APCER Pharma Solutions' webinar on 2010 FDA drug safety and pharmacovigilance initiatives

APCER Pharma Solutions, Inc.’s webinar on 2010 FDA drug safety and pharmacovigilance initiatives gave more than 250 professionals in the life sciences-related industries the jump start they needed to prepare for important changes next year.

The agenda covered FDA initiatives from Food and Drug Administration Amendments Act (FDAAA) and Prescription Drug User Fee Act (PDUFA IV). These included:

• OMOP (Observational Medical Outcomes Partnership
• The Sentinel Initiative
• IMPACT (Initiative for Maximizing the Benefit of Passive Adverse Event Throughout a Product’s Lifecycle)
• REMS (Risk Evaluation & Minimization Systems)
• Registries
• Post-Marketing Commitments
• FDA Commissioner Dr. Hamburg's tightening of FDA's handling of 483 inspection results and new policy on Warning letters

Additionally, respected industry publication Bio-IT World’s eCliniqua included comments from webinar presenter Barton Cobert MD, APCER Pharmacovigilance Strategy and Client Services Advisor, in an article on FDA drug safety. The article is available at http://www.bio-itworld.com/2009/11/3/eclin-FDA.html.

APCER Vice President of Sales and Marketing Susan Jalbert said, “The tremendous response to our webinar demonstrates that companies in the pharmaceutical and biotechnology industries are concerned about next year’s FDA pharmacovigilance initiatives. APCER is uniquely positioned to prepare our customers and partners for increasingly tight industry surveillance.”