SPEAKERS

Geraldine's career spans over 20 years and her earlier career included roles at Novartis, Pfizer (Consumer Healthcare), and Eisai Europe Limited, where her adept management of PV activities underscored her comprehensive industry knowledge. Her journey started at Roche Products Limited, UK, in...

Kapil Bhutada is a seasoned professional with extensive experience in safety operations and compliance within the pharmaceutical industry. Currently serving as the Head of Safety Operations and Compliance at AskBio, Kapil plays a pivotal role in the Medical Safety & Pharmacovigilance...

Mariette Boerstoel-Streefland, MD, MBA, MSc(epi), has been in the pharmaceutical industry for 30 years, and is currently SVP, World Wide Patient Safety Officer at BMS. Mariette joined the pharmaceutical industry from clinical practice in 1989, and had a progressive career, holding various...

Stacey Brandsma is the Digital Product Senior Manager at Amgen, where she drives AI & technology innovation for Global Patient Safety. With a background spanning data science, analytics, and product strategy, Stacey brings deep expertise in leveraging artificial intelligence to enhance...

Dr. James Buchanan is presently an independent drug safety consultant. He graduated from the University of California, San Francisco with a PharmD degree in clinical pharmacy. He worked in the area of clinical toxicology at the Bay Area Regional Poison Control Center at San Francisco General...

Chrissy Burton is a results-driven Senior Director of Clinical Operations at BridgeBio Gene Therapy, with a proven track record of leading successful clinical trials globally in the biopharmaceutical industry. With over 15 years of experience in drug development and over 20 years as am RN with...

MPH María Pía Bustos María Pía Bustos is an accomplished professional in the life sciences sector, boasting 18 years of experience and over 10 years dedicated to pharmacovigilance within the pharmaceutical industry. Her career trajectory includes roles as Senior Analyst, Deputy Local QPPV, and...

Alison is a pharmacologist with a PhD in biochemistry. Her long career includes significant academic and regulatory experience, the latter initially at the Medicines Control Agency and then in senior roles within the Vigilance and Risk Management of Medicine Group at the Medicines and Healthcare...

Rabia Ayse Cetin is a pharmacist (MSc in Toxicology) with over 20 years of experience in the pharmaceutical industry, including hospital pharmacy, retail pharmacy management, regulatory affairs, and executive leadership. For the past decade, she has led PharmaSoft as Co-Founder and General...

Experienced drug safety and regulatory systems leader with a strong track record of managing multiple software vendors and ensuring validated application states throughout the software lifecycle. Deep expertise in global regulatory requirements, including FDA, MHPD, EMA, and E2B standards for...

Michelle Motta DardenoMichelle Motta Dardeno is a seasoned biopharmaceutical executive with more than 25 years of leadership in Pharmacovigilance (PV) and Risk Management. She has built and led global safety organizations from the ground up, steering strategy, regulatory compliance, and patient...

Jay has overall 17 years of experience with more than 16 years concentrated in Patient safety. Dental surgeon by qualification, he also holds Masters in Clinical research with Post Graduate Diploma in Clinical Trial Management.  His wealth of exposure includes Risk Minimisation, Medical...

Neşe Devenot, PhD (they/them) is a Senior Lecturer in the University Writing Program at Johns Hopkins University. Their scholarship explores the intersections between health humanities, psychedelic bioethics, and comparative literature. Dr. Devenot's psychedelic ethics research has appeared in...

Hari Droupathi is an Associate Director in Patient Safety Evolution at Bristol Myers Squibb, where he leads strategic transformation initiatives across the Patient Safety organization. With 16 years of professional experience spanning business intelligence, data analytics, and...

Dr. Dubois is a seasoned healthcare leader with over 20 years of experience spanning clinical trial research, academic medicine, and executive roles in the pharmaceutical industry. As the head of Global Patient Safety for the US Region at EMD Serono, she drives pharmacovigilance...

Kal Elhoregy is an accomplished healthcare industry executive with 25+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems and Pharmacovigilance Quality and Compliance for companies within the pharmaceutical industry.In his current role as a Senior...

Pharmacovigilance expert possessing diverse pharmaceutical, device, and consumer product experience in areas of global safety, pharmacovigilance, and signal/risk management. Recent opportunities within Takeda have led to my participation and leadership of multiple projects which focus on the use of ...

Norm holds a BS in Biology from the University of North Carolina at Chapel Hill. He started out at the laboratory bench, then spent a few years brewing beer before returning to lab work.  In 2002 when the company he was working for found out that he’d essentially built a laboratory information...

Josh is Vice President and Global Head of Epidemiology, an Enterprise-wide, world-class center of excellence for innovation in epidemiological science within the Office of the Chief Medical Officer. He also co-chairs the enterprise-wide J&J AI Council. Prior to joining J&J, Josh was the...

I have over 30 years’ experience applying state of the art technology solutions to the Clinical R&D sector of the biopharma and medical device industry. I’ve been with Roche/Genentech for 4 years in the role of Technology Enablement Director, Compliance Systems, responsible for identifying and...

Jacqueline Gerena is Director of Risk Management Strategy at Johnson & Johnson Innovative Medicine, where she leads a team dedicated to advancing Risk Evaluation and Mitigation Strategies (REMS) across multiple therapeutic areas. With more than 15 years of experience in drug safety and risk...

Alicia Gomez is a dedicated Social Work Coordinator Consultant at BridgeBio Gene Therapy, with a passion for improving patient outcomes and enhancing the quality of care in the biotechnology industry. With a strong background in social work and healthcare, Alicia brings a unique perspective to drug ...

Israel is an accomplished Global Executive with 30 years of experience building multi-therapeutic area medical affairs, clinical development, drug safety, Pharmaceutical teams, inter-academic collaboration, pharmaceutical partner management, and monitoring of drug development. Has provided...

Peter Hjelmström is the Director/CEO of Uppsala Monitoring Centre (UMC) since 2023 and he has overall responsibility for the operations of the foundation. Peter is physician and scientist, with MD and PhD degrees from Karolinska Institutet, and he did his postdoctoral fellowship at Yale...

Stacy ensures that patients and caregivers have a seat at the table to translate their lived experience and recommendations into improvements in the drug development process at its earliest stages. She brings a unique perspective as a stage IV cancer survivor, caregiver to her son who has an...

Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 15 years of experience in...

Dr. Johnson is an experimental psychologist who conducts clinical research on drugs and behavior. Dr. Johnson is known for his expertise in behavioral economics, addiction, sexual risk behavior, and research with a wide variety of drugs including...

Juhaeri Juhaeri is an epidemiologist with over thirty years of experience in real-world evidence and epidemiology in academia and in the pharmaceutical industry. Currently, he is Vice President and Global Head of Epidemiology and Benefit – Risk at Sanofi. He has implemented new innovative...

Dr. Vineet Kacker is a Pharmacologist by training, having done a PhD in Pharmacology from All India Institute of Medical Sciences in India.  Dr. Kacker switched his interests from academia to private industry more than 21 years ago and has managed the Regulatory and Pharmacovigilance functions at...

Dr. Nina Kola, MD, MB. ChB, FFPM - Vice President Medical Safety Assessment Therapeutic Area Head, Hematology and Oncology, Patient Safety, Bristol-Myers Squibb Dr. Nina Kola has over 20 years of extensive experience in the pharmaceutical industry, and has consistently demonstrated her expertise...

With a first degree in Biochemistry and Pharmacology, and a Ph.D. focusing on drug metabolism and Pharmacokinetics, Graeme has worked in the areas of Drug Safety and Medical services for over 35 years. Having worked as a Head of Global Pharmacovigilance for a multi-national innovator Company and EU ...

Elaine Lippmann, J.D., is a Principal at Leavitt Partners based on Washington, D.C., bringing more than 15 years of leadership experience at the U.S. Food and Drug Administration (FDA) and deep expertise in pharmaceutical regulatory policy to her client work.  Elaine most recently served in a...

Accomplished pharmacovigilance professional with more than 16 years of experience. Have successfully led teams both as a vendor and as a sponsor. I have been the lead PV scientist for two gene therapy approvals and have enjoyed communicating with the FDA; also preparing and part-taking at the...

Vrunda Mahadevia is an accomplished Associate Director in US Safety and Risk Management at Novartis, with a proven track record of driving innovation and excellence in drug safety practices. With over a decade of experience in the pharmaceutical industry and the risk management space, Vrunda is a...

Judith Maro is an Associate Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). Dr. Maro's main research interest is...

Dr. Mondal completed Ph. D. from Tata Institute of Fundamental Research (TIFR), Mumbai, India and then continued his postdoctoral research at the Oxford University, England and Harvard University Medical School, USA, in the areas of Molecular Pharmacology and Biomarkers.  After working on toxicity...

Daniel Naranjo, MDDr. Daniel Naranjo is a senior biotechnology and pharmaceutical safety leader with deep expertise in oncology and hematology drug development. A former combat veteran, research physician, and he is recognized for pioneering predictive risk modeling and advancing proactive safety...

Uzodinma Ndibe is Director and Medical Safety Assessment Physician at Bristol Myers Squibb, where he is recognized for advancing innovation and excellence in drug safety. With more than a decade of experience in the pharmaceutical industry, Uzodinma has developed deep expertise in...

Kenneth Onu is the Head/Coordinator of the African Union Smart Safety Surveillance (AU-3S) Programme at the African Union Development Agency – NEPAD based in Midrand Johannesburg, South Africa since 1st October 2024. Kenneth is responsible for the day-to-day management of the AU-3S programme which...

I am a physician nephrologist with over 17 years of extensive experience in the pharmaceutical and biotech industries. My expertise lies in pharmacovigilance across diverse therapeutic areas, including neuropsychiatry, rare diseases, and neurology. Currently, I serve as Senior Medical Director and...

Anuj Parikh, MD, FACEP, is an Associate Director of Medical Safety at Jazz Pharmaceuticals. He earned his medical degree from Jefferson Medical College and completed his Emergency Medicine residency at Thomas Jefferson University Hospital, both in Philadelphia, Pennsylvania. Dr. Parikh brings a...

Dr. Charles Pollack is a Clinician-Scientist with an academic appointment in the Department of Emergency Medicine at the University of Mississippi School of Medicine.  He has long been active in teaching and clinical research and is an international leader in emergency medicine. He is the only...

Eric Prugh is the Chief Product Officer at Authenticx and leads product strategy, design, and product marketing. Eric has spent more than 15+ years building and scaling software companies in go to market, product, and international functions. Prior to Authenticx, Eric was Co-founder and Chief...

Asad Rashid brings over 18 years of experience in the life sciences industry, with a strong focus on innovation, technology, and global leadership in Pharmacovigilance (PV) and Safety operations. Currently serving as Vice President at Syneos Health, Asad leads technology-enabled PV strategies that...

Pav is a dynamic and visionary healthcare leader, with 25 years of extensive experience across various safety (and PV) functions, which include senior management and leadership roles within the  (PV) discipline. He is recognised as a credible and respected global figure in the industry and remains...

Satya Sagi is a visionary leader and innovator in the field of life sciences. As the Founder and CEO of Techsol Life Sciences, Satya brings over 20 years of experience in driving technological advancements and operational excellence in drug safety and pharmacovigilance. His passion for leveraging...

Dana Singer, MD, Medical Director, is a Safety Physician at Jazz Pharmaceuticals. Trained as a pediatrician at the Dana-Dwek Children’s Hospital in Tel Aviv, Dr. Singer brings over a decade of combined clinical and pharmaceutical industry experience, including leadership in pharmacovigilance and...

Ankita Srivastava is a seasoned pharmacovigilance professional with a proven track record in drug development and pharmacovigilance. As the Head of Pharmacovigilance at Vistagen, Ankita brings a wealth of experience and expertise to the table. With a strong background in medicine and drug safety...

Michael von Forstner is a seasoned leader in drug safety and pharmacovigilance. With 25 years of experience in the pharmaceutical industry, Michael has a proven track record of driving strategic innovation, leveraging technology, and enhancing performance in pharmacovigilance and patient safety. ...

Sanjay Vyas is the President of Global Safety Services & Clinical Logistics and also the Country Head / Managing Director for India at Parexel. In this role, he is responsible for the company's global drug safety and pharmacovigilance services, as well as clinical trial supplies &...

Colleen Walsh is a veteran biotech professional with over two decades of experience working in multiple areas of the industry, with a primary focus in pharmacovigilance and quality. She has worked in senior management roles in small, mid, and large sized organizations and has expertise in all areas ...

Aman Wasan is the CEO of ArisGlobal. Aman is a Scientist by training with a degree in Human Genomics. He has a deep knowledge of the Life Sciences industry, a well-established background in global leadership roles, and an expert in operational management and commercial leadership. Prior to taking...

With over 18 years of dedicated experience in the field of pharmacovigilance, Jennifer White has established a distinguished career marked by a commitment to patient safety and regulatory compliance. Currently serving as the Director of Pharmacovigilance for the PPD Clinical Research business of...

Jamie Wilkins, PharmD, is a leading global expert in pharmacovigilance, risk management and global safety policy, with a robust background as a regulator at the US FDA and in the pharmaceutical industry.Dr. Wilkins holds a Doctor of Pharmacy degree from the University of Maryland School of Pharmacy ...

Oleg Zvenigorodsky is a seasoned professional in the field of drug safety with a wealth of experience and expertise. As the Director of Medical Safety at Jazz Pharmaceuticals, Oleg is responsible for overseeing and implementing strategies to ensure the safety and well-being of patients using the...