Raj is an MSc qualified Quality Assurance Professional with 20 years of diverse Pharmaceutical Industry experience based in the UK. Broad expertise in different GxPs, e.g., GVP, GCP, GMP, and GDP. Areas of subject matter expertise include Audits & Inspections, Quality Management System & Pharmacovigilance System. Eight years of Pharmaceutical Manufacturing experience with Eli Lilly. Twelve years in R&D Quality at Shire/Takeda and most recent positions with Jazz Pharmaceuticals Heading R&D Audits & Inspections.

Managed and hosted MAH, Supervisory Authority & many local PV system inspections (e.g., UK, EU, China, Saudi Arabia, South Africa, Australia).

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.

Max Waschbusch is a physician with more than 15 years of clinical practice experience and more than 20 years in the pharmaceutical industry. He is a recognized leader in the cardiovascular and metabolic drug safety development space. He worked for Bristol Myer Squibb, Sanofi, and has lately joined CSL Behring in the role of Head of Cardiovascular and Metabolism in the Clinical Safety and Pharmacovigilance department. He is a member of the American College of Cardiologist and the DIA-ASA BRAT task force. He has been actively involved in the area of Benefit-Risk assessment, signal assessment, and risk management. 

Marie-Laure Kürzinger has more than 20 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. Since 2018, she is a benefit-risk expert and leads the development of benefit-risk models for drugs under development but also marketed drugs, and in close collaboration with stakeholders from other functions (e.g. pharmacovigilance, pharmacoepidemiology, medical, regulatory, statistician, clinical operations, affiliates).​

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.

Aman heads the Global Client Partners organization at ArisGlobal. In this role, he is responsible for the commercial as well as the account management strategy for ArisGlobal’s existing customers globally. Aman previously served as Vice President of ArisGlobal’s Safety business unit, allowing him to bring a unique product management perspective to our existing customers. Prior to ArisGlobal, Aman held increasingly senior roles at BioClinica to support large scale safety case processing initiatives for top global life sciences firms.

Irina is a pharmacist by education, born and raised in Romania. She has started her career in pharmacovigilance and patient safety in 2009 and worked with a variety of regulatory requirements (EU, US, non-EU as well). Had the chance to be part of building up pharmacovigilance systems for small and medium-sized generic or biotech type companies. Now she is based in France, working for the last 3 years in the area of drug safety. Currently in the role of deputy QPPV Novartis with a focus on radioligand therapies.

Melvin S. Munsaka is a Senior Director and Head of the Safety Statistics at AbbVie in the Statistical Sciences department. He has a PhD in Mathematical Statistics from Queen’s University in Canada and an MSc in Mathematical Statistics and an MEd in Mathematics Teaching from McGill University in Canada. Melvin has been in the pharmaceutical industry for more than 20 years. He co-leads some initiatives of the Drug Information Association Bayesian Scientific Working Group Safety Subteam, the ASA Biopharmaceutical Section Safety Working Group, and the PHUSE Safety Analytics Sub-team. He is also the Publicity Chair of the Midwest Biopharmaceutical Statistics Workshop and has held positions of President, Program Chair, and Chapter Representative of the Northeastern Illinois Chapter of the ASA. He is also a Past Chair of the ASA Section for Statistical Programmers and Analysts and a member-at-large of the Executive Committee of the ASA Biopharmaceutical Section. Melvin is also a lecturer in Biostatistics at the University of Chicago Graham School of Continuing Liberal and Professional Studies. He is a member and Secretary of the Board of Directors of the Chicago Public Schools STEM Program. He continues to take courses in his areas of interest and to explore new ideas related to quantitative analysis and visual analytics of safety data, big data, machine learning, artificial intelligence, neural networks, and natural language processing, especially as to how these apply to patient safety data. He continues to publish papers and present at professional meetings, and performs peer-review journal articles when requested for various journals.