Bethesda North Marriott Hotel and Conference Center

2017 年 02 月 06 日 7:00 上午 - 2017 年 02 月 08 日 5:00 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

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Continuing-Education

Short Course or Primer

To keep you at the forefront.

2017 年 02 月 06 日

Course 1:

Global Identification of Medicinal Products (IDMP)

2017 年 02 月 06 日

Course 3:

Achieving Regulatory Operations Excellence Through Outsourcing

2017 年 02 月 05 日

Regulatory Content and Submissions Primer:

项目委员会

  • Michelle L. Charles, MPH
    Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program
    University of Pennsylvania, Perelman School of Medicine, United States
  • Ginny  Hussong
    Ginny Hussong Branch Chief, Data Standards, CBER
    FDA, United States
  • Sarah  Powell, RAC
    Sarah Powell, RAC President
    Powell Regulatory Services, United States
  • Jamie  Toth, MS
    Jamie Toth, MS Global Head, TMF Management & Records
    Beigene, United States
  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA Healthcare and Life Sciences Strategic Advisor
    VB Insights, LLC, United States
  • Christian A. Buckley, MBA, RAC
    Christian A. Buckley, MBA, RAC Associate Director, Regulatory Affairs
    Astellas, United States
  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Vice President, Advisory and Delivery
    Epista Life Sciences, United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States

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