Bethany Van Veen has focused her entire career on pharmacovigilance (PV). Starting in the late 1990s, she began her PV career in drug safety operations at Elan Pharmaceuticals and continued to hold a variety of operational leadership roles within small and large organizations including J&J, Millennium and InterMune. She began her consulting career in 2013 and has advised over 125 companies. She values the importance of leveraging strong PV foundational skills to curate new ways of meeting global challenges. In 2017, she founded Perspective Pharmacovigilance, a think tank of PV experts. PPV’s global staff of industry leaders, former PV department heads, and ex-regulators, design innovative solutions to a rapidly changing PV landscape.

LCDR Scott Janiczak, PharmD, MPH, BCPS, is a pharmacy officer in the U.S. Public Health Service, who serves as a Team Leader in the Division of Pharmacovigilance-I (DPV-I) within FDA’s Center for Drug Evaluation and Research. In this role, he leads a multidisciplinary team reviewing post-market drug safety across therapeutic areas. Previously, he served as a safety evaluator in DPV-I (2020-2024) and regulatory affairs pharmacist in FDA’s Office of Generic Drugs (2014-2020). LCDR Janiczak earned his PharmD from Midwestern University, completed a PGY-1 residency at Franciscan Health (Dyer, IN), and is board certified in Pharmacotherapy. He frequently presents on FDA drug safety initiatives at national conferences and academic institutions.

Extensive experience in both post-marketing and pharmacovigilance in clinical trials for over 19 years. In-depth global filing experience as a safety lead for both small molecule and biologics. Co-chair of Cardiovascular Internal Safety Advisory Group at AbbVie. Member of DIA ASA Safety WG (workstream 3). Intimate knowledge of processes and regulations in ICSR, aggregate reporting and signal detection. Current knowledge of PV regulations including EU good pharmacovigilance practices. Comprehensive and current knowledge of Internal Medicine (current Board certification). Comprehensive knowledge of drug development process and conduct and reporting of post authorization studies.

Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around signal and benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis and signal management methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.

Balmeet Gurm is an accomplished physician with extensive experience in the pharmaceutical industry, specializing in oncology and cardiovascular therapeutic areas. Currently serving as Executive Director, Therapeutic Area Lead in Patient Safety at Bristol Myers Squibb (BMS), Balmeet brings a wealth of expertise in pharmacovigilance, risk management, and drug development. Balmeet transitioned to the pharmaceutical industry after practicing medicine for a few years and has held critical leadership roles in safety and pharmacovigilance across multiple organizations. Throughout a distinguished career, Balmeet has contributed significantly to advancing patient safety, regulatory compliance, and the successful development of innovative therapie

Dr. Tarek Hammad, VP & Head of Medical Safety for Marketed Products at Takeda Pharmaceuticals, is a renowned expert in drug safety, benefit-risk assessment, and pharmacoepidemiology. With extensive experience at major pharmaceutical companies like Sanofi and Merck, as well as a distinguished 13-year career at the US FDA, he has received numerous awards for his contributions. Dr. Hammad is a sought-after speaker, actively involved in industry initiatives and has held several academic appointments. He has authored over 80 peer-reviewed articles, book chapters, and letters to the editor, offering valuable insights in the field. Learn more at www.DrTarekHammad.com.

Stephanie is the Deputy Director of Benefit Risk Evaluation II in the Safety and Surveillance group at the MHRA. Prior to her current role she held a variety of management and assessor positions in the Agency. She has a masters degree in Clinical Pharmacology and a PhD in Cell Biology. She joined the Agency following a career in academia and has now over 20 years experience in drug regulation with particular experience in post-authorisation procedures and 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. As a strategist and accessible leader with experience in Pharmacovigilance and Quality Risk Management within the pharmaceutical industry, Kal has developed the infrastructure for managing all REMS programs and RMPs in collaboration with multiple disciplines. Kal believes in leadership and teamwork and focuses on what is important to achieve successful results in ensuring patient safety and regulatory compliance.

Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior to her role at Pfizer, Jamie served as the Deputy Director for the Division of Risk Management (DRM) at the US FDA. She is a two-time recipient of the FDA Francis O. Kelsey drug safety award, and has a deep passion for safety, and risk management science.

Vanessa Zapata is the Global Clinical Safety & Pharmacovigilance Training Lead at Merck & Co., Inc., where she leads PV training strategy, governance, and oversight. She serves as the business owner of Merck's global PV training, assigned annually to more than 120,000 employees and partners worldwide. With more than 25 years of pharmaceutical industry experience, including over a decade in PV, she has held positions of increasing responsibility across safety operations, compliance, and training. She is passionate about advancing patient safety through capability development and continuous learning.

Mariette Boerstoel-Streefland, MD, MBA, MSc(epi), has been in the pharmaceutical industry for 30 years, and is currently SVP, Worldwide Patient Safety Officer at BMS. Mariette joined pharma industry from clinical practice in 1989 and held various leadership positions in drug safety at Organon (now Merck), Mayne Pharma (now Hospira/Pfizer), Forest Labs (now Abbvie). In 2014 she joined Baxter to establish a new safety organization for Baxalta, and upon the acquisition by Shire led the new combined safety organizations. In 2018 she moved to Alexion and with the acquisition by AZ was appointed Chief Safety Officer, SVP Global patient safety. In August 2023 she joined BMS. Mariette has an MD degree from the University of Utrecht, a MSc Pharma

Mark is a founder and managing partner at Axian Consulting, where he focuses on improving benefit-risk balance and outcomes for patients through improving communication and adding value using digital approaches. He has a >20 year pharma career which has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI, Foresight, PopeWoodhead, Huron and now is a founder and managing partner of Axian Consulting). He is now focusing on the opportunities presented by improved benefit-risk management approaches to enhance risk management decision-making in development and on adding value to the interactions of industry and customers to maximise B-R balance and improve outcomes in REMS and aRMM programmes.