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Park Plaza Amsterdam Airport

May 14, 2019 8:00 AM - May 15, 2019 5:15 PM

Melbournestraat 1, 1175 RM Lijnden, Netherlands

Regulatory Aspects in Pharmacovigilance and Practical Examples

Module 2 of the MEB/DIA Excellence in Pharmacovigilance training course covers key elements for the establishment of a quality system in Pharmacovigilance including aspects of safety reporting requirement in the clinical trial as well as post-authorisation phase.

Faculty

Kiki  Cheung

Kiki Cheung

Inspector, IGJ, Netherlands

Kiki Cheung works as a pharmacovigilance inspector at the Dutch Health and Youth Care inspectorate since 2013 after finishing her master in Epidemiology. Besides conducting inspections, she has also been involved in the development of a Risk-Based system for national inspections to effectively monitor the compliance of marketing authorisation holders.

Ineke  Crijns

Ineke Crijns

Senior Pharmacovigilance Assesor, Medicines Evaluation Board, Netherlands

Ineke Crijns is a medical doctor specialised in Pharmaceutical Medicine and PhD. After working as a resident / house officer in Obstetrics and Gynaecology, started working for a contract research organisation, followed by a position as medical adviser in pharmaceutical industry and working for the Dutch MEB as a senior assessor pharmacovigilance since 2000. During 2001-2009, she was (alternate) member of the Pharmacovigilance Working Party of the CHMP on behalf of the MEB.

Wendy  Huisman, PharmD

Wendy Huisman, PharmD

VP Quality and Patient Safety, Avanzanite Bioscience, Netherlands

Over the past 25 years Wendy has been dedicated to pharmacovigilance. She has broad experience as EU QPPV for generic and innovative products in complex companies. She also has wealth of experience in lobbying and networking in trade associations/working groups. In her current role, Wendy provides pharmacovigilance support to Pharmaceutical Industry and SMEs (startups). She enjoys setting up the PV system and supports in the development of the PSMF with associated documents. Since 2020 Wendy is a trained professional in Transactional Analysis (TA). TA is a theory of human personality and social behavior. TA gives a wealth of options to work with challenges and changes in organisational and personal development.

Maris  Kuningas, PhD

Maris Kuningas, PhD

Coordinating Specialist Pharmacovigilance Inspector, Dutch Health and Youth Care Inspectorate, Netherlands

Maris Kuningas has worked as a pharmacovigilance inspector at the Dutch Health and Youth Care Inspectorate since August 2011. Before joining IGJ, Maris worked as postdoctoral researcher at the department of Epidemiology in Rotterdam, the Netherlands. Maris has a PhD in genetic epidemiology from the Leiden University Medical Center, the Netherlands.

Stephany  Suoth

Stephany Suoth

Pharmacovigilance assessor, Medicines Evaluation Board, Netherlands

Stéphany Suoth is a pharmacovigilance assessor at the Dutch national agency (MEB) since 2011, with deep interest in databases/Eudravigilance (EV) and in depth knowledge of signal and risk management procedures and operations. Next to assessment of post-marketing safety reports, she also participates the PhV business team and the EV Expert Working Group meetings. Prior to working at the MEB, she held different positions at the pharmaceutical industry with a portfolio of contraceptives and HRT for 7 years.

Gaby L. Danan, MD, PhD

Gaby L. Danan, MD, PhD

Pharmacovigilance Expert, GLD, France

Gaby Danan, MD, PhD, was the EU QPPV for Sanofi until his retirement in 2010. He has served on the Council for International Organizations of Medical Sciences and International Conference on Harmonisation Expert Working Groups, as the European Federation of Pharmaceutical Industries and Associations Clinical Safety E2B topic leader and co-chaired the EudraVigilance Expert Working Group from its inception until 2009. Dr. Danan co-published the Roussel Uclaf Causality Assessment Method for drug-induced liver injury, has authored papers on pharmacovigilance definitions and methodologies, chaired the DIA 2010 Annual Meeting, serves on the DIA Safety Training Committee, and instructs several DIA training courses.

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