Developing and Maintaining Sponsor/CRO Partnership Regulatory Submissions Processes: Challenges and Successes
Track
:
Track 03: Innovative Partnering Models and Outsourcing Strategies
Program Code:
228
Date:
Tuesday, June 25, 2013
Time:
10:15 AM to 11:45 AM
EST
Location:
104AB
CHAIR
:
Bill Leslie, (SCHNON), Executive Director, Global Regulatory Submissions, Covance Inc., United States
Bill joined Covance in May 2009 where he leads the Global Regulatory Submissions department. GRS is responsible for submissions to global regulatory authorities in support of clinical trials and marketing applications. Bill had similar roles in large pharma for over 25 years before joining Covance.
SPEAKER
(S):
Denise Booker, MS (SPKNON), Associate Director and Relationship Manager, Merck & Co., Inc., United States
Responsible for developing and optimizing Global Strategy and Services, focused on worldwide clinical trial applications for bio/pharmaceutical and medical device client companies. She advises clients in the areas of drug development strategy and best regulatory and clinical practices.
Description
Over four years ago, Merck selected Covance and PAREXEL as alliance partners. Representatives from each company will speak to challenges faced in building relationships leading to successful processes and enabling quality regulatory submissions.