06 Aug

Mr. Nadolny is a pragmatic leader focusing on technology, innovation, strategic planning, change management, and the setup of new capabilities. Mr. Nadolny is currently the Global head of Clinical Data Management and Programming at Allergan. In his role, Patrick also leads change management initiatives in the field system…

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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Ni A. Khin, M.D., is Director of Division of Clinical Compliance Evaluation, within Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research, at FDA. In this position, she provides scientific oversight for CDER-assigned bioresearch monitoring (BIMO) activities including compliance programs of clinical investigators,…

11 Jun

Kassa Ayalew

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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

Jean Mulinde

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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…