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Sep 07, 2021 7:00 PM - Sep 10, 2021 12:30 AM

(Central Europe Standard Time)

Pharmacovigilance Strategies Workshop

Navigating the changing PV landscape in your daily work. Anniversary edition: 5 years


Francoise  Sillan, MD

Francoise Sillan, MD

EU1 UK 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 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

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.

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.

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.

Giovanna  Rizzetto

Giovanna Rizzetto

Senior Manager, Regulatory, Drug development and Manufacturing, EFPIA, Belgium

Giovanna Rizzetto is Senior Manager for the Regulatory, Drug Development and Manufacturing team and ICH Coordinator at EFPIA. She is responsible for the coordination of the Pharmacovigilance and Preclinical Development WGs. She previously held a position as a project manager where she was responsible for the management of international pharma-academic clinical trials. Giovanna has also worked in other Brussels industry trade associations and prior to that as an analytical chemist in different companies. She holds a Master's degree in industrial chemistry from the University of Venice (Italy) / University of Warwick (UK).

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.

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.

Elena  Popa, MPharm

Elena Popa, MPharm

Regulatory Policy and Innovation Lead, Bayer, Switzerland

Elena is a pharmacist by training with a master in drug safety and pharmacovigilance. She joined Bayer as a Regulatory Policy & Intelligence Lead and provides direction and development of Regulatory Policy & Intelligence activities supporting Bayer’s pipeline and strategies, with a particular emphasis on the regulatory use and acceptance of RWD/RWE in drug development. Before joining Bayer, Elena was a Senior Manager, Scientific Programmes at Drug Information Association and engaged annually with over 500 stakeholders and volunteers from the entire healthcare ecosystem. In her free time, Elena is passionate about traveling, visiting art museums, painting and watching Formula 1 (#essereFerrari).

Pedro  Barroca

Pedro Barroca

Associate Director, Operations Transformation & Innovation, DIA, Switzerland

Guy  Demol

Guy Demol

EU QPPV, MSD, Belgium

Guy Demol is the European Qualified Person for Pharmacovigilance (EU QPPV) for MSD since October 2013. Previously, he was Vice President Development for sanofi pasteur MSD (SPMSD) as of 2009. As such he was leading SPMSD’s activities in Clinical Research, Epidemiology, Regulatory Affairs, Pharmacovigilance and Risk Management, and Quality and Pharmaceutical Affairs. He joined SPMSD in 2007 as Executive Director Pharmacovigilance and Risk Management and EU QPPV. Before joining SPMSD, he was the franchise head for vaccines in the European Regulatory Affairs Department of MSD in Brussels.

Anne M Ambrose, MPharm, MSc, RPh, RAC

Anne M Ambrose, MPharm, MSc, RPh, RAC

Specialist in Post Authorisation Operations and Safety Issues, Medicines & Healthcare Products Regulatory Agency, United Kingdom

Anne Ambrose is an Expert Pharmaceutical Assessor and Specialist in Post Authorisation Operations and Safety Issues in the Vigilance and Risk Management of Medicines (VRMM) Division, MHRA, UK. She is a qualified pharmacist and has worked in hospital and retail pharmacy and the pharmaceutical industry. She worked for a number of years in Regulatory Affairs in the pharmaceutical industry before joining the Medicines Control Agency (now MHRA) in January 1995 as a pharmaceutical assessor. Anne was a UK expert to CMDh 2005-2020 and was involved in various CMDh working groups and was chair of the CMDh Working Party on Pharmacovigilance Procedures Worksharing (formerly EU PSUR Work Sharing Group) 2010-2017.

Beatrice  Panico

Beatrice Panico

Senior Medical Assessor, Clinical Trials Unit, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Maria Beatrice Panico is currently a Senior Medical Assessor in the Clinical Trials Unit at the Medicines and Healthcare products Regulatory Agency (MHRA). She is a medical doctor, fully qualified in Neurology with a PhD in Neuroscience. She has extensive experience in pharmacovigilance in the pharmaceutical industry.

Giovanna  Ferrari, PhD

Giovanna Ferrari, PhD

Regional Labelling Lead, Senior Director, Pfizer Ltd, United Kingdom

Giovanna Ferrari is a Senior Director at Pfizer with over 15 years’ experience working in the regulatory sector of the pharmaceutical industry, specialising in labelling & product information since 2009. She currently works within the Pfizer International Labeling Group with regional responsibility for Europe and is also the global business owner for the Pfizer process for management of country labeling documents. Externally, Giovanna has represented Pfizer in a wide range of industry forums over the last few years, in particular focussing on e-labelling, and is the industry lead for a highly innovative and patient-focussed digital health information project that is being progressed via an IMI public-private partnership – Gravitate Health

Michael  Forstner, PhD, MPH, MSc

Michael Forstner, PhD, MPH, MSc

Head of Global Safety Science, SOBI, Switzerland

Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis and signal management methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.

Paul  Knights

Paul Knights

Senior Director, Head Pharmacovigilance Strategy Policy & Standards and UK QPPV, Pfizer, United Kingdom

Paul Knights has worked within the pharmaceutical industry for over 26 years initially in discovery research, followed by non-clinical R&D and for the past 15 years in pharmacovigilance where his current role is of Head of Pharmacovigilance Strategy Policy and Standards in Pfizer where focus is on the continuing development of the PV system, awareness and input into developing legislation, internal and external advocacy and advisor to the Pfizer business with regards to new business development deals with respect to pharmacovigilance considerations. In 2021, Paul was nominated as Pfizer's UK QPPV following completion of the Brexit Transitional Period between UK and EU.

Joanne  Webbe

Joanne Webbe

Vice President, Patient Safety, Gilead Sciences International Ltd., United Kingdom

Jo is a Pharmacovigilance professional in operational and compliance Pharmacovigilance roles in both Clinical Trial and Post Marketing areas. Prior to working on PV activities at MSD, Jo started her career in the ADR team at the MHRA and later Post Marketing Operations at GSK. She joined Gilead in 2006 as Manager of Clinical Trials in the Adverse Event Management team. Subsequently she worked in various roles within GLPS at Gilead leading PV Compliance and PV Affiliate teams. Currently leads teams responsible for PV Excellence in affiliates across global regions, PV in Distributors, supporting local QPPVs and key partner to the EU QPPV and PV Agreements, PV Compliance including audit and inspection support and governance for REMS and PSPs.

Gabrielle  Amselem, PharmD

Gabrielle Amselem, PharmD

Dir, Pharmacovigilance Excellence Expert, Alexion, AstraZeneca Rare Disease, France

Gabrielle got a pharmaceutical degree from the University Paris-Sud in France and has a 4-year experience in Pharmacovigilance. At Alexion since 2016, she has taken up different roles, first being the Local Safety Officer for France then joining the QPPV Office in 2018. Gabrielle coordinates compliance activities within the QPPV office and is also the PSMF manager. She was appointed Deputy QPPV for Alexion in early 2019.

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.

David John Lewis, PhD

David John Lewis, PhD

Head QPPV PRRC Office, Patient Safety & Pharmacovigilance, Novartis Pharma Gmbh, Switzerland

Prof 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 Visiting Professor, School of Life and Medical Sciences, University of Hertfordshire, a member of the ICH E2D(R1) Expert Working Group, was Project Coordinator for the IMI WEB-RADR 2 consortium, and is Work Package Co-Leader for IMI ConcePTION.

Nuria  Semis-Costa, MSc

Nuria Semis-Costa, MSc

Scientific Specialist (Risk Management), 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.

Emil Andrei  Cochino, MD, MHS

Emil Andrei Cochino, MD, MHS

Scientific Senior Specialist (Risk Management), 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 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.

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.

Mick  Foy

Mick Foy

Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

Stephanie  Tcherny- Lessenot, MD, MPH, MSc

Stephanie Tcherny- Lessenot, MD, MPH, MSc

Head of Benefit-Risk Evaluation, Epidemiology & Benefit-Risk Evaluation, Sanofi, France

Stephanie Tcherny-Lessenot is a physician, public health specialist. She has been working over the past ten years in pharma companies on pharmacoepidemiological studies to support market access, pricing and risk management plans. Within Sanofi Global Pharmacovigilance & Epidemiology department, she supported registration and post-marketing referrals for CNS, multiple sclerosis and rare diseases drugs. She has also contributed to IMI projects PROTECT and WEB RADR.

Ernesto  Vera-Sanchez

Ernesto Vera-Sanchez

Vice President of Regulatory Strategy and Head of GxP consulting services, CATO SMS, Spain

Ernesto has a Physician Degree with a specialty in Anaesthesiology, Master in Public Health and in Health services management and has a PhD degree in Pharmacology and Therapeutics. He joined the Pharmacoepidemiology and Pharmacovigilance Division in the Spanish Medicines and Medical Devices Agency (AEMPS) in 1998 as Safety official until 2003 when went back to the clinical activity. Currently is the Head of GCP and PhV inspectorate in AEMPS. He was involved in the revision of the Good Pharmacovigilance Practices for the Pharmaceutical industry in Spain which first version was published in 2001. He is member of the GCP Inspector Working group, Pharmacovigilance Inspectors working group, the Working party of CMD/GCP.

Patrick M. Caubel, MD, PhD, MBA

Patrick M. Caubel, MD, PhD, MBA

Chief Safety Officer, Pfizer Inc, United States

Patrick Caubel is Chief Safety Officer and Global Head of Worldwide Safety for Pfizer . Patrick earned his M.D. degree, with specialization in Gynecology, Obstetrics and Oncology, from the University of Paris XIII (France), followed by a Ph.D. in Clinical and Experimental Pharmacology from the University of Paris VII (France) and later a M.B.A from Rutgers University. He worked in positions of increasing responsibility first in academia, and subsequently for Merck KgaA, Johnson & Johnson and Sanofi. Pfizer Worldwide Safety is in charge of safety monitoring and reporting for all Pfizer products around the globe. Patrick has been actively involved in COVID vaccine and antivirals development and safety monitoring during the COVID-19 pandemic.

Martin  Huber, MPH, MPharm

Martin Huber, MPH, MPharm

Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Dr Martin Huber is the Vice Chair of the Pharmacovigilance Risk Assessment Committee (PRAC) and has been a member of the Pharmacovigilance Working Party (PhVWP) before. He has been actively involved in many pharmacovigilance procedures including important referrals at PRAC and also contributes to the work of several working groups at the European level. Being a pharmacist by training and holding a degree in public health he gathered detailed experience in pharmacovigilance in a hospital setting before entering BfArM in 2010. Since 2013 he is head of the unit 'PRAC, Legal Status, Adverse Reaction Reports, Medication Errors'.

Inge  Zomerdijk, MSc

Inge Zomerdijk, MSc

Pharmacovigilance Assessor, Medicines Evaluation Board (MEB), Netherlands

Inge Zomerdijk has been in the pharmacovigilance department of MEB since 2010. A senior pharmacovigilance assessor and as a regulator has experiences in assessing Risk Management Plans, study protocols and results of evaluations of risk minimisation measures, national implementation of risk minimization measures as well as benefit-risk assessments of both new drug applications or post marketing follow up. In 2015 she completed her PhD research at the Erasmus Medical Center, focusing on how to evaluate risk minimization measures, the impact of these measures on the benefit-risk balance of drugs and translating possibilities and challenges to practical implications for regulatory authorities and industry and remains involved in research.

Frederic  Bouder, PhD

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.

Elke  Stahl, PhD

Elke Stahl, PhD

Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany

Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany. Clinical Trials Senior Expert. CoChair of the Clinical Trial Facilitation Group (CTFG) till 2022. Involved in EMA’s EU CTIS groups as BfArM’s representative, National Contact Point for the CTR in Germany, representative in European Commissions CT working groups. Prior BfArM 10 years experiences as a pharmacokineticist at Bayer HealthCare AG, Germany, in early research up to candidate selection. PostDoc at Hoffmann-La Roche Inc and University of North Carolina (UNC). Ph.D. in pharmacology and licenced pharmacist.

Jean-Christophe  Delumeau, MD, PhD

Jean-Christophe Delumeau, MD, PhD

Senior Expert, Institute of Pharmacovigilance, Czech Republic

Jean-Christophe Delumeau graduated in medicine (MD), molecular pharmacology (PhD), toxicology and psychiatry in France. Then he joined a research program on intracellular signaling at Inserm. In 1991, he re-oriented to clinical research in neurology in France, Switzerland and Japan. In 2002 he was appointed by Bayer to lead pharmacovigilance organisations in Japan (until 2009) then in Asia-Pacific. He is a founding member and coordinator of ISoP’s Special Interest Group on Risk Minimisation Methods for Asian Countries. His focus is to create and facilitate the deployment of novel risk minimization methods applicable to a wide array of countries and health care systems, especially in developing countries.

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