Global Forum for Qualified Persons for Pharmacovigilance (QPPV)
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.
Angela Van Der Salm, PhD, MSc
- Director Pharmacovigilance, Managing partner
- DADA Consultancy BV, Netherlands
Over 15 years of experience in PV with more than a decade of functioning as a QPPV. 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.
- Regional Pharmacovigilance Manager - Africa, Middle East and Turkey
- Newbridge Pharmaceuticals, United Arab Emirates
Shahinaz, B.Sc. Degree in Pharmacy, has more than 18 years’ experience. Starting as pharmacist in Cairo University Med-School Teaching Hospital working with top Healthcare professionals. She joined the pharmaceutical industry working in Regulatory Affairs then in Pharmacovigilance as a member of the medical affairs department in a role enabling her to interact with industry colleagues and CA PV departments to enhance patient safety in the region. Shahinaz continues to provide industry perspective on PV and patient safety matters being an integral member of the pharmacovigilance middle east industry group (PHAME).
- Vice President, Pharmacovigilance Excellence and International QPPV
- AbbVie, Inc., 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.
Gemma Jimenez Sese
- CORPORATE DRUG SAFETY HEAD - EUQPPV
- ALMIRALL, S.A., 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.
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.
Elspeth McIntosh, MBA, RN
- 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 works as a contract QPPV for small companies and provides general PV support to a wide range of pharma companies. Post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies.
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
- Principal Quality Lead, PDQ Quality Assurance Process GVP
- Roche, United Kingdom
Kiernan Trevett has worked as a GPvP Inspector at the Medicines and Healthcare products Regulatory Agency since April 2012 and is currently working in the role of Expert GPvP Inspector. She has contributed to the development of the EU Good Pharmacovigilance Practices (GVP), has had a role in the training of GPvP Inspectors in other EU Member States and has 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.
Nicolas Tsiakkas, MD
- Scientific Director
- Nicolas Tsiakkas & Co OE VAT Nr EL099974907, Greece
Also Head of Pharmacovigilance Working Group of EUCROF. Nicolas received his medical degree from the University of Würzburg, Germany, in 1985 and worked as a physician in Greece and Austria until 1989. In 1989, he joined Schering Plough Greece as Medical Director and Pharmacovigilance Manager. In 1995, he moved to Rhone Poulenc Rorer Greece, initially as Medical Director and Pharmacovigilance Manager and, following the merger with Hoechst in 1999, as Regional Medical Director of Aventis for the Balkan countries. Since 2005, he is the Scientific Director of Medwork Greece. Nicolas has extensive experience in pre-approval and post-marketing pharmacovigilance and is a contracted QPPV.
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.
Magnus Ysander, MD
- EU & UK QPPV & Head Pharmacovigilance Excellence
- AstraZeneca, Sweden
Magnus Ysander is the EU QPPV for AstraZeneca since 2015 and is based in Gothenburg, Sweden. He joined the company in 2002 and has had several specialist, project lead and line managerial roles within the AstraZeneca pharmacovigilance organisation. This has lead to experience from both development and marketed medicinal products, small molecules as well as biologics. Trained as an Orthopedic Surgeon, Magnus has worked as a clinician at a county hospital and has also been engaged in an innovation medical device company, developing bone anchored prostheses for lower limb amputees. A long-term member of DIA, previously contributed to training workshops for new QPPVs as well as functioned as session lead and presenter at the DIA QPPV Forum.
- EU QPPV
- ELC Group, Czech Republic
Aurel Ignat is an EU QPPV at ELC Group for selected MAH. He joined the company in 2019 after working as a Medical Advisor at Sun Pharma. As a background, Aurel is a Veterinary Physician and before starting his pharmacovigilance journey, he performed veterinary clinical, hematological, biochemical investigations in animals and worked for improving animals and humans welfare.
Elena Popa, MPharm
- Regulatory Policy & Intelligence Lead
- Bayer AG, Switzerland
Previously in her role at DIA, Elena engaged annually with over 500 stakeholders and volunteers from public heath sector. She led the strategy for the Global Pharmacovigilance Portfolio and in 2019 has established the first PV Workshop in the MENA region. Elena had also initiated a platform in DIA for pharmaceutical and life sciences young professionals, globally know as “Leader of Tomorrow”, which increased DIA’s visibility amongst 2000 students & young professionals across the regions. Elena has a MSc in Pharmacy, degree she completed at the University of Medicine and Pharmacy “Iuliu Hatieganu”, Romania. In 2016, Elena specialized in Pharmacovigilance and started her career as a qualified community pharmacist.
- Senior Director, Vault Safety Strategy, EU
- Veeva Systems, United Kingdom
Sharmila Sabaratnam is a Senior Director at Veeva Systems responsible for EU SMB Vault Safety Strategy helping customers to transform their business through a unified safety platform. A physiologist by training with research experience within oncology and arthritis. She has 10+ years’ experience within safety, previously leading safety and regulatory advisory services for Top-25 and Top-100 companies within Ernst & Young and Navitas. Her experience includes operating model design and safety strategy, PV automation, benefit-risk management, and performance benchmarking. As a senior leader within the NHS,she led R&D clinical operations with a large oncology clinical trials portfolio, including the Biomedical Centre for Translational Research.
- Senior Director, PV & Lifecycle Management Quality
- BMS, Belgium
Katrien Solemé has over 22 years of experience in pharmacovigilance, regulatory affairs, clinical development and quality assurance from medium to large pharmaceutical/biotech companies and CRO. She is passionate about improving Patient and Public health by driving sustainable impact through operational excellence, innovation and collaboration. Katrien has been a people manager over the past 16+ years and enjoys interacting with peers in industry.
Doris Irene Stenver, MD, MPA
- Independent Pharmacovigilance Adviser
- Unique Advice, Denmark
Doris Stenver is the founder of Unique Advice and she is specialised in internal medicine and has a master degree in public administration. She is former Chief Medical Officer at the Danish Medicines Agency and former member of the EU Pharmacovigilance Risk Assessment Committee (PRAC). Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, and communication to health care professionals and the public.
- Sidley Austin, Belgium
ANNA-SHARI MELIN is a life sciences lawyer and German Rechtsanwältin. Her practice encompasses a broad range of EU and German regulatory and compliance matters affecting pharmaceutical, biotechnology and medical device companies as well as food, cosmetics, consumer goods and digital health companies. Anna-Shari advises clients throughout the product life cycle including analyses and strategy/risk assessments in relation to clinical trials, GMP compliance, early access programs and market access, pharmacovigilance, medicinal product shortages, recalls, and compliance. Clients benefit from Anna-Shari’s EU and German law practice, in which she brings valuable perspective at the intersection of European and German national law.
Johanna Strandell, DrMed, MSc
- QPPV/Director Drug Safety
- Camurus AB, Sweden
Jan Cleerbout, MD
- Senior Director, deputy EU QPPV
- Janssen Pharmaceutical Companies of Johnson&Johnson, Belgium
Medical Doctor with substantial Industry experience in global Drug Safety & Pharmacovigilance. Values a lifecycle integrated benefit-risk management approach, transparency, diversity, building cross-functional relationships and putting patients first. After a career at UCB Pharma and GSK Vaccines, joined Janssen Pharmaceuticals in 2016 as a Medical Safety Officer before joining the Office of the QPPV in 2019. Currently the Janssen deputy EU QPPV and Head of the PV System Oversight team.
Ruth Hopper, RN
- Director, Safety Governance
- GSK, United Kingdom
A nurse by training, Ruth has 21 years’ experience in clinical research across the UK national health service, academia and the pharmaceutical industry in all phases and covering GMP, GLP, GCP and GVP. Following 4 years working in Scientific Engagement and Medical Affairs QA Ruth joined the GSK Office of the EU QPPV as PSMF Coordinator. She is currently a Director in the Safety Governance team where she continues to support development and coordination of the PSMF, the EU QPPV in his oversight of the global PV system, and also the local QPPVs globally. She is a member of the PVnet PSMF working group.
Sabine Jeck-Thole, DrMed, MD
- EU QPPV & Head Regional GPV EUCAN & EM
- Boehringer Ingelheim International Gmbh, Germany
Nuria Semis-Costa, MSc
- Scientific Officer
- European Medicines Agency, Netherlands
Núria Semis-Costa is a biochemist (Universitat Autònoma de Barcelona) with a MSc in Pharmacovigilance (Universitat de Barcelona). After working in the industry in the field of blood products, she joined the EMA as a Risk Management Specialist in 2015, where she works in the areas of rheumatology, immunology and advanced therapies. Núria is also involved in initiatives related to risk management of biosimilars and medicines in pregnancy, the maintenance of the RMP template and the update of GVP XVI.
Valerie E. Simmons, MD, FFPM
- Senior Medical Fellow, Global Patient Safety
- Eli Lilly and Company Ltd, United Kingdom
Dr. Simmons is currently Senior Medical Fellow (formally the EU QPPV) in Global Patient safety for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focused her career drug safety through senior management positions in Glaxo/Glaxo Welcome and Eli Lilly and Co. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Expert Working Group, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management
- Head of Vigilance Operations, Safety & Surveillance
- Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Head of Vigilance Operations within the MHRA's Safety & Surveillance function and has over eighteen years of experience working in pharmacovigilance. Prior to his current role Phil spent nine years leading and developing the Signal Management function, including systems, processes, and relevant aspects of Pharmacovigilance Legislation. He is responsible for the operational delivery of the Vigilance, Intelligence and Research Group, including delivery of relevant aspects of the Agency’s digital transformation programme.
- Executive Director, Head of EU/International PV & Global Risk Management and EEA
- Gentium Srl, A Jazz Pharmaceuticals Company, Italy
Achint Kumar Gupta, DrMed, MD
- EU QPPV - Safety & Benefit-Riak Management
- Biogen, Netherlands
Achint Kumar is the EU QPPV at Biogen. He is a physician by training and has been working in Pharmacovigilance since 2005. Currently, he is also an active member at EFPIA PV Expert Group.
Moonjung Kim, RPh
- Korea Institute of Drug Safety and Risk Management, Korea, Republic of
Moonjung Kim is a registered pharmacist with experience in the clinical research and pharmacovigilance field in Korea. She has been working at Korea Institute of Drug Safety and Risk Management(KIDS) since 2014, mainly for the signal detection•evaluation and communication, development of drug utilization review criteria, study projects and pharmacovigilance training/education for experts (including QPPV) and students.
Michael Richardson, MD, FFPM, FRCP
- Senior Vice President, WorldWide Patient Safety
- Bristol-Myers Squibb, United Kingdom
Michael Richardson has many years of global management experience in research based life Sciences companies. He has worked in major multinational companies’ across the globe both at a Regional management level and heading up Research and Development in Asia. Currently Head of Bristol Myers Squibb’s Pharmacovigilance Function. Prior to this role he headed BMS and Eli Lilly’s Development and Medical Organization across Asia Pacific. Before joining Lilly he worked in a joint venture in Japan, Fujisawa-Fisons setting up their development and quality control organisations and prior to that with Organon laboratories in the UK as Medical Director.
- EU QPPV
- Eisai, Germany
Linda J. Scarazzini, MD, RPh
- Vice President, Pharmacovigilance and Patient Safety
- AbbVie, United States
She is currently Vice President, Head of Pharmacovigilance and Patient Safety at AbbVie. Prior to joining AbbVie, Dr. Scarazzini served as Director of the Division of Pharmacovigilance in the Office of Pharmacovigilance and Epidemiology, CDER, FDA. She began her career in pharmacovigilance at Sanofi-Aventis, ultimately serving as Associate Vice President of Pharmacovigilance and Risk Management. In 2016, she was selected by her industry peers to serve as the BioPharma Representative on FDA Drug Safety and Risk Management Advisory Committee. Dr Scarazzini’s publications include the recently-released textbook “Pharmacovigilance: A Practical Approach,” as co-author and co-editor along with members of her AbbVie PV team
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.
Yael Troub, MPharm, MSc
- Head of PV, ASR & Local QPPV
- AbbVie, Israel
Judith Weigel, MSc
- Pharmacist, Pharmacovigilance/ Interface Regulatory Affairs,
- vfa - Association of Research-Based Pharmaceutical Companies, Germany
Judith has almost 10 years of experience in pharmacovigilance and is member of the EFPIA Pharmacovigilance Expert Group since 2012. After studying pharmacy and two years in the biomaterial development area, she started working for a contract research organization where she was responsible for safety reporting in the clinical development. Within vfa, the German association for researched-based pharmaceutical companies, Judith covers pharmacovigilance and the interface to regulatory affairs. Judith holds a MSc in Consumer Health Care.
Heather Yoo, MPharm, RPh
- Head of Patient Safety, South East Asia
- Bristol-Myers Squibb, Singapore
Heather has over 18 years of experience in the pharmaceutical industry and held several roles in Regulatory, Medical Information and Pharmacovigilance department. Heather is a registered pharmacist in Korea and currently working in Bristol Myers Squibb in Singapore as a Head of Patient Safety, South East Asia. Heather was a member of PV sub-committee of the KRPIA and was a member of KSCD and contributed to the Korean PV industry. Additionally, she worked with MFDS as a member of various Working Groups and has contributed to Risk Management Guideline proposal and supporting the electronic reporting system for foreign cases. Heather holds a Bachelor of Science in Pharmacy and a Master of Clinical Pharmacy at Ewha Woman’s University.
Barry Arnold, MD
- EU Qualified Person for Pharmacovigilance
- AstraZeneca, United Kingdom
Qualified MD 1980. Joined industry 1986 - experience in all phases of clinical development. Head Drug Safety (ICI/ Zeneca/AstraZeneca) 1992-2006; EU Qualified Person for PV in June 06. Chairs EFPIA PV ad hoc group; represented EFPIA on MedDRA Management Board, ICH E2E and ICH E2F EWGs.
- Director, Global Clinical Safety and Pharmacovigilance (GCSP) Regions Lead (Asia
- -Pacific), CSL Behring, Australia
Strategic and operational leader with over 20 years experience in pharmacovigilance in local, regional and global roles, including project and team management in pharma and biotech companies. Sophie developed a significant experience from France, first at the hospital (CRPV), then in Boehringer Ingelheim, and moved to Singapore as Head of Regional Centre Pharmacovigilance for Asia and Middle East North Africa (40 countries). She is now based in Australia part of the Global Clinical Safety and PV organization in CSL Behring, providing leadership for the Asia Pacific region. Sophie holds a Doctorate in Pharmacy, a Master of Biological and Medical Sciences, a Diploma in Statistics applied to Epidemiology and a University Degree in Health Law.
Barbara De Bernardi, MD
- EUQPPV Vice President - Head of Global QPPV Office
- Pfizer S.r.l., Italy
- Directrice Générale
- Centre National De Pharmacovigilance et De Matériovigilance (CNPM), Algeria
A doctor graduated from the University of Algiers, holding a Diploma of Advanced Studies from the Faculty of Medicine of Paris (France), a university degree in pharmacovigilance from the university Claude Bernard of Lyon and a doctoral thesis in clinical pharmacology at the Faculty of Medicine of Besançon. She took part in the creation of the CNPM with its founder Professor A Helali in 1998. Since 2016, she has introduced the concept of Phytovigilance, Réactovigilance, Cosmetovigilance, in addition to the vigilance of the drug, the medical device and the vaccine already established. Teacher at the Faculty of Medicine of Algiers. Editor of the independent Medical journal "la Revue Prescrire" since 2007.
Stephanie A Millican, PhD, MSc
- Benefit_risk Unit Manager
- MHRA, United Kingdom
- Head of Iraqi Pharmacovigilance Centre, Directorate of Technical Affairs
- Ministry of Health, Iraq
PhD and master’s degree in clinical pharmacy. She trained and has a wide range of experience. She laid the establishment and the expansion of the Iraqi pharmacovigilance system. On the national level, she represents Iraq in the WHO international drug monitoring program, currently a member in many committees including Biologicals and Biosimilars registration, Iraqi clinical pharmacy advisory board, pharmaceutical ethical promotion, the central committee for containing antimicrobial resistance and many others. On the international level, she is an ISOP board member, FIP and ISOP Middle East chapter scientific committee member. She had authored more than 20 articles in different drug safety related subjects.
Reem El Essa
- Senior Pharmacy Specialist and Inspector Pharmacist at Drug Inspection
- Administration, Pharmacovigilance Focal Point in Kuwait Drug and Food Control, Kuwait
Ana Paula Goncalvez
- Head of Patient Safety, Brazil
- Bristol-Myers Squibb , Brazil
Ana Paula Gonçalves is a Pharmacist. She has been working for Bristol Myers Squibb since 2002, based in São Paulo, Brazil. She began her career in regulatory affairs before moving into Pharmacovigilance in 2003. She has a lot of experience in all aspects of pharmacovigilance. She is responsible for managing the Brazil local market pharmacovigilance function and ensures adherence to regulatory requirements, local legislation and to relevant global procedures.
Olga Ermishina, MD
- Pharmacovigilance Country Head, Qualified Person for Pharmacovigilance in EAEU
- Bayer, Russian Federation
Ermishina Olga is the Pharmacovigilance Country Head, EAEU Qualified Person for Pharmacovigilance in Bayer company. She graduated from Russian State Medical University, biophysics course. Olga is in pharmaceutical business since 1997, being involved in product promotion, medical support, non-interventional studies and interventional clinical trials. For the last 15 years she is in pharmacovigilance function. Olga is the chair of Russian AIPM Pharmacovigilance task force and the EFPIA CIS Pharmacovigilance team.