Pharmacovigilance Strategies Workshop
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.
Maarten Lagendijk, MSc
- Deputy EU QPPV
- MSD, 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.
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
- 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
- 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.
- 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
- 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.
- Scientific Programs Team
- DIA, Switzerland
Frederic Bouder, PhD
- Professor in Risk Management
- University of Stavanger, Norway
Frederic Bouder is Assistant Professor at Maastricht University in the Department of Technology and Society Studies and Research Associate at King's College London. For over ten years he has developed policy oriented research on risk communication and risk regulation. Frederic has focused on a range of pharmaceutical issues including cardiovascular conditions, impurities in drugs, antivirals, vaccines, biotechnologies and genetic testing.
Esther De Vries, MSc
- UMCG, CBG-MEB, Netherlands
Esther de Vries is a PhD student at the University Medical Center Groningen in the Netherlands. Her PhD centres around the Direct Healthcare Professional Communication (DHPC) within the hospital setting in the Netherlands. With studies focussing on the uptake of DHPCs by the media, the handling of DHPCs in Dutch hospitals, and the preferences and actions stated in response to the DHPC. Besides her research, she is a parttime pharmacovigilance assessor at the Dutch national agency (MEB).
- Senior Director, Global Risk Management TA Lead
- Bristol Myers Squibb, United Kingdom
Randip Kahlon is the Global Risk Management Therapeutic Area Lead for Oncology at Bristol Myers Squibb, with 20 years experience in pharmacovigilance and risk management. He has co-authored scientific publications on risk minimisation effectiveness evaluation studies and presented on digital approaches for risk minimisation at several external conferences. Randip holds a BSc (Hons) Degree in Medical Biochemistry and Diploma in Professional Development, both from Brunel University London.
- Associate Director, Risk Management
- AstraZeneca, United Kingdom
Sean Burke, MSc
- Pharmacovigilance Lead, EEMEA
- Merck , United Kingdom
18 years working in pharmacovigilance, of which 10 have been as a director of pharmacovigilance for the affiliates at MSD. In his current role, Sean provides pharmacovigilance support to primarily the Eastern Europe, Middle East and Africa regions. Responsible for Pharmacovigilance activities in the EEMEA region as well as global PV Intelligence and Operational activities within the International PV organization. Sean supports the development of local PSMF’s at MSD, which are legislatively required or requested pre-inspection. Sean is a chairperson of two EFPIA PV working groups, (Africa and the Middle East).
Ihsene Salaa-Lebcira, PhD, MPharm
- Head of Safety Unit in France
- Pfizer, France
- Signal Management Team Manager, Patient Safety Monitoring
- MHRA, United Kingdom
Lilly currently leads the Signal Management Team within the Patient Safety Monitoring Group of Safety and Surveillance at the MHRA. She has worked across a range of areas in pharmacovigilance from adverse event evaluation, signal detection and assessment as well as management of adverse incidents and signal analysis.
Aalaa Afdal Mogheith, MPA, MPharm
- Head of Pharmaceutical Vigilance, General Administrator
- Egyptian Drug Authority (EDA), Egypt
The manager of PV General Administration within the Egyptian Drug authority (EDA). She holds MSc. in clinical pharmacotherapy, and Masters of Public Administration from the American University in Cairo. She is a Harvard Medical School associate alumnus, and an American board certified for Pharmacotherapy Specialty. She has profound working history in regulating pharmaceutical practices in Egypt, supporting the implementation of post-marketing PV activities. Additionally, she represents the EDA as an Observer at the International Cooperation on Cosmetic Regulations working group. Previously, she used to be the Antimicrobial Stewardship national coordinator, and participated in the National Action Plan for Antimicrobial Resistance development
- Astrazeneca, United Kingdom
Isobel has worked at AstraZeneca for over 20 years in a variety of informatics and data analytic roles, having gained her BSc in Molecular Biology and PhD in Bioinformatics from the University of Manchester. She is currently Data Analytics Director within Global Patient Safety focussing on the use of clinical data for safety surveillance and signal management.
- Head of Benefit-Risk Unit for Vaccines, Infectious Disease and Diagnostics
- MHRA, United Kingdom
Catherine currently leads the Vaccines, Infectious Disease and Diagnostics team in the Benefit-Risk Evaluation Group of Safety and Surveillance at the MHRA. She has worked across a range of areas in pharmacovigilance from adverse event evaluation, signal detection and assessment, risk management, risk-benefit evaluation and risk communication, with a focus in the area of treatment and prevention of infectious disease. Since April 2021, Catherine has overseen the post authorization benefit-risk assessment of COVID-19 vaccines and therapeutics at the MHRA and since June 2022 has also been responsible for post market surveillance for diagnostics.
- Astrazeneca, United Kingdom
Emil Andrei Cochino, MD, MHS
- Scientific Officer, Risk Management Specialist, Office of vaccines and therapies
- European Medicines Agency, Netherlands
Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Human Medicines Department as a Scientific Senior Specialist (Risk Management), where he is responsible for peer-reviewing risk management plans for centrally authorised products (ATMPs and vaccines) and improving the access of ATMPs to the market by supporting the collaboration with the HTA and payers organisations. Furthermore, he has overseen the revision 2 update of GVP Module V – Risk Management Systems and coreRMP19 guidance.
Virginie Hivert, PharmD, PhD
- Therapeutic Development Director
- Eurordis-Rare Disease Europe, France
Virginie Hivert joined EURORDIS in 2014 as Therapeutic Development Director.Virginie is responsible for following the development of orphan drugs as an observer on the Committee for Orphan Medicinal Products at the European Medicines Agency.She coordinates the group of high-level EURORDIS representatives/volunteers who sit on the various scientific committees/working parties at the EMA, known as the Therapeutic Action Group (TAG).
David John Lewis, PhD
- Head QPPV PRRC Office, Chief Medical Office & Patient Safety
- Novartis Pharma AG, Switzerland
Dr Dave Lewis joined Novartis in March 2007 following 20 years’ pharmacovigilance at GSK and at Shire. He has worked in country affiliates and in a variety of global safety & risk management functions with both investigational & marketed products, as well as in roles involving systems and processes. Dr Lewis is the author of papers on the safety of medicines as well as research papers on neuropharmacology. He is Senior Visiting Research Fellow, Department of Clinical, Pharmaceutical and Biological Sciences, School of Life and Medical Sciences, University of Hertfordshire, a member of the ICH E2D(R1) Expert Working Group, Project Coordinator for the IMI WEB-RADR 2 consortium, and Work Package Co-Leader for IMI ConcePTION.
Melanie Weber Weber, MSc
- Pharmacovigilance Expert
- Pietrek Associates Gmbh, Germany
Pharmacovigilance consultant with more than 20 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. PV consultancy expertise also covers PV/ quality management training, corrective and preventative action (CAPA) plan generation and CAPA effectiveness checks, as well as generation of a pharmacovigilance system master file (PSMF).
Claire Longman, MSc
- Interim Head of GCP and Senior Pharmacovigilance Inspector
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
I am a Senior GPvP Inspector at the MHRA. I have over 5 years experience as an Inspector in Pharmacovigilance and have recently taken on the role as Head of the Good Clinical Practice Compliance Team within the MHRA. Prior to joining the MHRA I worked in Industry where I held various roles within Pharmacovigilance and Medical Information.
Robert Massouh, MPharm, RPh
- Director - Risk Management Product Lead
- Pfizer Ltd, United Kingdom
Robert is a Risk Management Product Lead at Pfizer, supporting the development and execution of Risk Management strategies for Pfizer products. He was previously at the MHRA working as a Scientific Assessor within the Benefit Risk Management Group. Robert is a registered Pharmacist and received his MPharm at the University of Manchester.
- Active Medical Products
- TÜV SÜD, Germany
Marianne Lunzer, DrMed
- Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
- AGES, Austria
Marianne is a medical doctor by training and joined AGES in 2008 as a pharmacovigilance assessor. She was an alternate PRAC member between 2015 and 2017. In 2017, she joined the clinical trial unit at AGES as a safety assessor and has since been part of the Clinical Trials Facilitation and Coordination Group (CTFG) group. Since 2022 she is chairing the group now called Clinical trials coordination group (CTCG). Marianne contributed to the CTFG best practice guidelines for safety assessors for clinical trials and is a member of the drafting team for the Commission implementing regulation for the cooperation in safety assessment of clinical trials.
Stephanie Millican, PhD, MSc
- Unit Manager
- MHRA, United Kingdom
Stephanie is currently Head of the Immunology, Biocompatibility and Non-clinical team in the Safety and Surveillance group at the MHRA. She has a masters degree in Clinical Pharmacology and a PhD in Cell Biology. Following a career in academia she joined the MHRA and has now over 20 years experience in drug regulation with particular emphasis experience post-authorisation procedures and pharmacovigilance.