CONFERENCE PRESENTATION · September 13, 2022
SCDM 2022 Annual Conference - Regulatory Panel
OverviewThis SCDM 2022 Regulatory Town Hall, a conference favorite, included both US and European regulatory officials.
The town hall speakers are representatives from the US Food and Drug Administration, the Danish Medicines Agency and from Germany, The Federal Institute for Drugs and Medical Devices (BfArM).
This 2022 topics covered a review of the proposals related to PDUFA VII (with a focus on topics of interest to the SCDM community – RWE, Digital Health Technologies), a deeper dive into the Sponsor/CRO Program Guide and follow up with case studies demonstrating the importance of good data governance practices. Finally, updates on ICH E6 (r3), Artificial Intelligence and Decentralized Clinical Trials guidance were also covered.
Meet the Presenters
President & COO, CRIOAs President and COO,Jonathan leads CRIO’s customer experience and quality management teams. With 25+ years of experience, Jonathan brings extensive expertise developing eClinical services that integrate data and technology to help life science companies optimize study execution.
Prior to CRIO, Jonathan served in numerous roles at Clinical Ink, including leading sales, solution management, operations and data management to help sponsors and CROs better leverage eSource, eCOA and ePRO data.
Jonathan joined Clinical Ink from BioClinica where he led the eClinical Solutions Group to develop their current service offerings, including data management, quality management, implementation services and IRT. Prior to BioClinica, Jonathan worked in pharmaceutical consulting and with CROs focused on quality, data management and validation.
An active thought leader, blogger and presenter, Jonathan has served as chair of the Society for Clinical Data Management (SCDM) in 2008 and 2013 and currently serves as the society’s Treasurer. Jonathan is an active member of DIA (Program Committee), Decentralized Trials Research Alliance (DTRA), eCOA Consortium and ASQ. Jonathan earned his bachelor’s and master’s degrees from Temple University’s College of Liberal Arts and Graduate School of Pharmacy and Jonathan is a Certified Quality Auditor (CQA) and Certified Clinical Data Manager (CCDM®).
GCP Inspector, BfArMDr Torsten Stemmler obtained his doctorate in Biology (focus on Neurobiology and Psychophysics) at Bremen University, Germany in 2011. Then he moved to the RWTH Aachen, were worked as a post-doc on visual perception. He retrained as a Data Manager and developed data base solutions at the University Hospital Aachen. In 2017, he started at the Federal Institute for Drugs and Medical Devices as GCP inspector.
After five years as GCP inspector, he contributed in the regulatory network on developing guidelines, qualification opinions and scientific advice. His main contributions are on trial documentation, electronic data, computer systems, and artificial intelligence.
Artificial intelligence has captured his interest since his time as doctoral candidate, where he was part of a team at Serre Lab that tried to distinguish cognitive states by measuring pupil size (Single-trial decoding of binocular rivalry switches from oculometric and pupil data, Journal of Vison 2011).
Clinical Pharmacologist, US Food and Drug AdministrationCheryl Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and scientific and clinical oversight to FDA field investigators. She serves as a subject matter expert in GCP inspections to evaluate data integrity, quality, and safety of human subjects in clinical trials.
Medical Officer, Policy Advisor, US Food and Drug AdministrationDr. 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 Drugs. 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. Before joining the FDA, she served as Assistant Professor of Medicine in the Division of Infectious Diseases, Program of Traumatology, at the University of Maryland’s R. Adams Cowley Shock Trauma Center.
Lisbeth Bregnhøj, The Danish Medicines AgencyLisbeth has been a GCP/PhV inspector at the Danish Medicines Agency since 2006. Prior to that, experience with regulatory affairs and as a clinical trial assessor. She also has experience from a research and hospital perspective from working with clinical pharmacology at a University Hospital in Denmark and experience as ab auditor in the medicinal industry.
Lisbeth has for the last 16+ years performed numerous national and international GCP and GVP inspections, on behalf of the Danish Medicines Agency and the European Medicines Agency in various settings such as sponsor sites, CRO/vendor sites and investigator sites.
Lisbeth is part of the GCP Inspectors Working Group and of the e-sub group currently drafting the guidance on expectations for electronic systems and data in clinical trials. She is also part of the ICH E6 revision 3 Expert Working Group
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