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...

Aysha has been with Teva for over 3 years where she has been responsible for leading a team in pharmacovigilance, drug safety and risk management programs for investigational and marketed products. Led successful implementation, execution and maintenance of safety-related strategies and processes...

Rawad is a seasoned pharmaceutical professional with broad experience in pharmacovigilance, regulatory affairs, and quality. He has worked in Canada and the United States, leading local and global multidisciplinary teams. In his last role, he was responsible for bringing together subject matter...

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 ...

Jennifer is an experienced pharmacovigilance (PV) professional with 16 years of experience in the drug safety arena. After many years working in PV management, she has spent the last three years at Teva in Compliance, with first-hand experience in managing audits, inspections, along with building...

Pharmacist by training and have Masters in Regulatory Affairs. I have been in PV Industry for 15 years and worked in CRO, Big-Midsize and Small Pharma and biotech with experience in ICSR Processing, Training and Compliance, Signal management, Auditing and Inspection Hosting.

Amanda has over 18 years of life sciences experience including over 15 years specializing and consulting in pharmacovigilance and patient safety. She helps life sciences organizations transform their business by applying and delivering innovations in technology and processes to protect patient...

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...

Glenn Carroll is a Principal in the Life Science practice with over 18 years of Pharmaceutical experience. Glenn has significant consulting experience in Compliance, R&D, Medical Affairs and Pharmacovigilance. He leads both the Medical and Safety practices in Deloitte US. His work includes...

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 ...

Cristina Damatarca has over 20 years 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. Cristina received a medical...

Jeffrey DiFrancesco, M.Eng, M.Sci., SSMBB, is the Executive Vice President & Chief Officer of Life Science at Tabula Rasa HealthCare in Moorestown, N.J.  With over thirty-five years of technology, healthcare, and life science experience, Mr. DiFrancesco is a specialist in companies with novel...

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...

Birol Emir, PhD, is Senior Director and RWE Statistics Group Lead in the Statistical Research and Data Science Center at Pfizer Inc. In addition, he is an Adjunct Professor of Statistics at Columbia University in New York and External PhD Committee Member in the Graduate School of Arts and Sciences ...

Trained as a clinical psychologist, Dr. Feehan has extensive research experience in public health and marketing science, utilizing RWE from primary survey  & qualitative data, and secondary claims data. At Kantar Health he designs and leads strategic US and Global research engagements for...

Tracy Follansbee is a Risk, Regulatory and Safety Manager for Elsevier Life Sciences.  She has extensive experience in direct patient care as a Registered Nurse in various areas such as neurorehabilitation, pediatric hematology/oncology, stroke management and transplant services.  Tracy served as...

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...

Kishore Gopu, M.S, MBA, Senior Director, REMS Operations has been with Teva since 2007 and has served in many departments including Regulatory Affairs, Commercial Operations, Patient Solutions, Market Access, and Pharmacovigilance. Since joining Teva, Kishore has built REMS department from the...

Rave Harpaz is a Senior Director of Research and Data Science leading R&D of Oracle Health Sciences’ suite of AI powered safety products. Prior to joining Oracle, Rave spent six years at Stanford and Columbia Universities performing drug safety research, and prior to that two years at Merrill...

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...

Pooja Jain currently works in the Life Sciences Division at Elsevier and brings with her over 15 years of experience in the health/pharmaceutical science sector. After obtaining her Master’s degree from McGill University in Experimental Medicine in 2004, she worked in academia for 2 years in the...

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...

A dynamic, result driven, and decisive thought leader with strong skills in Strategy Planning, Client Relations, Solution Delivery and Program Management experience in Life Sciences, Healthcare domain. Over 21 years in IT/ KPO/BPO industry with 10 years of experience in leadership roles servicing...

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...

Published in peer reviewed medical journals from academia like Harvard. 20+ years of experience in pharma drug development/safety in FIH oncology  e.g. TKIs, mTOR inhibitors & immunotherapies e.g. CTLA-4 & PD-1 inhibitors.

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...

Stephen (“Steve”) KUSKE, has been Vice-President,, Head of Global Pharmacovigilance (PV) Operations since 2015. Steve has oversight of the global PV operations, including Case Management and Medical Evaluation, Periodic Safety Reporting, and Safety Systems and Data Management and reports to...

Anna’s background of over 15 years in the Pharmaceuticals industry gives her the operational insight needed to understand and manage the ever-changing technological, centralization and outsourcing needs of clients. Her extensive knowledge of Regulatory and Pharmacovigilance requirements allows her...

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...

Deanna recently joined Moderna as the Sr. Director Global case management. She holds her PharmD and has been working within GPV for more than 17 years. Deanna has been instrumental in the development and evolution of several Global PV Organizations. She has played a significant roles in numerous...

Raj started his career in PV about 20 years ago at Relsys, the company that developed Argus Safety suite, and was one of the key persons in building Relsys. He started in QA, grew through the ranks and was VP of Services & Strategy at the time of Oracle acquisition of Relsys in 2009.At...

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 ...

Nneka is the Director of Pharmacovigilance (PV) at Nurix Therapeutics. She is a Registered Nurse with master’s degrees in Nursing and HealthCare Administration.  She has over ten years of PV experience in different therapeutic areas including rare disease, oncology, gene and cell therapy. Prior to...

Bruce is responsible for the strategic direction of the Oracle Health Sciences Safety Cloud – an integrated suite of the market-leading safety case management solution (Oracle Argus), and the market-leading safety signal management solution (Oracle Health Sciences Empirica), delivering unified...

Krishna Patel is a pharmacist and a drug safety leader with over 15 years of experience in pharmacovigilance operations and technology.  Mr. Patel specializes in process improvement, regulatory requirements, safety database implementations and upgrades.  Mr. Patel is the business system owner for...

Dr. Peabody is an international health care leader in measurement, health policy, health systems, and quality of clinical care. He has contributed to more than 200 peer-reviewed publications and several books on quality, measurement, economics, and healthcare systems. An actively funded National...

Vladimir has more than 25 years of Life Sciences R&D experience across a top 25 pharma, startups, and consulting / supplier organizations. He has managed large scale business operations initially in clinical development before transitioning to other functions in R&D. Based out of New Jersey ...

Dr. John Price is an executive physician with deep experience gained from over 25 years working across the breadth of regulatory affairs and pharmacovigilance worldwide.He has created and led high-functioning global departments for pharmacovigilance, regulatory and clinical operations, medical...

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...

Dr. Md. Abu Zafor Sadek is serving as a Marketing Manager of UniMed UniHealth Pharmaceuticals, one of the top tier pharmaceutical companies of Bangladesh. This company is working with ISR Immune System Regulation, Sweden to introduce nasal Covid vaccine first time in Bangladesh.Prior to joining...

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...

With background as Pharmacist in India and MS in Regulatory Affairs from Boston USA, Parivesh has over 9 years of experience in Drug Safety and Pharmacovigilance domain. He has worked with some of world’s top pharmaceutical companies such as Johnson & Johnson, Pfizer and currently works as MPV...

Jeanne Schow, MBA, is the Vice President and US Head of Business Development at APCER.  Jeanne has over 25 years of biotechnology and pharmaceutical industry experience leading and coaching business development teams as well as individually contributing to growth and strong long-term...

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...

Dr. Kan Shao is an Associate Professor of Environmental and Occupational Health at Indiana University School of Public Health, where he primarily works on human health risk assessment research and education. He received a dual Ph.D. degree in Civil & Environmental Engineering and Engineering...

Dr. Annette Stemhagen is an epidemiologist with more than 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the SVP of Safety, Epidemiology, Registries and Risk Management within UBC, where she...

Principal Scientist in Investigative Toxicology with 20 years of experience executing multidisciplinary translational projects, including 8 years contribution to pioneering research on the analysis of clinical, molecular, and genomic data for drug development and safety evaluation for rare and...

Max Waschbusch is an experienced clinician and drug development professional with more than 20 years in the pharmaceutical industry. Max leads the Global clinical safety cardiovascular and metabolic Team at CSL Behring. He has worked across all drug development phases in his current role and also...

Alan has been in the industry since 2005.  Since forming Arriello in 2008 with his business partner Anna Lukyanova, he has worked tirelessly to build experienced teams that deliver respected Pharmacovigilance and Regulatory services across the development and approval phases. Alan is a “people’s...

Beena Wood has been in the Information technology space building products for over 26 years, with experience across multiple domains. She has led Engineering as well as Product Management teams. She comes from Oracle where she was in the Pharmacovigilance space for over 15 years, leading their...

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...