ISCT Workshops
ISCT Satellite GRP Workshop
A Pre-Conference Event at the Phacilitate Cell & Gene Therapy Forum
10:00am - 5:30pm
January 27, 2013
Grand Hyatt Washington
Room Independence F-H
Washington, DC
USA
Session Topics:
- Regulatory Affairs in Europe - Hot Topics and Updates
- Upcoming New Clinical Trial Regulations in Europe
- Pharmacovigilance
- Multinational Clinical Trials
- How to Navigate the EU Centralized Regulatory System
- Agency Support and Resources for Industry in the EU
- Parallel Scientific Advice: U.S. FDA and EMA
- Scenario Cases - How and Where to Seek Advice and Resources
- Working Towards Regulatory Harmonization Between the EU, US and Canada
- GMP Harmonization
- US FDA and International Regulatory Efforts in Cellular and Gene Therapies
- Health Canada's Role and Recent Regulatory Activities on Cell Therapy Products
Confirmed Speakers, Panelists and Moderators:
- Judith Arcidiacono, MS - FDA, USA
- Ariel E., Arias MD, PhD - Health Canada, Canada
- Kimberly Benton, PhD - FDA, USA
- Christopher Bravery, PhD - Consulting on Advanced Biologicals, UK
- Scott Burger, MD - Advanced Cell & Gene Therapy, USA
- Jacquelyn Awigena-Cook, MSc - J&J, UK
- David H. Dorsey, JD - Janssen Research & Development, USA
- Lisa Beth Ferstenberg, MD - Technical Resources International, Inc., USA
- Maria Cristina Galli, PhD - CAT/EMA, Italy
- Gopalan Narayanan, MD, FRCP, FFPM - MHRA, UK
- Pirkko Puranen, PhD - Finnish Medicines Agency (FIMEA), Finland
- Edwin Wagena, PhD - Kiadis Pharma, The Netherlands
