Day Two Conference: 26th January 2011
08.00 Morning Coffee
08.50 Opening Remarks Chairperson
Rafik H. Bishara, PhD
Technical Advisor and Chair PCCIG USA Branch
PDA
09.00 United States Pharmacopeia (USP) <1079> Regulations And Future Supply Chain And Packaging Initiatives
- Agenda and timelines for the USP Packaging and Storage Expert Committee: How industry can get involved
- Final edits to <1079> including:
- Quality Management System (QMS)
- Storage Management System (SMS)
- Transportation Management System (TMS)
- Environmental Management System (EMS)
- New Chapters for discussion including Anti-Counterfeiting and Supply Chain Best Practices
Dr. Mary Foster
Chair, Packaging and Storage Expert Committee
US Pharmacopeia (USP)
09.40 MHRA Regulatory Input And Perspective: Definition Of A Quality System For Temperature Controlled Pharmaceutical Distribution
- A regulatory response to new temperature monitoring and cold chain logistics technology
- Observations of trends among pharma companies; Feedback from audits
- Will excursions be allowed without supporting stability data?
Ian Holloway
Manager, Defective Medicines Reporting Centre
MHRA
10.20 Morning Networking Break In Exhibition Arena
Join your peers to browse the 2011 Solution Hall. Open across the 2 days this is where
you’ll be able to find all the latest packaging/container, transportation, logistics,
temperature monitoring and data management solutions. The ideal place to meet
existing and new partners!
10.50 German National And European Requirements For GDP And Cold Chain Processes
- An overview of the guidelines which refer to GDP
- Requirements for GDP and cold chain processes
- Stability data for API and drug products requiring cold chain storage
- Stability issues relating to pharmaceutical bulk products
Cornelia Nopitsch-Mai
Scientist, Federal Institute for Drugs and Medical Devices Germany
BFARM
11.30 “Open Microphone’ Regulatory Discussion: What Are Realistic GDP Regulations For Temperature Control Distribution?
- Reviewing the regulatory trend moving from GMP to GDP: A focus on the supply chain
- Practical realities vs. regulatory expectations
- To what extent should shipping conditions and transport conditions be included into the documentation?
Moderator:
Rafik H. Bishara
PhD, Technical Advisor and Chair PCCIG USA Branch
PDA
Panellists:
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Ian Holloway
Manager, Defective Medicines Reporting Centre
MHRA
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Cornelia Nopitsch-Mai
Scientist, Federal Institute for Drugs and Medical Devices Germany
BFARM
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Dr. Mary Foster
Chair, Packaging and Storage Expert Committee
US Pharmacopeia (USP)
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12.30 Networking Lunch
Discuss the morning’s presentations and current concerns with like-minded colleagues by joining the networking lunch with peers in QA, logistics, technology development or packaging.
Track A: Establishing Effective Operational Procedure for Temperature Sensitive Ocean Freight |
Track B: Developing a Regulatory Compliant Cool Chain Quality System |
13.30 Case Study: Assessing The Benefits Of Shipping High-Value Pharma Via Ocean
- Pharma consolidation opportunities: Examining the financial benefits of shipping by ocean
- Perceived risks and actual risks: Changeover in ports, on the quay while loading, arrival and delivery
- Security in the port
- Liability - Who’s responsible for shipments and temperature deviations?
- Temperature alarms functionalities out at sea and while on the quay
Jens Lamberth
Global Category Manager
AstraZeneca
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13:30 Development Of A Methodology To Review Global Regulations On Good Distribution Practices To Determine Acceptable Shipping Practices For A Given Country/Region
Since the various global regulatory authorities have not yet harmonized requirements for the distribution of temperature sensitive products, it is difficult for the industry to develop global solutions. This presentation will provide
- A risk management approach to evaluating shipping practices
- The methodology utilized to assess Global GDP Regulations & Climate Conditions by Country/Region for determining acceptance of alternative shipping conditions based on the products stability data, which is a key element in the risk management model
Gwyn Murdoch
Director of the Materials/Packaging Quality System
Eli Lilly and Company
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14.10 Case Study: Temperature Monitoring Of Ocean Freight And Security In Port: Case Study
- Contract with carrier/ship
- Insurance considerations
- Container flow in the supply chain
- Security in port
Sonja Roeper
Senior Manager South East Asia & China, Distribution Logistics
Merck KGaA
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14.10 Novo Nordisk Case Study: Risk Analysis In Shipping
- Risk analysis according to the text book
- What they don’t write in the text book
- Sharing firsthand experience
Søren Kåre Nielsen
Quality & Projects, Shipping & Customer Service
Novo Nordisk A/S
Morten Duus Eriksen
International Freight Manager
Novo Nordisk A/S
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14.50 Afternoon Networking Break
15.20 Understanding The Business Of A Reefer Ocean Carrier And How Critical Temperatures Are Maintained From Origin To Destination
- Day to day volumes and commodities being shipped by ocean reefer
- Challenges of handling high value and temperature-sensitive products
- Advantages of shipping temperature-sensitive products via reefer containers
- Handling processes for high value and temperature-sensitive cargo
- SMARTemp™: Continuous temperature and humidity monitoring, real-time data and temperature alarms
- Case examples: Shipping pharmaceutical and high value products with SMARTemp™
Eric Eng
Vice President, Global Reefer Trade
APL Co Pte Ltd
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15.20 Cold Chain Risk Mitigation: Where To Start?
- Update on the PCCIG project Risk Management for Temperature Controlled Distribution
- Application of FMEA
- Risks in ocean, road and air transport
- Detecting and analysing potential risks throughout the cold chain
- Integration of cold chain risk management into the QMS
Erik Van Asselt
Cold Chain Improvement Manager, Vaccines
Merck Sharp & Dohme BV
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16.00 Panel Discussion: Defining Best Practice Operational Procedures With Ocean Freight Stakeholders
- PCCIG Working Group initiative on ocean shipping: Qualifying equipment and qualifying the process
- Positioning of temperature monitors
- Measuring humidity
- Decreasing condensation
- Dealing with the reefer ‘lottery’: Not knowing type, age or manufacturer of container will be used for your product
- Contract and quality agreements
- Insurance cost considerations
Panelists:
Jens Lamberth
Global Category Manager
AstraZeneca
Sonja Roeper
Senior Manager South East Asia & China, Distribution Logistics
Merck KGaA
Eric Eng
Vice President, Global Reefer Trade
APL Co Pte Ltd
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16.00 Case Study: Managing External Contractors To Ensure Effective Transfer Of Investigational Medicinal Products
- Assessing and selecting sub-contractors for packaging, labelling and clinical “cold chain” supply
- Setting up packaging and distribution processes, KPIs and metrics with partners
- Audit frequency and schedule
- Deciding best practice for packaging temperature sensitive IMPs, temperature monitoring and reporting procedures
- A QP point of view: Assessing temperature excursions and while keeping partners accountable and IMPs safe for administration
- Implementing continuous long-term improvements with partners
Sam Corveleyn
Director CMC & QP
ActoGeniX N.V.
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16.40 Closing Remarks From Chairperson And End Of Conference