CSL Behring is an international company which conducts business in 60 countries and is headquartered in Australia. The company has a remarkable and industry-leading patient- centric approach truly placing patients first and foremost. Currently the company is experiencing strong growth and is expanding. Susan heads the global PV function at this exciting and dynamic company. She has 28 years of industry experience with over 15 years overseeing PV directly or as part of clinical development/medical affairs roles. Before CSL, Susan served as VP of Safety Strategy at Pfizer, VP Medical Safety at BMS, and Chief Safety Officer at Sanofi.

Earlier in her career, Susan held senior roles in medical affairs, clinical development, general management, finance, and IT. She worked as the Chief Knowledge Officer at Monsanto and then as Corporate Officer, SVP & Chief Science Officer at Express Scripts, establishing the company by designing formulary strategies e.g. multi-tier formulary and specialty distribution services and co-founding one of the world’s first real world evidence companies, Practice Patterns Science. Following this, she served as CEO of Charis Pharma and as CEO of Snowdon Pharma successfully transferring the companies on when key milestones were achieved.

Susan holds an MBChB (British equivalent MD) and a Bachelor of Science from University of Leeds, UK. Her Master’s in Information Management is from Washington University, St. Louis, USA, and her MBA is from the University of California at Berkeley, USA. Susan is a licensed physician with UK practicing rights. She is an elected Fellow, Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians UK (FFPM), Member, Royal College of General Practitioners, UK and Royal College of Psychiatrists UK, Diplomate, Royal College of Obstetricians & Gynaecologists UK, and Member, American College of Physicians. Before industry, Susan practiced medicine for 10 years in the UK serving for 6 years as a military officer in Britain’s Royal Air Force and completing many military challenges around the world. Upon leaving, she was granted the life-long title of “Squadron Leader (Retired)”.

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.

Diane Beck is Vice President, Head of Global Pharmacovigilance Services at Takeda Pharmaceuticals. She has worked in various areas of the pharmaceutical industry of which the last 25 years have been in the areas of drug safety and pharmacovigilance. Diane began her career in pharmacovigilance operations starting with Gensia Laboratories (now Teva) and since then has held roles with increasing responsibility at Pfizer La Jolla, MedImmune, Amylin Pharmaceuticals, Allergan, and Dohmen Life Sciences. During her career, she has worked closely with numerous service providers to outsource and oversee various pharmacovigilance activities from both a fee-for-service to a strategic partnership perspective.

Diane holds a BS in pharmacy from the University of the Sciences in Philadelphia and a diploma in Pharmacovigilance from the University of Hertfordshire.

Dr. Julia Appelskog has recently joined Merck as Pharmacovigilance Quality Management System Strategy Director. Previously she as was the QPPV and the Head of PV Department at Bluefish for 4 years and a Chairman of PV working Group at Swedish Generic Medicines Association (FGL).

Julia has more than 15 years of experience in Pharmacovigilance field and was responsible for Pharmacovigilance at affiliate level at MSD, Johnson & Johnson, and Sanofi Pasteur MSD. Her expertise spans the entire product life cycle and covers medicinal products (Rx, OTC, generic and vaccines), medical device, and cosmetics. In her previous roles she was responsible for the Quality Assurance, Regulatory Affairs, and Medical Information departments at Nordic affiliates.

She has completed a Doctor of Medicine in endocrinology at the Karolinska Institute (Sweden) in 2001 and was working as a researcher with diabetes, epigenetic mechanisms, DNA modification, and its implication on brain tumours.

Olga Kuhlmann holds a master’s degree in Biomedicine. She started her career in Pharmacovigilance 8 years ago and since then gained extensive experience in Pharmacovigilance Quality Management including Compliance Monitoring, SOP coordination and PSMF maintenance. For the past 4 years, she is responsible at Boehringer Ingelheim for leading the coordination of PV inspections worldwide and for supporting internal PV audits as well as audits by License Partners. She is also responsible for the Global Pharmacovigilance Training Strategy.

Dr. Eichorn did his medical training in the US and practiced general adult medicine in the outpatient and hospital settings for 10 years before joining the pharmaceutical industry. He joined Pfizer (UK) in 2002 and since then has served a number of roles in the safety, risk management and regulatory documentation functions, including provision of crossportfolio guidance on the RMP. Much of his current work also focuses on partnering with commercial and other non-safety colleagues to promote the quality of AE reports resulting from patient support programs, market research and other activities that involve communication between the company and HCPs, patients and consumers.

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.

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.

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.

Nicole Lang is a medical doctor by background, working in the pharmaceutical industry since 2003, and having more than 12 years of experience in pharmacovigilance. She held various roles within ratiopharm and Teva Pharmacovigilance. With Teva being a global company combining branded and generic portfolios, she was responsible for the safety of a variety of small molecule, biologic, and biosimilar drug developments in pre- and post-marketing phase and the generic portfolio. Currently she is leading the biologics, respiratory, and internal medicine therapeutic areas in Teva. Within Medicines for Europe PhV working group, she is leading the signal work stream.

Jackie Roberts is the Executive Director for regulatory, pharmacovigilance, medical, and healthcare compliance at Accord Healthcare Ltd and is also the Qualified Person for Pharmacovigilance for the legacy Actavis part of the business. She has a PhD from Imperial College in London and an MBA from Warwick Business School. Her previous experience includes pharma, the UK regulatory authority, and a CRO.

Dr. Pavel Vaclavik holds a master’s degree in Genetics and Molecular Biology and a PhD in Molecular Biology. He has more than 11 years of experience in pharmacovigilance with a main focus on data management, reporting, and PV technology. In his current role as a Senior Manager in Global Patient Safety at Baxter, he leads a data management team responsible for all data requests from the global pharmacovigilance database. Pavel also participated in various pharmacovigilance technology projects including PV database upgrades, data migration projects, EudraVigilance Upgrade project, data clean-up projects, process improvements project etc.

Dr. Jiri Juchelka has 14 years´ experience in the pharmaceutical industry and in clinical research. After he obtained his Medical Degree at Olomouc University (Czech Republic), Hospital de Cádiz (Spain), and Queens Medical Center Nottingham (UK), he trained and became board certified in general internal medicine. He later gained broad cross-functional experience in clinical research, medical/safety monitoring, and drug regulatory during his career in CRO (PAREXEL) and innovative pharma companies (MSD, Novartis), where he assumed leading roles in global multi-centre trials and projects mainly in cardiovascular, surgical, and intensive care indications, including large cardiovascular endpoint driven programs. Dr. Juchelka assumed pre-graduate university teaching activities as well as clinical research staff training and mentoring, works closely with Pharmacovigilance teams worldwide, and is regularly engaged in the coordination group for development, review and approval of standard operating procedures, guidelines, and quality processes of Global Medical Sciences division.

Mariana Almas has a master’s degree in Pharmaceutical Sciences in addition to a master’s in Epidemiology, and a certificate in Pharmacovigilance. She has over 7 years experience in drug safety: 4 in in the context of a pharmaceutical company including pre- and postmarketing safety reporting, Risk Management Plan and Periodic Safety Report writing and submission; and 3 years in a CRO environment developing protocols and clinical study reports for Post-Authorisation Safety Studies (PASS). As part of her master’s in Epidemiology dissertation she conducted a review on “Lessons Learned on the design and the conduct of PASS: Review of 3 years of PRAC oversight”, which she has published in a peer-reviewed journal and presented at ICPE 2016 and 2017.

Dr. Ursell has a PhD in Developmental Biology and an MSc in Pharmacovigilance. She has worked in the industry since 2004. Dr. Ursell has been with Mapi since February 2013, as a consultant specializing in European pharmacovigilance and providing the services of EEA Qualified Person for Pharmacovigilance (QPPV) to clients. Prior to joining Mapi, Dr. Ursell has worked both in pharmaceutical companies and in CROs, with experience in every aspect of pharmacovigilance from case processing to audits and inspections. Dr. Ursell has experience of setting up and running a European Pharmacovigilance team and working with several organisations to ensure compliant global pharmacovigilance systems are followed. Dr. Ursell has facilitated a number of Regulatory Authority inspections, client audits, and internal audits.