Complimentary McKesson webinar on FDA REMS

CBI's Complimentary Webinar: Submitting a Proposed REMS-- How to Comply with FDA Guidance

Sponsored By: McKesson

Date: Wednesday, January 13, 2010

Time: 12:00 PM - 1:00 PM ET 

Speakers:

• Ravi Deshpande, Pharm.D., Vice President Risks and Registry Solutions, McKesson Corp.
• Heather Morel, Vice President & General manager Reimbursement & Access Services, McKesson Corp.

In September, the FDA issued its draft guidance document "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications." The document reflects the FDA's current thinking about REMS and provides initial guidance and templates for REMS submissions to the FDA. It is the first guidance provided by the FDA on REMS since the Food and Drug Administration Act of 2007 was enacted and is a critical document for pharmaceutical and biotech manufacturers to understand and integrate with its go-to-market strategies.

This webinar provides:

·         Third-party interpretation and perspective on FDA REMS draft guidance document

·         Tips on completing REMS submissions following the templates and guidance of the FDA and based on real experiences

·         Perspective of FDA trends and patterns in imposing REMS programs

·         Increased awareness of potential future intentions of FDA when it releases its final FDA guidance document on REMS in 2010

To register, please click here. For more information, please visit our website.

Who should participate:

Drug Safety Medical Affairs Pharmacoepidemiology Pharmacovigilance Safety Surveillance Risk Assessment Adverse Event Reporting Regulatory Affairs Risk Management Medical Product Safety Assessment Phase IV/Post-Marketing Studies

Health Outcomes Global Drug Safety Global Medical Affairs Clinical Affairs Scientific Affairs Product Management Clinical Development Product Safety Safety Scientists Medical Advisor