CBI’s Summit on Post-Marketing Studies
February 7 – 8, 2005 London, UK
Visit the conference website for more information and to register.
Post-marketing studies in Europe are continuing to increase at a rapid pace and are being used widely to delineate additional information, including drug risks, benefits and optimal use. EU clinical trials directives will also have a dramatic impact on post-marketing studies by establishing new definitions and bringing out more uniformity.
Some of the challenges of conducting post-marketing studies in Europe are the cost and workload. Phase IV studies often have to be better designed than Phase III because they have smaller budgets, less time, multiple objectives, more public scrutiny, less regulatory protection and less-experienced investigators. The review process is also difficult and can lead to more follow up measures. Additional common problems are that Phase IV studies are poorly designed (under powered, unclear objectives and too many variables), poorly conducted (poor compliance, high variability and loss of power), poor recruitment (uninterested investigators, over-restrictive criteria) and lack of GCP compliance.
Attend CBIs European Summit on Post-marketing Studies and hear strategies on balancing the local and global needs in post-marketing studies, the impact of EU clinical directives on post-marketing studies, privacy protection and much more!
Conference Highlights Include:
- 10 Industry perspectives from: Wyeth Europa Ltd, GlaxoSmithKline, Novo Nordisk A/S, Amgen, Pfizer Inc, Eli Lilly, Bayer Vital GmbH
- Maximizing the Impact of Post Marketing Studies
- EU Directives on Post-Marketing Studies
- Examine Post-Marketing Studies that can provide relevant information that can be use in Risk Management Plans
- ..And much more!