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

Welcome and Opening Remarks

Session Chair(s)

Sudip  Parikh, PhD

Sudip Parikh, PhD

Senior Vice President and Managing Director, DIA Americas

DIA, United States

Welcome and Opening Remarks

Speaker(s)

Sarah  Powell, RAC

Program Co-Chair

Sarah Powell, RAC

Powell Regulatory Services, United States

President

Jamie  Toth, MS

Program Co-Chair

Jamie Toth, MS

Beigene, United States

Global Head, TMF Management & Records

Michelle L. Charles, MPH

Program Co-Chair

Michelle L. Charles, MPH

University of Pennsylvania, Perelman School of Medicine, United States

Director, Regulatory Affairs, Gene Therapy Program

Ginny  Hussong

Program Co-Chair

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

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