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San Diego Convention Center

Jun 15, 2014 9:00 AM - Jun 15, 2014 5:00 PM

111 W Harbor Drive, , San Diego, CA 92101 , USA

#44: Quality by Design: From Theory to Practice

Speakers

Annemarie  Forrest, MPH, MS, RN

Annemarie Forrest, MPH, MS, RN

Research Senior Supervisor/Program Manager, University of Michigan, United States

Annemarie Forrest is the Director of Projects for CTTI. Ms. Forrest provides senior operational leadership for core activities such as project management, site management, personnel management, financial performance, regulatory compliance, information systems, and process improvement.

Jean M. Mulinde, MD

Jean M. Mulinde, MD

Associate Director, Division of Clinical Compliance Evaluation, OSI, FDA, United States

Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in OND. She received her M.D. and completed a residency in Internal Medicine at the University Of South Alabama School Of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine.

Ann  Meeker-O'Connell, MS

Ann Meeker-O'Connell, MS

Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC, FDA, United States

Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy (OCLiP) in the Office of the Commissioner. In this role, she leads an organization that coordinates and supports the development of clinical trial and human subject protection -related policy across the agency. Ms. Meeker-O’Connell has more than 20 years of experience in biomedical research and development in government, academic, and industry settings, including prior FDA service as the Acting Director of the Division of Good Clinical Practice Compliance in CDER. Ann earned her MS in Pharmacology, and was an NIH Integrated Toxicology Fellow, at Duke University.

John H. Alexander, MD

John H. Alexander, MD

Director, Cardiovascular Research; Vice Chief, Clinical Research, Cardiology, Duke Clinical Research Institute, United States

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