Graduated at Milan University in Pharmaceutical Biotechnology and bachelor degree in Biology Applied to Biomedical Research, started the work experience as a researcher in the field of infectious diseases. From 2009 he starts in the technical / scientific management team as QPPV deputy and responsible for Medical Information at Teofarma.
Anupam Agarwal is a cardiologist with over two decades of experience in treating patients and clinical research in academia. He was involved with research in the genetics of hypertension; drug eluted coronary stents at Brigham and Women’s Hospital, Boston. He has conducted multiple drug trials in many therapeutic areas including cardiovascular, respiratory, anti-inflammatory, GI, oncology and Alzheimer’s disease.
Budhesh Dhamija is currently working in Global Regulatory Affairs department of CSL Behring GmbH in Germany since June 2018. His main responsibilities includes monitoring and assessing the European regulatory environment to anticipate and communicate regulatory trends through an understanding of regulatory guidelines, regulations, and laws that may have an impact on CSLB’s products and regulatory business processes.
Dr. Calin Lungu is the CEO of DDCS, a pharmacovigilance quality assurance consulting firm located in the Grand-Duchy of Luxembourg.
Dr. Lungu has been a professional trainer in the use of the EudraVigilance Data Analysis System for European National Competent Authorities and the European Medicines Agency between 2008 and 2012, is currently training the use of EVDAS for MAHs and is performing EVDAS analysis for several MAHs.
Claudia Nolte is Director, Global Pharmacovigilance & Regulatory Quality Assurance (PVQA) within Global Quality of CSL Behring, being located in Marburg, Germany. In the current role she is responsible for CSLBs’ global PV Audit Program, as well as for other aspects of the PV Quality Management System including Inspection Preparation and Management, Deviation and CAPA Management, 3rd Party Quality Management, Change Management, and Continuous Improvement.
Dennis Vargo MD FACP is a general internist and Clinical Pharmacologist with ~ 30 years pharmaceutical medicine experience, currently the Vice President and head of Drug Safety and Pharmacovigilance at Akebia pharma in Cambridge MA USA. Dennis started his career in early phase clinical development at Zeneca (now AstraZeneca), including designing and running Phase 1 studies from the former AstraZeneca global R&D headquarters in Cheshire, UK.
Dr. Julia Appelskog is heading the EU QPPVs and Consulting Services at TFS, focusing on the strategic initiatives, innovation and integrated management system within PV. She about 20 years of experience in Pharmacovigilance combined with 8 years of experience in cancer and diabetes research.
Margherita D’Antuono graduated in Pharmacy and obtained the PhD in Neuroscience. She worked in the pre-clinical research field in Italy and Canada focusing on neurological diseases for more than 12 years before joining the pharmaceutical industry and relocating to Italy. She has served various roles in the safety / risk management / pharmacovigilance areas during the last 12 years.
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. Since 2018, she is a benefit-risk expert and leads the development of benefit risk models for drugs under development but also marketed drugs in close collaboration with stakeholders from other functions (e.g. pharmacovigilance, pharmacoepidemiology, medical, regulatory, statistician, clinical operations, affiliates).
Executive leader with 10 years of experience within the pharma industry and another 10+ years in consulting. Martin is an experienced manager and strategist, with understanding across the pharma business value chain, and an expert on Pharmacovigilance.
Massoud Toussi is the global offering lead for post authorization safety and effectiveness studies (PASS/PAES/REMS/DUS/Phase IV). He has more than 20 years of experience in the design, development and conduct of studies. He was involved as principal investigator, epidemiologist or clinician in more than 300 studies, including clinical trials, post authorization safety studies (PASS), and outcomes research (OR) studies using both primary and secondary data.
Mircea Ciuca, MD is currently Global Therapeutic Area Head (Respiratory & Transplant) in Clinical Safety and Pharmacovigilance department at CSL Behring. He is leading a team of safety physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings.
After graduating from University of Medicine and Pharmacy in Bucharest Romania, he became specialist in Emergency Medicine, and later in Obstetrics & Gynecology. He was involved in clinical practice and academic teaching for about 12 years. Later he has completed postgraduate studies in Pharmacovigilance at University of Hertfordshire, UK.
Robert Weber is Product Management Director in the Oracle Heath Sciences Global Business Unit. His responsibilities include the Empirica Signal Detection and Management products in the Oracle Pharmacovigilance suite. Robert works with regulatory agencies, key industry partners and research organizations to provide direction and manage priorities for the Oracle Safety products, define areas for enhancements and identify new solution opportunities.
Salvatore is currently Senior Director, Safety Science and PASS, in Worldwide Patient Safety at BMS.
During his tenure Salvatore has led a wide spectrum of PV activities including PV Innovation, Case Management, Safety Operations and he has also acted as Deputy QPPV.
Dr. Susana Almeida is Clinical Development and Safety Director at Medicines for Europe (formerly EGA). Before joining Medicines for Europe, Susana was the Chair of the Association’s Bioequivalence Working Group for almost 15 years. She has worked in clinical trials and pharmacovigilance in Europe and in North America, and her experience includes the pharmaceutical industry and clinical research organizations. She has overseen the conduction of dozens of clinical trials carried out in Europe, North and South America and Asia.
Dr Tjark Reblin earned his MD from the Universitay of Hamburg, Germany. He also holds an MBA from Duke University, USA. He received his board certification in internal medicine after having spent 8 years working primarily in intensive care mendicine at the University hospital of Hamburg before joining the industry 20 years ago where he spent 16 years at GSK and 3.5 years at Roche before joining Vifor in 2019.
Valentina Mancini, Pharmacovigilance Director and EU QPPV in Shionogi. Valentina is currently responsible for PV system implementation in EEA countries and in UK and coordinates local QPPVs.
Before joining Shionogi, she worked in Pfizer, Takeda and Baxter where she covered roles with increasing responsibilities in Pharmacovigilance (PV responsible of the Italian Affiliate; head of Southern Europe PV cluster) but also in clinical QA and Medical information.