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Related Conference:
Third Annual
Post-Approval
Drug Safety Strategies

PHV Con banner
 
November 12-14, 2008
Arlington, Virginia

Risk Management Legislation, Guidance and Best Practices


 

The webinar will introduce strategies for solutions around common problems in implementing risk management plans.  Additionally, the webinar will detail definitions, components and processes associated with risk management, how to evaluate risks during clinical trials and post-marketing implementation of a risk management plan. 

What You Will Learn:

  • When to write a risk management plan
  • What should be included in a risk management plan
  • What risk management activities can be performed and when
  • How to establish your risk management activities within EU and FDA guidances
  • An understanding of risk management terminology
  • How to build the documentation of a risk management plan
  • How annual safety reports compare to risk management plans
  • How to test a risk management plan to ensure it will collect appropriate data without providing too much burden for health care providers

Instructor(s)
Robert G. Sharrar, M.D., M.Sc., Executive Director, Epidemiology and Risk Management, United BioSource Corporation
Chad Clark, Senior Vice President, Operations, United BioSource Corporation

Symposium Date
Wednesday, October 22, 2008

Symposium Length and Time
1.5 hours  12:00 – 1:30 p.m. (EST)

Symposium Fee
$495

Who Should Attend:

  • Safety
  • Regulatory
  • Epidemiology
  • Risk Management
  • Pharmacovigilance Staff
  • Commercial and Brand Team Leaders (Marketing)


For Sponsorship Information:
Contact: Arnie Wolfson,
Manager of Business Development
Pharmaceutical Strategy Series
Tel: 781-972-5431
Email: awolfson@healthtech.com



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