Dr. Frank Schippers has been trained as anesthesiologist and intensive care physician at the Long Island Jewish Hospital, the Army Hospital in Berlin, the North Shore Hospital Sydney and the University of Cologne. After more than 10 years of clinical practice he then joined the pharmaceutical industry, where he held positions in both clinical development and pharmacovigilance. Within PV, he engaged in single case processing and in signal / risk management on global Level. Frank currently serves as VP Global Clinical Development at PAION UK Limited, which includes responsibilities for the ongoing studies in all phases as well as for pharmacovigilance. Particular challenge at the mo­ment is leading the Transformation of a development safety department into a fully functioning pharmacovigilance department, incl. the implementation of all required processes and the assessment of possibilities to outsource tasks.

For 12 years (July 1986 – May 1998), she worked as a physician at university hospitals in the Copenhagen area (Hvidovre, Frederiksberg, Herlev, Roskilde), primarily in departments specialising in internal medicine, nephrology, and endocrinology. In 1995, she became a specialist in internal medicine. Her clinical experience also covers haematology, cardiology, and infectious diseases. Her research activities and publications were primarily within the areas of haematology, immunology, nephrology, and endocrinology. She joined the Danish Medicines Agency in June 1998, initially as senior medical officer; in 2002 appointed chief medical officer (current position). She was member of the EU Pharmacovigilance Working Party from June 1998 until July 2012. Since July 2012, she has been member of the 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. She is also the author of several international publications on various aspects of pharmacovigilance.

Dr. René Haltiner studied veterinary medicine and holds a PhD in molecu­lar biology (cardiac arrhythmias). In 16 years in pharmaceutical industry, he worked mainly in clinical development, drug safety and pharmacovigilance in large international companies. In his recent position he worked as Pharmaco­vigilance Director responsible for local PV systems around the globe. In 2013, he found the Conceptual Process Solution GmbH focusing on the automation of safety case processing and the development of personalized medicine in the context of drug safety

Marie-Laure Kürzinger has 18 years of experience in Epidemiology. Before joining the pharma industry, Marie-Laure worked in academia where she developed field epidemiology expertise. In 2008, she joined the pharma industry first at Sanofi Pasteur MSD in the vaccine area and then at Sanofi as an Associate Director of Pharmacoepidemiology. She is responsible for epidemiological studies within the General Medicines and Emerging Markets Business Unit to support new drugs or marketed drugs. She is also involved in Web-based signal detection projects internal and external to Sanofi.

Dr. Inge Lefèvre is a physician, specialist in tropical medicine and MBA with trainings at the university of Leuven, Tropical Institute of Antwerp and the Vlerick Business School. In her 14 years in pharmaceutical industry, she held various positions in clinical development, regulatory affairs, labelling and more recently in pharmacovigilance. In clinical development, she lead various vac­cine development programs to registration mainly in the international region. In regulatory affairs, she has provided strategic and scientific leadership in regulatory submissions worldwide and initiatives to improve global health such as polio eradication, malaria etc... Since January 2016, Inge serves as Deputy EU-QPPV & Head PV Global Process Owners at GSK Vaccines. In this role, she interacts at an enterprise level to ensure alignment across PV systems and processes. In addition, her responsibilities also include participation in quality investigations with her team providing toxicology and safety assessments of manufacturing incidents and product complaints

Isabelle Lalande-Luesink started her career in Biotechnology and Oncology Research Departments at Ciba Geigy Basel, Switzerland, in 1990, and eventu­ally moved to Global Drug Regulatory Affairs at Novartis Headquarters where she held roles of increasing responsibilities within the Global Labeling group, including membership at the Global Labeling Committee. In 2006, she joined the Drug Safety &Epidemiology department as Clinical Safety Team Leader and was subsequently promoted to Global Head Safety Operations in 2011. Isabelle Lalande-Luesink holds a Master Degree and Engineer Degree in Ap­plied Microbiology from the University of Marseille, France.

Mircea Ciuca, MD is head of medical & clinical drug safety at Vifor Pharma in Switzerland. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance. Dr. Ciuca has about 11 years’ experience in drug safety. Prior to joining Vifor Pharma, he held various positions (Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large pharmaceutical companies in The Netherlands, after successfully establishing and leading the medical-scientific department of a mediumsized CRO in Rotterdam. He graduated from the University of Medicine and Pharmacy in Bucharest, Romania. He specialised in emergency medicine and later in obstetrics & gynaecology. He was involved in clinical practice and academic teaching for about 12 years.

Berit Nautrup Andersen, BN & MSc Drug Development, is EEA QPPV and Head of QPPV Office at Merck. She has thorough expertise in pharmacovigilance gained through more than 15 years in the field. Berit has held various global and regional leadership roles in global medium-sized pharmaceutical com­panies and has extensive experience in drug safety standards and compli­ance, safety operations, risk management and the implementation and main­tenance of global procedures across affiliates. She is a change-leader and has actively taken part in merger of quality and pharmacovigilance systems through mergers & acquisitions.

After a formal training as biochemist, including a PhD thesis, the professional develop­ment covers 20 years in the pharmaceutical industry where Dr. Manske has been able to gain profound expertise in the areas of clinical research and pharmacovigilance. For over 13 years Dr. Manske worked in different quality assurance departments and held responsibilities for planning, conducting and reporting of relevant audits in the areas of Good Clinical Practice, Good Laboratory Practice, Computerized System Validations and Good Vigilance Practice. For a worldwide acting pharmaceutical company was responsible to setting the global audit strategy/ program for pharmacovigilance includ­ing vendors, affiliates and headquarter functions on a risk-based approach. Since Dec 2012 Dr. Manske is in current position as Lead Quality Management, which includes leadership, oversight and support for the PV System and the PV Quality Management System. Responsible for maintenance of the Pharmacovigilance System Master File (PSMF), coordinate internal and 3rd party audits and regulatory inspections and moni­tor international regulations and ensure that applicable regulations are adequately covered by pharmacovigilance SOP system.

Dr. Tanja Peters is a physician and specialist in clinical pharmacology with trainings at the universities of Cologne, Glasgow and Heidelberg. In her 20 years in pharmaceutical industry, she held various positions in early drug development, regulatory affairs, and pharmacovigilance. In her 11 years in corporate pharmacovigilance departments, she engaged in signal detection and risk management of diverse medicinal products as well as various phar­macovigilance system activities. Tanja currently serves as Deputy EU-QPPV & Head PV Intelligence at Boehringer Ingelheim. Her activities also include the support of global and local PV system inspections and the management of license partner audits.

Professor Saad Shakir qualified in Medicine in 1976 and worked in hospital medicine for eleven years before moving to general practice. He has been working in pharmacovigilance & pharmacoepidemiology for more than a de­cade, initially at the Medicines Control Agency (MCA) in the UK then in the international pharmaceutical industry. He was appointed as the Director of the Drug Safety Research Unit (DSRU) in Southampton in 1999. The DSRU is an academic Unit associated with the University of Portsmouth. At the DSRU he leads a research team with an active programme for monitoring and study­ing the safety of medicines. Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London, a Fellow of the Faculty of Pharmaceutical Medicine, a Fellow of the International Society of Pharmaco­epidemiology and a Member of the Royal College of General Practitioners in the UK. He continues to practice clinical medicine part-time. He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is an author of many publications in scientific jour­nals on pharmacovigilance and pharmacoepidemiology and is a member of the editorial board of the journals of Pharmacoepidemiology and Drug Safety. Saad Shakir has led, co-ordinated and participated in many postgraduate edu­cational and training programmes. He supervises postgraduate students for higher degrees and has been involved with a number of international initia­tives to promote and develop pharmacovigilance and pharmacoepidemiology.

Dr. Cedric Bousquet, PharmD, PhD is pharmacist and clinical practioner in the unit of public health of the University hospital of Saint-Etienne in France, with a previous experience of working three years in a pharmacovigilance regional center. He is also a researcher in medical informatics at INSERM in the LIMICS team (Laboratory of medical informatics and knowledge engineer­ing for e-health). His main research topic is about computational approaches in pharmacovigilance, especially developing knowledge based approaches for grouping MedDRA terms. He was the coordinator of several French funded re­search projects on pharmacovigilance (EI-Xplore on automated signal detec­tion, VigiTerms on knowledge engineering, and Vigi4MED on the exploration of social networks). He contributed to Workpackage 3 of the Pharmacoepide­miological Research on Outcomes of Therapeutics by a European Consortium (PROTECT), a collaborative European project that comprises a programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance, where he co-authored recommendations on Good Signal Detection Practices.

Nicole Baker, PhD, provide strategic, operational and scientific leadership for clinical, post-marketing and QPPV projects, covering multinational companies with products at different stages of their lifecycle.

Expertise: Over three years’ experience as EEA QPPV. Over 15 years’ experi­ence in key therapeutic areas: vaccines, transplantation, metabolic, autoim­mune and infectious diseases gained within Academia, Industry, Regulatory Agency and CRO. She has extensive expertise in Global and EU legislation and guidelines for Regulatory Affairs, Pharmacovigilance and Clinical Trials. She has extensive matrix project management experience. Clinical and post-marketing safety experience gained within academia, industry, regulatory au­thority and CRO. Extensive experience with MAA, IBs, DSURs, PSURs/PBRERs, PADERs, signal detection and risk management, company core safety infor­mation and labelling updates and maintenance, PV agreements and PSMFs. She has been the Pharmacovigilance leader on many projects, including im­plementation, maintenance and close out of programs.

Dr. Steinar Madsen is medical director at the Norwegian Medicines Agency. He has been working with generic substitution since it was introduced in Norway in 2001 and with biosimilars since 2006. He is member and previously chair­man of the committee for generic substitution at the Agency. Dr. Madsen is also engaged in the drug information service, with a special interest in the safe and cost effective use of drugs. He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology.