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Virtual Event

Oct 06, 2020 8:45 AM - Oct 08, 2020 1:00 PM

(Central Europe Standard Time)

4051 Basel, Switzerland

Global Forum for Qualified Persons for Pharmacovigilance (QPPV)


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.

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.

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.

Peter  De Veene, MD

Peter De Veene, MD

GQPPV, MSD Belgium, Belgium

Peter got his medical degree from the Catholic University of Leuven in Belgium and until the end of 2003, Peter practised as a General Practitioner in the UK. In 2004, he joined Roche as a drug safety physician in the local organisation. Taking up roles with increasing responsibility, Peter was appointed Qualified Person for Pharmacovigilance for Roche in 2011. He left Roche at the end of 2014 to take a role at Daichii Sankyo and moved on to be the Head of Global Drug Safety & QPPV for Grunenthal. Peter has extensive experience in pre-approval and post-marketing pharmacovigilance.

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.

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.

Mette  Stockner, MD

Mette Stockner, MD

Senior Pharmacovigilance Director, Savara ApS, Denmark

Mette is a Medical Doctor by training with more than 20 years of hands on experience within Headquarter pharmacovigilance in small to large sized pharmaceutical companies and has worked in the USA, Switzerland and in Denmark. She has been heading up global operational and scientific safety functions and been the Qualified Person for Pharmacovigilance and Deputy QPPV and Head of PV Compliance. Currently overseeing the safety function in a small company working within rare diseases.

Doris Irene Stenver, MD, MPA

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.

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.

Nicolas  Tsiakkas, MD

Nicolas Tsiakkas, MD

Scientific Director, NIKOLAS TSIAKKAS AND CO OE, 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.

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.

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.

Georgy  Genov, MD

Georgy Genov, MD

Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department, European Medicines Agency, Netherlands

Dr Georgy Genov is the Head of Pharmacovigilance Office, within Quality and Safety of Medicines Department, European Medicines Agency (EMA). The office oversees and manages lifecycle pharmacovigilance activities in the EU, including signal detection and management; evaluates the impact of regulatory interventions and develops pharmacovigilance guidelines and standards; ensures leadership, coordination and clear roles and responsibilities for a quality assured EMA’s and EU pharmacovigilance systems; collaborates closely with EMA scientific committees and working parties, in particular the Pharmacovigilance Risk Assessment Committee (PRAC). Oversees the development and maintenance of IT systems for pharmacovigilance.

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.

Jose Alberto Ayala  Ortiz, MPharm, MSc

Jose Alberto Ayala Ortiz, MPharm, MSc

QPPV, PVpharm, Spain

José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2004, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.

Anna  Pavlou

Anna Pavlou

Legal Counsel, Galderma, Belgium

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.

Jean  Kilgour-Christie, BSN, MSc

Jean Kilgour-Christie, BSN, MSc

Deputy EU QPPV Head, UK QPPV, Sandoz International GmbH, Germany

My background is one of a Nursing degree and Masters in Clinical Pharmacology. I have been in the Pharmaceutical Industry for almost 30 years. Most spent in Pharmacovigilance in all areas, globally and locally. I spent some time as Director Regulatory Operations. My career has been spent mainly in Big Pharma although I have covered most therapeutic areas including generics, biosimilars, innovators etc. I have been a deputy QPPV for 8 years and most recently in Novartis since 2018. I have experience in different external committees and industry partnerships.

Monika  Pietrek, MD, PhD, MSc

Monika Pietrek, MD, PhD, MSc

Managing Director and Senior Consultant, Pietrek Associates GmbH, Germany

Dr. Monika M. Pietrek is a medical doctor and epidemiologist with more than 30 years of experience in international drug development and post-authorization safety monitoring/risk management. She has worked in clinical care, pharmaceutical and CRO industries as well as at the German regulatory agency responsible for vaccines and biologics. Founder of Pietrek Associates GmbH, an independent consultancy firm to the pharmaceutical, biotechnology and medical device industry, focussing on B/R product assessment, PV system performance and organisational excellence. She has been co-chairing the EU Pharmacovigilance (PV) Working Group of industry experts for more than 12 years.

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.

Phil  Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.

Rebecca  Webb

Rebecca Webb

Director, Pharmacovigilance Quality Assurance, Abbvie, United Kingdom

Rebecca is the Director of Pharmacovigilance Quality Assurance at AbbVie, having joined in January 2016. Prior to this Rebecca spent 10 years at the UK Medicines and Healthcare products Regulatory Agency (MHRA) in variety of operational roles within the Vigilance and Risk Management of Medicines division and later as a Senior Pharmacovigilance Inspector within the Inspection, Enforcement and Standards division.

Marco  Anelli, MD

Marco Anelli, MD

Principal Consultants Coordinator and Head of Data, Information, Knowledge & , Productlife Group, Italy

Marco Anelli is Head of Pharmacovigilance and Medical Affairs Advisory Services at ProductLife Group . In the past 25 years he has worked in Phase I-IV and PV. In addition, Marco is also QPPV and has prepared and signed over 200 non-clinical and clinical overviews and summaries. Before PLG, Marco was R&D Director at Keypharma and Medical Affairs Director at Eurand. He has an MD from Milan University and a master’s degree in pharmacoeconomics from Pompeu Fabra University in Barcelona.

Amal  Arafah, MPH

Amal Arafah, MPH

Medication Safety Specialist , Saudi Food and Drug Authority, Saudi Arabia

Amal Arafah is a pharmacist and holding a Master of public health in health systems and quality management. Amal started her career in 2013 as in/out-patient pharmacist between privet\ government hospitals and top of that she worked as medication safety officer for one year. At the end of 2017, she joined Eli Lilly company as the qualified person responsible for pharmacovigilance. Now Amal is working with Saudi Food & Drug Authority in Pharmacovigilance inspection department. She participated in 52 inspection and re-inspection visits over pharma companies in Saudi Arabia.

Jens-Ulrich  Stegmann, MD, RN

Jens-Ulrich Stegmann, MD, RN

Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV, GSK , Belgium

A trained registered nurse with an M.D degree in nursing from the University of Essen Germany and a PhD in Physiology from Christian-Albrechts University in Kiel Germany, Jens worked as an anaesthesiologist and emergency doctor at the University of Dusseldorf. At Grünenthal he contributed to the development of several acting analgesics as clinical lead before moving into Safety in 2008.He joined GSK Vaccines in 2012 as Head of Safety Evaluation and Risk Management in Safety and was appointed Deputy EU-QPPV before becoming Head of Clinical Safety and Pharmacovigilance for the business unit. In 2019, he took on the role as EU-QPPV for GSK and ViiV Healthcare and later became Head Clinical Safety and Pharmacovigilance for GSK in 2020.

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.

Salvatore Giorgio  Cicirello, PharmD

Salvatore Giorgio Cicirello, PharmD

Senior Director Safety Science & PASS, Celgene a BMS Company, Switzerland

Jane  Feron

Jane Feron

Risk Management Director, AstraZeneca UK Ltd, United Kingdom

Jane Feron BSc (Hons) has spent most of here working life in the pharmaceutical industry. After working in Clinical Research for nearly 10 years, she joined the PV department at AstraZeneca. She worked in safety surveillance before becoming the process owner for Risk Management and subsequently taking the role of PV processes lead, where she was responsible for all the PV processes at AstraZeneca. Currently she is a Risk Management Director and is responsible for developing risk minimisation strategies primarily for the oncology portfolio, supporting affiliates in the implementation of local risk management regulations and risk minimisation measures, and maintaining global oversight of risk management activities internally and externally.

Pieter  Grotenhuis

Pieter Grotenhuis

Senior Inspector for Pharmacovigilance, Health and Youth Care Inspectorate, Netherlands

After obtaining a MSc in Drug Discovery and Safety at the VU Amsterdam, Pieter started working in pharmacovigilance in 2010. He worked as Drug Safety Officer and Senior Safety Scientist for different pharmaceutical companies and NGOs, specializing in Argus configuration and international legislation before he became Manager Affiliate Governance at the QPPV office at Incyte Biosciences in Lausanne, Switzerland. In 2019 he accepted a position as Senior Inspector Pharmacovigilance at the Dutch Health and Youth Care Inspectorate, performing national and EMA inspections.

Carla  Rodriguez-Watson, PhD, MPH

Carla Rodriguez-Watson, PhD, MPH

, Reagan-Udall Foundation for the FDA, United States

Dr. Carla Rodriguez-Watson is the Scientific Director of the Innovation in Medical Evidence Development and Surveillance (IMEDS) program at the Reagan-Udall Foundation for the FDA. The Foudation’s mission is to advance FDA’s mission to modernize product development, accelerate innovation, and enhance product safety. The IMEDS program is a transformational public-private partnership focused on accelerating and improving real world evidence generation for risk/benefit assessment of medical products. Carla, an epidemiologist by training, is grateful to bring 25 years of experience in the use of observational data for public health and health services research to help advance the public health mission of the Foundation and the FDA.

Suzie  Seabroke, PhD, MSc

Suzie Seabroke, PhD, MSc

Senior Pharmacoepidemiologist, Vigilance and Risk Management Division, MHRA, United Kingdom

Suzie is a senior pharmacoepidemiologist working in the MHRA's Benefit/Risk Management Group. She joined the MHRA in 2003 and has a specific interests in vaccines, medicines used in pregnancy and signal detection methodology. Suzie has responsibility for optimising methods for drug/vaccine safety signal detection at the MHRA, conducting observational research studies to support regulatory decision making and assessing post-authorisation safety studies.

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.

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.

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.

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