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Virtual

Nov 17, 2021 8:30 AM - Nov 18, 2021 12:30 PM

(Central Europe Standard Time)

Joint DIA/MEB “Excellence in Pharmacovigilance” Module 3: Quality Management System

In Module 3, key elements will be provided for the establishment of a quality system in Pharmacovigilance including aspects of the applicable GVP modules the preparation for and the conduct of audits and inspections.

Faculty

Pieter  Grotenhuis

Pieter Grotenhuis

Senior Inspector for Pharmacovigilance, Health and Youth Care Inspectorate, Netherlands

After obtaining a MSc in Drug Discovery and Safety at the VU Amsterdam, Pieter started working in pharmacovigilance in 2010. He worked as Drug Safety Officer and Senior Safety Scientist for different pharmaceutical companies and NGOs, specializing in Argus configuration and international legislation before he became Manager Affiliate Governance at the QPPV office at Incyte Biosciences in Lausanne, Switzerland. In 2019 he accepted a position as Senior Inspector Pharmacovigilance at the Dutch Health and Youth Care Inspectorate, performing national and EMA inspections.

Wendy  Huisman, PharmD

Wendy Huisman, PharmD

Director, Vigifit, 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.

Fakhredin Sayed Tabatabaei, MD, PhD

Fakhredin Sayed Tabatabaei, MD, PhD

Senior Assessor, MEB, Netherlands

Fakhredin Sayed Tabatabaei is a medical doctor and epidemiologist, working as Senior Assessor Pharmacovigilance at the Dutch national agency (MEB) for more than 17 years. He is also the chairman of the CMDh HaRP Project (Harmonization of Risk Management Plan). Fakhredin was an active member of the European Pioneer Group drafting the electronic product information (ePI) Key Principles that is published in 2020, and he is currently involved in the ePI Pilot Project in the Netherlands. Besides, he is the MEB representative in the Gravitate Health project, and the Network Subject Matter Expert in the Product Management Services (PMS) project.

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