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Virtual

Nov 22, 2021 8:30 AM - Nov 23, 2021 2:00 PM

(Central Europe Standard Time)

Joint DIA/MEB “Excellence in Pharmacovigilance” Module 4: Risk Management

Module 4 focus on risk minimisation measures from both regulatory and industry perspectives. It also covers epidemiological methods used in Pharmacovigilance, as well as risk management plans.

Faculty

Jan  Petracek, MD, MSc

Jan Petracek, MD, MSc

CEO, Ivigee, Czech Republic

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

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.

Paul  ten Berg

Paul ten Berg

Pharmacovigilance Assessor, Medicines Evaluation Board (MEB), Netherlands

Paul ten Berg is a medical doctor. After obtaining his PhD in Amsterdam, he performed translational research on biomarker discovery in liver toxicity in Edinburgh. At the same time, he followed postgraduate courses in public health, pharmacoepidemiology and pharmacovigilance in the UK. Since January 2018, he has been working as Pharmacovigilance assessor at Dutch Medicines Evaluation Board. One of his focus areas is signal detection management. He is also member of the 'Harmonisation of RMP (HaRP) in Europe’.

Inge  Zomerdijk, MSc

Inge Zomerdijk, MSc

Pharmacovigilance Assessor, Medicines Evaluation Board (MEB), Netherlands

Inge Zomerdijk has been in the pharmacovigilance department of MEB since 2010. A senior pharmacovigilance assessor and as a regulator has experiences in assessing Risk Management Plans, study protocols and results of evaluations of risk minimisation measures, national implementation of risk minimization measures as well as benefit-risk assessments of both new drug applications or post marketing follow up. In 2015 she completed her PhD research at the Erasmus Medical Center, focusing on how to evaluate risk minimization measures, the impact of these measures on the benefit-risk balance of drugs and translating possibilities and challenges to practical implications for regulatory authorities and industry and remains involved in research.

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.

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