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Online

Protocols, Research Participants, and Safety in the Context of War

Complimentary 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

Anina  Adelfio

Anina Adelfio

COO, Association of Clinical Research Organizations (ACRO), United States

Beate  Aurich

Beate Aurich

Pharmacovigilance and Drug Safety Consultant, conect4children, France

Dr. Beate Aurich is a pharmacovigilance/ drug safety physician, general paediatrician (MRCPCH London) and a methodological expert for paediatric pharmacovigilance in the 'conecting4children' (c4c) network. She has twenty years of pharmacovigilance and drug safety experience in pharmaceutical industry and academia. She is a member of ISOP, ISPE and ESDPPP and fellow of the governance, ethics, evidence, policy, practice (GE2P2) Global Foundation. Currently she is the head of Drug Safety Consulting S.A.S.U., an independent pharmacovigilance and drug safety consultancy for academic and industry sponsored paediatric and adult clinical research.

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.

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.

Olena  Popova

Olena Popova

Sr. Director, Clinical Operations and General Manager, IQVIA, Ukraine

Olena Popova is the Sr. Director, Clinical Operations and General Manager, IQVIA RDS Ukraine. From 1985 till 1992, she studied at National Medical University. From 1992 till 2000, she worked as a physician at endocrinology hospital. From 2000 till the present, she has been working for IQVIA RDS Ukraine holding CRA, Clinical Operation Manager, Site Management Head roles.

Anastasiia  Saliuk

Anastasiia Saliuk

Senior Project Manager, Ukraine Response, EURORDIS - Rare Diseases Europe, France

Anastasiia joined EURORDIS in May 2022 as Senior Project Manager where she takes responsibility for the operational components of the Ukraine response project and helps refine the organization’s priorities and activities in this area. Prior to EURORDIS, Anastasiia worked in humanitarian aid and international public law including leading two Council of Europe human rights projects in the Republic of Moldova. Prior, she worked in aid agencies, such as the International Committee of the Red Cross and Doctors Without Borders, supporting the organisations’ activities in Ukraine. She holds a Master of Laws degree from the Kyiv National Economic University and a Master’s degree in European Public Affairs and Policy from the College of Europe.

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