embraced by all BA

members is one of the key components for success and sustainability of the

organization. Training programs, guideline development, networking events and

other activities have to be designed according to the short and long term reaches

of the plan, as resources are to be allocated accordingly.

Human resources are possibly the most important component of successful BAs.

The Board/Council should identify and bring onboard committed individuals, help

them to develop professional skills and motivate them to contribute on the

execution of the strategic plan. Product development, in the form of trainings,

documentation, etc., must respond to the needs of the local community, in line

with the strategic plan. Proactive networking must be promoted at all times and

appropriate/professional expertise should be looked for and possibly outsourced,

particularly in areas such as accounting, fundraising, legal, public relations,

marketing, event planning and catering.

Although financial resources may be considered a critical issue to address, a well-

designed strategic plan and a proactive business plan can attract funding.

Multiple sources can be available for non-profit BAs, including membership and

registration fees, as well as funds coming from national and international bodies,

government funds, corporate funding programs, private trusts/charities and

commercial sponsorship. Successful professional associations, particularly those of

Medicine professionals, have existed for decades in most parts of the world. BAs

should learn from their lessons and resource on experienced fundraisers and

committed individuals in order to execute their strategic plan.

Biosafety and Biosecurity Capacity Building Efforts in Afghanistan (In Contrast to

Similar Efforts Elsewhere)

Samuel Yingst, Armed Forces Research Institute for Medical Sciences

Achieving cost effective and sustainable solutions in biosafety and laboratory

biosecurity capacity building is challenging in any resource poor environment.

Some lessons learned are broadly applicable, however, it is also essential to

approach each engagement as unique and tailor the effort to the conditions.

The Presenter's experiences in building laboratory capacity in Afghanistan will be

used as an example and a backdrop for comparison and contrast with other

efforts.

Outline:

1. Infrastructure vs. mindset

2. Balancing the goals of external/expatriate stakeholders with the goals of

host country laboratory staff and Ministry leadership

3. Tailoring the approach to the situation, especially in light of capacity for the

engaged staff to absorb and apply training in their own context

4. Evaluating success of capacity building; sustaining and redirecting as

necessary

Five Years of Institutional Biosafety Capacity Building Through Cost Effective

Training Programs Initiated by BioSafety Association of Pakistan

Shahana Urooj Kazmi, BioSafety Association of Pakistan

Disease prevention is the key to public health. High incidence of preventable

infectious diseases, due to unsafe practices by containment laboratories which

provide bulk of diagnostic services , not only cause enormous suffering , they strain

the capabilities of our poor health-care system and deplete financial resources.

The laboratories in most research centers lack basic measures to safeguard their

worker‘s health. Majority of the individuals involved in handling and disposing

infected clinical material are not aware of the potential threats to their health

and the health of the community. Improper disposal of hospital, public health

laboratory waste in open areas or in big bodies of water is a source of disease

epidemics and loss of life. Proper handling, processing and containment of all

microbes as well as samples of human or animal origin infected with serious

human pathogens by the laboratory personnel is essential to limiting the spread of

infection and for the safety of community , environment and the health of our

food crops , animals and their products. In an effort to build our capacity and

improving biosafety and biosecurity practices in Pakistan , BioSafety Association of

Pakistan initiated a series of hands-on training workshops in 2006, in collaboration

with ministry of health , environment , planning and agriculture and experts from

American Biological Safety Association and Pakistan Society for Microbiology. The

purpose of these workshops was to develop an appreciation of biosafety and

biosecurity issues, increase BSL 2-3 level knowledge and skills using hands on

experience to handle real time situations and to enhance local institution‘s

biosafety capacity within the limited available resources to effectively contribute

to national fight against emerging infectious diseases. During the last 5 years we

have developed and introduced special courses and organized Training

Workshops at 15 different Universities , Hospitals , Pathological laboratories in

Islamabad , Multan, Karachi , Lahore , Hyderabad , Khairpur , Peshawer and

Quetta – Balochistan with very active participation from public and private sector

scientists , medical professionals , paramedical staff , technicians and senior

students . In each workshop, we trained 100-400 participants on infections and

their sources , isolation , identification of causative agents , disposal of infected

specimens , development of laboratory safety and security measures , selection

and use of appropriate PPE , operation of biological safety cabinets , assessment

of possible risks , animal handling procedures , spill management etc. The major

challenges we faced during the training programs were lack of awareness about

the importance of biosafety practices to control Avian and Swine Influenza,

Dengue and Congo Fever virus and other Epidemics , lack of awareness about

standard procedures among the mangers , technicians etc , lack of proper

facilities /gadgets / requirements for implementing biosafety programs , lack of

commitments by hospitals / Laboratory / research institutions to implement

biosafety measures due to financial constraints . Although, overall analysis of the

data was very encouraging , we still need to continue our efforts for national

biosafety capacity building in other institutions because we feel that hands on

learning experience of the participants improved their know how about biosafety

issues to identify biological risks and mitigate them by cost effective solutions

which will help them in formulating institutional biosafety policies and programs to

reduce the incidence of serious infections like TB, Hepatitis , Bird Flu etc as well

heavy economic losses and possible threat of bioterrorism by misuse of select

agents.

Saving lives, building capacity – sustainable and better biosafety for low resource

settings

Heather Sheeley, HPA Microbiology Services

The need for improved laboratory capacity for local disease detection and

surveillance has never been greater. The ability to build state of the art

laboratories in [remote/need] locations is very expense and reliant on funds from

outside the region. Sustained capacity to not only build but run the laboratories

safely also requires high levels input. This model provides excellent facilities, initially

but only limited in coverage. More sustainable would be more laboratories as

sentinel in situ laboratories geared to provide immediate diagnosis who then in

turn feed into more sophisticated laboratories, resulting in greater coverage and

local and regional co-operation . The requirement to provide safe laboratories to

do routine and appropriate capacity is vital. The ability, locally to run safely (viz.

without adding to the disease burden) such laboratories. If laboratory design and

operation had a rethink to consider sustainable appropriate facilities, with lower

demands on power, water and other resources, yet provides a safer environment

for the laboratory workers then more facilities could be provided and run with

local resources.

TAKING STOCK…THE WAY FORWARD

James M. Welch, Elizabeth R. Griffin Research Foundation

An overview of the ‗2011 – Year of Building International Biosafety Communities‘

initiative and the collaborative roles of the partners involved. Also presented will

be the outline of the 2012 IFBA-ERGRF Sustainable Engineering Award initiative and

similar regional awards that will be presented at next year‘s conference. There will

also be a brief review of the discussions of Day 1.

Implementing an Electronic IFBA Information Sharing and Collaboration Suite

Brad Goble, IFBA

Effective laboratory diagnostic and surveillance capacity to fight infectious

diseases requires scientists, biosafety professionals, laboratory personnel, animal

and public health professionals, architects, engineers, academics and policy

makers to make decisions on a daily basis. Complete, accurate and timely

Biosafety and Biosecurity Situation Awareness is essential to ensure that these

decisions are based on the best available evidence at the time.

The International Federation of Biosafety Associations (IFBA) has embarked on an

initiative to implement bio-intelligence sharing and collaboration resources to

support evidence-based decision-making among members. Together with

implementing simple collaboration tools to support member activities (eg., on-line

organization and document sharing/management tools), IFBA is designing and

investigating the implementation of a real-time, secure, Bio-Intelligence (BI)

Service. Unlike currently available news-feeds and listservs, the BI service will

aggregate, process, distil, disseminate, and analyze bio-intelligence to support

members.

Designed with the needs of end-users in mind, the BI Service will provide a user-

friendly, intuitive, personalizable, and secure BI experience accessible over the

internet. BI will be gathered, processed, packaged, and presented using an

innovative information management system. Customization features will enable

members to personalize the service to meet their individual needs. The underlying

technologies will ensure accuracy in the collection, processing, analysis and

distribution of bio-intelligence relevant to members. Information will only collected

from reliable sources, and it will be processed by content experts with state-of-the-

art tools to ensure data integrity and reliability. The event-based system will

leverage intelligent mapping technologies and support location-based services

accessible using smartphone applications.

Established in 2001, IFBA is a not-for-profit, non-governmental organization that

works with national and international public and animal health authorities to

enhance biosafety, biosecurity and biocontainment laboratory capacity within

the greater framework of strengthening health systems.

Promoting Biosecurity Education: Resource and Programme

Cathy Bollaert, Bradford Disarmament Research Centre & Larbi Baassi, National

Institute of Hygiene,

Ministry of Health

This is a joint presentation which reviews a series of activities to promote global

biosecurity education which the University of Bradford has been involved in. Firstly,

the presentation summarises key findings from the international surveys on

biosecurity education. Secondly, the scope and content of the freely available

online Education Module Resource (EMR) is illustrated. The EMR was jointly

developed by the University of Bradford in UK, the National Defense Medical

College in Japan and the Landau Network Centro Volta in Italy. It has been

integrated into biosecurity education programmes at certain European and

Japanese universities. Thirdly, based on these activities, our effort has now

expanded to the development of an online Applied Dual-Use Biosecurity/Bioethics

Train-the-Trainer module/course. The module is designed to provide life scientists

with information about biosecurity and bioethics to raise awareness about the

dual-use dilemma, and seeks to facilitate cultural change in life science education

and practice. The module pursues a two-fold objective. First, it seeks to

disseminate information to trainers about biosecurity and dual-use concerns.

Second, it seeks to transfer awareness and knowledge acquired by the trainers for

subsequent dissemination throughout their life science communities.

Preliminary Activities and Considerations from the IFBA Working Group on Biosafety

Professional Accreditation

Michelle McKinney, SAIC, Alexandria, VA, USA and Shahida Qureshi, Aga Khan

University, Karachi, Pakistan

The IFBA 2011 Year of Building International Biosafety Communities has established

a Biosafety Accreditation Program working group. The group consists of a wide

range of international members representing countries with and without biosafety

associations and existing accreditation programs. While two national

accreditation programs exist for biosafety professionals administered by the

American Biological Safety Association (ABSA), there are no equivalent

international accreditation programs and participation in the ABSA credentialing

program has limitations that are difficult for some international constituents to

overcome. The CEN Workshop 53 Biosafety Professionals Competence initiative is

currently underway to define the tasks and competency requirements of the

biosafety professional. Working together with ABSA and CEN, the scope of this

project will be defined over time and while we will begin to discuss potential

options for Biosafety Professionals Accreditation Programs it is understood that

there may not be any one scheme that works for all countries and there is not an

immediate one-fits-all solution.

This working group is currently at the stage of gathering information about specific

needs for accreditation and limitations of current accreditation programs. Many

questions and concerns remain, such as: 1) What is the value of certification and is

it the same for each country; 2) Should individuals be able to demonstrate both

local and international understanding of application and implementation of

regulations and guidelines; 3) Who will determine the competencies and will they

be the same for each country; and 4) Who will assess the competencies of

participants and sustain the program.

Following our kick-off meeting in October 2010, potential short-term activities

include working with the ABSA International Credentialing Task Force to assess the

limitations of the current review process for international participants and

determine if there could be any improvements to the process. Potential long term

activities include working with national/local biosafety associations to facilitate

their implementation of a universal framework (i.e. CEN WS 53) for biosafety

professional credentialing and/or a new international accrediting body to provide

coordination for all national/local biosafety associations.

Laboratory Biorisk Management: “Bringing biosafety and biosecurity to the next

level”

Stefan Wagener, Foreign Affairs and International Trade Canada/Public Health

Agency of Canada

Laboratory Biorisk Management (BRM) is a comprehensive approach addressing

the risks (safety and security) associated with biological materials in the lab. Based

on the newly developed ―AMP‖ (Assessment, Mitigation, and Performance)

model, laboratories have to rethink on how they deal with biosafety and

biosecurity. Over the last 30+ years, the prime focus has been on mitigation.

Laboratories are told to look at risk groups and biosafety levels and only lately and

very slowly, has the concept of risk assessment re-emerged only to suffer from the

lack of clear tangible tools and methodologies. In addition, the concept of

performance (control, assurance and improvement) is largely unknown in today‘s

laboratories as it relates to biosafety and is one of the major reasons why

laboratories still fail, laboratory acquired infections still happen and the public is

increasingly loosing trust and confidence, leading to risk perception (and not real

risk assessment) driving an increasing and non-sustainable emphasis on largely

engineering controls. This presentation will outline the concepts of BRM and current

initiatives around the world (e.g., CWA 15793) to remedy this situation. Lessons

learned will be presented and tools and methodologies introduced to assist

laboratories to move into a sustainable and affordable biorisk management

system promoting and achieving safety and security.

International Regulatory Cooperation: the Global Human Pathogens Biosafety and

Biosecurity Group

Marianne Heisz, Global Human Pathogens Biosafety and Biosecurity Group

The Global Human Pathogens Biosafety and Biosecurity Group (GHPBBG) was

formed in 2007 to bring together countries from around the world who have legal

authority within their borders for the oversight of human pathogen biosafety and

biosecurity. In this forum, national regulators exchange informations on their

legislative frameworks, share best practises, lessons learned and discuss

approaches to new and emerging issues that may require regulatory and/or

policy intervention. As the World Health Organization's (WHO) "Laboratory

Biosafety Manual" is the underpinning laboratory biosafety resource on a global

scale, the WHO is also an active member of this group. With the integration of

those numerous national agencies and the WHO, the GHPBBG can provide an

international perspective to the regulatory issues specific to the biosafety and

biosecurity of human pathogens; the GHPBBG is a resource for regulated parties

and the international community for a global discussion on the issues specific to

legal oversight of human pathogens, such as regulations, standards, compliance

verification, inspection frameworks, as well as approaches for specific topics, such

as the oversight of synthetic DNA.

AALAS Animal Biosafety Training Program

Ann Turner, Kathryn Deshpande, and Nicole Duffee, The American Association for

Laboratory Animal Science

There is a growing need for training programs to prepare animal care technicians

and others with dedicated animal research responsibilities to work in animal

biocontainment. The American Association for Laboratory Animal Science

(AALAS), in cooperation with American Biological Safety Association (ABSA) and

the Centers for Disease Control and Prevention (CDC), is generating a knowledge-

based, online training program whose target audience is animal technicians and

includes basic principles of regulations, safe practices, facilities, and equipment

that are applicable to working in this field. The training program will consist of

courses fundamental to understanding biocontainment work in most institutions

and courses focused on working safely with common laboratory animal species in

biocontainment. Sixteen courses are currently in development by biosafety

professionals and veterinarians experienced with biocontainment. Program

courses and exams will be distributed via the AALAS Learning Library, an online

learning platform, which will automatically generate a certificate for participants

completing the program. The knowledge derived from the AALAS training

program will serve as a foundation to complement the skills-based, instructor-led

biosafety programs of individual institutions. The presentation will provide an

update on the progress of this program.

Outline

Core Concepts Courses: all required

1. Introduction to Animal Biocontainment

2. Risk Assessment and Management

3. Animal Biosafety Levels 2 and 3

4. Occupational Health

5. Animal Biocontainment Facilities

6. Animal Biocontainment Equipment

7. Laboratory Biosecurity

8. Biological Decontamination

9. Basics in Institutional Responsibilities

10. General Animal Biocontainment Operations

Safe Operational Activities Courses: one course (of four) required

1. Rodents

2. Nonhuman Primates

3. Other Small Mammals—Rabbits, Ferrets, Guinea Pigs, Prairie

Dogs

4. Ungulates – horses, sheep, pigs

Description

Development of the Animal Biosafety Certificate Program is under the guidance of

AALAS‘ Biosafety Specialization Implementation Subcommittee. The BSIS

subcommittee is composed of AALAS members and consultants with expertise in

animal biocontainment and biosafety. The subcommittee includes facility

managers, facility directors, biosafety specialists, and veterinarians from

academia, industry, and government.

The training program is aimed at the experienced laboratory animal technician

and others new to animal biocontainment. The program‘s courses offer a practical

guide to the concepts, practices, and regulations relevant to safely working at

Animal Biosafety Levels (ABSLs) 2 and 3, including enhanced ABSLs. The program is

intended to complement skills and other site-specific training which should be

provided by each institution.

The program courses will be distributed as online training via the AALAS Learning

Library, which is the AALAS learning management system. Each course will have

self-assessment tests and a final exam. To successfully complete the program,

individuals must complete all Core Concept courses and one Safe Operational

Activities course for a species group. The program will require approximately 15-20

hr for completion, which and will culminate in a certificate of training. The program

will be launched in Q4 2011.

Enabling high biosafety containment designers and operators in low-resource

countries

Felix K Gmuender, Basler & Hofmann Singapore and Sunee Korbsrisate, Dept of

Immunology, Siriraj Hospital, Bangkok

BSL-3 high containment biosafety facilities require special safety engineering

features, appropriate operational risk control elements, and skilled personnel. In

low-resource countries, there often is a lack of qualified and experienced

engineers, contractors, and personnel. As a result, many BSL-3 facilities suffer from

insufficient design and/or inappropriate operational biorisk control. This paper

presents a case study on how local engineering and biorisk programme

competences were developed in a sustainable way, and how the people

involved got enabled. In 2008, the Siriraj Hospital of Mahidol University, Bangkok,

had plans to retrofit an obsolete biocontainment laboratory. The objective was

that the retrofited BSL-3 conforms with current good biosafety engineering and

biorisk programme requirements. The BSL-3 should serve as a research laboratory

for work with Burkholderia pseudomallei. The approach to reach the objective was

based on a partnership between Shiraj Hospital as the owner and future operator,

a local contractor, and a biorisk consulting firm. The project started with a

workshop on BSL-3 design, engineering, and biorisk management. The necessary

architectural modifications to the lab were small. The ACMV system needed a

complete redesign. The consultants supplied the contractor with the engineering

and system requirements, and ensured the proper adoption by repeatedly

checking and discussing the progress. The retrofitted BSL-3 conforms with current

engineering and systems requirements during normal and failure operation. In

terms of the scientific protocols for culturing Burkholderia, Siriraj Hospital received

support from London School of Hygiene & Tropical Medicine, and Universities of

Exeter and Singapore. To implement the biorisk programme, the consultant shared

the required contents, and some templates and training requirements with the

future operators and users. The whole programme was developed by the staff

themselves. A final inspection of compliance revealed that the BSL-3 laboratory is

compliant, and staff competent.

National & Regional Biosafety Associations- What Role can Associations Play?

TM Chua, Asia-Pacific Biosafety Association

In the recent years, we have seen a number of national and regional biosafety

associations being formed around the world. This indeed, is a reflection of an

increasing need of the stake holders in biosafety and biosecurity from various

agencies and organizations to find a common professional platform to address the

challenges of biorisk management in the handling infectious materials and to

promote best practices in the field of biosafety and biosecurity.

Biosafety is a multi-disciplinary science that requires a multi-disciplinary approach

and Biosafety associations are not-for-profit professional associations that provides

that platform for professionals of different disciplines to interact in activities that

promotes knowledge and the sharing of valuable experiences in biorisk

management.

This presentation will highlight some of the challenges of national and regional

biosafety associations in promoting biosafety and biosecurity and the increasing

role it can play as a professional organization in supporting biosafety programme

through collaboration in education, technical support and laboratory networking

with stakeholders and international agencies that share similar goals.

Role of Egyptian Biosafety Association (EGBSA) in Promoting Biosafety and

Biosecurity

Aly,M.M.; Hassan,M.K.; Zaki,E.R.;Soliman,M.A.; Kholosy,S

Animal Health Research Institute, National Lab for veterinary quality control on

poultry production, Agriculture Research Center, Ministry of Agriculture, Egypt

The Egyptian Biosafety Association (EGBSA) was established in 2009 to implement

biosafety and biosecurity, and create platform for sharing experiences of best

practices in life science laboratories. EGBSA has more than 100 active members

from ministries of Agriculture, Health, Environment, Higher Education, and other

stakeholders.

EGBSA is focusing on providing Biosafety and Biosecurity education and

counselling for researchers and lab personnel in both government and private

sectors. It is expected that through providing training and technical support, it will

be possible to have a direct and positive effect on the personnel and environment

safety, food security and public health issues. EGBSA offers training and risk analysis

of microbiological and chemical hazards.

Recently, EGBSA organized international workshop ‗‗Strengthening Biosafety

and Biosecurity in Biological Laboratories through National Associations‖ that

invited decision makers and addressed the importance of biosafety

associations worldwide and to develop biosafety community that will work

toward safe and secure environment in life science laboratories.

EGBSA will establish ad-hoc groups that include professionals in the field of

biosafety and biosecurity which will influence and support emerging legislation

and standards in the areas of biological safety, biosecurity, biotechnology,

transport of biological agents and extension and awareness activities.

EGBSA is facing enormous and divergent challenges including: absence of official

governmental committee or organization for establishing, implementation and

auditing of biorisk management, absence of public awareness about basic rules

of biorisk and limitation of funding resources.

Concerning the international cooperation with other organisations, EGBSA is

actively participating in international workshops and conferences concerning

biorisk management to gain experience exchanges and technical support from

different international associations.

Georgian Biosafety Association: Efforts Towards Partnership in the Region

Lela Bakanidze, Georgian Biosafety Association (GeBSA)

Georgian Biosafety Association (GeBSA) is the union of specialists dealing with

pathogenic biological agents. For about two decades after collapse of Soviet

Union health care system of Georgia had undergone a series of reforms, and very

often the principles of biosafety/biosecurity were neglected. GeBSA, established

two years ago, tries to unite professionals in this field. Today, when international

connections are very tight, and the threat of bioterrorism is more realistic, for

maintaining safe environment very important is collaboration with the countries in

the region, and great help in it can be involving national and international

biosafety associations, like Azerbaijan Biosafety Association and Biosafety

Association of Central Asia and Caucasus (BACAC).

The American Biological Safety Association (ABSA): Committed to Promoting

Biosafety Worldwide

Ben Fontes, American Biological Safety Association

The American Biological Safety Association (ABSA) was founded in 1984 to

promote Biosafety as a scientific discipline and serve the growing needs of

biosafety professionals throughout the world. ABSA is interested in promoting a

shared vision for working with our international partners to strengthen biosafety

across the world. ABSA‘s Goals are to provide a professional association that

represents the interests and needs of practitioners of biological safety

internationally and to provide a forum for the continued and timely exchange of

biosafety information. ABSA strives to remain the world‘s premier resource for

biosafety. ABSA currently has 1600 members worldwide, with 289 international

members from 37 countries in addition to the United States. In addition to ABSA‘s

1600 members, ABSA‘s international affiliates include: ABSA Canada; AfBSA, the

African Biological Safety Association; A-PBA, the Asia-Pacific Biosafety

Association, ANBio, the Brazilian Biological Safety Association, JBSA, the Japanese

Biosafety Association; ISBA, the Israeli biosafety Association, and TBSA, the

Taiwanese Biological Safety Association. Within the United States, ABSA affiliates

foster biosafety and biosecurity efforts in their region – BioNet, BSAF and the UC

BSO Working Group in California; CABSA, North and South Carolinas; MABioN, in

the Midwest; MABSA, in the mid-Atlantic, ChABSA, in the Chesapeake Bay area,

NBSA, in the Northeast; NEBSA, in New England, SBA, Southern Biosafety

Association and SEBSA, the Southeastern Biosafety Association.

The presentation will review ABSA‘s growth and lessons learned from over 26 years

as an incorporated organization. We will also review the recent parallel growth in

biosafety activities, biosafety associations, and biosafety collaboration. ABSA

realizes the importance of biosafety associations worldwide for sustainable

professional development and creating ongoing networks for advancement. The

presentation will also outline how established biosafety associations can work with

new biosafety associations by sharing its history, process, structure, and lessons

learned. The presentation will also discuss utilizing established models for

mobilization of volunteer members and for successfully sustaining and growing an

organization. Examples where ABSA has collaborated with new international

Biosafety associations will be provided and reviewed as a mechanism to generate

discussion for future opportunities.

Action at the Regional Level - Forming Partnerships

Terence Taylor and Mohammed Hassar

To be successful any approach to enhancing biosafety and biosecurity should

embrace the full spectrum of biological risks (Figure 1). These range from naturally

occurring infectious disease outbreaks, to unintended events (e.g. laboratory

accidents) to intentional or deliberate acts using biological organisms and

associated technologies as weapons. Extraordinary advances being made in

biotechnology bring enormous benefits to society but potential for accidents,

sabotage or misuse requires a balanced understanding of the risks.

SPECTRUM OF BIOLOGICAL RISKS

Natural Unintended Intentional

Figure 1: Spectrum of Biological Risk

(From EMBO Reports, Science and Security Series 2006 (Terence Taylor))

With local leadership regional collaborations through networking can exploit the

advances in the life sciences relevant to mitigating the risks to human, animal and

plant health in their communities. The aim should be to ensure that the advances

deliver maximum societal benefits at an acceptable cost.

The Biosafety and Biosecurity International Conference (BBIC) process for the

Middle East and North Africa aims to enable the countries of region to identify the

biological risks to which they are exposed and mitigate them through the

development of national and regional biosafety and biosecurity strategies

underpinned by legislative, human and physical infrastructure. Beginning in 2007

through a two regional conference (in Abu Dhabi (2007) and Casablanca (2009)),

involving representatives from 22 countries in the region, a Framework Document

has been developed for Regional and National Biosafety and Biosecurity

Strategies. A modest infrastructure has developed comprising a Steering

Committee and working groups on physical infrastructure building, human

capacity development, regulatory and policy issues. Within this framework

national biosafety associations are being nurtured and steps towards a regional

federation are under consideration. Similarly, through cross-border collaborations,

a plan for regional training centres is under development.

Keys to success in regional partnerships are local management of the process and

navigating the very challenging and sensitive political barriers in the MENA region

to achieve substantive collaborations.

Naturally Re-emerging Unintended Laboratory Ignorance Policy Negligence Crime & Attack Bioweapons Occurring Infectious Consequences Accidents (Lack of Choices (Not follow Counterfeit Sabotage Resulting (Terrorism &

Pandemics Diseases of Research Awareness) Procedures) Drugs in Release State BW)

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Biosafety Biosecurity BiocontainmentBiorisk Management Solutions

Serving the Global Market

For more information on how we may assist you, contact Barbara Johnson, PhD, RBP at:

Some Current & Past Clients

International Vaccine Institute, KoreaPrivate and Government facilities in SingaporeMahidol-Oxford Tropical Medicine Research Unit, ThailandInternational Centre for Diarrheal Disease Research, BangladeshChinese University of Hong KongOxford University Clinical Research Unit, Viet NamForeign institutes in: Korea, Thailand, Japan, Hong Kong, Taiwan, Singapore, Indonesia, Philippines, Bangladesh, Viet Nam, Canada, Bahamas, Germany, Sweden, Turkey, Uzbekistan, Kazakhstan, Ukraine, and RussiaForeign Ministries (Canada, Japan and Singapore)International Science and Technology Center, Russia

US Centers for Disease Control US National Institutes of HealthHoward Hughes Medical Institute US Occupational Safety and Health Administration US National LaboratoriesUS National Biosafety and Biosecurity Training Program US Public Health LaboratoriesUniversities in the US and overseas (veterinary and basic research)US Departments of: Health and Human Services, Energy, Justice, Homeland Security, State, Agriculture, and DefensePrivate industry, biotech and corporations

Ph 703-444-5028 [email protected]

Our Experience

Biosafety Biosecurity International is licensed,insured and headquartered in Virginia with professionals located across North America and the Asia-Pacific Region. The company provides a full range biosafety, biosecurity and biocontain-ment consulting and training services in the USand overseas. Our architects, engineers, indus-trial hygienists, biosafety professionals, and specialty equipment manufacturers have on average 20 years of biocontainment expertise

to support all of our customers needs.

Our Services

Biosafety and Biosecurity Program Development and Implementation

Biorisk Analysis and ManagementFacility Design ReviewLaboratory Verification, Certification and

AuditTraining and Education Development and

FacilitationProgram for Providing Biosafety ProfessionalsPreparation for Select Agent InspectionsTechnical GuidanceRisk Assessment ConsultationPreparation with International Compliance

RequirementsDevelopment of Manuals and SOPs

Biosafety Biosecurity BiocontainmentBiorisk Management Solutions

Serving the Global Market

Approved Facility Certifier by the Singapore Ministry of Health

CANADA’S GLOBAL PARTNERSHIP PROGRAM

Disease is the world's oldest weapon of mass destruction. Throughout history, disease has proven itself to be ruthlessly efficient, persistent and adaptive, and has been responsible for unparalleled suffering and death. The effectiveness of disease as a killing machine attracted the attention of a number of military programs in the twentieth century; dozens of diseases were weaponised and sophisticated biological weapons programs were developed.

Biological weapons pose unique risks owing to the widespread availability of dangerous pathogens (e.g. anthrax, plague, Ebola), the inability to destroy all weapons-usable material (as it is required for disease diagnosis) and the highly infectious and/or contagious nature of certain biological agents (which raises the prospect of one incident causing a major disease outbreak or global pandemic). In addition, only a minute quantity of agent is required to develop a massive BW capability (owing to the self-replicating nature of living disease organisms). Technology does not yet exist to remotely detect biological agents associated with WMD that could be stolen from a biological facility.

The Government of Canada, through its Global Partnership Program (GPP), has developed a comprehensive strategy to confront the full spectrum of the bioterrorist threat. This strategy enhances the global community’s ability to mitigate the risk and prevent bioterrorist attacks from occurring, while also allowing it to prepare for, respond to, and recover from biological incidents. By pursuing a broad range of cooperative initiatives designed to Strengthen Global Biological Security and thereby prevent terrorists from acquiring biological materials, GPP represents an important pillar of Canada's international bioterrorism mitigation and prevention effort:

Secure and account for materials that represent biological proliferation threats; Develop and maintain appropriate and effective measures to prevent, prepare for and

respond to the deliberate misuse of biological agents; Strengthen national and global networks to rapidly identify, confirm and respond

to deliberate biological attacks; Reinforce and strengthen biological non-proliferation principles, practices and

instruments, such as the Biological and Toxin Weapons Convention (BTWC); Reduce proliferation risks through the advancement and promotion of safe and

responsible conduct in biological sciences.

Canada’s GPP and its strategy for Strengthening Global Biological Security is making a tangible contribution to Canada’s efforts to combat terrorism and to enhance international security.

The Biosecurity Engagement Program (BEP) efforts leverage technical resources and experts from numerous U.S. agencies, universities, international organizations, NGOs, and the National Academies of Sciences to meet its core objectives. In addition to interagency and organizational collaborations, CTR programs work closely with U.S. Embassies, host country governments and international donor nations to identify needs and implement assistance to ensure safe, secure and sustainable bioscience capacity while reducing global biological threats. Over the past four years, BEP has expanded its scope of work, countries of engagement, and funding commitment. In every country in which BEP is engaged, the long-term goal of our programmatic activities is to work with governments and other stakeholders to build sustainable capacity for biosecurity, biosafety, disease surveillance, and scientific inquiry. To assess our success, we are working with collaborators to develop metrics that will enable assessment of not only the nature and extent of our engagement, but also the sustainability of the programs and capacities that we are introducing.

Three Pillars of Biosecurity Engagement Built on a Foundation of Sustainable Capacity

Biosafety/Biosecurity: Increase biosafety and biosecurity through technical consultations, risk assessments, and training courses and build the human capacity and internal expertise to create a sustainable culture of laboratory biorisk management

Disease Detection and Control: Strengthen the capacity for public and veterinary health systems to detect, report, and control infectious disease outbreaks

Scientist Engagement: Enhance global health security and foster safe, secure and sustainable bioscience capacity through joint scientific collaborations designed to help prevent, detect, and respond to biological threats

Sustainable Capacity: Focus on long-term sustainability and capacity building that creates an infrastructure for biorisk management and disease detection and control at all levels within a country and region

Three Pillars of Biosecurity

Engagement

Biosafety/

Biosecurity

Disease Detection &

Control

Scientist Engagement

Sustainable Capacity