Pre-Conference Evening Seminar: Tuesday, 27th January, 2009
18.15 - 21.15 Seminar: Assessing Opportunities and Overcoming Challenges in New Markets: China, India and Africa
As China is now part of WTO, the FDA has set up an office to monitor pharmaceutical manufacturing, transport and product quality. This timely seminar reflecting today’s current challenges will be a valuable opportunity to examine current challenges in meeting regulatory requirements.
Session I: Shipping Vaccines in Emerging Economies
- Understanding the structure of distribution chains and differences between manufacturers, distributors and government handling vaccines
- Cold Chain logistics challenges - vaccine storage, distribution, handling at point of use
- Taking lessons from recent experiences in Nigeria - Is it possible to plan for the worst?
- Conducting field assessments and identifying problems Identifying risks and taking steps to minimize them
Anthony Battersby
Partner
FBA Health Systems Analysts
Session II: Overview of the Indian market: shipping temperature sensitive pharmaceuticals in/out and handling customs challenges
- Regulatory expectations for this new pharmaceutical market
- Overcoming challenges in getting continuous shipments out of India
- Developing a trusted network of supply chain and transport partners
Session III: Training Chinese Affiliates to Ensure Product Safety, Transport Effectiveness, and Packaging Qualification
Wyeth has recently embarked on a new venture training a Chinese affiliate who is distributing their product. Pack outs are different, the supply chain is more complex, their 'cold chain systems' are extremely basic. In this session, Richard will relay their experiences in training Chinese distributors on re-qualifying shippers, including a look at the use of passive systems and the trials and tribulations of getting their very outdated systems up to speed with modern technology, regulations and complex supply chains.
- Overall impressions and differences noted of temperature controlled pharmaceutical shipping in China
- Redefining cold chain processes from 'old' methods to modern
- Packaging technology used, available, changed and validated
- Making heads and tails of new international regulatory requirements
Richard Peck
Cold Chain Technology Lead
Wye