Speakers for this Event: Dr. Michael N. Eakins, Principal Consultant, Eakins & Associates  Martin Page, General Manager, Catalent Pharma Solutions  Andrew Willis, VP of Regulatory Affairs, Catalent Pharma Solutions  Phil Wilson, Director of Global Trade Operations, Supply Chain and Corp. Security, Catalent Pharma Solutions

Sponsored by:

Pharmaceutical companies are conducting more clinical trials than ever before, in order to spur growth, maintain profit margins and replenish shrinking pipelines. The rising costs, complexity, as well as regulatory challenges caused by the increasingly global nature of these clinical trials presents significant challenges for pharmaceutical companies seeking to effectively manage the clinical supply chain.  

R&D and clinical supply leaders must face these challenges with a flexible, cost effective approach that accounts for the complexity of the global distribution of the clinical trial supplies.

We will discuss:

• Regulatory and global trade requirements and implications for shipment into key clinical trial markets.
• The challenges facing global importers and exporters in a post 9/11 world.
• How to manage a “time and temperature” sensitive supply chain.
• How other government agencies affect the supply chain – US Customs is not your only hurdle at the time of import/export.
• Critical Documents Required.
• The significance of study start-up.
• Key activities to ensure seamless supply of clinical materials such as labeling management, labeling requirements in different countries, translation management of labels and inserts.
• The basic requirements of the QP process.
• Differences between IMPs and commercial products.
• Considerations to make the QP release process as quick and easy as possible.
• Application of USP General Chapter <1079> Good Storage and Shipping/Practices to Clinical Supply Chain Management.
• Revision of <1079> - Progress and Timeline.

Please note: There will be time allotted to ask questions prior to the conclusion of the webinar.