Web Seminar: REMS, EU-RMP and FDAAA: Navigating the Clinical Trial Safety, Postmarketing Pharmacovigilance and Risk Management Alphabet Soup

Join us for a web seminar presented by Stephen A. Goldman, MD, FAPM, DFAPA !

Title: REMS, EU-RMP and FDAAA: Navigating the Clinical Trial Safety, Postmarketing Pharmacovigilance and Risk Management Alphabet Soup

Date: Wednesday, September 9, 2009

Time: 2:00 PM - 3:00 PM EDT

Reserve your Webinar seat now at:
http://bit.ly/PartnershipsWebinarBlog


About the web seminar:
Current pharmaceutical safety is a sophisticated system in which benefit/risk assessment begins with animal testing and continues throughout human clinical trials, licensing approval and marketing of the product. It is critical to monitor evolving safety profiles of marketed products throughout their life cycles, and optimally employ risk management tools in service of public health.

This seminar will examine current national, regional and international perspectives and approaches to clinical trial safety, pharmacovigilance planning and risk management. Current EMEA and FDA regulatory requirements and standards, in combination with the vital ICH E2E guideline, will be discussed and also examined via case examples of risk assessment, communication and minimization methods.

Drug Approvals

Much has been said in the news regarding drug recalls such as this latest article from NY Times, where they discuss how certain drug imports from an Indian drug maker have been stopped. Also, as we mentioned yesterday, one tool CROs can use are LIMS to help with the authorization processes set in place by regulatory agencies. In relation to these news items, PharmaVoice mentions here, that there is a real need for technology to be updated in order to combat drug safety concerns. As of September 2007, the FDAA was updated to require certain sponsors to submit a “proposed REMS”. In addition, the EU is requiring a PSURs to be submitted every 6 months for the first 2 years. The PharmaVoice article summarizes:

“This will require companies to invest in more advanced pharmacovigilance technologies and to develop new processes for the analysis of adverse events both in the postmarketing environment and during development.”