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Joint DIA/MEB "Excellence in Pharmacovigilance" Module 1: Post-Marketing

Module 1 will cover individual and periodic adverse reaction reporting requirements.


Faculty

  • Liana  Gross-Martirosyan

    Liana Gross-Martirosyan

    • Alternate PRAC Member
    • Medicines Evaluation Board (MEB), Netherlands

    Liana Gross-Martirosyan has been with Medicines Evaluation board since 2012 in the field of pharmacovigilance. Since 2008 she is the alternate PRAC member from the Netherlands. Liana is a medical doctor and holds MPH degree and PhD in pharmacoepidemiology. Special interests of Liana include interventions in clinical practice to minimize the drug safety risks and evaluation of additional risk minimization measures’ effectiveness.

  • Wendy  Huisman, PharmD

    Wendy Huisman, PharmD

    • Director
    • Vigifit, Netherlands

    Over the past 23 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.

  • Helen  Morrison, MA

    Helen Morrison, MA

    • Global Periodic Reports Officer, Global Patient Safety & Pediatrics
    • Amgen, United Kingdom

    Helen is currently the Periodic Reports Officer within Amgen. With over 20 years’ pharmaceutical industry experience across a number of organisations including various roles of increasing responsibility in Regulatory Affairs, Medical Information and Pharmacovigilance. Helen holds an M.A in Natural Sciences from the University of Cambridge.

  • Joao  Rocha, PharmD, PhD, MSc

    Joao Rocha, PharmD, PhD, MSc

    • Professor of Pharmacology, Immunopharmacology and Pharmacotherapy
    • Faculty of Pharmacy – University of Lisbon, Portugal

    Graduated in Pharmaceutical Sciences at the Faculty of Pharmacy – University of Lisbon followed by a MSc in Herbal Medicines and a PhD in Pharmacology and Pharmacotherapy in the area of Inflammation and Lung Injury. Currently, he is a Professor at the Faculty of Pharmacy – University of Lisbon, responsible for the disciplines of Pharmacology I, Immunopharmacology and Mental Health Pharmacotherapy and also lecturing Pharmacotherapy I and II, Oncology Pharmacotherapy, Pharmacovigilance and Pharmacoepidemiology, among others. Additionally, he is an expert member of the Medicines Evaluation Board at the INFARMED in the area of Pharmacology and Toxicology and an expert for the EMA in the area of Clinical Pharmacology.

  • Anja  Van Haren, MSc

    Anja Van Haren, MSc

    • EudraVigilance Coordinator
    • Medicines Evaluation Board (MEB), Netherlands

    Anja van Haren holds a Master in Health Policy and Management from the Erasmus University in Rotterdam. Her career at the Medicines Evaluation Board (MEB) in the Netherlands started in 1998 as a Pharmacovigilance assessor. Since 2004 she has been responsible for technical and procedural aspects of expedited Adverse Drug Reaction reporting in pharmacovigilance. In her current position at the MEB as EudraVigilance Coordinator the focus of her work is on ADR reports, signal detection and signal management. Anja is co-chair of the EudraVigilance Expert Working Group, co-chair of the Pharmacovigilance Business Team and representative of the EU in the ICH E2B(R3) and ICH E2D(R1) Expert Working Groups.

  • Fakhredin Sayed Tabatabaei, MD, PhD

    Fakhredin Sayed Tabatabaei, MD, PhD

    • Senior Pharmacovigilance Assessor
    • Medicines Evaluation Board, Netherlands

    Fakhredin Sayed Tabatabaei is a medical doctor and an epidemiologist. He works as a senior assessor at the pharmacovigilance department of the Dutch national agency (MEB) for more than 14 years. Since 2017, he is part of the ‘Better Use Programme,’ initiated within the MEB, focusing on improving access to product information, so that both patients and healthcare providers can search for, find, consult and use information about medicines. He is also a member of the ‘electronic Product Information (ePI)’ and the chairman of the ‘Harmonisation of RMP (HaRP)’ projects in Europe.

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