SCDM #EMEA24 Regulatory Townhall

Jonathan leads CRIO’s customer experience, engineering, product management, quality management and sales and marketing teams. With over 27 years of experience in operations, data management, quality and commercial operations, Jonathan brings a wealth of real-world experience. An active thought leader, blogger and presenter, Jonathan serves on the board and executive committee of the Society for Clinical Data Management (SCDM) and has been on the advisory boards of CDISC and DIA. Jonathan is co-lead with the Decentralized Trials and Research Alliance (DTRA) workstream initiative and a co-author on upcoming eCOA Consortium publications.

Kassa Ayalew is Division Director for 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 data submitted to the FDA in support of new drug and biologic applications and the protection and assurance of the rights and welfare of human research subjects.

Dr. Ayalew received his M.D. in 1989 from Haile Selassie University Medical Faculty in Addis Ababa, Ethiopia. Following graduation, he worked as an Assistant Professor in the Department of Pediatrics at the Gondar University of Medical Sciences. He completed postgraduate training in pediatrics and child health at Leipzig University in Germany and at the Long Island College of Hospital followed by a fellowship program at Children’s National Medical Center/ George Washington University where he also obtained an MPH in public health. Dr. Ayalew holds an active license to practice medicine in State of Virginia. He is board certified in Pediatrics and Infectious Disease.

Dr. Ayalew also works at Patient First Primary and Urgent Care in Virginia where he provides clinical services to both pediatrics and adult patients. He has given numerous didactic lectures, case presentations and published publications in peer review journals. He has decades of clinical and regulatory work experience.

Dr. 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.

Lisbeth 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.

Mandy Budwal-Jagait is the Head of GCP at the Medicines and Healthcare Products Regulatory Agency (MHRA). She is responsible for the MHRA GCP Inspection Programme and is also a Lead Senior GCP Inspector. Mandy has worked in the MHRA as an inspector since 2014 and during this time was also Head of the pharmacovigilance inspection team for 2 years.

Prior to joining the Agency, Mandy has held Clinical Research and Quality Assurance roles in the Pharmaceutical Industry. She holds a MSc in Toxicology and BSc (Hons) in Medical Biochemistry