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Event Manager
Compliance4All
161 Mission Falls Lane, Suite 216
Fremont, CA 94539
(800) 447-9407

Event Description

Event Overview: 

Considering drug safety in an isolated way, i.e., not integrating the drug benefits into a BR statement has been detrimental to patients and the pharmaceutical industry. Over the last years regulatory authorities, patient interest groups and the industry have become more and more interested in structured approaches to benefit risk management.

The change in the structure of the PSUR to a Periodic Benefit-Risk Evaluation Report complementing the Risk Management Plan is probably the most important example of how benefit-risk thinking is integrated into the lifecycle management of a drug. Several methodologies available for the qualitative and (semi-)quantitative analysis of benefit-risk profiles are going to be discussed, including their relative advantages and disadvantages. Finally, we are going to cover reasons why the decision framework for BR may change post-approval and how to address these changes in order to maintain a favorable BR balance. 

Why should you Attend: The systematic assessment of a drug’s benefit-risk profile for the purpose of developing an integrated BR statement that helps in bringing a drug to the market and maintaining it there is a rather new challenge to the pharmaceutical industry triggered partially by a change in the format of periodic safety reports (PSUR) to Periodic Benefit-Risk Evaluation Reports (PBRER). Several methodologies for the development of such BR statements have been discussed and the choice of the "correct" one is not easy. A further challenge arises from the requirement to continuously re-assess the BR profile post-approval in an objective and transparent way. In this webinar we discuss ways to achieve a high-quality BR statement that satisfies the needs of regulators and aids patients and physicians in decision making about the use of a drug.

Areas Covered in the Session:

  • From "Drug Safety" to "Benefit-Risk Management"
  • The PBRER
  • Structure Benefit-Risk assessment / Frameworks
  • Challenges in BR management post-marketing


Who Will Benefit:

  • Pharmacovigilance professionals
  • Drug Safety Scientists
  • Safety Physicians
  • Regulatory Affairs Managers and Leaders
  • Medical Affairs Staff
  • Clinical Development Leaders

Contact Information:
Compliance4All
Phone: 800-447-9407
Fax: 302-288-6884
support@compliance4All.com
http://www.compliance4all.com
Event Link - http://bit.ly/1yHInWq

There may be many networking opportunities at the Benefit-Risk Assessment and Management. Find out more in the event details below.

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Event Details

Website: http://www.compliance4all.com/control/w_product/~product_id=500164LIVE...
Conference/Event Dates: 01/14/2015 - 01/14/2015
Classification: B2B
Primary Industry: Pharmaceutical
Other Industries: Clinical Pharmacology, Pharmaceutical, Professional Healthcare
Audience: Who Will Benefit:
Pharmacovigilance professionals
Drug Safety Scientists
Safety Physicians
Regulatory Affairs Managers and Leaders
Medical Affairs Staff
Clinical Development Leaders

Booth Details

Booth Size Booth Cost   Available Amenities
No exhibiting at this event.   Electricity: Yes - Unknown Price
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

Advance Networking

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Mark Travers

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