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Monday – 13 March 2017CEIV Pharma Workshop
IATA Competition Law Compliance Follow the prepared agenda.
Do not discuss:– Pricing, including fares, service charges, commissions, etc.– Bids on contracts or allocation of customers – Geographic/Product market allocations and marketing plans, including
• Expanding or withdrawing from markets• Group boycotts• Your commercial relations with agents, airlines or other third parties
– Any discussion aimed at influencing the independent business decisions of your competitors
You will be asked to leave the meeting, and the meeting may be terminated, if the above-mentioned discussions occur.
Remember: All discussions count, even informal ones outside the meeting room!
Introduction
Frederic Leger, Director, IATA
Ronald Schaefer, Assistant Director, Cargo/Ground Handling and CEIV Consulting, IATA
Background: Pharmaceutical Market DevelopmentThe global biopharma sales trend continues to go upwards through 2020
By 2020, world sales of cold-chain drugs and of biologics such as vaccines and blood plasma products will likely top $361 billion, in a global biopharma market exceeding $1.4 trillion.
The outlook for global biopharma sales is for continued expansion through 2020, at an average growth rate of about 4 - 5% per year.
Growth rate driven by the continuing transition to biologically based products, tightening requirements for life sciences shipments; growing internationalizationof pharmaceutical trade and broader adoption in underdeveloped economies.
Global Biopharma Sales Trend, 2014 - 2020($ Billions)
Source: Pharmaceutical Commerce
$218 $260 $309 $360$788 $876 $968 $1,054
$1,006$1,136
$1,277$1,415
$0$200$400$600$800
$1,000$1,200$1,400$1,600
2014 2016 2018 2020
Cold Chain (+65% growth) Non-Cold Chain (+34% growth)Total (+41% growth)
Background: Pharmaceutical Market DevelopmentSpending in biopharma logistics will continue to rise to meet the demand: An encouraging outlook
Global Biopharma Logistics Spending, 2014 - 2020($ Billions)
Source: Pharmaceutical Commerce
It is estimated cold-chain logistics spending in 2016 will be about $10.1 billion worldwide in a $58 billion overall pharma logistics market.
Clinical trial logistics, a substantial market for temperature-assured transport, is forecasted to grow at 2.5%/yr
$61.5 $66.2 $71.4 $77.1
$11.0$12.6
$14.4$16.7
$0$10$20$30$40$50$60$70$80$90
$100
2014 2016 2018 2020
Non-Cold Chain Cold Chain
Background: Pharmaceutical Market DevelopmentCold chain logistics spending fastest in Asia and in North America
Global Biopharma Logistics Spending 2014 - 2020($ Billions)
Source: Pharmaceutical Commerce
With 20% of world’s population, Europe and North America consume more than 60% of the total pharmaceutical products (in dollar terms).
If Asia and the rest of the world used pharmaceuticals at the same level as Europe and North America, the global market would be 3x as large.
Asia is expected to account for the largest regional share growth with more than $1.2 billion of cold-chain growth between 2015 -2019.
$2.42 $2.90 $3.47 $4.16$2.86 $3.06 $3.28
$3.52$3.04
$3.44$3.91
$4.43$0.65
$0.70$0.77
$0.84
$0
$2
$4
$6
$8
$10
$12
$14
2013 2015 2017 2019Asia Europe North America Rest of World
CEIV Pharma DevelopmentFrom Pilot, via launch and community to network approach
09/13 11/13 01/14 03/14 05/14 07/14 09/14 11/14 01/15
Discussion with SATS about a Pilot
SATS Pilot
Joint development of Community Concept with BRU
Launch of Community Concept at BRU
Development of CEIV Pharma Standard 1.0
CEIV Pharma Standard 1.0 CEIV Pharma Standard 1.1 + Guidelines
03/15 05/15
Official launch of CEIV Pharma program
Unreliable cargo industry loosing pharma industry: IATA sleeping
CEIV Pharma Standard 1.2 + Guidelines
12/16
Pilot of Network approach with two companies
Numbers of entities assessedIATA Independent Validators assessed 127 entities by end of 2016
Numbers of entities certifiedIATA Independent Validators certified 46 entities by end of 2016
Number of Airports / LocationsIATA will have conducted assessments at 39 airports between SEP/2014 and DEC/2016
Update of the CEIV Pharma Program
Ronald Schaefer, Assistant Director, Cargo/Ground Handling and CEIV Consulting, IATA
CEIV Pharma (Certified Entities)Certified Pharmaceutical Trade Lanes Development
CEIV Pharma (Certified Entities)IATA expects to have a minimum of +146 entities certified by the end of the year… and counting
CEIV Pharma (Community Approach)11 communities on-going and five under discussion
CEIV Pharma (Community Approach)Latest addition in 2017
Presenters / Moderators / Special Guest
Ronald SCHAEFERAssistant Director, Cargo/Ground Handling and CEIV [email protected]
Frederic LEGERDirector, APCS [email protected]
Andrea GRUBERSenior Manager, Special [email protected]
Ricardo AITKENManager, CEIV [email protected]
Introduction Special Guest (in the afternoon)
Nick CAREENSVP, [email protected]
Presenters / Moderators
Aim of the Workshop
• Provide an update of the CEIV Pharma program
• Hear what the industry expectations are
• Provide insight on topics addressed by CEIV Pharma: Risk Management
• Hear from the companies that are undergoing CEIV Pharma Certification or have been certified
• Ask companies participating in the CEIV Pharma program about their experience with the process
• Seek your input and constructive feedback on the solution IATA is implementing in the industry
Agenda
09:00 – 09:15
09:15 – 09:30
09:30 – 09:40
09:40 – 10:00
10:00 – 10:30
Welcome and introduction Pharmaceutical business - A growing segment?Ronald Schaefer, Assistant Director, Cargo/Ground Handling and CEIV Consulting, IATA
Center of Excellence for Independent Validators (CEIV) in PharmaceuticalLogisticsRonald Schaefer, Assistant Director, Cargo/Ground Handling and CEIV Consulting, IATA
Update of the CEIV Pharma ProgramRonald Schaefer, Assistant Director, Cargo/Ground Handling and CEIV Consulting, IATA
Changes to the CEIV Pharma StandardAndrea Gruber, Senior Manager, Special Cargo, IATA
CEIV Pharma Checklist Hot Topic: Introduction to Risk AssessmentAynur Rasulova-Rzepa, Independent Validator for CEIV Pharma
10:30 – 11:15 Network Coffee Break
Agenda
11:15 – 11:30
11:30 – 11:45
11:45 – 12:00
12:00 – 12:15
12:15 – 12:30
CEIV Pharma Perspective – A Perspective from the Middle EastSunil Doshi, Managing Director, Pharmsol GmbH
CEIV Pharma Perspective – A Perspective from a ground handler in Middle EastClaus Nickel, Position, dnata, Cargo Manager
CEIV Pharma Perspective – A Perspective from a ground handler in South AmericaBruno Guella, Cargo Manager, Terminales de Carga Uruguay
CEIV Pharma Perspective – Experience of the ATH CommunityAlexis Sioris, Manager of Cargo, AIA
Panel: Sunil Doshi, Managing Director, Pharmsol GmbH; Claus Nickel, Position, dnata, Cargo Manager; Bruno Guella, Cargo Manager, TCU; Alexis Sioris, Manager of Cargo, AIA
12:30 – 14:00 Networking Lunch
Agenda
14:00 – 14:45
14:45 – 15:00
15:00 – 15:15
15:15 – 15:30
Panel: CEIV Pharma Network Approach – A global multi station approachNina Heinz, DHL, Global Head of CargoReinier Dankaarts, Kühne + Nagel, Global and Western Europe Air Competence Director Pharma & Healthcare
CEIV Pharma Perspective – The Community Approach – Two years down the lineNathan de Valck, Cargo Manager, BRU Cargo
CEIV Pharma Perspective – Experience of the AMS CommunityJonas van Stekelenburg, Head of Cargo, Schiphol
Question and Answers / Final remarksRonald Schaefer, Assistant Director, Cargo/Ground Handling and CEIV Consulting, IATA
15:30 End of session
Introduction to CEIV Pharma Program
Ricardo Aitken, Manager, Cargo/Ground Handling and CEIV Pharma, IATA
Background: The impact of mode shift on pharmaceutical logisticsThe pharmaceutical industry has relied heavily on the airline industry for its speed and efficiency but air cargo’s share of global pharmaceutical products transport has dropped
Source: Pharmaceutical Commerce
HOWEVER
17
11
2000 2013
Air cargo’s share of global pharmaceutical products transport (in %)
Over the past 10 years, air carriers, handlers and freight forwarders have responded with branded products and services to grab a share of this lucrative and niche market.
Pharma air cargo growth; 2008-2018in %
6
12
2008-2013 2013-2018
Background: Critical Issues Raised by the ShippersThe use of air-mode transportation is re-considered unless industry partners ensure quality services
Due to a lack of compliance, standardization, accountability and transparency across the air transport supply chain a majority of all temperature excursions occur while the package is in the hands of airlines/airports
Temperature deviation denature the product, render it worthless and be harmful to the health of the patient Products can be lost, scrapped, returned leading to significant costs
25% Of vaccines reach their destination degraded because of incorrect shipping
30% Of scrapped pharmaceuticals can be attributed to logistics issues alone
20% Of temperature-sensitive products are damaged during transport due to a broken cold chain
Background: Critical Issues Raised by the ShippersLooses associated with temperature excursions in healthcare are around a staggering ~USD 35B
1.00
3.65
5.65
8.60
15.20
Wasted Logistic Costs Replacement CostsClinical Trial Costs Root Cause Analysis
1.3
2
2.34
Trial Production CostsDirect Labor CostsOpportunity Labor Costs
Source: World Health Organization, Parenteral Drug Association, worldpharmaceuticals.net, cargosense.com, other industrial analysis
The average costs of root cause analysis for each excursion can range from $3K to up to $10K (avg. USD 6.5K per year)
Losses associated with temperature excursionsIn USD Billion
Total: USD 34.1B
Common audit format to minimize the disruptions and increase effectiveness
Background: Critical Issues Raised by the ShippersLooses associated with temperature excursions in healthcare are around a staggering ~USD 35B
Maintain the original quality of pharma products
Use of the air-mode is re-considered unless industry partners ensure quality services
Temperature excursions happen while in the hands of supply chain
partners
Meeting the growing number of national & international
regulations
Properly trained stakeholders on regulations and standards
Adequately equipped facilities throughout the supply chain Easily search and identify
stakeholders that meet requirements
Industry’s Call for Action
(Sep. 2013)
“The air cargo industry and IATA need to act urgently to prevent further modal shift of pharmaceutical traffic to sea freight, on the basis of quality rather than price, according
to forwarders and shippers.”
“You have various standards and systems out there and it is a nightmarefor those that are inside the sandwich, the ground handler, who is forced to
enforce various systems and procedures –and it is chaos…IATA is
sleeping”
“Air freight’s share of global pharmaceutical transport has
dropped from 17% in 2000 to just 11% today…”
“We need you, IATA, to spearhead the air cargo GDP standard development. It can only be you, and we are waiting for a long time already –way
too long, and I don’t know why it is not happening. My question to IATA and the carriers behind IATA is
– are you really willing?”
CEIV PharmaTo ensure the integrity of the product throughout the supply chain
OBJECTIVES
Prevent sanitary issues caused by temperature excursions during
transportation.
Improve handling of pharmaceutical products and compliance with existing
regulations + standards.
Elevate level staff competency through efficient and robust training program.
Create a global and consistent certification that industry can rely on.
Ensure product integrity
CEIV Pharma TargetsWho does CEIV Pharma target? The supply chain
CEIV Pharma StandardCEIV Pharma standard focuses on global coverage and universality
CEIV Pharma Certification Approach and MethodologyIATA will certify companies in several steps
Changes to the CEIV Pharma Standards
Andrea Gruber, Senior Manager, Special Cargo, IATA
Upcoming Pharmaceutical Requirements
Develop a Sensitive Cargo Strategic Roadmap
Define new Road Feeder Services to better address the distribution of
healthcare products
Investigate wider temperature ranges standards to meet shipper’s
expectations
Refine supply chain stakeholder’s processes, roles and responsibilities (e.g.
focus on GHA)
Upcoming Industry Trends & Challenges ?
Real Time Monitoring
Transforming Challenges into Success through an
Integrated, Efficient, Collaborative Supply Chain and…
…Continuous Improvement !
CEIV Pharma Checklist Hot Topic: Introduction to Risk-based Quality Management
Aynur Rasulova-Rzepa, Independent Validator, IATA
Transform Today: Shape Tomorrow
Stepping Towards Challengesby Aynur Rasulova-Rzepa
Overcoming The Challenges
CEIV Pharma at a Glance
• Quality Management System• Documentation• Training • Internal Audit Program• Supplier Management• Risk Management
CEIV Pharma at a Glance
• Implementation (operations)
• Infrastructure & Equipment
• CEIV Pharma Assessments
• Validation & Certification
• Re-validations
Stepping Towards Challenges
• CEIV Pharma Programme & Concepts within:
– Company Transformation & Improvement Opportunity– Company Culture Change– With our withOUT the certificate– Program Concepts Good On Their Own– Readymade Solution for Common Organisational Challenges
IATA Expertise
CHALLENGES• Attracting customers• Customer retention• Temperature excursions• Poor supplier performance• Low employee motivation• Claims• Poor company performance
SOLUTIONS• Various CEIV Pharma-used
concepts applied in companies selectively
• Not necessarily under the CEIV Pharma project
• Not just for pharma
Approaches that can help:
• Organizational:– Quality Management System– Quality Risk Management &
PDCA– CAPA & RCA– Documentation & Training– Supplier Management– Internal Auditing– LEAN
• Workshop Level– Temperature Mapping– Lane Validations– Infrastructure & Equipment
MASTERING ONE AT A TIMEChallenges Resolved:
Quality Management System
• Appropriate organizational structure
• Documented processes• Sufficient and competent
resources• Provisions for sustaining
confidence in quality
Quality Management System
• Approved written procedures• Roles and responsibilities• Corrective and preventive action plan (CAPA)• Documented training program• Applicable calibration program• Quality metrics• Audit program• Deviation management• Change and management controls
Benefits of Certified QMS
• Meet customer quality expectations
• Enhance customer satisfaction
• Satisfy regulatory requirements
• Continual improvement
• Help in setting quality goals and standards
• Decrease cost of non quality
Quality Management System
Designed to make the company work as one efficient organism in a continuous improvementenvironment
Quality Risk Management
• In QRM, risk is defined as the combination of the probability of occurrence and the severity of that harm
• QRM is the risk to the QUALITY within the premises of QMS
• Risk-based Approach is the Important aspect of any success!
Understand the process
Identify &
quantify the risks
Mitigate the risk
Monitor the
process
Review & re-assess
Flow charts, facts & data
Severity, frequency,
cost
Eliminate or reduce
Evaluateimpact
Implementchanges
Risk Assessment Methodology
PDCA – The Deming Cycle
Quality Assurance = Continuous Improvement
Process improvement is cyclical rather than linear
PLANDO
CHECKACT
PDCA – The Deming Cycle
Corrective And Preventive Action Plan
A strong CAPA system requires this efficient deviation handling system which evaluates the event according to the associated risk, categorizes it and acts accordingly in a timely manner, and verifies the effectiveness of the actions taken.
Under this approach, a sequence of steps may be identified when handling events and possible deviations:
• Event Detection • Decision Making Process / Deviation Categorization • Deviation Treatment • Root cause analysis (RCA) • CAPA actions
Root Cause Analysis
Identification of the factors that resulted in the nature, magnitude, location and timing of harmful outcomes or consequences of one or more past events in order to identify the behaviors, actions, inactions or conditions that need to be changed to prevent recurrence of similar, harmful outcomes
Root Cause Analysis
• Performed systematically as part of an investigation• Conclusions and root cause must be backed up by
documented evidence• May consist of more than one root cause• Prevention of recurrence should be done in the
simplest and most cost-effective way• Should establish a sequence of events to understand
the relationship of causal or contributory factors• Changes a reactive culture to a predictive one
Evaluate effective implementation of QMS and operational policies
How is the QMS lived within your organization
Determine if processes and products meet established parameters and prescribed specifications
Internal Auditing
Other Continuous Improvement & Quality Assurance Concepts
Other similar concept to QRM, PDCA, CAPA:
• LEAN Management• Etc.
CHOOSE THE ONE OR FEW, SUITABLE FOR YOUR COMPANY’S SITUATION
As part of the QMS, Quality Assurance,Training improvement efforts, etc. revision and enhancement of the company’s controlled documentation is key to success
Documentation Enhancement
Training Program
As an important part of Resource Managementunder the premises of QMS, QRM, CAPA etc., a robust Training Program that would satisfy all regulatory as well as company requirements must be in place.
Supplier Management
Outsourcing is the contracting-out of a business process to a third-party
• help firms to perform well in their core competencies and mitigate shortage of skill or expertise in the areas where they want to outsource
• although can offer greater budget flexibility, cost control, also creates risks
• Must be well-managed!
IATA is Sharing Knowledge
IATA’s vast expertise and experience is available to help air cargo industry players to enhance and strengthen in these challenging times
QUESTIONS?
Coffee Break
10:45 – 11:30
CEIV Pharma Perspective –A Perspective from the Middle East
Sunil Doshi, Managing Director, Pharmsol GmbH
Sharing CEIV Pharma Experience – The Perspective from MENA Region
Sunil DoshiManaging Director – PharmSol Group
The views and opinions expressed in this presentation are purely based on the experience of PharmSol and the same may not necessarily
represent the views of the stakeholders / regulators.
Disclaimer
PharmSol is an integrated pharma service provider focused on Compliance and Project Management. PharmSol Group is a partner
of choice, not only for Pharma manufacturers and marketers, but for every member of Pharma Value Chain
About PharmSol
PharmSol Group
Pharmaceutical Solutions FZCO, Dubai
- Corporate Headquarter
PharmSol GmbH, Bad Oldesloe, Germany- EU Imports- Storage
- Batch Release
PharmSol India Pvt Ltd, Hyderabad, India
- Technical Talent Pool
- Compliance Management & Project Management
Pharmaceutical Solutions DMCC, Dubai
- Business Development,Commercial, Financial, HR & Admin
PharmSol MPCC LLC, Dubai
- Registration, Marketing & Distribution of Pharma & Allied Products in GCC & MENA
PharmSol Europe Ltd, Malta
- EU Imports- Batch Release
PharmSol (Zhuhai) Pharmaceutical Technology Co., Ltd, China
- Pharma Capability Enhancement- Compliance & Regulatory
PharmSol APAC Limited, Hong Kong
- Generics Gateway to & from APAC
PharmSol Services
Compliance
• EU GMP Certification
• GMP Audits (QP Audits)
• GDP, GLP, GCP Audits
• Facility Feasibility Audits
• Computer System Validations
• Data Integrity Solutions
Market Access & Supply Chain
• Dossier / ANDA Submissions
• Pharmacovigilance
• MA Holding
• EU Importation, Batch Control / Release
• GCC Product / Company Registration, Marketing & Distribution
GDP
• Compliance Assessment
• Capability Enhancement
• Certification
• GDPNet Membership
• GDPvigilance®
• Support for CEIV Pharma Certification
Project Management
• Product Developments (API & FDF)
• Tech Transfers & Scale ups
• Facility Design & Upgradation
• QMS Set up
• Licensing In / Out
PharmSol & CEIV
Early 2015
•As an extension of its service portfolio, PharmSol was looking at developing a Compliance Solution tailored to the needs of Cargo Industry
H2, 2015•Started discussion with IATA
Mar 2016
•Trained and Qualified 10 of PharmSol’s Pharma Auditors as CEIV Pharma Independent Validators – adding Capacity & Speed to IATA initiative
Jun 2016•First Audits Conducted – CHANGI Singapore
Sep 2016•Signed up - IATA Strategic Partner Program
Oct 2016 • CEIV Pharma Audit conducted at DNATA Dubai
Nov 2016
•Participated in 13th China Air Cargo Summit
•Third Audit Conducted at Hong Kong Airport Community
2017•Till date conducted 6 company Audits under Hong Kong Airport Community
CEIV and Compliance Perspective – Focus MENA
Compliance Scenario
• Guidelines effective for +2 years
• Certifications –Capacity constraints
• Compliance enforcement is limited
• Compliance standards reasonably high
• High Expectations from Cargo industry
• Resistance to accept higher
• Investing in infrastructure
• Bracing up for increase in Pharma Cargo Volume
• Coming to terms with compliance
Pharma Regulators
Pharma Manufacturers
Cargo Industry
CARGO INDUSTRY STAKEHOLDERS
Guideline Framework Transition
Good Distribution Practice of medicinal products for human
use (2013/C 343/01) - 5 November 2013
Annex 5 WHO good distribution practices for pharmaceutical products
Annex 9 Model guidance for the storage and transport of
time and temperature –sensitive pharmaceutical
products
PIC/S GUIDE TO GOOD DISTRIBUTION PRACTICE FOR
MEDICINAL PRODUCTS - 1 June 2014
USP 1083 GOOD DISTRIBUTION PRACTICES—
SUPPLY CHAIN INTEGRITY
The CEIV Pharma program assimilates the key provision of all guidelines
GCC Governed by – “GCC Guidance for the Storage and Transport of Time- and Temperature – Sensitive
Pharmaceutical Products” – Harmonized with EU GDP Guideline
Key Challenges (Pharma Business)
Challenges / Opportunities
Extreme Climatic conditions
Delivering small volume yet high value and sensitive cargo
Uniform compliance across locations
Keeping pace with constantly evolving compliance needs
Regulatory environment – structured and still evolving
Proximity to Non-regulated market, which makes it vulnerable to transportationof Pharma goods under unauthorized channels - Leaves a room for counterfeitand misuse of drugs
Pharma Logistics in GCC / MENA Region
Challenges / Opportunities
The GCC Healthcare market is expected to grow from $40.3 Billion in 2015 to $71.3 Billion in 2020 at a growth of 12.1% CAGR showing an pharmergingmarket-type growth.
Overall MENA Healthcare Market is expected to reach a value of $ 144 Billionby 2020
With the proximity to Asian manufacturing bases, GCC Region becomes anatural choice for transit cargo hub
Data Source: Alpen Capital
Pharma Logistics in GCC / MENA Region
Responding to Challenges
Carriers (EK, QR, EY, G9…..)
Innovative applications (White Cover Advanced)
Capacity expansion (Pharma Express)
Adopting compliance solutions
Hubs (Airports, Logistic Players……)
Infrastructure investment
Quality System Upgrade
Compliance Certifications
Data Source: Alpen Capital
Pharma Logistics in GCC / MENA Region
Responding to Challenges
Regulators
Guidelines adopted
Enhancing industry knowledge base
Certification on the increase
Enforcement – soon to start
However, a large section of stakeholders are still
strategizing on responding to challenges.
Data Source: Alpen Capital
Pharma Logistics in GCC / MENA Region
V/S
The Common Question
GDP
GDP - A SIMPLIFIED VIEW (Without Prejudice)
A compliance mechanism instituted by Drug Regulatory Bodies in consultation withPharma Industry
EU GDP Guideline – issued in September 2013 – one of the most recent reference
Provides a framework for the Pharma Industry to transport Pharma Cargo
Lays down broad requirements to be followed by Cargo Movers to be enforced byPharma Industry
Certification is done by National authorities which limits the reach
Does not specifically address the needs of Cargo Industry, esp Air Cargo
Does not delve into the challenges of Air Cargo industry (Geography, Multiplicity ofagencies, Security Systems, Human Resource, Skill sets etc.
Harmonizing the binding requirements of the national and international GDPregulations that are already in place into a globally valid program using air-freight-focused, on-site training and an integrated yet independent, auditcapability.
Aims to make air freight a more attractive choice of transportation for pharmacompanies
Provides an opportunity for certification of multiple locations acrossgeographies
In the experience of PharmSol, can be made adaptable to Sea Cargo Industry
CEIV Pharma
CEIV Pharma – A Simplified View (without prejudice)
CEIV Pharma: Comprehensive, Customized, User Friendly
Compliance Solutionfor Air Cargo Industryto deliver Compliance
Required by Pharma Industry (it may not be an overstatement if we say that CEIV Pharma encompasses GDP in the context of Air Cargo Industry)
CEIV Pharma
Optimizing CEIV Pharma Benefits
Community Approach (Airports)
NetworkApproach (MNCs)
Upcoming Challenges
Preventing Counterfeit medicines
Preventing illegal sale of drugs
Prevent the sale of smuggled drugs
Preventing barcode scams
Upcoming Challenges
Pharma Industry is bracing for Serialization…Is Cargo industry keeping pace?
Each Pharmaceutical Unit Will be tracked
Hospital Pharmacy
Patient
Manufacturer Port / Airport Wholesale
Serialization
United States:
The Drug Supply Chain Security Act (DSCSA) mandates that manufacturers beginserializing all drug products at the saleable unit and case level for the U.S.market starting in Nov. 2017, with repackage deadlines beginning in 2018.
European Union:
Manufacturers serving the EU are preparing to meet serialization requirementsat the package level which are expected to start in early 2018, requirementsthat include supporting both global and national identifiers and following strictuniqueness regulations.
KSA:
SFDA Guidelines issued for phased implementation from 2017
Serialization – Regulatory Requirements
Online Pharmacies are already in existence for a few years now.
Distribution of Pharmaceuticals on an online system is soon catching up (eg;Google)
Challenge:
Coping up to the compliance for online distribution
Opportunity:
Partnering with IT Majors
Online Pharmacy / Distribution
Increase awareness
Acceptance of compliance need
Outsource Compliance Knowledge
Replace
Compliance v/s Competitionby
Competition with Compliance Certification alone are not enough, strive for continued compliance
Knowledge sharing with Pharma Industry
Appraise Pharma Industry on inherent constraints of air cargo industry
Let compliance be system driven
What needs to be done
Questions & Answers
CEIV Pharma Perspective –A Perspective from a ground handler in the Middle East
Claus Nickel, Cargo Manager, dnata
dnata Cargo IATA – CEIVaccreditation 2017
Claus NickelManager Cargo Planning and Operations Support
The pharmaceutical industry will never go into recession.
Overview
Global annual spend on Pharmaceuticals is estimated at 1.6 Trillion US dollars in 2016.
With a lot of patents expiring the industry for low cost generic versions will start to boom.
Most of the governments are seeking low cost health care for their citizens.
Growth markets
Emerging markets and emerging economies will fuel growth and represent a huge potential demand.
India, M.East & Africa, Russia & CIS and China are the emerging pharma growth markets.
Manufacturers are changing
To cut logistic costs major manufacturers are outsourcing services
More and more freight forwarders and airlines now have specialized pharma divisions
The need to stay cool
As per 2015 study results 8 out of 10 pharma products will require temperature control during the supply chain.
The dnata story
Vision
Mission
We will deliver the promises our customers make
Values
Safety and security
Performance driven
Service excellence
Delighting customers
Imagination
Respect
Our Vision, Mission & Values (VMV)
To be the world’s most admired air services provider
One Vision, One dnata
Today, we have become one of the world’s largest air services providers of Ground handling, Cargo Services, Travel and Inflight Catering.
Backed by over 55 years of proud history, we are now a performance-driven organisation, a global player in various markets, an innovator, and a customer centric business
We have over
30,000employees
We handle over
440,000 flights per year
Number of airports
103
We move over
2.3 million tonnes of cargo per year
75countries on 6 continents
Over Airlines served
250
We handle over
81 million pieces of baggage
We help over
222,000passengers each day
Serve over
320,000meals everyday
Over
200Travel outlets
Our Growth
1959, Dubai
1993, Pakistan
1998, Philippines
2004, Singapore
2007, Australia & Switzerland
2010, U.K,& Erbil
2013, Broadlex (AUS)
2015, Amsterdam, Milan, Brazil (NEW)
2014, MAN, BHX, GLA, EMA, NCL
Our Services
Cargo Handling
We operate at 28 Airports in 10 countries and have inaugurated 11 new cargo warehouse facilities. In the UK, we are the leading third party cargo handler at Heathrow “dnata City”.
Our Services Include:
Station ManagementWarehousingImport/ExportTransfer & TransitAcceptance & MonitoringDocumentation HandlingIrregularities HandlingCargo LogisticsEquipment Supply
A trusted partner for Airlines
dnata cargo and IATA
dnata Cargo and IATA - CEIV
A workshop was organised in Apr’2016 to coincide with the 36th IATA TTTF workshop in Dubai which was hosted by dnata Cargo.
Participants included airlines, MOH, Dubai Airports, shippers.
dnata Cargo and IATA - CEIV
The main aim of the workshop was to have an independent and neutral approach to deciding on the way forward for the certification.
After much deliberations, dnata Cargo decided on IATA-CEIV as their partner.
Contract for certification was signed in August’2016 and the assessment audit done in Oct’2016 for DXB
The validation visit will happen in Mar’2017
what next?
Tonnage handled
The next steps
Use of cool dolly on the ramp to provide enhanced protection.
The next steps
Various levels of service for the customers to choose from.Cool Chain – Fresh (TBA)
Cool Chain – Pharma (TBA)
Cool Chain – Premium (TBA)
Certification will enable customers (airlines, shippers and freight forwarders) to promote DXB as part of the trade lane.
The next steps
Real time temperature monitoring.
Attaching the temperature information at shipment level.
Information will be sent to customers if requested.
Thank you. Any questions?
CEIV Pharma Perspective –A Perspective from a ground handler in South America
Bruno Guella, Managing Director, MVD Free Airport – TCU S.A.
Holding company with operations in 3 continents and 10 countries
Highly diversified businesses: airports, agribusiness, services, energy, infrastructure, technology
Airport business: 53 airports under management
TCU: country’s main air cargo terminal
Strategically located logistics hub: challenging the status quo
MVD Free Airport: a value-added logistics platform that enables a multimodal smart supply chain for Lat Am region
Compliance: Excellence…not only be, but appear to be so
Pharma – a strategic business for air cargo
Pharma industry: from “nice-to-have” to mandatory requests
Legitimize new infrastructures and SOP
SCM within LAC –Key Differentiating Factor
A program that meets global standards, regulations and best practices
Industry-wide increasing recognition among pharma companies
Risk analysis rules the validation and competitiveness of Network & trade lanes
Certification includes solid training to key personnel
Visibility – IATA as a “partner”
Limited presence of competitive global players
Poor infrastructure at several locations (warehouses capabilities, roads safety) Little to no use of information systems making information inaccesible
Lack of transparency and a service-oriented culture
We are focused on turning these shortcomings into best-in-class solutions
Most countries in the region have significant import hurdles/barriers Time spent on product registration by health authorities
License approval for each shipment
Customs uncertainty Currency reserve /approval by Central Banks
Over-labeling necessary for most products due to local requirements
Complexity on domestic taxes influences logistics network design (ex: Brazil)
In addition: lack of reliable/competitive 3PL partners for Regional Distribution due to:
Supply chain: hard to control
High excursion risks
URUGUAY Focused on adding value in logistics services,
Uruguay as regional logistics hub is a state policy
Economic, political and social stability
MVD Free Airport: Only “free zone” regime inside an airport in LAC
Advantageous legal framework
Attractive tax exemption regime including free repatriation of profits
Free movement of goods
Storage without time limits
State-of-the-art infrastructure designed for pharma
Flexibility to meet specific SOPs
75% Regional GDP within a 2-hour flight
Not only air, but safe road transportation to major markets in the region (BR,AR,PY,CH)
15-25 °C: 720 positions2 -8 °C: 120 positions-18 °C: 20 positions
9600 m3
Temp-controlledvalue-added areas Docks with coating
Automated data capturing and
processing
20 strategically located CCTV
cameras
www.mvdfreeairport.com
CEIV Pharma Perspective –Experience of the ATH Community
Alexis Sioris, Manager of Cargo, AIA
Alexios Sioris
Manager Ground Handling and Cargo Development AIA
Air Cargo Forum in Abu Dhabi, 13 March 2017
Athens International Airport (AIA)
Cargo Development and CEIV Pharma
General information on AIA
Ground handling and cargo
development department
The cargo strategy & environment
The cluster mentality and
the cargo cluster
The competitive advantages
The current situation
The Greek pharma market
CEIV Pharma at AIA
Presentation outline
General info on AIA - the concept
A pioneer “Public-Private Partnership” scheme
AviAlliance GmbH*26.67%
AviAlliance Capital GmbH*13.33%
Copelouzos Family4.99%
Hellenic Republic Asset
Development Fund 30%
Greek State 25%
• Ministry of Economy & Finance
• Ministry of Infrastructure, Transportation & Networks
A 2.2 billion Euro Project
60% funded by commercial debt
Construction period of 51 months
An Airport Development Agreement (ADA)
30 years of “usufruct” BOT contract (1996-2026)
Ratified by the Greek Parliament
* Former Hochtief Airport – sold by Hochtief group to the Canadian Pubic Sector Pension Investment Board (PSP Investments)
General info on AIA - the role
Active
Infrastructure Manager
Business
Development
Airport
Marketing
IT&T
Provider
Airline Services
112 Service Providers
Concessions Outsourcing
Terminal Commercial
Real Estate
Retail (18)
F&B (5)
Services (14)
Advertising (1)
Hotel (1)
Office Building (1)
Gasoline Station (1)
Retail Park (4)
Exhibition Centre (1)
Security
(3)
Fire & First Aid
(2)
Maintenance &
Cleaning
(11)
Waste
(2)
Parking
(1)
IT&T
(2)
Total: 45 Total: 38 Total: 8 Total: 21
General info on AIA - the network
Payroll: 625 Outsourced: 1,100Concessed: 7,500 Total: 9,100
7% 12%81% 100%
Ramp & Baggage
Handling (3)
Cargo (3)
Pax Handling (5)
IF-Catering (2)
Refueling (2)
Ancillary (29)
Ground Handling
Rights
Award & MonitoringAirport
Users
State Authorities
Cargo Communit
y Committee
Centralized infrastruct
ure
Catering
Fuelling
Ramp Manageme
nt
Baggage Handling
Cargo Operations
& Developme
nt
ACI’s Europe Ground
Handling
Task Force
PRM
Assistance Services
Ground Handling & Cargo Development
The cargo strategy
Facility development by AIA
Award of multiple concession rights to the “experts”
AIA as guarantor of quality, safety & security and competitionto the benefit of the users
AIA’s Cargo Development team as orchestrator of the cargo community and developer and marketer of new cargo relevant projects
We integr
ate
We facilitat
e
The cargo environment
B25 Postal Authority
B15b - DHL
B15a – available
B23Skyserv Handling
B24Goldair Handling
B27 Customs & Forwarders
B26aVets
3 Cargo Terminals (B23/B24/B15a) – 1 Distribution Center (B15b): an operational area of 30,000m2 with 275,000 t. annual capacity
Additional cargo related infrastructure (B25/B26a/B27) of 9,500m2
Complex
multiplayer
environment
AIA in the role of the
√ communicator
√ facilitator and
√ integrator
Cluster development to
√ streamline actions
√ achieve operational excellence
√ trigger development
The cluster mentality
The cargo cluster
Establish a living supply chain
by connecting the members of the local cargo community
through an efficient communication platform:
the Airport Cargo Community Committee (ACCC)
AIA
Hellenic
PostHandle
rs
Integrators
Airlines
Cargo Agents
Vets
Customs
Customs
Brokers
Police
Greek Atomic Energy
Committee
Civil Aviation Authority
Piraeus Port
Hellenic Institute of
Logistics Management
The cargo cluster – the benefits
“We make things fit as
we fit together”
New projects Road
Feeder Services
Sea-Air cargo
MSDS
Crisis Manage
ment
Cargo KPI
Simplified Customs clearance
Joint promotion at global events
Airport Export
Initiative
The cargo cluster – the promotion
“It’s the synergy, stupid!”
The cargo cluster – the recognition
“The Cargo Airport of the Year Award” 2006
(100,000-500,000 t. category - worldwide)
“The Air Cargo Award of Excellence”
(100,000-500,000 t. category worldwide)
2009: 1st place in own category & top score worldwide 2007 & 2008: Top ten list
“Transport and Logistics Awards 2015 “ Outstanding performance for the collaborative approach in the cargo business
Modern state-of-the-art cargo
infrastructure
24h / 365 day service – no curfew
Functional environment
Cluster mentality
Attractive financial incentives
Strategic position to serve the
Balkan countries → transit potential
Multimodal transport potential
The competitive advantages
The current situation
Peak year: 2008 – 122,000 tonnes
Recession period 2009-2013: - 38.7%
Weak recovery in 2014: +3.3%
Further recovery in 2015: +4.1%
Strong recovery in 2016: + 10.1%
- 90,000 tonnes
Challenge:
Sustain cargo traffic
Support airlines & handlers
Keep quality standards
Develop the cargo market: emphasize on
exports
niche markets, such as pharma products
The Greek pharma market
A € 4 billion business /air cargo: € 0.5 billion
3 to 1 import to export ratio
18%-drop from 2010 to 2015 (air cargo 37%)
2%-growth from 2015-2016 (air cargo 10%)
The Greek pharma market (2)
Air cargo share down from 27% to 13% in value (from 8% to 3.5% in volume) since 2004
Limitation of a/c cargo capacity in recent years an additional constraint
Growth potential due to new direct routes to both USA and SE Asia from mid ‘17
0%
20%
40%
60%
80%
100%
2004 2010 2015 2016
Exports by mode of transport
SEA VALUE SEA VOLUME ROAD VALUE
ROAD VOLUME AIR VALUE AIR VOLUME
Initiative under the umbrella of AIA
Discussions with the local community since May 2016
Organization of 4 pharma workshops until Dec 2016
Signing of contracts with interested parties in Jan 2017
Contact with the two Pharma Associations in early 2017
Hellenic Pharmaceutical Association (members are the 20 Greek pharma
producers & the 1 multinational)
Hellenic Association of Pharmaceutical Companies (has 65 member
companies: 27 Greek & 38 multinationals accounting for 95% of the
pharma industry in Greece)
Meetings and presentations to the members of the pharma
association planned within 2017
CEIV Pharma at AIA – the steps
6 initial participants
Skyserv Handling (RH & CH)
Goldair Handling (RH & CH)
Swissport Greece (RH)
DHL Global Forwarding (FW)
GAC Shipping (FW)
Talos Transport (FW & TR)
Kick-off meeting: 16 Feb 2017
1st training: end of Feb 2017
2nd training: end of March 2017
Assessment: May 2017 (est.)
Validation & certification: November 2017 (est.)
Ongoing promotion locally and abroad
CEIV Pharma at AIA – the project
RH: Ramp Handler – CH: Cargo Handler – FW: Forwarder – TR: Trucking company
Athens International Airport S.A.
Ground Handling and Cargo Development
Web: www.aia.gr
Thank you
Networking Lunch
12:30 – 14:00
Network Approach
Ronald Schaefer, Assistant Director, Cargo/Ground Handling and CEIV Consulting, IATA
Background: Network ApproachMatch challenge of certifying a network vs. individual stations
``Key issue for companies with many pharma hubs over the globe
Certifying each station individually is costly.
Communities only at major hubs.
How can a company specific network approach fit into the IATA standard approach?
What would be the right balance and a representative approach between assessments, validations and offline-auditing?
How should the certifications for the locations be timed?
How can IATA certify a company’s network
Individual Approach Community approach
One company decides to get "CEIV Pharma Certified“
One or several stations
A group of companies at one airport decide to get "CEIV Pharma Certified"
Form a “pharma gateway”
Supply chain approach
IATA CEIV Pharma Certification for Panalpina NetworkTo qualify for a network approach companies need to fulfil certain pre-requisites
Corporates have a large number of stations that transport pharmaceuticalshipments around the globe.
Corporates have a centralized quality management system, an internal auditprogram and auditors who audit their stations to ensure that relevant regulationsand standards are followed in all stations.
Corporates have initial and continuing training relevant to personnel roles andresponsibilities with a written training program.
1
2
3
Network Approach
Nina Heinz, Global Head of Quality, DHL Global Forwarding
IATA CEIV PHARMADGF NETWORK APPROACHDELIVERING HEALTHCARE TO THE WORLDNina HeinzAbu Dhabi, 13 March 2017
151151
Taking a hands on approach
IATA CEIV Pharma DGF Network Approach | Abu Dhabi| 13 March 2017
152152
Anchored in our DGF corporate values and behaviors
Passion means we really care for our customers, their goodsand DGF as if they were our own.
Entrepreneurshipmeans that we do things in a way that saves time, effort and money for us and our customers.
Excellence implies that we always aim to get things right 1st time to deliver our promise to customers.
Teamwork is the way wework to deliver to our customers an outstanding experience. This is true for within a country but also across the network.
– with our colleagues, customers and business partners.
IATA CEIV Pharma DGF Network Approach | Abu Dhabi| 13 March 2017
153153
GDP Compliance with DHL ThermonetNetwork - True scalability and expertise with anetwork of certified Life Sciences Stations on allcontinents
Quality & Compliance - High standard of controland product integrity through our qualitymanagement system and GDP guidelines
Cold Chain Design and Implementation –Customer has control over the design andimplementation of our Standard OperatingProcedure (SOP)
IT Platform - ‘LifeTrack’, our IT system, allows youto access information relating to the movement ofyour product – anywhere, any time
Visibility & Monitoring – 24/7/365 world wideproactive monitoring and intervention
IATA CEIV Pharma DGF Network Approach | Abu Dhabi| 13 March 2017
154154
DHL Thermonet QMS & GDP Foundations
DGF GDP Best
Practices
DGF IMS based on ISO 9001
DGF Policies &
Procedures
Change Control
Management Review
Document & Record Control
Internal Audit
Risk Management
Security
Business Continuity
Customer Satisfaction
Customer Complaints
Certification & Recertification
Air/Ocean Carrier Management
Temperature Control
Pest Control & Cleaning
Customer Audits
Training & Development
CAPA… and more
IATA CEIV Pharma DGF Network Approach | Abu Dhabi| 13 March 2017
155155
DHL Thermonet Internal Certification Audit Process
Audit Report
QualifiedAudit Team
Compliance Findings
CAPAs
Re-Certificat
ionSelf Inspecti
onsPerform
ance
For Cause Audits
IATA CEIV Pharma DGF Network Approach | Abu Dhabi| 13 March 2017
156156
DHL Thermonet Community & Training
IATA CEIV Pharma DGF Network Approach | Abu Dhabi| 13 March 2017
157157
DGF Brussels certification Jan2016 – Community Approach
IATA CEIV Pharma DGF Network Approach | Abu Dhabi| 13 March 2017
158158
DHL Thermonet and IATA CEIV Pharma Network
DHL Air Thermonet Global Network
Coverage TNX Stations
Current (2017) 32 IATA CEIV
97
UnderConsideration 3
BRU
YULYUL
MIARDU
ORDCVG
LAX PHLBOS
SJUMEX
PTYBOG
CCSVLN
SJO
SAO(VCP/GRU)RIO
SFO
BUE
DUBORKSNN MAN
MAD BCNPAR, LYS, SXB
IND
ROMMIL
BSL, GVA, ZRH VIELNZ
AMSMUC, STR
FRA, HAM, LEJCPH
MLACAI
STOHEL
ISTTLV
LON
JNB
MELSYD
PEK
SHATYOSEL
TPEHKG
SIN
AKL
MNLBKK
KUL
MOW (DME/SVO)
BOMHYD
BLR
DEL
DXB
MVD
NBO
DCA
JKT(CGK)
JFK
ATL OSA NGO
LOS
CANSZX
CPT
MSP
PER
IAH
SGN
LIM
DFW
CGN BER BFE/FMO
BUD
BRU
AMD
SCL
GUA
BOD
UIO
LJU
IATA CEIV Pharma DGF Network Approach | Abu Dhabi| 13 March 2017
159159
IATA CEIV Pharma DGF Corporate certification
IATA CEIV Pharma DGF Network Approach | Abu Dhabi| 13 March 2017
160160
DHL Preferred Life Sciences Carrier Program
Life sciences quality
agreements
Risk based onsite & remote
audits
Performance monitoring &
monthly scorecards
Regular Business Reviews
Joint pharma workshops
Customer complaint handling & escalation
Lane risk assessments
DHL CARE award
Developing pharma
capabilities on other carriers
IATA CEIV Pharma DGF Network Approach | Abu Dhabi| 13 March 2017
161161
IATA CEIV Pharma Partnership Approach
IATA CEIV Pharma DGF Network Approach | Abu Dhabi| 13 March 2017
THANK YOU
Network Approach
Reinier Danckaarts, Global and Western Europe Air Competence Director Pharma & Healthcare,Kuehne+Nagel
IATA CEIV Pharma KN PharmaChain Network CertificationReinier DanckaartsAirfreight Pharma Competence Director March 13 2017
p. 164
p. 165
KN PharmaChain – IATA CEIV PharmaShared ambition to drive industry standards
Agenda
• Back to basics• GXP Compliance• Pre-requisites for network Certification• Where to start• Implementation and roll-out• How-to• Future outlook
p. 166
Back to basicsAirfreight and QSHE collaboration
p. 167
Kuehne + Nagel
Global GXP standard in all modes of transport
CEIV Pharma
GXP Audits
GXP ComplianceBasis for successful implementation
p. 168
GXP implementationKN Attestation
IATA CEIV PharmaGlobal GXP Network pre-requisites
• Buy-in at Management Board level• QMS
• Quality standard + GXP across entire dedicated network• Network qualification program
• Qualified Pharma auditors• Internal audit program• Subject matter experts• Defined service offer• Training program• Continuous improvement
p. 169
IATA CEIV PharmaWhere to start
p. 170
• Gap analysis GXP vs IATA CEIV Pharma checklist• Global – Regional – Local
• Define gap closure(s) – extrapolate to network environment• Training
• Material qualified by IATA• CEIV Pharma specific module added• Global (re)training to all involved staff
• 1200+ CBT participants• 500 seats live training
• Project plan• Communication, Q&A• Verification of effectiveness• Feedback from network• Drive common understanding• Coordination
Communication is key ........... and the most difficult to get rightp. 171
IATA CEIV PharmaRolling out in a network environment
• Corporate, global and network structure• Quality Management System• Service offering within a dedicated network
• Minimum standards• Station definition and scope
• Understanding: develop, control and release
Explanation of concept to Lead Auditor
IATA CEIV Pharma Network CertificationNetwork Forwarding – a different cup-a-tea
p. 172
TEAM WORK
p. 173
IATA CEIV Pharma Network CertificationAudits and scope
Scope: Validation of Global KN PharmaChain GXP process
• Risk assessments• KPIs• Management reviews• Best practice examples
Minor findings closed to improve status quo
IATA CEIV Pharma Network CertificationAudit findings
No major findings
p. 174
p. 175
KN PharmaChain – IATA CEIV PharmaCertification process
p. 176
KN PharmaChain – IATA CEIV PharmaNetwork Certification
All CEIV Pharma related audits led by IATA
p. 177
KN PharmaChain – IATA CEIV PharmaFuture outlook – critical success factor (VISUAL)
• Continuous improvement of IATA CEIV Pharma program• KN PharmaChain standards will enhance• Regulations will increase, Aircargo industry to follow• Customer requirements will become more demanding
Network Certification is NOT a combination of separate audits
Questions?
p. 178
CEIV Pharma Perspective –The Community Approach –Two years down the line
Nathan de Valck, Cargo Manager, BRUCargo
B r u s s e l s A i r p o r t
Nathan De Valck
Cargo & Product Development managerBrussels Airport Company
Building a Pharma Cargo Community
LOW R I SK MEDI UM R I SK HI GH R I SK
THE PHARMA CHALLENGE IN AIR CARGO:
GUARANTEE AN UNBROKEN COOL CHAIN
TEMPERATURE DEVIATIONS:
Reliability Transparency
R E L I A B I L I T Y
DO WE ONLY FOCUS ON THIS ??
T R UC K E R F O R W AR D E R T R UC K E R H AN D L I N G AG E N T AI R L I N E
M AN UF AC T U R E R S
& S H I P P E R S
AI R L I N E
D I S T R I B U T O R S &
C O N S I G N E E S
F O R W AR D E R T R UC K E RH AN D L I N G AG E N T
R E L I A B I L I T Y
OR DO WE TAKE CARE OF THE ENTIRE COOL CHAIN??
T R UC K E R F O R W AR D E R T R UC K E R H AN D L I N G AG E N T AI R L I N E
M AN UF AC T U R E R S
& S H I P P E R S
AI R L I N E
D I S T R I B U T O R S &
C O N S I G N E E S
F O R W AR D E R T R UC K E RH AN D L I N G AG E N T
Building infrastructure for
an unbroken cool chain
R E L I A B I L I T Y
Existing GDP licensed or
compliant pharma warehouses
DEDICATED PHARMA TEMPERATURE CONTROLLED INFRASTRUCTURE
CRT: 6.400 m²
2-8°C: 1.800 m²
-20°C: 115 m²
CRT: 9.250 m²
2-8°C: 1.700 m²
-20°C: 50 m²
Temp Controlled
Infrastructure
First line : total 8.315 m²
Second line : total 11.000 m²
• No central pharma infrastructure managed by the airport
• Instead, investments from many stakeholders at BRUcargo
R E L I A B I L I T Y
Aligning and standardizing
an unbroken cool chain
R E L I A B I L I T Y
B R U C A R G O P H A R M A C O M M U N I T Y C E R T I F I C A T I O N
R E L I A B I L I T Y
Forwarders
Handlers
Airlines
Airp
ort
Co
ol C
ha
in
Truckers
O U T C O M E O F T H E P R O G R A M
CLOSED COOL CHAIN
LOWER RISK PROFILE
PREFERRED PHARMA GATEWAY
GROWTH OF PHARMA VOLUMES
COMMUNITY DYNAMIC
FOLLOW UP IMPROVEMENT PROJECTS
R E L I A B I L I T Y
O U T C O M E O F T H E P R O G R A M
R E L I A B I L I T Y
E V O L U T I O N O F B R U P H A R M A V O L U M E S
T O T A L E X P O R T E X P O R T F L O W N E X P O R T R F S
2 0 1 6 V S 2 0 1 5 1 1 6 % 1 3 6 % 9 6 %
Source: BRU data analysis
I M P R O V E D Q U A L I T Y P E R F O R M A N C E
P H A R M A A C C E P T A N C E
N O N - C O N F O R M I T I E S- 4 5 %
Source: BRU Pharma Quality Dashboard
Eliminating temperature risk
R E L I A B I L I T Y
Eliminating temperature risk
R E L I A B I L I T Y
Temperature• Garanteed range
5°C – 25°C
• Continuous pre-conditioning
Autonomy• 36h during summer• 24h during winter
• Solar Pannels
E L I M I N A T I N G T E M P E R A T U R E R I S K
Eliminating temperature risk
R E L I A B I L I T Y
Low total operating cost• Easy, reliable and effective• Combination pharma - general
cargo
• Pooled equipment
€
Lower deck contour• Aircraft containers
• Aircraft pallets
• Loose cargo
E L I M I N A T I N G T E M P E R A T U R E R I S K
Sharing data
Digitization
T R A N S P A R E N C Y
Roll-out of different
applications
use Big Data analytics tocreate new
insights
DIGITALIZED BRUcargo
Simplify processes/
Increase quality
Better visibility
Modernize systems
T R A N S P A R E N C Y
* sample, based on demo-data
P H A R M A Q U A L I T YD A S H B O A R D
Statistics
AppPharma
Dashboard
Equipment
Booking AppSlot Booking
App
External Apps
/ New Apps
Single-truth data
One-to-many communication
Existing Applications In development
T R A N S P A R E N C Y
BRU RFID
Pharma dolly
GPRS tracking data
Weather data
End-to-end collaboration
R E L I A B I L I T Y & T R A N S P A R E N C Y
PHARMA.AERO is a powerful cross-industrycollaboration for Pharma Shippers, CEIVcertified cargo communities, Airport Operatorsand other air cargo industry stakeholders.
PHARMA.AERO is an initiative from BrusselsAirport together with Miami Airport, based uponthe CEIV program.
PHARMA.AERO is a new world wide platform.
Our visionAchieve excellence in reliable end-to-end air transportation forpharma shippers.
Our missionFoster collaboration between CEIV certified airportcommunities dedicated in developing and leading when itcomes to handling pharmaceuticals.
Objectives/Goals Strategic partner for pharma shippers Advocate the best interests of the pharma industry Develop air cargo as a reliable transport mode for pharma Become/remain leaders in developing cool chain solutions Grow the pharma business at our airports
Vision
Mission
Objectives
Specific Strategy
Full members
Status March 2017
Strategic members
Associate members
Founding members
w w w . b r u s s e l s a i r p o r t . b e
CEIV Pharma Perspective –Experience of the AMS Community
Jonas van Stekelenburg, Head of Cargo, Schiphol Airport
So, AMS focuses on the hand-over moments
IATA: Pharma temperatureincursions do not happen when in transit but at hand-over moments. So, AMS focuses on the hand-over moments.
Good network: less hand-over moments
Dutch health care is no. 1 in Europe, mainly due to quality and inspection
Pharma at AMS is regulated by the Dutch Health Care Inspectorate – guaranteeing unrivalledquality inspection and lower chance of incursions.
Dutch healthcare is unrivalled. So are the Inspections: better hand-overs
Dutch health care is no. 1 in Europe, mainly due to quality and inspection
Pharma at AMS is regulated by the Dutch Health Care Inspectorate – guaranteeing unrivalledquality inspection and lower chance of incursions.
Dutch Customs is unrivalled. So is their handling of Pharma airfreight: better hand-overs
Dutch Customs is no. 2 in the world Europe and has a world class service.
Dutch Customs is second best in the world in Pharma handling!
With our Pharma Gateway Amsterdam community we will focus on hand-overs
2016 – the year with Pharma Gateway Amsterdam
• 6 PGA members CEIV certified in the last 12 months, expect others in the coming months
• 13 community members in PGA, expecting to double the community in 2017
• Tomorrow: press release about PGA’s new innovation effort
PGA Launch March 2016 at WCS
Closing Remarks
Ronald Schaefer, Assistant Director, Cargo/Ground Handling and CEIV Consulting, IATA
THANK YOUFor further information, contact:
Ronald SCHAEFERAssistant Director, Cargo/Ground Handling and CEIV Consulting,
IATAMiami, FL
Email: [email protected]: + 1 305 779 9873
Mob: + 1 305 586 4666
