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Pharmacovigilance Strategies Workshop

Engage in the sharing of good practices between industry representatives and seek advice from regulators in this unique workshop


Speakers

  • Maarten  Lagendijk, MSc

    Maarten Lagendijk, MSc

    • Deputy EU QPPV
    • MSD B.V., Netherlands

    Maarten Lagendijk is currently Deputy EU QPPV at MSD. Previously he has held different positions in pharmacovigilance at the Medicines Evaluation Board (MEB), the Dutch Regulatory Authority, with increasing responsibilities. With over 15 years of experience in pharmacovigilance, Maarten has a good understanding of all different aspects of safety and risk evaluation of medicines in a broad range of therapeutic areas, most notably in oncology and hematology, as well as in immunology and pulmonology. Through the years he has also focused on developments around risk communication and additional risk minimisation, as well as the evolution of risk management and efforts to streamline and harmonise risk management plans.

  • Bianca  Mulder, PharmD, MPharm, MSc

    Bianca Mulder, PharmD, MPharm, MSc

    • Pharmacovigilance Assessor
    • Medicines Evaluation Board, Netherlands

    Bianca Mulder is a pharmacist with a PhD in pharmacoepidemiology. Her research focused on the use of medication during pregnancy and the development of atopic diseases in children. She worked briefly in a pharmacovigilance position at a pharmaceutical company before she started working as a pharmacovigilance assessor at the Dutch national agency (MEB) in 2016.

  • James  Whitehead, MSc

    James Whitehead, MSc

    • Patient Safety Medical Device Lead
    • Astrazeneca, United Kingdom

    James Whitehead is the Patient Safety Medical Device Lead at AstraZeneca working within Patient Safety Center of Excellence, having started his career with AZ as a Pharmacovigilance Scientist in Oncology and then Principal Process Owner. Since graduating with a BSc in Psychology from the University of Leicester, James has held positions at CROs, Pharmaceutical Companies and Consulting Practises with a focus on Signal and Risk Management. That passion for Signal and Risk Management culminated in a MSc in Pharmacovigilance from the University of Hertfordshire, James is now a Visiting Lecturer on the course.

  • Francoise  Sillan, MD

    Francoise Sillan, MD

    • VP GPS TA ENDO-ONCO & EU QPPV
    • Ipsen, France

    Françoise is a medical doctor as background, working in Pharmacovigilance for more than 30 years in big Pharmaceutical companies with different managerial roles, interactions with Health Authorities, and coordination of international networks of Pharmacovigilance. She has spent 15 Years on Vaccine Pharmacovigilance where she contributed to the development of standards definitions and methods through CIOMS WHO working groups on vaccine safety. Within the EFPIA Pharmacovigilance expert group, she analysed the influence of EU pharmacovigilance regulations outside Europe and of non EU regulations on the EUQPPV role.

  • 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.

  • Shahin  Kauser

    Shahin Kauser

    • Leading Senior Scientific Assessor
    • MHRA, United Kingdom

    Shahin Kauser also has a Certificate in Pharmacoepidemiology & Pharmacovigilance from the London School of Hygiene and Tropical Medicine. Shahin is a Leading Senior Scientific Assessor and joined the MHRA Agency (former MCA) in 2001. She has extensive experience of the ‘life-cycle’ of pharmacovigilance both nationally and in Europe. Her current portfolio includes monitoring the post-marketing safety of medicines in various therapeutic areas including blood disorders, multiple myeloma and malignant melanoma. Shahin has expertise in assessing benefit/risk, PSURs, safety Variations and risk management plans, additional risk minimisation measures and assessing their effectiveness.

  • Willemijn  van der Spuij, MSc

    Willemijn van der Spuij, MSc

    • Executive Director, WorldWide Patient Safety International, Europe
    • Bristol-Myers Squibb, Switzerland

    Responsible for Pharmacovigilance activities in the EU and Balkans, as well as PV Intelligence and Operational activities within the International PV organization. As part of the Operational activities she holds responsibility for the PSMF. She previously served as Intelligence and Training expert in PV as part of the Quality Standards and Training Group in Bristol Myers Squibb and managed PV projects. Willemijn is a member of the EFPIA Pharmacovigilance Expert Working Group and the International Pharmacovigilance Group where she chairs the CIS and Balkan sub-teams. She started her career in Quintiles, followed by Aventis where she was involved in GCP activities.

  • Claudia   Ferreira

    Claudia Ferreira

    • Scientific Programs Team
    • DIA, Switzerland

  • Isobel  Anderson

    Isobel Anderson

    • Astrazeneca, United Kingdom

  • Sean  Burke, MS

    Sean Burke, MS

    • Regional Director, Pharmacovigilance
    • MSD, United Kingdom

  • Emma  Woods

    Emma Woods

    • Astrazeneca, United Kingdom

  • Melanie  Weber, MSc

    Melanie Weber, MSc

    • Pharmacovigilance Expert
    • Pietrek Associates Gmbh, Germany

    Over 10 years of experience in the CRO industry, expert in drug safety processes and regulatory requirements. Special interests include process analysis and enhancement, pharmacovigilance system audits and mock inspections as well as in-depth knowledge of international PV regulations and guidelines.

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+41 61 225 51 51