Become a member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Renaissance Glendale Hotel and Spa

Mar 16, 2015 1:00 PM - Mar 18, 2015 4:30 PM

9495 W. Coyotes Boulevard, Glendale, AZ 85305

Medical & Scientific Communications 2015 Annual Forum

Back to Agenda

Session 7 Track C: Safety is at the Core: Impact of Core RMP on Labeling and PBRERs

Session Chair(s)

Valerie Perentesis, PharmD

Senior Director, Pharmacovigilance Evaluation, Reporting & Systems

Janssen Research & Development, LLC, United States

A key responsibility that pharmaceutical companies bear when marketing a drug product is to increase knowledge about the safety of the product, identify effective ways to manage risks, and evaluate the risk-benefit profile of the product on a routine basis. This responsibility is growing as the landscape of pharmacovigilance continues to evolve and the pressure has rightfully increased for companies to be more transparent, more proactive, and more sophisticated with regard to patient safety. In today’s environment of increased public scrutiny, high standards in good pharmacovigilance practices, regulatory hurdles, and the complexity of more information from more places, companies need to strategically manage all aspects of safety. The Risk Management Plan and Periodic Benefit Risk Evaluation Report (PBRER) are core strategic documents that enable a company to help fulfill their rigorous safety obligations and communicate the appropriate benefit risk message of the product. This session will provide different perspectives on how to develop and align these documents from a unified position.

Learning Objective : • Summarize regulatory guidelines on risk management plans and periodic benefit risk evaluation reports
• Identify different approaches to creating core risk management plans including how to account for regional differences
• Describe the connections between risk management plans and periodic benefit risk evaluation reports
• Identify potential concerns and solutions when leveraging a core risk management plan in the PBRER

Speaker(s)

Faculty

Dessislava Dimitrova, MD, PhD

Janssen Research and Development, LLC, United States

Snr. Director, Head of Risk Management Center of Excellence, Global Medical Org.

Natalie Gearhart, PharmD

Faculty

Natalie Gearhart, PharmD

Johnson and Johnson, United States

Associate Director, External Engagement Strategy, Medical Affairs

Faculty

Ana L. Aymes, PharmD, RPh

Bristol-Myers Squibb, United States

Associcate Director (Manager) Global Aggregate Reporting & Documentation

Have an account?