2021 Speakers

He is an Associate Professor of Healthcare Ergonomics and Director of the Ergonomics Research centre at the University of Guadalajara, Mexico. The fundamental underpinning of his research and teaching practice is based on a degree in Psychology which was complemented with a PhD in Human...

Wassim is the VP of Pharmacovigilance at Mersana Therapeutics. Before Mersana, he worked at Cerevel, Takeda, Agios, Roche-Genentech, and Abbott. Wassim brings a wealth of global drug development experience. He has worked on different approved medicines and drugs in development, small and large...

Jason Ancell is Associate Director, Global Risk Management for Bristol Myers Squibb (BMS).  In his current role, Jason provides risk management support for BMS?s immunomodulatory drug class, including U.S. REMS.  Jason has over twelve years? U.S. REMS experience; ranging from REMS...

Elizabeth Baker, Esq., is the Pharmaceutical Policy Program Director for the Physicians Committee for Responsible Medicine, a nonprofit working for more effective, efficient, and ethical medical research, product testing, and training. Elizabeth leads the Physicians Committee's work to...

Immunologist and Pharmacovigilance Professional with very strong interest in innovation. Extensive knowledge in global legislation and guidelines for Medical Affairs, Regulatory Affairs, Pharmacovigilance and Clinical Trials, gained by leading and managing global, multi-disciplinary...

Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas.  His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several ...

Raj is a Quality professional with over 20 years? experience of working in the pharmaceutical industry. She is currently Head of the R&D Audits and Inspections Team at Jazz Pharmaceuticals, and the scope of her current role includes Audit and inspection management across GCP, GLP &...

Dr Siva is a Physician by training and was working in an Emergency room before choosing a career in Pharmacovigilance. He is also certified in Lean Six Sigma. During his career in PV he has worked for different CROs and life sciences companies with experience in ICSRs, Signal Management, Risk...

Mijal has over 17 years’ experience in the Pharma/Drug Development industry and has focused her career in Pharmacovigilance Quality. She specialises in PV inspection management and has gained a wealth of knowledge through her various roles with companies that have allowed her to manage and lead the ...

David is the holder of an MD from the University of Zimbabwe and a MSc in Epidemiology from the University of London. He brings 15 years of patient safety and pharmacovigilance experience in early to late-stage clinical development for advanced medicines including cell and gene therapies. While at ...

Mircea Ciuca, MD is currently Global Therapeutic Area Head for Immunology & Neurology/Transplant, in the Global Clinical Safety and Pharmacovigilance (GCSP) department of CSL Behring. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance, in both...

Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay leads the ...

Dr. Damatarca has over 20 years of experience in the biopharmaceutical industry across all stages of development and product commercialization, and has worked in Drug Safety and Pharmacovigilance in multiple leadership capacities, most with global responsibilities. Dr. Damatarca received a medical...

Kal Elhoregy is an accomplished healthcare industry executive with 24+ years? experience focused on implementation of Risk Minimization Programs, Quality Management Systems (QMS) and Pharmacovigilance (PV) Compliance within the pharmaceutical industry. In his current role as a Director, Risk...

E. Stewart Geary, MD, is Global Safety Officer and a Senior Vice President at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII...

Jacqueline Gerena transitioned into the pharmaceutical industry from the private payer area of healthcare over a decade ago. In the pharmaceutical industry she has concentrated on patient support and patient safety programs; having held roles of increasing responsibility that focused on...

Michael Glaser, MSEE & MBA, is the Innovation Technology Director within the PV Safety organization at GlaxoSmithKline. Michael has over two decades of experience in the areas of hardware and software design, product management and technology advocation. At GlaxoSmithKline, Michael champions...

Aaron Goodstein is the Senior Director, Medical Safety Strategy and Operations for the Medical Device Sector of Johnson & Johnson.  He is responsible for the processes governing the independent Medical Safety oversight of all products within the J&J Medical Device portfolio throughout the...

Dr. Große-Michaelis is a clinical pharmacologist trained in internal medicine and pharmacology and toxicology with a longstanding interest in the risk-benefit profile of drugs, and drug development and regulation. She obtained her medical degree from the Humboldt University of Berlin, Germany. The...

Peter has more than 14 years? experience in Pharmacovigilance activities in both European and US markets. He began his career in safety operations in Roche in the UK where he was responsible for a case processing team, lead interaction with outsourcing vendor and oversaw the implementation of E2B...

Paul “Skip” H. Hayashi, MD, MPH, FAASLD is an adult hepatologist at the FDA.  He is DILI Team Lead in the Division of Hepatology and Nutrition, Office of New Drugs, Center for Drug Evaluation and Research.  Prior to joining the FDA in February of 2020, he held positions in academia, civil service...

Raúl J. Andrade is Professor of Medicine and Director of the Department of Medicine at the University of Malaga. Director of the Unidad de Gestión Clínica of Ap Digestivo, University Hospital of Málaga. Founder and director of the Spanish Drug Induced Liver Injury (DILI) Registry (...

Advisor and director of private and public companies and institutions in Chile and Latin America. Speaker of conferences and seminars, counselor of foundations and associations. Career of more than 20 years in public office positions in Chile. Academic, National and International University...

Ray is Senior Director and Head, PV Systems at GlaxoSmithKline. In this role, Ray is responsible for the global technology platforms supporting Pharmacovigilance and Drug Safety. In addition, Ray is a member of the ICH E2B(R3) Implementation Working Group and a member of the Transcelerate...

Leandre Habib Kenmogne Cheteu is an excellent Graduate R&D Engineer at the Zhejiang Sci-Tech University located in Hangzhou, Zhejiang-China, and he has consistently obtained consecutive academic scholarships. He is also a certified in Introduction to Project Management from the University of...

Rahul Khajuria, Senior Director, Global Product Safety & PV Systems & Analytics has been working with UT in Global Product Safety and Pharmacovigilance since March 2017. He has more than 14 years pharmacovigilance, drug safety with vast experience in data warehousing / business...

Dr. Jerry K. Kounga, Ph.D., PharmD, is a well-respected R&D scientist with significant experience in ethnic cosmetic formulation, drug safety, and Pharmacovigilance.  His extensive clinical research at the Pasteur institute, University of Kansas, and Harvard helped design new therapeutics for...

Raj is a senior executive with over 25 years of experience in drug development and accelerating access. She has worked in different capacities as an executive pharma leader in regulatory and access in the UK, Europe, Switzerland, USA, and Singapore. Raj brings unique strategic expertise, blending...

Bruno Mendez started his career in Pharmaceutical industry almost 27 years ago. He spent most of his time in Clinical Development being the Global Head of Clinical Operations for Sanofi Pasteur. Then he had the opportunity to be the Chief of Staff of Sanofi Pasteur Chief Medical Officer and for the ...

Upon completion of his Ph. D. in molecular pharmacology in 1995 from Tata Institute of Fundamental Research (TIFR), Mumbai, India, Dr. Mondal joined the Oxford University in England for his postdoctoral research (1995-1998) in pharmacology, and continued to gain further postdoctoral experiences...

Medical doctor (Specialty: Clinical Genetics) with a Master´s degree in Pharmaceutical Medicine, now Lecturer and examiner for the PV module of this master course. Professional experience: wide clinical and laboratory expertise and 15 years of global clinical and local/global post-marketing...

Kishan is an ardent Pharmacovigilance and Quality Assurance professional with a primary interest in assessing, supporting and managing Quality and Compliance in PV activities. He is a Certified Biomedical Auditor (ASQ) and a trained ISO 9001 Lead Auditor (BSI); and he has been passionately engaging ...

Pharmacist, Epidemiologist, Ms Pharmaceutical Care, MsC Education. More than 15 years of experience, Angela is an international consultant and lecturer in pharmacovigilance, safe use of medications and medical devices, patient safety, management of information sources and patient...

Maha worked in pharmacovigilance (PV), clinical, and Bioresearch Quality & Compliance (BRQC) departments. In her current role within BRQC Quality Assurance at Janssen, Maha shapes the planning, conduct, and reporting of tactical and operational PV audit plans to ensure effectiveness and...

Satya SS Sagi is an accomplished professional with  + 20years of experience in Clinical, Medical, and Pharmacovigilance, as a Techno-Functional expert focused on developing solutions leveraging data sciences and analytics. Sagi is the Founder & CEO of Techsol Corporation a leading niche...

Dr. Vipin Sethi, a Critical Care and Emergency specialist by academic worked for Apollo hospital, New Delhi, India for many years, heading the Emergence Triage and later moved to Pharmaceutical industry. Before he completely moved to Pharma industry, he had the opportunity to work with MCN, an...

Marina is a passionate, experienced, and motivated professional with over 13 years of experience in the pharmaceutical industry, particularly safety surveillance. Her expertise and experience in pharmacovigilance and quality activities, combined with her innovative thinking style and enthusiasm has ...

Maria Alejandra Vazquez-Gragg, M.D. is the Global Head of Pharmacovigilance of Orchard Therapeutics. Dr. Vazquez-Gragg is committed to the development of biological products and providing oversight throughout the product life cycle while finding innovation to advanced products for...

Richard C. Zink, Ph.D. is Adjunct Professor of Biostatistics at the University of North Carolina at Chapel Hill. He was the 2019 Chair of the Biopharmaceutical Section of the American Statistical Association, and is currently host of the Biopharmaceutical Section Statistics Podcast and Associate...

Pharmacist, MSc.  Sciences-Pharmacology (c) from the National University of Colombia with more than 12 years of experience in clinical and administrative areas;   Clinical Pharmacy programs, pharmacovigilance, pharmaceutical care, rational use of antibiotics, safe use of medicines, pharmaceutical...