2014 Annual Meeting

MRCT Center at Harvard hosts its third Annual Meeting in 2014 at the Loeb House, 17 Quincy Street, Cambridge, MA ‎02138.

AGENDA:

2nd December 2014, Dinner

PART ONE (for Executive Committee, Steering Committee, & Conference Speakers)

6:00 – 8:00 pm: Dinner at Henrietta’s Table; welcoming of Harvard MRCT Executive and Steering Committee members as well as conference speakers

3rd December 2014, Annual Meeting

PART TWO (Open Meeting)

Registration and Breakfast

7:30 – 8:00 am: Participants’ Arrival, Registration, and Breakfast

8:00 – 8:30 am

Welcome

Introduction to Harvard MRCT and the Return of Results Guidance Document

Keynote Speakers on Returning Aggregate Results to Study Participants

8:30 – 8:50 am Regulatory perspective, EMA

Anabela Marcal, PharmD

8:50– 9:05 am Regulatory perspective, FDA

Richard Moscicki, M.D.

9:05 – 9:20am OHRP perspective

Jerry Menikoff, M.D., J.D.

9:20– 9:35am

NEJM perspective Jeffrey Drazen, M.D.

9:35 – 9:50 am Industry perspective, Merck

Michael Rosenblatt, M.D.

9:50 – 10:05 am PhRMA perspective

Jocelyn Ulrich

10:05 – 10:20 am Patient perspective, Dana-Farber

Elizabeth Frank

10:20 – 10:30 am NIH perspective

David Gordon, M.D., MPH, PhD

10:30 – 11:00 am Panel Discussion

Mark Barnes, J.D. (Moderator)

Break 11:00 – 11:20 am

11:20 – 12:00 pm India Regulatory

Trial Causality and Compensation Program

PART THREE

12:00 – 4:00 pm Closed Meeting for Executive and Steering Committees

PART FOUR

4:00 – 5:00 pm Executive Committee Session