11 Jun

As Chief Business Officer, Jonathan Andrus leads Clinical Ink’s solution management & compliance teams to help sponsors and CROs better leverage eSource, eCOA and ePRO data. With 20+ years of experience, Mr. Andrus brings extensive expertise developing eClinical services that integrate data and technology to help life science…

11 Jun

Lisbeth has been a GCP and pharmacovigilance inspector at the Danish Health and Medicines Authority since 2006. Prior to that, she has experience from the authority perspective on regulatory affairs and as an assessor of clinical trial protocols (1993-1999), from a research and hospital perspective (Clinical pharmacology at…

11 Jun

Ni Aye Khin

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Dr. Ni Khin is currently Division Director in Division of Clinical Compliance Evaluation, Office of Scientific Investigations, CDER, FDA. In this position, she provides regulatory scientific oversight for CDER assigned bioresearch monitoring activities. She participates in onsite inspections of sponsors/CRO and clinical investigators both in the US and…

11 Jun

Kassa Ayalew, M.D., M.P.H., serves as Branch Chief for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. Dr. Ayalew oversees verification of the integrity of efficacy and safety…

11 Jun

Dr. Mulinde is currently the Senior Policy Advisor for the 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 CDER’s Office of New…

11 Jun

Kent Thoelke is the Chief Scientific Officer and Executive Vice President of PRA Health Sciences.  With over 28 years in the drug development and clinical trials industry, Mr. Thoelke has had the opportunity to participate in all levels of drug research from the bench to the bedside globally. …

23 Jan

Carol, an Asset Lead in the Inflammation and Immunology therapeutic area at Pfizer, has 25+ years of Pharma experience where she started in research as a protein biochemist and moved into the Clinical Data Management arena in 2000. She has experience in both Early and Late Phase clinical…

07 Dec

Dawn has over 20 years of experience in the pharmaceutical industry. She has worked within every level of clinical data management, from Data Coordinator to Director where she has participated in or had oversight for more than 250 clinical trials across various therapeutic areas. During her time in…

07 Dec

Alexander Bragat currently serves as director of DataCore, an NYU Langone Health resource that provides services in clinical research data management, extraction, analysis and other areas. In this role, Mr. Bragat ensures that the NYU Langone clinical research community has access to best practices, expertise, processes and software…