Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Clarion Hotel Dublin City

Oct 07, 2013 2:00 PM - Oct 07, 2013 5:30 PM

Excise Walk, IFCS, Dublin 1, Ireland

Workshop 1: THE CLINICAL TRIALS TRANSFORMATION INITIATIVE

Speakers

Pamela  Tenaerts, MD, MBA

Pamela Tenaerts, MD, MBA

Chief Scientific Officer, Medable, United States

Dr. Pamela Tenaerts, currently serving as Medable's Chief Scientific Officer, is a respected advocate for clinical trial innovation. At Duke University, she previously led the Clinical Trials Transformation Initiative, improving efficiency and the quality of trials. With over three decades in conducting and researching clinical trials, her focus on patient engagement and evidence-based approaches has been notable. A board member at MedStar Research Institute, and an active member of the Drug Forum of the National Academies of Science, she holds an MD from the Catholic University of Leuven and an MBA from the University of South Florida.

Fergus  Sweeney, PhD

Fergus Sweeney, PhD

Head of Clinical Studies and Manufacturing Task Force, European Medicines Agency, Netherlands

Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing and personal data protection in health research on medicines. He joined the EMA Inspections Service in 1999, and became Head of Compliance and Inspections (2009) and Head of Division Inspections and Human Medicines Pharmacovigilance in 2013 (including Scientific Committee Services from 2016). He has a BA (Physiology 1979) a Dr de 3eme Cycle (cancer biology 1982), and PhD (Pharmacology 1986). Fergus worked in clinical research mainly in QA from 1982 to 1999.

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.

Christina   Reith

Christina Reith

Clinical Research Fellow, University of Oxford, United Kingdom

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.