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Speakers

Sabine Straus

CBG - MEB

Sabine

Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in The Netherlands since 1997, where she started as an assessor Pharmacovigilance. Prior to working at MEB she held different positions in the pharmaceutical industry for 12 years, her last job was Medical Director at Searle Monsanto in The Netherlands. In the period 2001 - 2004  she combined her work at the MEB with a research position at the Erasmus Medical Center in Rotterdam on the topic "drugs, Qtc prolongation and sudden cardiac death". In addition she started her training as clinical epidemiologist at the same university and completed her Master of Science in Clinical Epidemiology in 2002. Her research resulted in a PhD degree in 2005.

From December 2005 until July 2012 she was Head of the Department of Pharmacovigilence. As of July 2012 she is a staff member at the MEB and the Dutch representative in the Pharmacovigilance Risk Assessment Committee (PRAC). In addition to her work at the MEB she holds a position as associate professor at the Erasmus Medical Center, department of Medical Informatics in Rotterdam. Her main research focus is on additional risk minimisation, pregnancy prevention programs, signal detection and signal management.

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • The new PRAC: six months after inauguration

4th Annual Biopharmaceuticals Meeting:

  • Pharmacovigilance in the EU with emphasis on biopharmaceuticals – PRAC activities update

Markku Toivonen

NDA Advisory Services Ltd.

Markku

Dr. Toivonen qualified as a physician and specialist in internal medicine from Helsinki University. A regulatory professional with over 25 years of experience from positions in pharmaceutical industry (Orion Pharma), regulatory authorities and consultancy. As of April 2005, Dr. Toivonen is Scientific Director of NDA Advisory Services Ltd. and member of NDA Advisory Board. Prior to this he was Head of Section, Marketing Authorisation Department (2003 - 2005) and Senior Medical Officer (1997 - 2002) both at the National Agency for Medicine. He was a member of the CPMP/CHMP 1997 - 2004.

Dr. Toivonen chaired the EMEA Scientific Advice Working Party (2003-2004); the CPMP Scientific Advice Review Group (SciARG) (2000-2003); and the CPMP Ad hoc group on (pre-) clinical comparability of biotech products (2001-2002).

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • A case study for the indication multiple sclerosis

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