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 is the deputy QPPV at MSD since 2019 and is based in the Netherlands. Maarten has over 20 years of experience in pharmacovigilance. He has previously worked for the Medicines Evaluation Board in different pharmacovigilance related roles as well as a national expert at the European Medicines Agency.  Maarten has been involved with DIA for many years and is part of the programme committee for the Global QPPV Forum since 2020. 

James Whitehead is the Senior Director, Device & Digital Safety at AstraZeneca working within Global Patient Safety, having started his career with AZ as a Pharmacovigilance Scientist in Oncology. 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. Recently, James studied for an MBA and focused this project on innovation and digital transformation within Patient Safety.

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.

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.

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 is the Executive Director Europe in the WorldWide Patient Safety Organisation in Bristol Myers Squibb. She is responsible for Patient Safety in the European region, including the Balkans, Baltics and distributor markets. Prior to this role she was responsible for the European markets, PV Intelligence & International Operations including the PSMF as well as Training and Outsourcing activities. Willemijn holds a Nursing Degree from the Netherlands, a BA (Hons) in Sociology from Goldsmiths college, University of London, UK and an MSc in Pharmacovigilance from the University of Hertfordshire, UK. Willemijn is co-chair of the EFPIA Pharmacovigilance Expert Working Group and Chair of the EFPIA International Pharmacovigilance Group.

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 is a pharmacovigilance assessor at the Dutch national agency (MEB), while finishing her PhD at the University Medical Center Groningen in the Netherlands. Her PhD centres around the Direct Healthcare Professional Communication (DHPC) in the hospital setting in the Netherlands. In addition to these activities, she is involved in digitalising the DHPC in the Netherlands.

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.

Ryan has over 10 years’ experience in the field of patient safety and medicines development, in both CRO and big pharma environments, encompassing clinical and post-marketing products across a broad range of therapeutic areas. Most recently, Ryan has specialised in risk management implementation, successfully leading and coordinating complex global risk management strategies including digital elements to plan.

20 years working in pharmacovigilance, of which 12 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. Sean supports the local offices during inspections, in the development of local PSMF’s at MSD, which are legislatively required or requested pre-inspection. Responsible for Pharmacovigilance activities such as PV Intelligence and Operational activities within the International PV organization. Sean is a chairperson of two EFPIA PV working groups, (Africa and the Middle East). 

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.

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

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.

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.

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 Advanced Therapy Medicinal Products. Furthermore, he is overseeing the revision 3 update of GVP Module V – Risk Management Systems and is coordinating the Agency’s transparency efforts for RMPs.

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).

Dr Dave Lewis is Visiting Professor of Pharmacovigilance within the School of Life and Medical Sciences at the University of Hertfordshire, UK. Dave worked for over forty years in Patient Safety and Pharmacovigilance at GSK, Shire and Novartis. He was an active contributor to the ICH E2B (electronic reporting) and E2D (post-marketing data management) Expert Working Groups. He led the Innovative Medicines Initiative WEB-RADR project focusing on pharmacovigilance and social media, and was Co-Lead for Work Package 2 of the IHI ConcePTION project, researching pharmacovigilance in pregnancy and breastfeeding. PUBLICATIONS: Bibliography of ~40 publications on pharmacovigilance can be provided upon request.

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 is the Expert Pharmacovigilance Inspector at the MHRA. She has 10 years experience at the MHRA holding various positions within the MHRA Compliance Teams. Claire has led multiple high profile inspections as well as given a variety of presentations and talks at numerous events in the UK and overseas. In Claire's current role as the Expert Inspector, she is responsible for developing the strategy of the GPvP Compliance Team and aligning this with other GxPs across the MHRA. Prior to joining the MHRA Claire worked in Industry where she gained experience in a number of aspects of Pharmacovigilance and Medical Information.

Rob Massouh, is the Head of Safety (PV) Risk Management and Benefit-Risk Evaluation at GSK. In this role, he serves as the subject matter expert in risk management strategy and benefit-risk evaluation. Rob was previously at the MHRA working as a Scientific Assessor within the Benefit Risk Management Group. Rob is a registered Pharmacist and received his MPharm at the University of Manchester.

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 is Head of the Immunology, Biocompatibility and Non-clinical team in the Safety and Surveillance group at the MHRA. Prior to her current role she held a variety of management and assessor positions in the Agency. She has a masters degree in Clinical Pharmacology and a PhD in Cell Biology. She joined the Agency following a career in academia and has now over 20 years experience in drug regulation with particular experience in post-authorisation procedures and pharmacovigilance.