Today, approval for NDA's is no longer assured upon completion of Phase III trials and research shows the FDA is now requiring post-marketing studies in over 70% of cases to prove a drug's long-term efficacy and safety. The situation is compounded by increasing costs – the average cost is now approaching the $4 million mark - to carry trials to phase III and beyond, difficulties with patient and clinician retention and much more. The Speakers To answer these concerns and to provide attendees with an essential industry update, the SAE Media Group has produced a strategic event that will be delivered by an excellent panel of industry leaders, including: | |
- Bill Duval, Vice President, Global Operations for IIIB/IV Research, Quintiles Strategic Research and Safety
- Mason W Diamond, Vice President, Clinical and Regulatory Affairs, TyRx Pharma, Inc.
- Michael Edwin Kafrissen, Vice President, Clinical Affairs, Ortho-McNeil Janssen Scientific Affairs, LLC
- Gurdyal Kalsi, Director, Medical Affairs and pharmacovigilance, MDS Pharma Services
- Dr Ferdinando Vegni, Director, Risk Management Strategy, Safety and Risk Management, Pfizer
- David Parker, Director, Investigator Sponsored Studies Programme, AstraZeneca
- Michael Herschel, Director, Clinical Research, GlaxoSAE Media GroupthKline
- Imre Pavo, Director, Medical & Regulatory Affairs, Central/Eastern Europe, Africa, Middle East & CIS, Eli Lilly
- Glenn Matfin, Head of Medical Affairs, Novo Nordisk Inc.
- Wolfgang Schumann, Senior Medical Safety Advisor, Bayer-Schering Pharma
- Matthew Wintle, Director, Medical Affairs Programmes, Amylin Pharmaceuticals Inc
Why should I attend?
The conference will address your key concerns in a practical forum and give you the opportunity to explore how companies are:
- MEETING safety, scientific, regulatory and commercial goals
- IDENTIFYING the best method for observation
- MANAGING costs in phase IV studies
- AGGREGATING and integrating data, making best use of technologies like Electronic Data Capture
- CAPTURING and interpreting Patient Reported Outcomes effectively
- COMBINING medical affairs and marketing; marrying good science with good communications strategies
- LEVERAGING IISS to expand the scientific knowledge of drugs
- SUPPORTING credibility with observational data in a post-market environment
- And lots more
Who should attend?