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 works as a Safety Team Lead at Pfizer Drug Safety Unit Canada and has been with the company since 2022. He has been working in the industry for 14 years in the Montreal area. A couple of years after graduating as a Physician in Peru, Ricardo moved to Canada and started working in Pharmacovigilance and Medical Information to later focus on his new passion, Pharmacovigilance and Drug Safety. He has completed different Pharmacovigilance trainings including the PV course by Kusuri Canada Corp., GVP course at Cegep Gerald Godin in Montreal and Preclinical Safety Assessment and Pharmacovigilance given by the 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.

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.

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.

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.

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.

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.

Ivy Salter has been with the Ottawa Hospital Research Institute (OHRI) for over 11 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, and since 2024, has served as Manager of Regulatory and 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.

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.

Anaya Rehman is a Senior Transparency Specialist at Certara, 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.