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Mercure Amsterdam City Hotel

Nov 08, 2023 8:30 AM - Nov 09, 2023 5:15 PM

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

This Forum provides valuable insights into the most pressing issues QPPVs are facing today. This event has limited capacity, register early!


Gemma  Jimenez Sese

Gemma Jimenez Sese

Senior Director, Deputy EU QPPV, AstraZeneca, Spain

Gemma Jimenez Sese is the EUQPPV for Almirall since 2011 and is based in Barcelona, Spain. Pharmacist by education, after a short period in hospital research moved to pharma industry working in UK and Spain, first in regulatory affairs and for the last 15 years in pharmacovigilance taking up roles with increasing responsibility. In PV she has been involved in a broad scope of activities, from safety in development to marketed medicinal products support, from small mollecules to biologics. Passionate about science and strong believer in our mission of putting always the patient first.

Magnus  Ysander, MD

Magnus Ysander, MD

EU & UK QPPV & Head Pharmacovigilance Excellence, AstraZeneca, Sweden

Magnus Ysander is the EU and UK QPPV for the AstraZeneca group of companies since 2015 and is based in Gothenburg, Sweden. He joined the company in 2002 and have had several specialist, oversight and line managerial roles within the AstraZeneca pharmacovigilance organisation. Magnus is a MD and has previously worked as a certified Orthopedic Surgeon. He is a member of EFPIA Pharmacovigilance Expert Group and the Program Committee for the DIA QPPV Forum.

Angela  Van Der Salm, PhD, MSc

Angela Van Der Salm, PhD, MSc

Director PV, Managing partner, DADA Consultancy B.V., Netherlands

Angela has over 15 years of experience in PV with more than a decade of functioning as a QPPV. She provides customized pharmacovigilance support, including QPPV provision and responsibility for the clients pharmacovigilance systems. After completing her PhD in 2005, she started her career in pharmacovigilance and in 2008, she joined Organon to gain experience in PV during the different mergers taking place at that time. In 2010, she joined DADA Consultancy to start up a department of PV consultants to take on global and local responsibilities from clients in need of PV support. Her personal interests lie with Compliance management and auditing, as well as Risk Management, and she recently obtained a MSc in Epidemiology.

Shahinaz  Badr

Shahinaz Badr

Pharmacovigilance Consultant and PVQA Auditor - EMEA, Pharma Quality Europe, United Arab Emirates

Pharmacist with >20 years’ experience in pharmacy & pharmaceutical business, started as clinical pharmacist in Cairo Univ. Med-School Teaching Hospital integrating with top HCPs of different specialties where safety monitoring is an integral part of clinical practice. Using her expertise, she joined the pharmaceutical industry working in RA & regional positions before focusing on Pharmacovigilance. Actively working in PV Reg-Intel in a role enabling her to interact with industry colleagues and Competent Authority PV departments. Contributed to several international initiatives and partnerships to support patient safety & improve drug safety monitoring. She’s an active ISOP member collaborating in the initiation of the Global PV Certificate.

Vicki  Edwards, RPh

Vicki Edwards, RPh

Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom

Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community pharmacy. In 1996 Vicki joined GlaxoWellcome and started her career in pharmacovigilance. In 2002 she moved to AstraZeneca UK Ltd as the Drug Safety Manager moving on to become Head of Drug Safety & Medical Information. Vicki joined Abbott in 2005 as European Qualified Person for Pharmacovigilance (EU QPPV). In 2013 moved to AbbVie as EU QPPV and Head of Affiliate Safety Excellence (ASE) and is now VP, Pharmacovigilance Excellence and I-QPPV.

Maarten  Lagendijk, MSc

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.

Elspeth  McIntosh, MBA, RN

Elspeth McIntosh, MBA, RN

Director, Castle Pharmacovigilance Ltd, United Kingdom

Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance. She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products. Elspeth set up Castle Pharmacovigilance in 2009 and post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies and provides general PV support to a wide range of pharma companies.

Katarzyna  Swiderek, MPharm, RPh

Katarzyna Swiderek, MPharm, RPh

Director, Safety Evaluation Risk Management (SERM), GlaxoSmithKline, Poland

Katarzyna qualified as a pharmacist and joined GlaxoSmithKline in 2017 as the Safety Evaluation Risk Management Scientist in a central team supporting established products. She is responsible for a broad range of pharmacovigilance activities, such as the global signal detection, preparation of periodic safety reports, RMPs and safety input to queries from regulatory agencies. Katarzyna has been extensively involved in associative work throughout her whole pharmacy studies, up to the European level when she was the President of the European Pharmaceutical Students’ Association (EPSA), representing 160 000 European pharmacy students and young professionals.

Kiernan  Trevett, MSc

Kiernan Trevett, MSc

Principal Quality Lead, PDQ Quality Assurance Process GVP, Genentech, A Member of the Roche Group, United States

Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP, had a role in the training of GPvP Inspectors in other EU Member States and contributed significantly to the MHRA’s preparedness work in relation to the UK’s withdrawal from the EU. Before joining the MHRA, Kiernan worked as a certified Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials. Kiernan has a Master of Biomedical Sciences degree from the University of Southampton.

Claire  Longman, MSc

Claire Longman, MSc

Expert 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.

Willemijn  van der Spuij, MSc

Willemijn van der Spuij, MSc

Executive Director, WorldWide Patient Safety International, Europe, 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.

Helen  Fiddes

Helen Fiddes

Head of Country Pharmacovigilance, UK and Ireland, United Kingdom

Helen Fiddes, Head of Patient Safety, UK and Ireland at Bristol-Myers Squibb, based in Uxbridge, United Kingdom. Managing a team of nearly thirty Pharmacovigilance professionals, working on a diverse portfolio including three Pregnancy Prevention Programmes for thalidomide and its derivatives. Been in the industry and pharmacovigilance for over 20 years. Prior to that community pharmacy, after graduating from the University of Strathclyde, in Glasgow.

James  Whitehead, MBA, MSc

James Whitehead, MBA, MSc

Senior Director, Device & Digital Safety, AstraZeneca, United Kingdom

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.

Sabine  Straus, MD, PhD, MSc

Sabine Straus, MD, PhD, MSc

PRAC Chair, Staff Member, Medicines Evaluation Board (MEB), Netherlands

Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in the Netherlands since 1997, where she started as an Assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry, her last job as Medical Director at Searle Monsanto in the Netherlands. As of July 2012 she is the Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC). In addition to her work at the MEB she holds a position as associate professor at the Erasmus Medical Center, department of Medical Informatics in Rotterdam. Her main research focus is on additional risk minimisation, pregnancy prevention programs, biologicals, signal detection and signal management.

Saad  Shakir, DrMed, MD, FFPM, FISPE, FRCP

Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Director, Drug Safety Research Unit, United Kingdom

Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is a service provider and associate department of the University of Portsmouth. At the DSRU Saad leads a research team with an active programme for monitoring and studying the safety of medicines in populations. He has led many important drug safety studies and has worked and advised on many drug safety issues including product withdrawals, major restrictions and important safety hazards.

Clare  Lavery, MSc

Clare Lavery, MSc

Pharmacovigilance Excellence Principal, AstraZeneca, United Kingdom

To date, the majority of Clare’s career has been in Regulatory Affairs working for companies such as Boehringer Ingelheim and Johnson & Johnson. Clare’s broad regulatory experience has been gained at the local affiliate level, in EU and US Regulatory Affairs supporting drug development and maintenance projects and in EU Regulatory Policy. Three years ago Clare moved to a Patient Safety role at AstraZeneca, joining the QPPV Office and one of her responsibilities is coordinating PSMF maintenance.

Dionne  Usher

Dionne Usher

Associate Director, Office of the EU QPPV, Merck Sharp & Dohme Limited, United Kingdom

Dionne works in the Office of the EU QPPV for MSD in the UK as the PSMF Owner. Interested in “all things PSMF” and other primary areas of support are EudraVigilance access management, PV Audits and Inspections and ad hoc EU QPPV Office projects and activities.

Michelle  Grimes, MSc

Michelle Grimes, MSc

Head, International Pharmacovigilance. GCS&PV, MSD, United Kingdom

Michelle is leading the International Pharmacovigilance organization at MSD. She has 25+ years of experience in the pharma industry and worked in clinical research and consulting prior to moving into pharmacovigilance (PV). Since joining MSD in 2002 she has performed various roles within PV including an EUQPPV support function, as well as prior regional operations roles in Asia Pacific and EMEA. Michelle has accountability for PV activities ex-US which consists of approx. 205 markets managed from 56 locations across the globe. Michelle is a part of the Global Clinical Safety and Pharmacovigilance Leadership Team, and works closely with HQ colleagues in the US. She is based in Europe.

Ilaria  Grisoni, MSc

Ilaria Grisoni, MSc

Executive Director, Head of EU/International PV & Global Risk Management and EEA, Gentium Srl, A Jazz Pharmaceuticals Company, Italy

Ruth  Luther, MPharm, RPh

Ruth Luther, MPharm, RPh

Director, Pharmacovigilance Excellence , Astrazeneca UK Ltd, United Kingdom

Ruth is a registered pharmacist who joined AstraZeneca in 1999 after completing her pre-registration training in hospital pharmacy. After several years working in a number of formulation development and regulatory CMC roles, she joined the Pharmacovigilance department in 2007. Ruth worked in the Safety Surveillance Group before moving on to become the process owner for a number of Pharmacovigilance processes including Safety Surveillance and Risk Management. Currently Ruth is a Pharmacovigilance Excellence Expert where, since 2017, her main responsibilities include support to the EU QPPV on process related matters and leading continuous improvement projects relevant to the content quality of key Pharmacovigilance deliverables.

Jessica  Mårlind Würtele, PhD, MSc

Jessica Mårlind Würtele, PhD, MSc

Director, Patient Safety Excellence, Astrazeneca, Sweden

Jessica is the Director of Patient Safety Excellence and an expert PV advisor in the AstraZeneca QPPV Office. She has been with the company for 8 years, including heading the global PV audit team. Jessica previously worked at Biogen in Switzerland as the Swiss QP and held several roles within Medical Affairs. She has thorough experience across multiple GxP areas both from a global and local perspective. Jessica holds a PhD in Immuno-oncology from the Swiss Federal Institute of Technology in Zurich.

Sina  Schader, DrMed

Sina Schader, DrMed

Head of QPPV Office and EU QPPV, AbbVie, Germany

Sina is the Head of the QPPV Office & EU QPPV in the department Pharmacovigilance and Patient Safety and located in Germany. She has been with Abbvie 14 years. Prior to joining Abbvie, Sina studied veterinary medicine and wrote her PHD thesis in the Virology department, working group Immunology on bone marrow transplantation. In her free time, Sina loves spending time with her husband and two little girls and enjoys horse-riding.

Sarah  Vaughan

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation of the Agency's vigilance systems for all medicinal product types.

Adela  Ashie

Adela Ashie

Principal Regulatory Officer, Food and Drugs Authority, Ghana

Adela Ashie is a pharmacist with over 15 years of experience in Pharmacovigilance. She holds a master’s in international health (MPH IH) from the University of Nottingham, United Kingdom and is currently Head of the Vigilance Unit under the Safety Monitoring Department of the Food and Drugs Authority-Ghana. Adela is involved in the strengthening of the pharmacovigilance system in Ghana through education of stakeholders including healthcare professionals and the general public. Adela’s recent works have been in assisting pharmaceutical companies in Ghana to establish efficient Pharmacovigilance systems through the training of Qualified Persons for Pharmacovigilance and the conduct of Good Pharmacovigilance Practice Inspections since 2016.

Caroline  Fitzsimons

Caroline Fitzsimons

Associate Director, Local QPPV Network Oversight, IQVIA, Ireland

Caroline has 25+ years of experience in the pharma industry. She started her career in clinical research, in Data Management and subsequently as a Clinical Research Associate and (CRA) and a Clinical Team Lead working across a number of therapeutic areas. She embarked her pharmacovigilance (PV) career in 2010, where she worked as a local QPPV managing the local PV system & Quality Complaints. Since re-joining IQVIA in 2015 she has performed various PV roles, including heading the Global PV Agreements services with a team of 15 managing >2000 agreements, as Quality Manager supporting Regulatory Inspections and deviation/process improvement strategies, as PSMF Coordinator and more recently within the Local QPPV team as Lead and Line Manager.

Koen  Van Der Heijden, MSc

Koen Van Der Heijden, MSc

QPPV, Menarini Stemline, Netherlands

Koen has over 15 years of experience in pharmacovigilance and more than 9 years as QPPV. Since summer 2021 he is the EU and UK QPPV for Galapagos, where he joined to help finalize the pharmacovigilance system in light of an upcoming transfer of a Market Authorisation. Prior to Galapagos he worked 10 years for Medtronic BioPharma, a small pharma entity in the medical device company Medtronic. Within this company he build up the pharmacovigilance system for the first pharma product of Medtronic. He has a Master in Biomedical Sciences, with a main focus on epidemiology and pathobiology.

Marylene  Zhan, MBA

Marylene Zhan, MBA

Senior consultant, Accestra Consulting Company, China

Marylene Zhan, a senior consultant at Accestra Consulting, brings extensive expertise in pharmacovigilance and regulatory affairs. Holding a Master's Degree from Zhongnan University of Economics and Law, she excels as a bilingual and bicultural consultant, specializing in China regulatory compliance and pharmacovigilance (RA/PV). With deep insights into Chinese Pharmaceutical regulations and market access, Marylene aids international pharma companies in entering China market. Her adept communication fosters strong client relationships, ensuring top-notch services aligned with business goals.

Barbara  Bovy

Barbara Bovy

Quality Auditing and Center of Excellence, Quality Assurance, UCB, Belgium

Barbara has worked in Quality at UCB for the past 5 years. Her current role is Head of Early & Development Solutions Quality Auditing and Center of Excellence. Prior to her current position, she was EU QPPV in Mithra Pharmaceuticals. Barbara studied epidemiology, public health, social sciences and business management. She holds a PHD in Pharmacovigilance and wrote her thesis on signals and whistleblowers in health and pharma sector.

Chimwemwe  Chamdimba

Chimwemwe Chamdimba

African Medicines Regulation Harmonization Programme Head, African Union Development Agency-NEPAD, South Africa

Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy expert, she leads reforms, harmonization, and partner coordination, contributing to vital continental policies including the AU Model Law on Medical Product Regulation; the Treaty for the establishment of the African Medicines Agency (AMA); and the AU Private Sector Engagement in Health Framework.

Pat  Harding

Pat Harding

Senior Advisor, Medicines Quality Organisation – International, , Eli Lilly and Company, United Kingdom

Pat Hawthorne works in the International Medicines Quality Organisation and is based at Eli Lilly in the UK. Primary responsibilities are leading the processes around the maintenance the EU PSMF and localised PSMFs and shaping affiliate vigilance.

Koen  Nauwelaerts, PharmD, PhD, MBA

Koen Nauwelaerts, PharmD, PhD, MBA

Regulatory Policy and Innovation Lead, Bayer AG, Belgium

Koen Nauwelaerts holds a Master’s degree in Pharmacy from Leuven University, Belgium and a PhD in Drug Development from the same university. Further he obtained an MBA degree from Vlerick Business School and completed the technology immersion program at MIT. Koen is currently working at Bayer as RA Policy and Innovation Lead. He joined Bayer as head of regulatory affairs and quality for the Belgium/Luxemburg region and previously has been active within MSD and Medicines for Europe in different roles in Regulatory Affairs and Quality. Within his current role as RA Policy and Innovation Lead, Koen leads the internal global e-labeling initiatives at Bayer and is vice-chair of the Inter Association TaskForce (IATF) for ePI.

Yusuf  Tanrikulu

Yusuf Tanrikulu

, Deutschland, Germany

Yusuf is the Deputy EU QPPV for Roche since 2018 and is based in Grenzach-Wyhlen in Germany. He has been with multiple international pharma companies in his career, spending more than a decade in pharmacovigilance. With a background in Bioinformatics, he had previously helped multiple organisations to set up their statistical signal detection and management systems, and gained experience in early drug development as well..

Rory  Littlebury

Rory Littlebury

Safety Governance Director, GSK, United Kingdom

Rory has over ten years’ experience working at the MHRA, and two years working at GSK in Safety Governance. Rory’s experience includes engagement with a variety of stakeholders, from multi-national pharma companies to healthcare professionals and patients, giving a well-rounded view of the difficulties and challenges faced by those in, or affected by, the regulations of pharmaceuticals.

Raphael  Van Eemeren

Raphael Van Eemeren

EU QPPV Director, Global Patient Safety , Amgen AB, Sweden

Lauren  Kelly

Lauren Kelly

Associate Director, PV Inspection Readiness & Deviation Management, Bristol-Myers Squibb, Ireland

Lauren has nearly 10 years’ experience working in the pharmaceutical industry in a variety of quality and compliance roles. She has worked in BMS for the last 4 years just recently taking the position of Associate Director, PV Inspection Readiness & Deviation Mgmt. which will involve leading the inspection readiness, audit CAPA and Deviation management teams within the PV Compliance function of BMS. Prior to this change, she worked in the same team supporting multiple inspections globally, audit CAPA management and execution of the inspection readiness program. Prior to BMS, she worked in the PV and country organisation quality auditing departments in both Pfizer and AbbVie.

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