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BioNJ Legal Forum

May 14, 2014

BioNJ Legal Forum

Wednesday, May 14, 2014
8:00 a.m. – 10:30 a.m.

Daiichi Sankyo, Inc.
Parsippany, NJ

“There’s No Such Thing as a Free Launch”
Key Factors for Ensuring Marketplace Success for Newly Approved Products 

The pressures brought to bear on a new product launch have never been greater than they are in today’s healthcare and regulatory environment. Successfully bringing a product to market starts well before FDA approval and there is much work to be done leading up to and following the commercial launch.

During this forum, we will look at the commercial, legal and regulatory considerations that must be accounted for as part of any launch team’s planning. Among other issues, we will examine the characteristics of recent launch successes, prudent communications and activities a company might engage in prior to approval, and strategies for ensuring promotional materials are available at launch while core launch pieces are under review by the Office of Prescription Drug Promotion (OPDP).

Agenda

8:00 a.m. – 8:30 a.m. – Registration and Networking Breakfast
8:30 a.m. – 10:30 a.m. – Program

Roundtable Panelists Include:

Candy Lurken
Senior Manager, Life Sciences Strategy
Deloitte Consulting, Inc.

Mark Meltz
Associate General Counsel, Corporate
Biogen Idec

Gina L. Vestea
Director, US Regulatory Affairs Marketed Products
Sanofi US

Moderator:
Mark Gaydos
Vice President, US Regulatory Affairs, Marketed Products
Sanofi US

Do not forget to sign in when you arrive. Attendees of this Forum are eligible for Continuing Education Credit. BioNJ is an Approved Provider for the NJ Board on Continuing Legal Education.

BioNJ Thanks Our Host

Daiichi Sankyo, Inc.

BioNJ Thanks Our Sponsors

Buchanan Ingersoll & RooneyDeloitte

Morgan LewisPepper Hamilton

ReedSmithSanofi

Registration

Details

Date:
May 14, 2014
Event Category:

Venue

Daiichi Sankyo, Inc.
9 Entin Road
Parsippany, NJ United States