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About

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Doris I. Stenver, MD, MPA

Independent Pharmacovigilance Adviser Founder of Unique Advice

Doris started her consulting business in 2019 after more than 30 years of clinical & regulatory experience. She is currently a Pharmacovigilance Adviser and the founder of Unique Advice, a consultancy specialized in
pharmacovigilance.

During 12 years (July 1986 – May 1998) she worked as a physician at university hospitals in the Copenhagen area, primarily in departments specialized in internal medicine, nephrology and endocrinology. In 1995 she became a specialist in internal medicine. Her clinical experience also covers hematology, cardiology and infectious diseases. Her research activities and publications were primarily within the areas of hematology, immunology, nephrology and endocrinology.

In June 1998 she joined the Danish Medicines Agency, initially as a senior medical officer; appointed chief medical officer in 2002. She was member of the EU Pharmacovigilance Working Party from June 1998 until July 2012. From July 2012 until end of February 2019 she was a member of the Pharmacovigilance Risk Assessment Committee (PRAC). Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, and communication to health care professionals and the public. She is the author of several international publications on various aspects of pharmacovigilance and an experienced conference organizing committee member and speaker / moderator.

Doris holds a Medical Degree from Copenhagen University, Faculty of Medicine (1986) and a Master Degree in Public Administration, Copenhagen Business School (2007).

Meet the Featured Guest

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Arthur Meiners

Pharmacovigilance Consultant Owner of Perspektivo, The Netherlands

Arthur Meiners grew up in the Caribean and studied in the USA and Netherlands. He is an internist-nephrologist by training until 1991. Started working as a clinical assessor in 1991, and then set up and headed the pharmacovigilance department at the Dutch Medicines Evaluation Board, was PhVWP member, and ICH E2B (and MedDRA) member) in the period 1993-2001. Switched to industry and was QPPV and deputy QPPV from 2001-2010 after which I became an independent consultant providing PV services such as general PV consultancy, PV training, product safety expert roles in several companies, PV audits, and due dilligence support for new opportunities. In addition, he has been tinkering with computers since the 1970s, was an early supporter/developer of multicopter drones, and makes kayaks from printed cloth covered styrofoam.