Speakers & Moderators

Information will be updated as additional speakers and moderators are identified.

Speakers
Michael Marcarelli, PharmD, M.S. Director Division of Bioresearch Monitoring	CDRH
Gina Brackett Compliance Officer – Medical Device Specialist	FDA Cincinnati District
Ken Sumner, Ph.D. WW VP, Clinical and Regulatory Affairs	Ethicon Endo-Surgery
Barbara Immel President, editor of Immel Report	Immel Resources LLC
Barbara Fant, PharmD President, Principal Regulatory Consultant	Clinical Research Consultants, Inc.
Paul Brooks VP, Country Manager	BSI Product Services
Monica Wilkins Sr. Director, Corporate QA and Compliance	Abbott Laboratories Former FDA

Session Moderators

Francis Blacha
Global Quality Leader – Devices

Eli Lilly and Company

Karen Coleman
Senior Compliance Expert

Consultant
Former FDA

Ken Sumner, Ph.D.
WW VP, Clinical and Regulatory Affairs

Ethicon Endo-Surgery

Barbara Immel
President, editor of Immel Report

Immel Resources LLC

Barbara Fant, PharmD
President, Principal Regulatory Consultant

Clinical Research Consultants, Inc.

Paul Brooks
VP, Country Manager

BSI Product Services

Monica Wilkins
Sr. Director, Corporate QA and Compliance

Abbott Laboratories
Former FDA