Day 4: Main Conference – Thursday, September 23, 2010

8:00 Opening Remarks From Chairperson

Jim Bacon
Senior Director, Global Demand Planning and Customer Operations
Talecris Biotherapeutics

International Transport and Logistics

8.10 Keynote Session: Pharmaceutical Import Safety From A Global Supply Chain Perspective

• Today's medicines supply chain: Increasing global trade, complex products and transnational food and drug supply chains
• Working in critical partnership with both industry and state and local health authorities domestically and internationally
• Good importer practices and experiences with industry to date

Lori Rose
Consumer Safety Officer
Food & Drug Administration (FDA)

8.50 Harmonizing Processes And Quality Systems For The Global Supply Chain

• Qualifying transportation partners and standardizing the qualification process
• Temperature excursion management

Maryann Gribbin
Manager Industry Compliance and Regulatory Affairs
Johnson & Johnson

10.00 Contingency Management: Mitigating Risk During International Shipment Of Temperature Sensitive Products

• Understanding the Quality Risk Management principles as defined in ICH Q10
• Identifying and measuring the impact of events on the supply chain
• Developing and implementing effective contingency plans
• Case study: Learning from a shipper’s perspective, including a risk based analysis or FMEA procedure

Chris Fore
Manager Industry Compliance and Regulatory Affairs
Envirotainer

10.40 Panel Discussion: Aligning Approaches Between Pharma, Freight Forwarders And 3PLs

• Contract negotiations: Optimizing costs for temperature control shipping
• Setting up service agreements and service levels
• Accessing real time data to achieve total product visibility
• Keeping partners accountable day to day
• New Markets: Consulting your supply chain partners and conducting independent new market research

Moderator:

Jim Bacon
Senior Director, Global Demand Planning and Customer Operations
Talecris Biotherapeutics

Panelists:

Shipping to New Markets

12.30 Brazil Case Study: Regulations And Quality Operations Of Shipping Temperature Control Pharmaceuticals

• Outlining specific requirements by ANVISA for handling, storing and distribution cold chain medicines in Brazil
• Product and temperature control by hospitals and distributor customers
• Importation of pharmaceutical products into Brazil: Overcoming custom challenges
• Experiences at airport with personnel and accessing cold chain shipments
• Working with affiliates to ensure effective international transportation and validation of products

Elaine Araujo Menezes
Quality Operations Coordinator
Abbott Brasil

1.10 Distributing Vaccines To Remote Populations In Peru

• Use of Thermal Bags as a safer way for packing
• Refrigerated truck for campaign of vaccination to places remote in Peruvian Andes
• Maintaining the cold chain in places without electricity, available roads and extreme weather

Humberto Laserna Zubiaga
Quality Coordinator
Pfizer-Peru

1.50 South American Andean Region Case Study: Distribution Of Vaccines Challenges And Opportunities

• Describing key challenges shipping in the Andean Region including Venezuela, Colombia, Peru, Ecuador and Bolivia
• Customs processes, facilities and imports regulations (Case of Private Market, Government purchase to PAHO)
• Weather conditions: Examining what happened when "El Niño" appeared and how we managed cold chain products
• Distribution from Pacific coast through mountains and jungle: Airports facilities, Cold Chambers capacity by town
• Security risks assessment: Cost considerations and review of key issues

Ursula Vértiz
Technical Project Manager
Salog Peru (Unihealth)

3.00 Introducing New Vaccines To Remote Markets Case Study: Distributing The First Fully-Liquid Pentavalent Vaccine

• Collaborating with The Global Alliance for Vaccines and Immunization (GAVI) to get needed vaccines to Asia and Africa and the Pan American Health Organization (PAHO) to distribute vaccines to Latin America
• Training immunization organizations and staff on cold chain and safe immunization practice
• Providing correct and sufficient documentation
• Options for public – private cooperation
• Encountering distribution challenges
• Lessons learned and suggested actions for improvements in the future

Sanja Saftic PhD.,
Forecasting Manager, Strategic Vaccines Supply, Accelerated Vaccine Introduction
PATH

3.40 Closing Keynote Address: Pharmaceutical Cold Chain Management In China: The Latest Progress

• Examining current regulatory standards in China for cold chain distribution
• Current and emerging issues regarding product safety environment in China: Assessing different pharmaceutical products using cold chain
• Managing pitfalls and strategies for cold chain distribution in China:
• Best Practices to be adopted when looking for a reliable Cold chain partner in China
• Devising cold chain Standard Operating Procedures (SOPs) with Chinese cold chain partners
• Technology updates for China: Utilizing RFID (and other latest innovations) for traceability, temperature logging and safety

4.40 Closing Remarks And Close Of Conference