PRINCETON, NJ – September 29, 2009 – APCER Pharma Solutions, Inc.’s (“APCER”) important new webinar will feature an enlightening approach to help prepare pharmaceutical companies for 2010 FDA drug safety and pharmacovigilance initiatives. The event is free of charge.

Title: FDA Pharmacovigilance 2010: New Initiatives & Compliance Matters

 Date: October 15, 2009
Time: 12:30 – 1:30pm EDT
To register: http://www.apcerpharma.com

The agenda will cover FDA initiatives from Food and Drug Administration Amendments Act (FDAAA) and Prescription Drug User Fee Act (PDUFA IV):

• OMOP (Observational Medical Outcomes Partnership) – Foundation of the NIH, FDA, PhRMA working together to assess the value, feasibility, and utility of observational data to identify and evaluate the safety risks and potential benefits of prescription drugs.
• The Sentinel Initiative – Will include development of the new electronic system, Sentinel System, to enable FDA to gather information about medical products by posing targeted queries of electronic health records, patient registry data, insurance claims data, and other large healthcare information databases.
• IMPACT (Initiative for Maximizing the Benefit of Passive Adverse Event Collection Throughout a Product’s Lifecycle) – Review of the FDA spontaneous reporting system starting later this year to last 12-24 months.
• REMS (Risk Evaluation & Mitigation Strategies)– Or, a Risk Management Plan (RMP), may now be required by FDA as at approval.
• Registries – Pregnancy registries and clinical trial registries now are required. FDA now is encouraging additional registries.
• Post-Marketing Commitments – From March to September 2008 FDA issued 21 letters requiring post-marketing studies for safety issues. Previously these were voluntary commitments.
• FDA Commissioner Dr. Hamburg's tightening of FDA's handling of 483 inspection results and new policy on Warning letters.

Presenters:

• Barton Cobert, MD, APCER Pharmacovigilance Strategy and Client Services Advisor – Dr. Cobert is a drug safety/pharmacovigilance expert physician with over 25 years experience in the pharmaceutical industry. His expertise includes gastroenterology, clinical research, regulatory affairs, ICH, compliance, training, risk management, drug safety crisis management, electronic data capture. Dr. Cobert was one of the founding members of the International Conference on Harmonisation (ICH) starting in 1989, has worked on several ICH Working Groups and co-chaired the PSUR update group. Dr. Cobert authored three textbooks on drug safety including The Manual of Drug Safety and Pharmacovigilance.
• Ron Lillie, APCER Client Services Director for Process Implementation, Training and Transition – Mr. Lillie has worked with safety service and software providers for more than 15 years. In the pharmaceutical industry he has served in a variety of consulting and product management roles supporting client safety initiatives and pharmacovigilance applications. Mr. Lillie is a member of the DIA and has presented topics such as Signal Detection, MedDRA and 21 CFR Part 11.