Conference Day One: Wednesday, 28th January, 2009
8.00 Registration And Morning Coffee
8.45 Pharma IQ Welcome
8.50 Opening Remarks From Conference Chair
Dr. Rafik H. Bishara
Technical Advisor and Chair of Pharmaceutical Cold Chain Interest Group (PCCIG) USA Branch
PDA
9.00 Understanding And Complying With MHRA Guidelines
- Shipping according to label claim: The regulatory position on variances and mixed shipments
- What if there is no stability data?
- Temperature deviations: Practical considerations and staying in compliance
- Where do regulators stand on energy efficiency measures?
Ian Holloway
Manager, Defective Medicines Reporting Centre
MHRA
09.45 Aligning Cool Chain Initiatives Across Industry And Partners
- New initiatives by the PCCIG: Including ‘Last Miles’ Task Force
- Highlighting some feedback to elements of Technical Report 39 that requires clarification
- Underlining the importance of partnerships to ensure effective, world-wide cool chain operations
- QA developments in the Cool Chain: In an effort to work towards developing more robust quality management systems
Dr. Rafik H. Bishara
Technical Advisor and Chair Pharmaceutical Cold Chain Interest Group (PCCIG) USA Branch
PDA
10.30 Morning Refreshments And Networking Break
11.00 Developing A Master Quality Agreement For Cool Chain Partners: Setting And Communicating Expectations
- ICH Q10 interpretation and inclusion into cool chain partner agreements
- Defining the responsibilities and communication processes for quality related activities of suppliers
- Streamlining quality agreements across transportation partners
- Developing quality agreement templates for qualification of supply chain partners
- Minimising human error and risks with several handovers by establishing an effective quality programme with updated contractual agreements
- Outlining necessary and useful KPIs in an effective quality agreement
- Measuring KPIs and putting a value on each (weighted/tiered approach)
- Tracking and communicating KPIs and keeping partners accountable (quality business reviews, QBRs)
- Monitoring incoming materials to ensure quality operations
David A Ulrich
QA Distribution Director, Global Pharmaceutical Operations (GPO), Strategic Quality Initiatives (SQI)
Abbott Laboratories
11.45 Panel Discussion: ‘Ask The Regulator’ How To Interpret And Implement European Regulations On Cold Chain
Transport of Biopharmaceuticals
(Anonymous questions may be submitted to the panel beforehand by sending to courtney.becker@iqpc.co.uk)
- How are companies justifying their actions and validation plans to regulators?
- Regulators advise they want to see more control over the cold chain – but what exactly will demonstrate this?
All morning speakers and participants are invited to join the discussion
12.45 Networking Lunch
Track A
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Track B
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14.00 Development Of Cold Chain Containers For Investigational Medicinal Products
Dr Peter Kulmburg 14.40 Cold Chain Distribution Of Clinical Supplies Case Study: Efficient Distribution Supplies Around The Globe
15.20 Developing Sufficient Stability Data To Maximise Label Conditions For Shipping And Storage Of Clinical Materials
All participants of this afternoon are invited to join this discussion 16.00 Networking Break |
14.00 Human Plasma Case Study: Transportation And Validation Via Land, Sea And Air
Oliver Gross 14.40 Optimising Cold Chain Logistics By Implementing Cost-Containment And Environmental Improvements
Gilles Labranque 15.20 Improving Transportation Processes And Product Integrity With 3PL Partners
Jim Bacon 16.00 Networking Break |
16.30 Roundtable Discussions
After a full day of presentations, it’s time for all participants to take an active role and get answers to specific questions. These informal discussions will provide an opportunity to exchange ideas related specifically to job functions and interests. Facilitators will present a short case study as an introduction to the 60 minute discussion and question session.
A: Modern Modes of Cold Chain Transport: Weighing Cost, Compliance, Control and Capabilities
B: Security Challenges and Tools for the Cool Chain
C: Weighing Cost/Benefit vs. Value of Green Packaging Solutions and Strategies for your Cold Chain
D: Investing in Training and Building a Skill-based Work Force to Decrease Turnover and Failed Shipments
E: Shipping ‘Living’ Biological Materials with Cryogenic Technology and Implementing Speciality Logistics for Large Molecule Drugs
F: Understanding What Temperature Excursions are Allowable and Where to Put in the Regulatory File
G: Improving Airline Logistics and Controlling Temperatures in the Air: IATA Developments
H: Ambient Shipping Justification and Requirements vs. ICH Stability
I: Ensuring Product Integrity Through to the “Last Miles” of the Cool Chain
J: Cold Medical Devices: Assessing Packaging Limitations and Transportation Solutions
17.30 Summary Of Roundtable Discussions
18.15 Closing Remarks From Chairperson
18.20 Networking Drinks Reception
19.30 Cool Chain Europe Dinner And Excellence Awards
To recognise a colleague’s achievements, to nominate a colleague for one of the CCE Awards:
- Most Influential Team, Person, Organisation or Project
- Top Technology Provider of the Year
- Best Service Provider of the Year
Dinner Keynote Address
20.00 Overcoming Current And Future Challenges Getting Vaccines To Remote Populations: Why The Cold Chain Matters So Much
- Statistics on improved healthcare: Why the cold chain matters
- Describing the challenges of the last miles of the vaccines supply chain today and in the coming years
- Defining the technology, systems and ingenuity needed to get life-saving vaccines to remote populations
- Working together to make a difference and utilising collaborations with Ministries of Health, WHO and NGO’s
- How pharmaceutical manufacturers can help
Dr. Michel Zaffran
Senior Advisor
World Health Organization and Director of Project Optimize