Programme

Panel Discussion | Case processing in EU: special topics for EV cases availability


About the speaker
Mircea Ciuca

Mircea Ciuca, MD is currently Global Head of Medical & Clinical Drug Safety at Vifor Pharma in Switzerland. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings.
Mr. Ciuca has about 13 years of experience in drug safety. Prior to join Vifor Pharma he held various positions (Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large pharmaceutical companies in The Netherlands, after successfully establishing and leading the medical-scientific department of a medium-size CRO in Rotterdam.
After graduating from University of Medicine and Pharmacy in Bucharest Romania, he became specialist in Emergency Medicine, and later in Obstetrics & Gynecology. He was involved in clinical practice and academic teaching for about 12 years. Later he has completed postgraduate studies in Pharmacovigilance at University of Hertfordshire, UK.

Jan Bart Hak

Jan-Bart Hak is heading the medical device department of ProPharma group, in Leiden, the Netherlands. He and his team provide services, internationally, in various medical device related areas such as quality management systems, regulatory affairs, clinical strategy and product development.

Prior to ProPharma Group, Jan Bart held different management positions in clinical and regulatory affairs at international oriented companies, such as Xendo, QPS and Cordis (Johnson & Johnson). He also worked at a small startup company in biodegradable medical devices. As a Medical Biologist, Jan Bart holds a Ph.D. degree in cardiac physiology.

Sonia López

Pharmacist. Master in Safety of Medicine: Pharmacovigilance and Studies Post-Autorization. Experience in Pharmacovigilance: 19 years. Management and coordination of Scientific Committee of Pharmacovigilance of the Spanish Association of Industry Pharmacists (AEFI) (2000 up to now). Collaboration with the Spanish Competent Authorities for the elaboration of Good Pharmacovigilance Practices. Professor/trainer in Pharmacovigilance courses/congress/symposiums (2010 up to now). She joined Asphalion: 2014
Professional experience and roles:
Acting as EU-QPPV and local QPPV as a service for third-party companies and in previous industry positions
Expert in auditing, creation and maintenance of PV Quality Systems, PV training, case management, PSUR and PSMF elaboration, Review and elaboration of PV Agreements.

Elena Prokofyeva

Dr. Elena Prokofyeva is head of the drug safety unit at the Department of Research & Development, DG PRE, FAMHP, Brussels, Belgium. She represents Belgium within the CTFG safety subgroup where she initiated and led an update of the Q&A-RSI document. She is also actively involved in the preparation of the safety related part of the Clinical Trials Regulation (EU) No 536/2014 Questions & Answers document and the Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials.
Dr. Prokofyeva holds a research doctorate from the University of Tuebingen, Germany, a Ph.D. and an M.D. from the Northern State Medical University, Arkhangelsk, Russia, and a Master of Public Health from the University of Umeå, Sweden. Harmonization of safety assessment across members of states in Europe, preparation for the implementation of safety related parts of clinical trial regulation, and safeguarding the safety of trial participants are the main objectives of her work.

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