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Regulatory Strategy Forum for Biologic Products

  September 21, 2012  
Regulatory Affairs Professionals Sociaty, Rockville, Maryland
10-11 December 2012


Tuesday, 11 December 2012
9:00 amWelcome and Day 2 Overview
9:10 amRegulatory Strategy Beyond Market Approval
This session will discuss postmarket requirements that should be considered in developing a regulatory strategy. Topics may include postmarket clinical studies, postmarket reporting requirements and advertising and promotion.
10:15 amBreak
10:30 amBiosimilars Regulatory Pathways
This session will provide an update on regulatory pathways for biosimilars in major regulatory systems. Special attention will focus on how the development of biosimilar products will affect regulatory strategy planning for an innovator product.
11:30 amCase Study Analysis
Participants will be divided into teams that will each prepare a global regulatory strategy (GRS) for the fictitious biologic product. This session will begin with an introduction of your fictional product, the Regulatory Strategy Document (RSD) template and the expectations for the template’s completion.
12:30 pmLunch
1:30 pmGroup Presentations:
In this session, the groups will present their results from the RSD with an active Q&A session.
2:00 pmRole of Regulatory Intelligence in Strategy Development
This session will illustrate the role of regulatory intelligence in developing a global regulatory strategy, and the various sources of information available to stay current on the global regulatory environment.
2:30 pmAdjourn
Organized by: Regulatory Affairs Professionals Sociaty
Invited Speakers: Speakers will be announced shortly.
Deadline for Abstracts: 30 November 2012
REGISTRATION FEESRegister by 19 NovemberRegister after 19 November
RAPS Member$1,195$1,345

* The above nonmember fees include RAPS membership for 12 months for qualified applicants. By registering you acknowledge that you have reviewed and understand the membership qualifications and accept membership with the Regulatory Affairs Professionals Society.

E-mail: acallery@raps.org
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