Stephanie Anderson is an Associate Director of Regulatory Affairs at Intrinsik Corp. She has been a part of the pharmaceutical/biotechnology sector since 2010 and now leads a dedicated team of Regulatory Affairs professionals. Stephanie has led a broad range of regulatory activities from clinical development to post-registration license maintenance across a wide range products and therapeutic areas. Stephanie has experience with FDA, Health Canada, EMA, BfArM, and MHRA. Stephanie has a Master of Science degree in Biochemistry and Physiology from the University of Western Ontario.

Myriam is currently serving as the National supervisor of the Clinical Trial Compliance Program at Health Canada. She previously coordinated the Good Pharmacovigilance Practice Inspection Program at Health Canada, worked as a pharmacovigilance scientific manager and a senior scientific evaluator for several years. She was involved in the implementation of several policies leading to a strengthened post market oversight of opioid products in Canada. Prior to joining Health Canada, she held various positions in the pharmaceutical industry and academia. She is a biochemist by training and holds a master’s degree in pharmacology from Université de Montréal and a master’s degree in Pharmacovigilance and Pharmacoepidemiology.

Mei Lam is the Pharmacovigilance Manager for Haleon Canada. She has over 15 years in industry, primarily in Pharmacovigilance (PV). In addition to PV, Mei has experience in medical information, medical affairs, and global deviation management. Mei is a registered Nurse in Ontario who volunteers for the Region of Peel Public Health Unit.

Dr. Yatika Kohli is an accomplished Senior Regulatory Professional with strong leadership skills, strategic foresight and business acumen. At NoNO Inc, Dr. Kohli is leading all strategic and global regulatory initiatives for NoNO’s products. With more than 20 years of experience in Biotech/Pharmaceutical industry, Dr. Kohli has expertise in developing global regulatory and clinical strategy with project and product management across multiple modalities and jurisdictions. She led the regulatory activities for the registration and launch of two blockbuster vaccines for Sanofi Pasteur in the USA and Apotex’s first biosimilar product in Europe.

Katalin Bertenyi is the manager of the Clinical Evaluation Division - Endocrine and Metabolic Diseases, situated in CBBB in the Biologic and Radiopharmaceutical Drugs Directorate of Health Canada. Her team is responsible for the evaluation of biologics for endocrine and metabolic diseases, including rare diseases. She has over 20 years of experience with Health Canada, in the clinical evaluation of biologic and pharmaceutical drugs in the areas of reproduction, urology, oncology, endocrinology and metabolism, as well as experience in regulatory affairs, and clinical trials for medical devices and pharmaceutical drugs. Katalin holds a B.Sc. (Honours) in Biotechnology/Biology and a M.Sc. in Biology, both from Carleton University in Ottawa.

Nessrine is Director of Clinical Operations at AbCellera, with close to 20 years of clinical research expertise. She leads the strategic planning and execution of early phase clinical studies in Canada and internationally, advancing antibody programs into trials. Previously, Nessrine was Senior Clinical Operation Manager at Bristol Myers Squibb, directing the hematology and cell therapy portfolio in Canada. Her diverse career began at the Jewish General Hospital, followed by industry roles as Clinical Safety Officer, CRA, and Project Manager. She holds a Bachelor in Biology and a Master in Pharmacology from McGill University. Outside work, she enjoys traveling, family time, hiking, and kayaking.

Foo-Lim Yeh brings more than 25 years of regulatory affairs experience in the pharmaceutical industry, with a strong track record of advancing innovative therapies through thoughtful regulatory strategy and cross-functional collaboration. He is passionate about leading high-performance teams and enabling timely patient access to important treatments. Foo-Lim has held positions of increasing responsibilities within Regulatory Affairs at Pfizer, Wyeth, Allergan and currently serves as Allergan Aesthetics, Neuroscience, and Specialty Head, Regulatory Affairs at AbbVie. Foo-Lim holds a M.Sc. from the University of Guelph.

Erin is Chief Clinical Research Officer for the CIHR Pan-Canadian Network for HIV and STBBI Clinical Trials Research (CTN+) and the Centre for Advancing Health Outcomes. Her expertise includes management of academic clinical research centres; clinical trial protocol development; international, multi-centre clinical trial project management oversight; monitoring/auditing clinical trial sites; co-designing and implementing competitive funding programs; and collaborative leadership of multidisciplinary teams that include patient partners. In addition to being current Chair of the Network of Networks Canada (N2) board of directors, she previously served as an elected member of the Society of Clinical Research Administrator board of directors.

Dr Hocine Abid is an international medical doctor graduate. Hocine also holds an MBA from École des Hautes Études Commerciales (École des HEC Montréal) and a Graduate Diploma in public administration from École Nationale d’Administration Publique. Hocine is the national manager for Health Canada’s Clinical Trial Compliance Program that oversees the inspections of clinical trials since 2018. Before this, he occupied different roles in various positions within Health Canada such as manager of the GMP inspection program, and Head of the medical cannabis program overseeing the evaluation and the delivery of authorizations to possess and produce cannabis for medical purposes.

Rosemarie J. Clarke, RN, MHM, CCRP, is President of AllWright Clarke Research Solutions, specializing in clinical research operations and GCP compliant study management. A former Clinical Research Manager and Project Manager at the University Health Network, she has over 20 years of experience leading national and international trials, including decentralized COVID 19 studies. Rosemarie also teaches in the Applied Clinical Research Program at McMaster University and is a long standing Certified Clinical Research Professional.

Anna Bussel is a pharmaceutical professional with 15+ years of experience in pharmacovigilance (PV), regulatory affairs (RA), and quality assurance (QA). Her career spans both the pharmaceutical industry—holding PV, RA, and QA roles at Eli Lilly and Company—and consulting, where she headed the PV & MI Department at Veristat, Science-First™ CRO, providing strategic PV & MI advice to multiple clients. She has led numerous GVP and GMP audits on behalf of Marketing Authorisation Holders and liaised with Health Authorities on market access and drug policy improvements. Anna holds a Master’s in Pharmacy and is an active member of the DIA.

Liliana Di Stabile is a pharmacovigilance professional currently serving as a Safety Physician at Knight Therapeutics Inc., where she oversees Canadian safety operations, aggregate reports, RMP development, signal detection, inspection readiness, and other core PV activities. With over 20 years in the pharmaceutical and biotechnology industry, she brings deep expertise in drug safety and clinical research. She previously led PV functions at Paladin Pharma and built the PV department at Thallion Pharmaceuticals. Her decade as an ER general surgeon in Argentina continues to ground her commitment to improving patients’ lives.

Daniel Greco is a licensed pharmacist with a passion for drug safety. He earned his H.BSc. and PharmD from the University of Toronto and completed a Master’s in Pharmacovigilance and Pharmacoepidemiology through the Eu2P program at the University of Bordeaux. His work in pharmacovigilance has focused on risk management at both local and global levels, and he currently serves as a Board Member of the Pharmacovigilance and Medical Information Network of Canada (PVN-MI). Daniel is particularly interested in the intersection of technology and pharmacovigilance, and closely follows developments in artificial intelligence and its potential to transform pharmacovigilance practice and advance drug safety.

Ricardo is a Safety Team Lead within Pfizer Canada's Drug Safety Unit. Originally trained as a physician in Peru, he relocated to Canada and has accumulated more than 16 years of experience in the pharmaceutical industry, specializing in pharmacovigilance and drug safety. Ricardo is passionate about patient safety and continuous learning, with particular interests in Canadian and international pharmacovigilance regulations, artificial intelligence applications in drug safety, automation and process innovation. He has experience supporting audits, regulatory inspections, and inspection-readiness activities. Ricardo has completed specialized pharmacovigilance training through institutions including Kusuri Canada Corp. and Uppsala University.

Riti Singh is a dynamic and strategic, transformational leader, accomplished in building departments from inception and transforming them into high performing, value-added, revenue generating functions. With over 20 years of broad therapeutic experience in the life sciences and healthcare sector, she has expertise in setting up pharmacovigilance, medical information, medical affairs, and quality operations for local and global organizations. Riti holds a PharmD degree from Leslie Dan Faculty of Pharmacy at University of Toronto and an MBA from California State University. Currently at Bayshore, Riti is the National Director overseeing Clinical Trials, RWE, Pharmacovigilance, Medical Information, Quality and Regulatory DEL/MDEL activities.

Yulia is a Scientific Evaluator at the Marketed Pharmaceuticals Bureau (MPB), Health Canada, where she focuses on drug safety. Prior to this role, she conducted research in genome stability and cell signaling at Université de Sherbrooke and McGill University, and later supported global clinical and regulatory strategies at Allucent. With over 15 years of experience in academia, industry, and government sectors, spanning fundamental and biomedical research, clinical trials and regulatory affairs, she brings a broad expertise across the drug development life cycle. Yulia holds a PhD degree in Cell and Molecular Biology from the University of Edinburgh, UK and RAPS Regulatory Affairs Certification (RAC-Drugs).

Adesola Adeyemi has been with Bayer Inc. since 2019 with the Regulatory Affairs team. Adesola has worked on various regulatory submissions for human and animal drug products during her career at Bayer Inc. Adesola has a Master of Science degree in Drug Design, a Bachelor of Science in Chemistry/Industrial Chemistry and a Post-graduate diploma in Regulatory Affairs.

Rebecca Humecky is an Associate Director of Regulatory Affairs – Chemistry Manufacturing and Controls (CMC) at Cytokinetics, Inc. with more than 20 years in the biotechnology/pharmaceutical industry. She has extensive experience developing and leading regulatory strategy in both the small and large molecule space. Prior to her time in regulatory, Rebecca held various positions within analytical development and quality assurance. Rebecca holds a B.S. in Chemistry from Westminster College and a M.S. in Pharmaceutical Science from Rutgers University.

Amy Chan is an Associate Director in Regulatory Affairs at Takeda Canada Inc., with over two decades of experience in the pharmaceutical industry across Regulatory Affairs and Pharmacovigilance. She also contributes to academia as a part-time professor at Seneca Polytechnic.

Angelina Habimana is a senior regulatory affairs leader with over 20 years of experience in the pharmaceutical industry, specializing in innovative medicines and biosimilars. She currently serves as Head of International Markets for Innovative Medicines and Biosimilars at Teva. Throughout her career, she has held progressive leadership roles at Teva, Sanofi, and other organizations, driving regulatory strategy, clinical development, and product lifecycle management across diverse portfolios. She serves as Vice-President of Women Leaders in Pharma as a volunteer activity and holds a Master’s degree in Pharmacology from the Université de Montréal.

Oxana Iliach, PhD is a Sr. Director, Regulatory Strategy and Policy at Certara/Synchrogenix. She has more than 15 years of experience in the healthcare industry including the last 10+ years in regulatory affairs. Her specialty is developing and executing regulatory strategies for drugs for rare diseases, pediatrics, advanced therapy products and biosimilars, with a focus on Chemistry, Manufacturing and Control (CMC). Oxana has experience with the FDA, EMA, Health Canada, and other smaller agencies. She is also a part-time lecturer at Northeastern University, Toronto campus and professor at Seneca College of Applied Arts and Technology. Oxana is a member of CAPRA, RAPS, CORD and IRDiRC.

Tamei Elliott, MS, is the Director of Global Scientific Content at the Drug Information Association (DIA). She leads DIA’s global scientific content strategy, ensuring alignment with regulatory priorities, industry trends, and evolving stakeholder needs across regions. She also established and leads DIA’s Global Science Content Center of Excellence, driving harmonization of content development and strategy across Europe, Asia, North Africa, and the Middle East. With expertise in regulatory science, she brings stakeholders together to address the life sciences industry’s most pressing challenges, driving outcomes that move toward solutions.

Celline Brasil is a pharmacist by training, with an MPH in Epidemiology and a PhD in Drug Utilization and Pharmaceutical Policy. As a pharmacist and researcher in Brazil, she contributed to advancing pharmaceutical policy and equitable access to high-cost medications for chronic and rare diseases within the public health system. As a postdoctoral fellow at McGill University, she conducted real-world comparative safety and effectiveness research to improve outcomes for vulnerable populations. Since 2021, Celline is a Senior Epidemiologist at Health Canada’s Marketed Health Products Directorate, where she assesses real-world evidence and provides expert advice on drug safety for regulatory decision-making.

Laurie Chapman, PhD is a Senior Scientific Evaluator at the Marketed Health Products Directorate of Health Canada, where she contributes to the scientific assessment and regulatory oversight of health products post-authorization. In her role, she works with multidisciplinary teams to evaluate scientific evidence supporting the safety, and effectiveness of natural health products, non-prescription drugs and other health products for self-selection helping to inform regulatory decision-making and protect the health of Canadians. She is committed to advancing regulatory science, fostering collaboration among stakeholders, and supporting innovation while maintaining rigorous standards for public health protection.

My is a Director of Regulatory Affairs at Innomar Strategies, a division of Cencora. She started out her career in healthcare working at Sunnybrook and Women`s Health College in their laboratory and then transitioned into the pharmaceutical industry. With over 20 years’ experience, My has worked on regulatory submissions for human and animal drug products, covering a variety of therapeutic areas and overseeing both RA and QA responsibilities. She enjoys coaching and mentoring team members and shares a true passion for her work. My has been an active CAPRA member over the years and is currently a Board of Director member and Chair of the Dinner Meeting Committee. She had spearheaded the NOC and eNOC publications and presented webinars.

Tharany Ganesh has been with AstraZeneca since 2006, holding progressive roles in Regulatory Affairs, Quality Assurance and Patient Safety. She has worked in several different therapy areas including Oncology, Cardiovascular, Respiratory, Vaccines and Infectious Diseases, Gastrointestinal and Neuroscience during her career at AstraZeneca and is the current Head of Regulatory Affairs for the Canadian business. Tharany holds a Master of Biotechnology degree from the University of Toronto, and an Honours Bachelor of Science degree from the University of Waterloo.

Kathy has more than 20 years of clinical research experience. She is currently responsible for the clinical trials at NoNO Inc (a Canadian research focused pharmaceutical company). Prior to NoNO, Kathy worked at Sanofi Pasteur, where she was the Director of Study Management and Logistics in Toronto and Singapore. She has worked in various therapeutic areas including stroke, vaccines and atopic dermatitis. Currently, she is working with the University of Calgary's Stroke Unit in an industry-academic collaboration, where central review and focused monitoring has been implemented.

Dr. Chaitanya Koduri serves as the Director of International Government and Regulatory Engagement in the Global External Affairs division of the United States Pharmacopeia. In this capacity, Dr. Koduri oversees international regulatory partnerships involving the United States Pharmacopeia, global regulatory agencies, pharmacopoeias, and additional government bodies concerned with health and pharmaceutical regulations. With over 16 years of diverse expertise, his background spans clinical fields, regulatory toxicology, nanotechnology, pharmaceuticals, and public health policy. Prior to his current role, he has occupied various roles in clinical and nonprofit institutions, focusing on public policy and regulatory affairs.

Evan Richardson began his career in the pharmaceutical industry 20 years ago and today serves as Senior Director of Regulatory Operations & Clinical Disclosure at Veristat. His experience includes drugs, biologics, and medical devices, and he has worked for both service providers and industry organizations of all sizes. Evan has held many roles throughout his career, including regulatory affairs, regulatory operations, quality management, and project management. In his current role, Evan leads a global team of subject matter experts at Veristat, helping clients navigate electronic regulatory submissions and clinical data disclosure requirements.

Kelly Robinson is the Director General of the Pharmaceutical Drugs Directorate at Health Canada. In this role she leads a multidisciplinary team responsible for the authorization of innovative and generic pharmaceuticals, clinical trial evaluation, and the Special Access Program. Kelly has held various leadership positions in drug authorization and post-market surveillance at HC. She has played a pivotal role in advancing national and international regulatory initiatives including HC's Reliance Order, Clinical Trial modernization, fostering alignment between HC and HTAs, enhancing international collaboration through platforms such as Access and ORBIS, and is a former co-chair of the ICMRA Working Group on Real-World Evidence.

Ivy Salter has been with the Ottawa Hospital Research Institute (OHRI) for over 12 years, contributing to a wide range of clinical trials across multiple therapeutic areas. In 2021, she transitioned from study coordination to Research Administration as a Clinical Research Facilitator. In 2024, Ivy became the Manager of Regulatory and Quality Assurance and has since taken on the role of Director of Clinical Research Quality Assurance. In this role, Ivy oversees institutional compliance and quality assurance initiatives, and leads ongoing education and training programs to ensure adherence to all applicable principles, regulations, and guidance governing clinical research.

Tatiana Stankevitch is a Regional Regulatory Compliance and Enforcement Specialist with Health Canada’s Health Product Compliance Directorate, specializing in post-market oversight of health products. She has over 19 years of experience in regulatory compliance, with expertise in pharmacovigilance inspections, risk-based oversight, and regulatory compliance monitoring. Tatiana conducts Good Pharmacovigilance Practices (GVP) inspections, contributes to national compliance initiatives and working groups, and holds a Regulatory Affairs Certification (RAC) and a Bachelor of Science in Biochemistry. She combines scientific expertise with regulatory knowledge to support public health and stakeholder collaboration.

Amanda Starr holds a BSc and MSc from the University of Guelph, and a PhD in Biochemistry from the University of British Columbia. She is currently a clinical Scientific Evaluator in the Metabolic and Musculoskeletal Drugs Division of the Pharmaceutical Drugs Directorate at Health Canada. With over 15 years of professional experience in academia and government, she has held progressively senior roles in leading research projects, clinical trial review, and design and implementation of internal workflows to improve review efficiency.

Sabina Agostino is a highly accomplished clinical operations leader with extensive expertise in clinical research, trial management, and operational oversight within the pharmaceutical industry. She currently serves as Country Clinical Operations Head – Clinical Study Management at AbbVie Canada, following nearly 12 years as Clinical Operations Manager. Her career reflects progressive leadership across roles including Senior Clinical Research Associate, Regulatory Affairs Specialist, and Clinical Trial Manager with AbbVie Canada, Quintiles Canada, and Teva Canada/Teva Neuroscience Canada. She is also a licensed clinical psychologist. Sabina holds a Master’s degree in Psychology from Antioch New England and a Bachelor’s degree in Psychology.

Sehir Ahmad has over 20 years of experience across the pharmaceutical, veterinary drug, and medical device industries, with extensive expertise in developing and leading regulatory strategy for both small and large molecules. Currently at Roche, Sehir leads a dedicated team of Regulatory Affairs professionals, overseeing complex regulatory initiatives. Sehir holds a BSc. in Biology and Environmental Studies and a Post-graduate diploma in Regulatory Affairs.

Maria Amaya is the Lead External Advocacy, North America in Quality Policy & Advocacy at Roche. In this position, Maria works within Roche/Genentech Global External Advocacy community to develop and deliver innovative quality and CGMP regulatory pathways, and collaborate with internal and external stakeholders including support in harmonization and streamlining of regulations. Maria holds a PhD in Protein Chemistry and a Masters in Protein Engineering from the Paris-Sud University in France and a Bachelors in Chemistry from the National University in Colombia. She has more than 13 years of experience in the pharmaceutical industry working in Product Development, Manufacturing Technology, Regulatory and Quality & Compliance.

Honieh is a pharmacist by training and has been a member of the Regulatory Operations and Enforcement Branch since 2018. As a Compliance and Enforcement Officer in Health Canada's Clinical Trial Compliance Program, she conducts inspections of clinical trial sponsors and investigator sites and supports compliance verification and promotion activities to help ensure compliance with clinical trial regulations. Prior to joining the public service, Honieh spent more than 10 years working in regulatory affairs in the private sector, bringing extensive industry experience to her current role.

Marie-Thérèse Bawolak is a Manager in the Marketed Health Products Directorate at Health Canada. She holds a B.Sc. in Pharmacology from Université de Sherbrooke, and a M.Sc. and a Ph.D. in Experimental Medicine, from Université Laval. Marie-Thérèse joined Health Canada as a Scientific Evaluator in 2011. She has experience in the pharmacovigilance and risk management of both biologic and pharmaceutical products. Marie-Thérèse is currently leading modernization activities related to Risk Management Plan reviews at Health Canada.

Dr. Ron Boch is the Vice President, Biotechnology and Industry Affairs with lead responsibility for BIOTECanada’s policy development reflecting the diverse nature of Canada’s health, industrial and agricultural biotechnology sectors. He brings a wide range of scientific, research and commercialization expertise in his work with emerging companies, vaccine manufacturers and global pharmaceutical companies, having worked for over 25 years with industry particularly regarding biotechnology products, vaccines and formulation. Dr. Boch serves advisory Boards including the Industry Advisory Committee of the Drug Development and Innovation Centre at the University of Alberta. He received the 2021 CSPS award of leadership in pharmaceutical Sciences

Saunya Dover is Director, Science and Methods at Canada's Drug Agency (CDA-AMC), where she leads a multidisciplinary team supporting health technology assessment (HTA) and evidence-informed healthcare decision-making. With almost 15 years experience in pediatric rare disease clinical research and health research methods, she oversees the development and application of quantitative methods, real-world evidence approaches, ethical analysis, and methodological guidance. Her work also focuses on integrating equity considerations and deliberative processes into HTA to support decisions that reflect both evidence and societal values. She holds an MSc in Health Systems Management and a BSc (Honours) in Human Kinetics from the University of Ottawa.

Safia Hassan is a Senior Regulatory Affairs Officer within the Pharmacovigilance Division of Health Canada’s Office of Cannabis Science and Surveillance. This division leads Health Canada’s vigilance framework for cannabis and cannabis products. Before joining this division, Safia has held various positions the public sector and the private sector, including the Microbiology Laboratories of the Canadian Food Inspection Agency and the R&D Division of Abbott Point of Care, a subsidiary of Abbott. Safia holds a Bachelor’s degree in Biomedical Sciences from the University of Ottawa and is completing a Master’s degree in Epidemiology from the University of Montreal.

Elisa Koppelman, MSW, LICSW, MPH, is a Program Manager at the MRCT Center of Brigham and Women’s Hospital and Harvard. She brings over ten years’ experience as a public health project director in an academic setting overseeing projects on a range of content issues with a particular focus on qualitative research methods. Prior to her immersion in the public health realm, Lisa worked for 15 years as a clinical social worker in a variety of settings. Lisa earned her BA from Tufts University, her MSW degree from Columbia University School of Social Work, and her MPH degree in International Health from Boston University School of Public Health. She is a certified yoga & trauma informed yoga teacher and is a trained Executive Coach.

Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance inspections and refining the MHRA's GPvP inspection programme. Inspector training, the development and update of pharmacovigilance legislation and guidance as well as stakeholder engagement and education continue to be a key part of her work. In previous roles, Sophie was responsible for the assessment of safety variations at the MHRA, and worked in medical information and on a regulatory affairs project in industry.

Sara Saunders is the Director of Global Regulatory Affairs at Florence Healthcare, where she leads global compliance and regulatory strategy to support decentralized and hybrid clinical trials. Drawing on extensive experience across vendor and site environments, she specializes in translating complex global regulatory requirements into practical, scalable digital solutions that help organizations stay ahead of evolving compliance expectations.

Stephanie Di Trapani is Director of the Operations Division within Health Canada's Health Products Shortages Directorate, where she oversees drug and medical device shortage operations. Since joining Health Canada in 2005, she has held a range of leadership roles, including responsibility for compliance and enforcement activities for drugs and natural health products. She is a graduate of Dalhousie University.

Bruce Gordon has been a scientific evaluator with the Marketed Health Products Directorate (MHPD) at Health Canada since 2001. He has a background in molecular biology, and significant experience in the post-market safety review of biologic products, including recombinant biotherapeutics and blood products. Over the past 25 years, he has led multiple high-profile safety reviews that resulted in regulatory actions as well as numerous risk communications. More recently, he has had important policy and process development roles in the MHPD, including leading the development and implementation of a new signal detection working group to evaluate all company-submitted Periodic Benefit-Risk Evaluation Reports (PBRERs) for biologics.

Dr. Christopher Gravel is an assistant professor of biostatistics in the School of Epidemiology and Public Health at the University of Ottawa. He obtained a PhD in Probability and Statistics from Carleton University and a post-doctoral fellowship from McGill University. His research is on the development and improvement of methods for drug and vaccine safety studies focused on measurement error, disproportionality analysis and causal inference. Dr. Gravel is an investigator with networks on post-market drug safety evaluation (PMDE), pediatric rare disease (RareKids-CAN) and perinatal pharmacoepidemiology (CAMCCO-L). Prior to joining the University of Ottawa Dr. Gravel worked for Health Canada in both pre and post market regulatory settings.

Ann Mary Thomas is a PharmD graduate currently working in clinical literature monitoring at Ephicacy Canada. She has over seven years of experience in pharmacovigilance, medical writing, and supporting global regulatory compliance. She is committed to continuous learning and is interested in advancing her expertise in drug safety and medical affairs, including the application of AI to drug safety.

Vandana Oza, MBA, B.Pharm, is Head of Medical Operations, Governance & Patient Access at Bayer Canada. With more than 18 years of pharmaceutical industry experience, she leads strategic initiatives across patient support programs, patient access, medical operations, governance, and real-world evidence generation. Vandana is passionate about advancing patient-centered healthcare solutions and leveraging data, innovation, and cross-functional collaboration to improve patient outcomes and support healthcare decision-making. Prior to her current role, she served as Country Head of Pharmacovigilance at Bayer Canada and has held leadership roles across medical affairs, patient support, and drug safety.

Anaya Rehman is a Regulatory Services Manager at Veristat, with over a decade of experience in healthcare, academic research, and the pharma industry. She provides technical leadership and expertise for clinical trial disclosure, helping sponsors navigate stringent regulations such as Health Canada’s PRCI, EMA Policy 0070 and EU Clinical Trial Regulation 536/2014. Anaya is a regular speaker at conferences on this subject, captivating audiences as she champions compliance and safeguards sensitive information in clinical documentation. She also serves on the Ontario Chapter leadership team at the Regulatory Affairs Professionals Society (RAPS), further solidifying her influence in the field.

Compliance and Enforcement Specialist, Clinical Trial Compliance Program (CTCP), Health Canada. Katarina holds a Bachelor’s in Pharmacy from the University of Belgrade and graduated with honours from Seneca College’s Pharmaceutical Regulatory Affairs and Quality Operations program. She joined Health Canada in 2008 and currently works as a Good Clinical Practices (GCP) Compliance Specialist, inspecting clinical trials under ICH guidelines and the FDRA. Previously a Drug Specialist, she has held roles including GVP Inspector, GVP Coordinator, and Compliance Inspector for drugs and natural health products. Katarina has also participated in joint inspections with foreign regulators and presented at national and international events.

Jennifer (JJ) Wilhelm is a regulatory affairs professional working as Director, Regulatory Affairs at Merck Canada Inc (Merck). She started in industry at a regulatory consulting firm, then worked for Canadian biotech companies, and has been with Merck since 2011. JJ holds an Honours BSc in Biomedical Sciences from the University of Guelph, an MSc in Pharmacology and Toxicology from McGill University, and an eMBA from JMSB at Concordia University, as well as the RAC (US) credential from RAPS. JJ is currently focused on CMC aspects of regulatory affairs in Canada, as well as related areas (DEL, drug shortages, etc). She is involved in policy activities, with Innovative Medicines Canada (Quality team) and BIOTECanada (BRAG), and Merck.