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Questions of Ethics in Clinical Trials & The War in Ukraine – Part 2

Complementary for DIA members, this global webinar series shares the clinical trial challenges in Ukraine and the region. Join us to create strategies for the future.

Presenters

Katrina  Bramstedt, PhD

Katrina Bramstedt, PhD

Global Head of Bioethics, Roche, Switzerland

Dr Bramstedt has 20-years' experience as a bioethicist across industry, academia, and clinical care. Additionally, she is an Associate Editor at the Journal of Bioethical Inquiry, as well as Adjunct Professor at Bond University's medical school. She has authored over 100 peer-reviewed journal articles on various topics including research ethics, research integrity, and donation/transplant ethics. She is the former Chief Executive of the Luxembourg Agency for Research Integrity, and former Sr Ethics Officer at Philips.

Francis P. Crawley, FFPM

Francis P. Crawley, FFPM

Executive Director, Good Clinical Practice Alliance - Europe (GCPA) (SIDCER), Belgium

Francis P. Crawley is the Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) and the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) in Brussels, Belgium. He is a philosopher specialised in ethical, legal, and regulatory issues in health research, having taught at several European, Asian, and Middle East universities. He is an expert in ethical review, data protection, and data sharing. He is a Data Protection Officer (DPO) on European Commission funded clinical research programmes. He currently chairs the methodologies sub-group of the Real Word Data Working Group at the Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians.

Viktoriia  Dobrova, DrSc, PharmD, PhD

Viktoriia Dobrova, DrSc, PharmD, PhD

Professor, Vice-chairperson, Research Ethics Committee of Clinical and, Diagnostics Centre, Ukraine

Viktoriia Dobrova is PhD (Medical Device) and Doctor of Science (Pharmacy), professor, and Vice-chair of the Research Ethics Committee of the Clinical and Diagnostics Centre of the National University of Pharmacy, Ukraine. She focused on studies in the fields of quality management and good statistics practice clinical trials, cost-effectiveness analysis, and research ethics. She took part in research ethics projects at international as well as national levels. She was involved in the development of regulatory guidelines, Master Degree Program “Clinical trials” for Clinical Research Professionals in Ukraine, and designed the curriculum and core courses for it. Now she is a Research Associate at Heidelberg University Hospital, Germany.

Courtney  Granville, PhD, MPH

Courtney Granville, PhD, MPH

Chief Scientific Officer, GO2 For Lung Cancer, United States

Dr. Granville provides insight, guidance, and a collaborative approach to build DIA’s thought leadership, research and content strategy to support innovation and building efficiency in drug, device and diagnostics development. She brings 2 decades of regulatory science-related research experience to her role at DIA. Her research career focused on developing data to support regulatory decision making in the fields of tobacco regulatory science, preclinical and molecular toxicology, nonclinical drug development, and public health. She holds a BS in Biology from Yale University, an MSPH in Environmental Health from UNC Chapel Hill and a PhD in Biochemistry and Molecular Genetics from George Washington University.

Sandor  Kerpel-Fronius, DrSc, MD

Sandor Kerpel-Fronius, DrSc, MD

Department of Pharmacology and Pharmacotherapy , Semmelweis University , Hungary

Dr. Kerpel-Fronius was born in Budapest, Hungary in 1940. He obtained medical diploma and board certificates in Clinical Laboratory Sciences and Clinical Pharmacology. He received PhD degree and DSc titles from the Hungarian Academy of Sciences. First, he worked in neurobiology at the Semmelweis University, later he led a clinical research group at the Hungarian National Institute of Oncology. Between 1989-2001 he worked in the international pharmaceutical industry. In 2001 he became Professor of Clinical Pharmacology at the Semmelweis University. In 2016 he was appointed Honorary Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians. He is member of the IFAPP Ethics Working Group.

Chieko Ms. Kurihara

Chieko Ms. Kurihara

Specially-appointed Professor, Kanagawa Dental University, Japan

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