CQ5254 Pharmaceutical and Medical Device Labelling Summit

Optimise Your Labelling Strategies to Ensure Accurate Product Information and Successful Regulatory Compliance

27th – 29th October 2015Maritim proArte Hotel Berlin, Germany

Stream 1: Pharmaceutical Labelling and Company Core Data Sheets

Crucial regulatory feedback ensuring effective product information and practical case studies on successfully writing and managing company core data sheets

Stream 2: Labelling Compliance and UDI Implementation for Medical Devices and IVDs

Industry case studies and essential regulatory updates for the future of medical device and IVD labelling and practical implementation of the UDI system

Patricia Lefebvre Sanofi

Sponsors:

Exhibitors:

The Pharmaceutical and Medical Device Labelling Summit

Klaus Menges BfarM

Jackie Rae ElkinMedtronic

Doris I. Stenver PRAC

www.pmdlsummit.com

Steve GrahamDepartment of Health, UK

Igor KnezevicBayer Pharma AG,

Beth A. LageBaxter Healthcare

Guido ClaesJanssen

Géraldine Lissalde-BonnetGS1 Global Office

Peter BoegeNovo Nordisk

Laura LocatiAbbott Vascular

Pharmaceutical Labelling Medical Device and IVD Labelling08.00 Conference Registration

08.50 Opening Remarks from the Chairperson

09.00 Pharmaceutical Labelling: Considering the Patient Regulatory and Legal Considerations of Labelling

Dual Discussion: The Life of a Diabetes Patient: Improving the Readability of Pharmaceutical Drug Labels

Carien Van der Karel van der Waarde Graphic Design Researcher GLO, The Netherlands

Have Diabetes Patient The Netherlands

Dealing with the Medical Device DirectiveJoachim Wilke Director Regulatory Affairs & Policy Europe Medtronic, Germany

09.40 Translating Pharmacovigilance Requirements into Effective Patient Information - Assessing the Relationship Between PV and Labelling

Theo Raynor, Professor of Pharmacy Practice, School of Healthcare University of Leeds, UK

Industry Case Study – How to Control and Comply with Country Specific Labelling Requirements.

Bianca Maria Gravenhorst Greve Senior Regulatory Affairs Manager Coloplast, Denmark

10.20 Effective Labelling for Medical Communication, Patient Safety and Patient Adherence to the Treatment

Ruxandra Rogosca Drug Safety Unit Manager Berlin-Chemie A.Menarini, Romania

Industry Feedback from Stryker on Destination Labelling

Gil Lee Program Manager of Global Labeling Team Stryker Corporation, USA

11.00 Morning Coffee & Exhibition Viewing

11.30 Ensuring Accuracy in Labelling and Preventing Errors Willie Schnaubelt Managing Director Schlafender Hase GmbH, Germany

Panel Discussion: The Likelihood of Global Labelling HarmonisationThis morning’s speakers will make up the

PA NEL

facilitators of this session

12.10 Risk Management E-Labelling

Panel Discussion: Best Approaches and Strategies to Make Pharmaceutical Labelling More Patient FriendlyThis morning’s speakers will make up the

IN

TERA CTIVE

facilitators of this session

E-Labelling at a Global levelMaurizio Suppo Principal Consultant Qarad, Italy

12.50 Lunch & Exhibition Viewing

14.15 Closing the Gap Between Signal Detection and Implementation in the Label

Boris Jankowski Head of Solution Architecture Services Sciformix, USA

Spotlight Session

SPO TLIG HT

If you are interested in presenting on this topic please contact Linda Cole: Email [email protected], Tel: +44 (0)20 7017 6631

14.55 Hear from the Regulators The Experience Exchange

An Interview with BfArMKlaus Menges, Director, Federal Institute of Drugs and Medical Devices (BfArM), Germany

Labelling Experience Exchange:This interactive break-out session will allow attendees to discuss particular challenges encountered with the implementation of labelling strategies in an informal environment. Attendees will gather in different groups specific to their manufacturing products to guarantee an industry-specific and accurate learning experience through sharing of perspectives and challenges.

15.35 Afternoon Tea & Exhibition Viewing

16.05 Spotlight Session If you are interested in presenting on this topic please contact Linda Cole: Email [email protected], Tel: +44 (0)20 7017 6631

Implementing Radio Frequency Identification (RFID)

Industry Case Study - RFID and Labelling in Medical Devices. A Timid Foray into a New Regulated Industry

Erik Paul Manager Regulatory Affairs Olympus Winter & Ibe GmbH, Germany

16.45 Update From The Pharmacovigilance Risk Assessment Committee (PRAC)

Doris I. Stenver MPA Chief Medical Office Pharmacovigilance Risk Assessment Committee Delegate, Denmark

Risk Management

Labelling and Safety Risk Management According to ISO14971

Peter Boege, Design Controls and Risk Management Expert, NovoNordisk, Denmark

1725 Utilising the QR Code Dominique Westphal Scientific Expert, EU-Co-operation Paul-Ehrlich-Institute, Germany

17.25 Closing Remarks from the Chairperson

17.30 End of Day 1

18.05 Closing Remarks from the Chairperson & End of Day 1

Day Tuesday 27th October 2015 1

INTERA CTIVE

S

PO TLIG HT

Pharmaceutical Labelling Medical Device and IVD Labelling08.50 Opening Remarks from the Chairperson

09.00 E-labelling, Software and Databases The New NHS eProcurement Strategy and its Effect on Labelling

The Benefits Electronic Labelling Can Bring to Industry

Igor Knezevic Global Labeling Manager Bayer Pharma AG, Germany

The NHS eProcurement Strategy : Why All Goods and Services Supplied to the NHS Must Be Compliant with GS1 and PEPPOL Standards

Steve GrahameProcurement Lead, Commercial DirectorateDepartment of Health, UK

09.40 The Challenges and Opportunities in Transition from XEVMPD to ISO IDMP

Guido Claes Pharma R&D Drug Development Information Governance Janssen, Belgium

Content Management Systems (CMS)

How to Maximise Content Management Systems (CMS)Sebastian Gottel Executive Vice President SCHEMA Consulting GmbH, Germany

10.20 Linking Risk Management and LabellingPatricia Lefebvre Global Labeling - Global regulatory affairs Sanofi, France

Industry Feedback on Implementing Content Management Systems (CMS)

Katrin Thelen Technical Writer Bess, Germany


11.30 Quick-fire Technology Showcase: Demonstration of the Current Software on the Market to Assist Data ManagementIf you are interested in presenting on this topic please contact Linda Cole: Email [email protected], Tel: +44 (0)20 7017 6631

Taking a Closer Look at the Label

Dual Discussion: Industry and Patient Perspective : Improving the Readability of Medical Device Labels

Carien Van der Have Diabetes Patient, The Netherlands IN

TERA CTIVE

Jennifer Perkins Technical Communications Manager Thoratec, USA

12.10 Understanding and Dealing with Current Standards

Identifying and Marking Pharmaceutical Products Using GS1 Standards

Géraldine Lissalde-Bonnet Public Policy Senior Manager GS1 Global Office, Belgium


14.15 Analysing the Importance of Tamper Proof Closures Stephen Wilkins Chief Executive Child-Safe Packaging Group, United Kingdom

Clarifying the Requirements for Symbols Used in Medical Device Labelling

Samantha Marshall Regulatory Affairs Manager EMEA Ansell Healthcare, UK

14.55 How to Manage Multiple Requests for Variation?Dorka Mihajlova Regulatory Specialists Alkaloid AD Skopje, Macedonia

Spotlight Session If you are interested in presenting on this topic

SPO TLIG HT

please contact Linda Cole: Email [email protected], Tel: +44 (0)20 7017 6631

15.35 Afternoon Tea & Speed Networking

16.05 Implementing Serialisation Guidance on Promotional Labelling

Serialisation: How? Why and When? Maarten Van Baelen Market Access Director, European Generic and Biosimilar Medicines Association (EGA)

Industry Feedback: Correctly Complying with Claims in Promotional Material

Elena Varini Intl Orthopedics Regulatory Manager Orthofix Srl, Italy

16.45 Interactive “Simulating the Campfire” SessionCome together in an informal environment to discuss the best approaches and strategies to prepare for serialisation

What are the Repercussions of Not Correctly Complying with Claims in Promotional Material

Shuna Mason Partner CMS Cameron McKenna LLP, UK


17.30 End of Day 2

To register or for the latest information, please visit: www.pmdlsummit.com Tel: +44 (0)20 7017 7481 Email: [email protected]

Day Wednesday 28th October 20152

IN

TERA CTIVE

Company Core Data Sheets UDI Implementation08.50 Opening Remarks from the Chairperson

09.00 Implementing Company Core Data Sheets (CCDS) UDI in the US

How to Compile a Company Core Data Sheet (CCDS)Barbara Lachmann Labeling Consulting, Germany

Panel Discussion: Reflecting on the UDI Class 3 and 2 Deadlines in the US

Gil Lee

PAN EL

Program Manager of Global Labeling Team Stryker Corporation, USA

Jackie Rae Elkin Rob Bergman, Global Process . W. L. Gore & Associates, Inc. Standard Product Packaging & Labeling, USA Medtronic, USA

Sharing Experience on Core Company Data Sheet and Core Company Safety Information

Michel Mikhail Expert in Global Regulatory Affairs, Member of the US Pharmacopiea Committee of Experts, Member of the Federal Governmental Institue of Risk Assessment, Germany

Industry Case Studies

09.40 Industry Case Study: Best Practice and Strategies for Implementing UDI

Jenny Gough Process Development Manager/GS1 & UDI Specialist Operations-Value Chain Development and Efficiency Molnlycke Health Care, UK

10.20 How to Organise and Implement Company Core Data Sheets (CCDS)

Aaron Barzey Senior Executive - Global Regulatory Affairs Reckitt Benckiser, UK

Implementing the UDI System Using GS1 StandardsGéraldine Lissalde-Bonnet Public Policy Senior Manager GS1 Global Office, Belgium


11.30 Industry Experience of Company Core Data Sheets (CCDS)

Anna Paul Manager Global Regulatory Affairs Grunenthal, Germany

UDI Industry-Specific Experience Exchange: IN

TE R A C TIVE

This interactive break-out session will allow attendees to discuss particular challenges encountered with the implementation of UDI strategies in an informal environment. Attendees will gather in different groups specific to their manufacturing products to guarantee an industry-specific and accurate learning experience through sharing of perspectives and challenges.

12.10 Pharmacovigilence UDI Globally

The Role of the Company Core Data Sheet (CCDS) as a Pharmacovigilence Document

Cathrine Lang Safety Surveillance Specialist NovoNordisk, Denmark

UDI Implementation and Global CompatibilityJackie Rae Elkin Global Process Owner - Standard Product Identification Medtronic, USA


Webinar: Updating and Tracking the Company Core Data Sheet (CCDS) WEBINAR

Beth A. Lage Associate Director, Global Regulatory Affairs,Regulatory Operations and Compliance – Labeling Baxter Healthcare Corporation, Inc., USA

UDI from Theory to Labelled ProductVirginie Siloret Head of Quality, E.M.S. Electro Medical Systems S.A., Switzerland

14.15

14.55 Brainstorm Session: Discovering the Best Approach Strategy to Company Core Data Sheets (CCDS)Facilitator:

Amer Alghabban Quality Assurance Adviser, Polyphor AG, Former Global Head, Director QA Merck Serono, Switzerland

Case Study: Implementing UDI in a Small-Medium Sized Global Company

Kaja Tengbjerg Senior Regulatory Affairs Professional Ambu, Denmark

15.35 Afternoon Tea & Exhibition Viewing

Company Core Data Sheets (CCDS) Globally Post Market Surveillance

16.05 Webinar: Dealing with Company Core Data Sheet (CCDS) When Working in Different Countries

Leander Fontaine Managing Director Pharmiceutics Labeling Services LLC, USA

UDI Implementation and Post Market Surveillance Laura Locati Regulatory Compliance and Quality System Director EMEA Abbott Vascular, Italy

16.45 Applying the CCDS to the Japanese Package InsertStewart Geary Chief Medical Officer & Senior Vice President Eisai Co., Ltd., Japan

Industry Feedback on the Pilot of the Revised Manufacturer Incident Reporting Form

Marta Carnielli Manager, Safety Risk Management & Surveillance Ortho Clinical Diagnostics, France


17.30 End of Day 3

Day Thursday 29th October 20153


WE BIN AR



UDI Regulatory Experiences World Café

Register 18.15 • Start 18.30 • Finish 20.30 • An evening networking dinner will be provided

This interactive break-out session will allow attendees to discuss particular challenges encountered with the implementation of UDI in an informal environment. Hear delegates share their anticipations and current state of play in their respective regions. Benchmark best approaches and strategies to prepare for UDI implementation and get your questions answered before joining another café table. World café tables will include:

Exploring Labelling Strategies Globally

Register 18.15 • Start 18.30 • Finish 20.30 • An evening networking dinner will be provided

This workshop provides a comprehensive understanding of labelling strategies and labelling regulation developments outside of the EU. Gain the opportunity to analyse and asses the similarities and difference between EU and the rest of the world. Optimise your success in entering these markets and hear success stories that could benefit your organisation.

Understanding The Falsified Medicines DirectiveRegister 18.15 • Start 18.30 • Finish 20.30 • An evening networking dinner will be provided

The Falsified Medicines Directive aims to target the increasing and ongoing threat to public health and safety of the circulation of falsified medicines. The directive affects all levels of the supply chain and inflicts manufacturers with numerous obligations. This workshop aims to clarify and strengthen your understanding of The Falsified Medicines Directive to ensure correct compliance, reduce the risk of decreased sales as well as address the below points:

• How far along are we in the project and what lies ahead?• How will the directive affect your workplace • Strategies for implementation• How will this affect countries outside the EU?• Exploring rulings coming in or already in place worldwide

to stop the trade in falsified medicines

Workshop leader: Amer Alghabban, Quality Assurance Adviser, Polyphor AG, Former Global Head, Director QA Merck Serono, Switzerland

Points to consider: • Do you completely understand the proposed regulations?• Are all stakeholders fully committed and aligned? • Are you prepared for the vast amounts of collection and

aggregation of regulatory data?• Do you understand the impact of UDI implementation on

your company’s operations?

Table 1: UK

Andrew Rutter, Regulatory Affairs Associate, Ortho Clinical Diagnostics, UK

Table 2: North America Jackie Rae Elkin, Global Process Owner - Standard Product Identification, Medtronic, USA

Table 3: Rest of EuropeGéraldine Lissalde-Bonnet, Public Policy Senior Manager, GS1 Global Office, Belgium

Each region specific session will address the following:

• The regulations in place for medical device labelling • Recent developments in regulation on medical devices• Case studies including best strategies and approaches to

dealing with multiple labelling requests• Key challenges and how these are overcome• Future developments for these regions

Session 1: US, CanadaRob Bergman, W. L. Gore & Associates, Inc. Packaging & Labeling, USA

Session 2: ChinaMaike Eva Kaae, Regulatory Affairs Specialist, Radiometer, Denmark

Session 3: India & ASEAN countriesMohan Umale, Assoc. Manager Regulatory Affairs, Stryker Global Technology Center, India

Session 4: Russia and CISAlexey Stepanov, Regulatory and Quality Assurance Manager, Sorin Group, Russia

Free with med dev

UDI day pass

Evening Seminar and Networking Dinner: Wednesday 28th October 2015

Evening Seminar and Networking Dinner: Wednesday 28th October 2015

Evening Seminar and Networking Dinner: Thursday 29th October 2015

Pharmaceutical Labelling and

Company Core Data Sheets

Labelling Compliance and

UDI Implementation for Medical Devices

and IVDs

1 event: 2 streamsThe Pharmaceutical and Medical

Device Labelling Summit



Sponsorship & Exhibition Opportunities

Sponsorship benefits include:

• Create a networking base at The Pharmaceutical and Medical Device Labelling Summit. with an exhibition stand in the main networking area, providing your team access to the whole audience; an opportunity to meet new clients and touch base with existing clients

• A speaking slot on the main programme giving your company the chance to showcase its expertise

• Logo visibility with branding packages that ensure that your company logo is seen by all of our attendees

• Networking drinks

Exclusive Opportunities:

• Lunch Sponsorship Raise your corporate profile, branding and exclusivity by hosting the delegate lunch which provides an opportunity to informally address the audience and network in a relaxed environment

Quick-fire Technology Showcase: Demonstration of the Current Software on the Market to Assist Data Management

We are looking for rising stars to showcase some of the latest labelling technologies. Each service provider will take the limelight for 15 minutes,providing a short and snappy summary of some emerging technologies in labelling as part of this interactive session.

Have you got the tech factor? If you are interested in presenting on this topic please contact Linda Cole: Email [email protected], Tel: +44 (0)20 7017 6631

• Chairing the event Demonstrate your company’s status and lead the audience

through the day’s programme whilst sharing your expertise by leading questions following individual presentations

Sponsored webinars

Take advantage of this new for 2015 opportunity to broaden and strength your target audience by showcasing your latest technologies and solutions to a global scale audience. This unique opportunity allows for a flexible arrangement for both vendors and customers.

,,

“

Sponsors and Exhibitors for 2015

Media Partners

Contact: Linda Cole Email [email protected] Telephone +44 (0)207 017 6631

27th – 29th October 2015 Maritim proArte Hotel Berlin, Germany

This was an excellent event. As a sponsor and speaker, I met many new contacts and it offered a perfect match for the companies we were looking to meet.Business Development, Schema

As a first time exhibitor at the Informa Labelling event, I was very impressed with it. We made far more new contacts than expected. This was a great platform for the future and I highly recommend it.mt-g medical translation GmbH & Co. KG



FACTS & FIGURES

Contact: Linda Cole Email [email protected] • Tel +44 (0)207 017 6631

over 100 different companies attended in 2014

and

with 60% being Manager-level & above

20 top

100 companies attended in 2014

Make sure you bring plenty of business cards as we are introducing speed networking

2015...

Did you know....

2014 STATS

CEO level 12%

Director 12%

Head 8%

Manager 34% Labelling professionals34%

47%

15%

10%

5%

6%

4%

2%2%

2%2%2%2% Regulatory

Director

Labelling

Manager Medical A�airs Project

Drug Safety Pharmacology Pharmacovigilance Product information Safety

Consultant

Past Pharmaceutical

Labelling Audience

Breakdown

44%

14%

9%

5%

6%

6%

3%

3%2%

2%2%

2%2%2%Regulatory Labelling Artwork Manager Quality Marketing Technical UDI Business Development Consultant Director Documentation Operations Packaging

Past Medical

Device Labelling Audience

Breakdown

27th – 29th October 2015 Maritim proArte Hotel Berlin, Germany

Where did the delegates come from in 2014?

40%

2%

2%

2%

2%

4%

13%

8%

6%

6%

8%6%

Our audience is interested to meet solution providers in the following areas:• Translation

• Readability testing /User testing

• Proofreading

• Structured content management

• Folded labels and labels in general

• Change control

• Software solutions

• Product information management software

Take advantage of our extensive database of labelling professionals:

+9000 Labelling contacts +700 Average unique pages

views per month in 2014

USA

Northern Europe

Southern Europe

3 Easy ways to register+44(0) 20 7017 7481

[email protected]

www.pmdlsummit.com

For group booking discounts please ring: Michael Dunnet, Tel: +44 (0) 20 7017 7870 Email: [email protected]

Conference Documentation: Cannot Attend? For those busy executives who cannot take full advantage of this event, the papers give you a useful record of the presentations made at the event. The set of speakers papers and/or slides from the conference is available after the event for £499 + 20% VAT. Contact Customer Services on tel: +44 (0) 20 7017 7481, fax: +44 (0) 20 7017 7823 or email: [email protected].

Terms and ConditionsFEE: this includes all technical sessions, refreshments, lunch and access to speakers’ presentations that we have permission to make available.CANCELLATIONS: Cancellations received in writing before and on 13th October 2015 will be subject to a service charge of £99. The full conference fees remain payable after 13th October 2015. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organiser to alter the content and timing of the programme or the identity of the speakers. In the unfortunate event that an event is cancelled Informa are not liable for any costs incurred by delegates in connection with their attendance. This contract is subject to English Law.ARE YOU REGISTERED?: You will always receive an acknowledgement of your booking. If you do not receive anything, please call us on +44(0) 20 7017 7481 to make sure we have received your booking.Due to unforeseen circumstances, the programme may change and Informa reserves the right to alter the venue and/or speakers. ©Copyright Informa BV, 2015. Yes I agree to the terms and conditions as stated on this form.

DATA PROTECTION: The personal information shown on this form, and/or provided by you, will be held on a database and may be shared with other companies in the Informa Group in the UK and internationally. If you do not wish your details to be avaialble to companies in the Informa Group please contact the Database Manager at Maple House, 149 Tottenham Court Road, London, W1T 7AD., Tel : +44 (0)20 7017 7077, Fax: +44 (0)20 7017 7828 or email: [email protected]. Occasionally your details may be obtained from, or made avaialble to, external companies who wish to communicate with you offers related to your business activities. If you do not wish to receive these offers, please tick the box INCORRECT MAILING If you are receiving multiple mailings or you would like us to change any details or remove your name from our database, please contact the Database Manager at the above addresss, Tel: +44 (0)20 7017 7077, Fax: +44 (0)20 7017 7828 or email: [email protected] - quoting the reference number printed on the mailing label.ANY SPECIAL REQUIREMENTS: Please inform us if you have any special requirements by calling Customer Services on +44(0) 20 7017 7481.

Head of Department:E-mail

Tel FaxBooking ContactE-mail

Tel FaxName of Company/Department

Address

City PostcodeCountry Tel FaxVAT Customer Number Nature of Company Business No. of employees on your site: 1) 0-49 2) 50-249 3) 250-499 4) 500-999 5) 1000+

(Mr/Mrs/Ms/Miss/Dr) Family NameE-mail

Tel Fax

ForenameJob TitleAny special requirements?

To assist us with future correspondence, please supply the following details:

DELEGATE DETAILS – Please photocopy form for multiple bookings!

Venue Details: Maritim proArte Hotel Berlin, Friedrichstrasse 15110117, Berlin, GermanyPhone +49 (0) 30 2033-5 Fax +49 (0) 30 2033-4090 Reservation phone +49 (0)30 [email protected] http://www.maritim.com/en/hotels/germany/proarte-hotel-berlin/hotel-overview

ACCOMMODATIONReduced rate accommodation: delegates are responsible for the arrangement and payment of their own travel and accommodation. Informa has negotiated a special room rate at the event venue and a number of hotels nearby, to take advantage please visit the “Accommodation” page of the conference website: www.pmdlsummit.com Please book early to avoid disappointment www.pmdlsummit.com

27 – 29 October 2015 • Maritim proArte Berlin, Germany www.pmdlsummit.com

To make payment by credit card: to ensure we provide the highest level of security for your credit card details we are unable to accept such payments via email or fax which ensures that these details are never stored on our network. To make payment by credit card on-line, please enter your credit card details in our secure payments website that you will use when making your booking via the event website (the event web address is near the top of the booking form). Alternatively call our customer service team on +44 (0) 20 7017 7481.

CQ5254

@Informa_Regs #pmdlsummit

Pass Book before 7th August 2015 SAVEBook between 7th August 2015

and 25th September 2015SAVE

Book after Friday 25th September 2015

Save

1 day pass plus seminar only for the med dev UDI day*

£1098 + VAT £200 £1198 + VAT £100 £1298 + VAT - 2 day pass £1399 + VAT £200 £1499 + VAT £100 £1599 + VAT - 3 day pass £2198 + VAT £200 £2298 + VAT £100 £2398 + VAT -

Upgrade your pass to include an Individual Evening Seminar* (can only be booked as part of a 2 or 3 day pass)

£499 + VAT

Tuesday 27th October 2015

PHARMA LABELLINGOR

MEDICAL DEVICE

Understanding The Falsified Medicines Directive Exploring Labelling Strategies Globally

Thursday 29th October 2015

MEDICAL DEVICE

UDI Regulatory Experiences World Café

* VAT at 19% - The VAT rate is subject to change and may differ from the advertised rate. * T&c’s: Workshops and Seminars are only sold in conjunction with a conference pass. Discounts cannot be accumulated. * 1 day pass T & Cs: One day pass only applies to UDI day. SMALL/START UPS: 50% off the current price tier.Only apply to 2 days pass .Does not apply to vendors or suppliers. Informa Life Sciences will verify whether you are a vendor/supplier when your registration is processed. ACADEMIC: Applies to a 2 day pass. Informa Life Sciences will verify whether you are considered an Academic.


ACADEMIC FLAT RATE

£499

( 2 day conference pass) * T&C’s Apply

SMALL BUSINESS / INDUSTRY START-UP

50% off*

current price tier

Documents

CQ5254 Pharmaceutical and Medical Device Labelling Summit