James Whitehead is a principal at AstraZeneca working within the pharmacovigi­lance processes, partnerships and systems team, 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.

Jackie Roberts has over 25 years’ experience within pharma, gained within in­dustry, the MHRA and consultancy. She has lead both regulatory and pharmaco­vigilance teams, and her current role is as the executive director of regulatory, pharmacovigilance and medical at Accord-UK Ltd., a leading generic and spe­cialty pharma company. Jackie has postgraduate qualifications in both science and business. She has a PhD in clinical medicine from Imperial College in London, and an MBA from Warwick University. Jackie has previously tutored on the MBA course at Warwick specialising in organisational behaviour.

As a head of PV strategy office of global patient safety at Merck, Dr. Julia Appel­skog is focussing on the strategic initiatives, innovation and integrated manage­ment system within pharmacovigilance. She has more than 16 years of experi­ence in pharmacovigilance and eight years of experience in biomedical research. In her previous role as EU QPPV and head of pharmacovigilance at Bluefish Pharmaceuticals, she was focussing on harmonisation of PV requirements world­wide. Julia has held different leading positions within pharmacovigilance in large pharma companies, such as MSD, Johnson & Johnson and Sanofi Pasteur MSD. Her expertise spans the entire product life cycle covering medicinal products, including biopharmaceuticals and vaccines, medical device and cosmetics. She has been involved in a variety of intervention and non-interventional epidemio­logical and clinical trials and was responsible for the quality assurance, regulatory affairs and medical information. Julia is currently a member of EMA EudraVigi­lance Working Group (EWPWG), EuropaBio and International PV Working Group (IPWG) at EFPIA. Previously, she was a member of PV Committee at Medicine for Europe, the Chairman of PV Working Group at Swedish Generic Medicines Association (FGL), a member of PV Focus Group at AESGP and a member of PV Committee at the Pharmaceutical Industry in Sweden (LIF).

Doris Stenver is the founder of Unique Advice, an independent consultancy spe­cialised in pharmacovigilance. Previously she was the chief medical officer of the Danish Medicines Agency. After spending 12 years as a physician at university hospitals, Doris became a specialist in internal medicine. Her research activities and publications were primarily within the areas of hematology, immunology, nephrology and endocrinology. She joined the Danish Medicines Agency in June 1998, initially as senior medical officer. In 2002, she was appointed chief medi­cal officer. She was a member of the EU Pharmacovigilance Working Party from June 1998 until July 2012. From July 2012 until end of February 2019 she was a 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’s the author of several international publications on various aspects of pharmaco­vigilance, and she’s an experienced conference speaker and moderator.

Deji Alli is the head of pharmacovigilance for Healthcare at Home and Respon­sible Person for GDP for the UK. He graduated from Cardiff University in 2010 with a Masters in Pharmacy. Initial hospital experience gained at Royal United Hospital. In 2014, he specialised in oncology and hematology at Milton Keynes Hospital, while also completing a Postgraduate Diploma in clinical pharmacy prac­tice. In 2016, he moved to Healthcare at Home as a cancer pharmacist, then the lead cancer pharmacist, before specialising in pharmacovigilance. Deji assumed the role of head of pharmacovigilance in 2017.

Bert van Leeuwen is the deputy-QPPV of Astellas Pharma. After obtaining his MD he worked in various hospitals for several years. Now working in Pharmacovigi­lance for over 15 years, he started at Organon leading two Therapeutic Areas, both for marketed products as well as clinical trials, in a quickly growing PV department; he was also closely involved with the implementation of Core Safety Data Sheets, MedDRA and the setup of a Signal Detection system. Thereafter he led the ‘Quality in PV’-group, implementing a Compliance Monitoring system and the PV Intelligence system as well as managing regulatory inspections. After the take-over by Schering-Plough he was actively involved in merging the two PV Quality Document systems. Then moving to Astellas, he led one of the two Therapeutic Groups in PV, before accepting his current role. As deputy-QPPV, a lot of time is devoted to review and approval and managing oversight of the PV system; next to this he is actively involved in the Signal Management group, several improvement initiatives and Quality Document updates. Next to the daily work he attended many conferences globally since 2000, some as a speaker, most of the time about PV Legislation, Signal Detection and PV Outsourcing; his last publications (in Therapeutic Innovation & Regulatory Science 2017;51;1:11- 15 and Pharmaceutical Medicine, 2017) were on the latter subject. He is an active member of a group of PV professionals working on a standard for PV outsourcing.

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.

Born in Munich, Ricarda Tiemeyer started her studies in biology at Munich Ludwig Maximilians University in 2006 with the main focus on cell biology, neuroscience, pharmacology, and toxicology. In 2011, after she graduated and developed a fascination about the fast changing and innovative scientific environment, she moved to Switzerland to start her career in the medical department at Roche. Ricarda became the Head of Drug Safety & Country PoC Medical Information at Roche Pharma (Switzerland) AG after multiple years of experience at Roche in the field of pharmacovigilance and compliance. Currently is Head of Drug Safety in Biogen.

Bert van Leeuwen is the deputy-QPPV of Astellas Pharma. After obtaining his MD he worked in various hospitals for several years. Now working in Pharmacovigi­lance for over 15 years, he started at Organon leading two Therapeutic Areas, both for marketed products as well as clinical trials, in a quickly growing PV department; he was also closely involved with the implementation of Core Safety Data Sheets, MedDRA and the setup of a Signal Detection system. Thereafter he led the ‘Quality in PV’-group, implementing a Compliance Monitoring system and the PV Intelligence system as well as managing regulatory inspections. After the take-over by Schering-Plough he was actively involved in merging the two PV Quality Document systems. Then moving to Astellas, he led one of the two Therapeutic Groups in PV, before accepting his current role. As deputy-QPPV, a lot of time is devoted to review and approval and managing oversight of the PV system; next to this he is actively involved in the Signal Management group, several improvement initiatives and Quality Document updates. Next to the daily work he attended many conferences globally since 2000, some as a speaker, most of the time about PV Legislation, Signal Detection and PV Outsourcing; his last publications (in Therapeutic Innovation & Regulatory Science 2017;51;1:11- 15 and Pharmaceutical Medicine, 2017) were on the latter subject. He is an active member of a group of PV professionals working on a standard for PV outsourcing.

Klaudija Marijanovic Barac is a physician with more than 16 years of experience in different aspects of pharmacovigilance and therapeutic areas. She started work­ing in the pharmaceutical industry in 2002, being one of the founders of the Pharmaco­vigilance Department in PLIVA. She was Lead Safety Physician in Barr Group and established RMP Group in Teva in 2015. She also led a project of development of an additional risk minimization implementation tracking tool in Teva. At present, she is Senior Director within TPC. Her team supports marketing authorizations in the EU and international markets for generic, innovative, and biological/biosimilar products. Klaudija is a member of the pharmacovigilance workstream within Medicines for Europe.

Gabrielle Amselem got a pharmaceutical degree from the University Paris-Sud in France and has four years of 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.

Currently Safety Risk Lead, Director at Pfizer, Giovanni holds a degree in chem­istry and pharmaceutical technology and qualifies pharmacist. He has about 20 years’ experience in the drug safety arena and has been an EU QPPV for many years. Expert in regulatory, operational and benefit-risk aspects of pharmacovigi­lance. Setup led and developed drug safety units and global pharmacovigilance systems, merged pharmacovigilance departments. Delivered presentations in major congresses and has published many articles on various pharmacovigilance topics.

Sutirtha Mukhopadhyay is a physician with approximately 14 years of experience. He has over 11 years of hands-on experience in industry across a variety of roles in organisations like ICON, Parexel and Ablynx. He is currently working as global safety officer in Sanofi and is based in Belgium. He has worked in all aspects of product life cycle (clinical development and post marketing pharmacovigilance) involving numerous therapeutic areas, especially oncology, immunology, cardiol­ogy and rheumatology. He also has broad experience of working with rare diseas­es – ovarian cancer, acute myeloid leukemia, restless leg syndrome, Parkinson’s disease, postherpetic neuralgia, amyotrophic lateral sclerosis, mastocytosis, Al­zheimer’s disease, gastrointestinal stromal tumors, thrombotic thrombocytopenic purpura, respiratory syncytial virus infection, etc

Before joining EXTEDO in January 2016, Andrea worked in the pharmaceutical industry for more than 11 years. Being a graduate biologist she started her ca­reer as a scientist in the pharmacovigilance department. After five years, Andrea took over the team leader position for global drug safety and in 2011 she became QPPV. In her role she was responsible to establish and maintain the global phar­macovigilance system within the company.