ICH 2010 Workshop Washington D.C., USA
Bethesda North Marriott
Don’t Miss this Unique Opportunity in North America
Event dates and times
6 October 13.00 – 18.00
7 October 08.30 – 18.10
8 October 08.30 – 13.00
There will be a networking reception on Wednesday at 18.30.
Building on the success of the European event, this North America ICH Workshop brings a unique opportunity for industry-regulator learning and interaction. Attendees will not only hear directly from the industry and regulator experts who developed the ICH guidelines and learn from case studies, but spend an entire day in small group workshops where industry and regulatory attendees will be able to have effective discussions. Join around 200 regulators in discussion breakouts addressing Design Space, Control Strategy, Pharmaceutical Quality System, and Quality Risk Management. Feedback from these sessions will be presented on the final day and delivered to the ICH working group to assist with the implementation of the new ICH guidelines. A major concluding feature will be the opportunity to put all your questions to a distinguished panel of Expert Working Group representatives.
**Workshop attendees will rotate through all four (4) discussion breakouts. Companies may wish to send multiple registrants for the most effective participation.
This is a unique Opportunity for Open Dialogue among Industry and Regulators
- Create shared understanding and influence how ICH Q8, Q9 and Q10 can be implemented by taking part in the dialogues that will shape the future of our industry and those who regulate it.
- Hear first-hand from ICH Expert Working Group members.
- Interact with over 150 FDA representatives together with regulators from Europe, Canada, China and other regions.
- Share experiences with industry and regulatory representatives in a highly-interactive format.
- Address and build upon conclusions from the European ICH event.
Case Studies and Discussion Topics
|How ICH Guidelines are Working Together throughout the Product Lifecycle||Moheb Nasr, FDA, Q-IQG|
|Product Development||Jean Wyvratt, Merck|
|Regulatory Assessment||Elaine Morefield, CDER, FDA|
|Implementation and PQS considerations||Nigel Hamilton, Sanofi-Aventis|
|Inspections at a Manufacturing Site||Jacques Morenas, AFSSAPS, France|
|Design Space||Moheb Nasr, FDA and Georges France, Pfizer|
|Control Strategy||Bob Baum, Pfizer and Jean-Louis Robert, Dept. QC of Medicines, Luxembourg|
|Pharmaceutical Quality System||David Cockburn, EMA and Swroop Sahota, Merck|
|Quality Risk Management||Stephan Rönninger, Roche and Diana Amador-Toro, ORA, FDA|