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.

Rebecca began as a bench cancer researcher and over the past 15 years has worked in different leadership roles, all related to enhancing health research capacity through sustainable systems, processes and robust stakeholder engagement. Prior to joining N2 she was responsible for helping lead the Canadian Tissue Repository Network and overseeing research engagement for the Vancouver Island Health Authority by serving as lead of the CIHR Strategy for Patient Oriented Research (SPOR) initiative within the Vancouver Island region. She also worked as Director of the University of Victoria’s Office of the Vice-President Research and Innovation. She holds a Bachelor of Science (Biology) and a Masters (Environmental Toxicology/Carcinogenesis).

Mr. Bartekian is President of Vantage BioTrials, an award-winning Canadian CRO specializing in clinical trial management services. He's contributed his drug development knowledge to the pharma & device industry for over 24 years and has gained vast experience handling complicated trials across an array of therapeutic areas. He has also contributed his knowledge as an Advisor to Global Affairs Canada’s Life Science division, and Colorectal Cancer Canada’s Scientific Advisory Board for the establishment of a Patient Group Pathway Model to Accessing Cancer Clinical Trials. Vatche was also honored in 2021 by his alma mater, Concordia University, as a “Top 50 under 50 Who are Shaping Tomorrow” for his work in combatting Covid-19.

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.

Louise Blythe has been with Bayer Canada Inc. since 2021 as the VP and Head of Regulatory Affairs for the pharmaceuticals division. With over 25 years of broad therapeutic experience in the biopharmaceutical industry, Louise is dedicated to supporting access to innovative medicines for patients. Louise has a Master of Science degree in Pharmacology from the University of Toronto, and an Honours Bachelor of Science degree in Life Sciences from Queen's University.

Melanie Cote, Senior Manager in Regulatory Affairs, has been with Otsuka Canada Pharmaceutical for 7 years working on regulatory filings in Canada. She studied biochemistry and worked for a few years in analytical development after graduating. She later completed a DESS (diplôme d’études supérieures spécialisées) in drug development, focusing on CMC, and has a Master of Pharmaceutical Sciences from the Université de Montréal. In 2010, Melanie fell in love with Regulatory Affairs and worked in European regulatory for 2 years at Mylan and AstraZeneca in the United Kingdom. Since 2013, Melanie has focused on Canadian regulatory. She is thrilled to be a committee member of the DIA Canada Annual Meeting for the first time this year.

My is a Senior Manager of Regulatory Affairs at Knight Therapeutics Inc. She started out her career in health care 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, animal and cannabis health 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 on the Board of Directors. She had spearheaded the NOC and eNOC publications, assisted in CAPRA dinner coordination and presented CAPRA webinars.

Zohra Douida is the Head of Regulatory Affairs for Indivior Canada Ltd.

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.

As Director of Clinical Operations at AbCellera, I am passionate about and proud to be working on clinical trials because they help to improve and save the lives of patients in need. I have more than 20 years of experience in Clinical Research. Before joining AbCellera, I spent 5 years as a Director of Clinical Operations at Merck, working in Oncology and General Medicine portfolios. Before moving to Merck, I worked as a Clinical / Sr. Clinical Project manager on the Asthma/Allergy, Cardiovascular, and HIV portfolios at Schering Canada. I completed a master’s degree in Drug Development from Université de Montréal.

Daniel Greco is the Associate Director of Patient Safety at Bristol Myers Squibb, with a specialization in Risk Management. In this capacity, Daniel has led substantial changes to the risk management program responsible for overseeing the risks associated with thalidomide and its derivatives in Canada. He earned his H.BSc. and PharmD from the University of Toronto, and is presently pursuing a Masters in Pharmacovigilance and Pharmacoepidemiology through the Eu2P program. Moreover, Daniel is practicing as a licensed Pharmacist in the province of Ontario, where he has gained invaluable firsthand experience in direct patient care.

Brenda Gryfe has been Director of Regulatory Affairs at TPIreg, a Division of Innomar Strategies since 2014. She is a pharmacist with over 25 years’ experience in the pharmaceutical industry. Ms. Gryfe has a business-focused understanding of Regulatory Affairs, gained from experience across several companies. Ms. Gryfe has guided Regulatory teams through a variety of strategically complex regulatory processes. She also provides support to promotional material development teams with regulatory advice and review services for the Canadian drug advertising environment. Since her research at U of Toronto in seniors’ understanding of prescription drug labels, Ms. Gryfe retains a particular interest in labeling and patient education materials.

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.

Nadiya Jirova is a manager for the Bureau of Biologics, Radiopharmaceuticals and Self-Care Products within the Marketed Health Products Directorate of Health Canada. Her section is responsible for post marketing surveillance of biotechnology products including blood, cells, tissues and organ products. She is also leading a team responsible for post market surveillance of Monoclonal Antibodies for COVID-19. She has over 15 years of experience in pharmacovigilance and risk management for biologic and pharmaceutical drugs working within Health Canada. Nadiya holds a Bachelor’s degree in Biochemistry from McGill University and a Master’s degree in Pharmaceutical Sciences with specialization in Drug Development from the University of Montreal.

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 governance. Mei is a registered Nurse in Ontario who volunteers for the Region of Peel Public Health Unit.

Randy Levitt is the Director of Pharmacovigilance and Medical Affairs at Paladin. He is also the local compliance champion and works closely with the legal and compliance teams at Endo, the parent company of Paladin. He joined Paladin in 2011 as Manager, Scientific Communications and Publications after Paladin’s acquisition of Labopharm, where he had worked in the medical department since 2008. Randy completed his undergraduate and graduate degrees at McGill University, graduating with his PhD in Experimental Medicine in 2006.

Amber McLeod has held the role of Lead, Regulatory Affairs at AbbVie Canada since May 1, 2020. She leads a team of Regulatory Affairs professionals focused primarily on the filing and approval with Health Canada of biopharmaceutical drug submissions for clinical development and commercial products in the areas of Immunology, Oncology, Virology, Neuroscience, Hormone Replacement Therapy, and Specialty Care. Amber joined Abbott in January 1999. Over her 24-year career with Abbott/AbbVie, she held various roles of increasing responsibility where she led and managed countless regulatory filings, approvals and product launches in different therapeutic areas. Amber holds a Doctorate in Pharmacology and Therapeutics from McGill University.

Nadia Mian is currently working as local pharmacovigilance lead for the affiliate office at Ipsen Biopharmaceuticals Canada. With over 20 years of successful experience in the Biotech/Pharmaceutical industry and expertise in Pharmacovigilance and Clinical research, she has a diverse range of experiences in different therapeutic areas: Neuroscience, Oncology, Hematology, Immunology, Renal disease and Rare diseases. She holds a Master’s degree in Pharmaceutical Science, Biopharmacy from King's College, University of London, UK.

Myriam Salem is currently a pharmacovigilance manager in the Health Products and Food Branch (HPFB) at Health Canada. She previously led the Good Pharmacovigilance Practices inspection Program within the Regulatory Operations and Enforcement Branch (ROEB) and worked within HPFB as a senior scientific evaluator for several years. Prior to joining Health Canada, she held various positions in the pharmaceutical industry and academia at Merck Frosst Canada and McGill's Lady Davis Institute. She holds a master’s degree in pharmacology from Université de Montréal and a master’s degree in Pharmacovigilance and Pharmacoepidemiology from a consortium of European Universities under the EU2P program.

Marcia Sam is enjoying her role as a Regulatory Affairs Strategy and Policy Manager at Roche Canada. With over 16 years of experience in the Biotech/Pharmaceutical industry, she has a diverse range of experiences with exposure to different areas of drug development, regulatory submissions in therapeutic areas as Hematology, Neuroscience, Oncology, Virology, Rare Diseases, etc., volunteered on the regulatory affairs committees of IMC, was a past guest speaker and instructor for regulatory courses at Seneca College of Applied Arts and Technology. She holds a BSc (Honours) degree in Neuroscience/Biology from the University of Toronto and a Post-graduate diploma in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College.

Vanessa Zapata started her career in the pharmaceutical industry in 1998. For 12 years, she fulfilled different roles in the Clinical research field. In 2011, she moved to Pharmacovigilance where she has held various roles of increasing responsibility. She currently fulfills a position of Associate Director, Regional Pharmacovigilance at Merck Canada Inc. She also is the business owner of the company’s Global Pharmacovigilance training that gets assigned annually to more that 115 000 employees and external partners around the world.

Neerja is the Director of Regulatory Strategy and Policy at GSK Canada. She currently oversees a number of functions including Regulatory policy and intelligence, compliance, training and operations. She has been in Regulatory for over 30 years with experiences in all aspects of Canadian regulatory. Neerja is also a long standing member of the Regulatory Affairs Operational Team at Innovative Medicines Canada, and is the IMC lead for ePMI.

Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric populations in Canada, among other files. Previously, Dr. Croker managed the Canada Excellence Research Chair and the Canada First Research Excellence Fund programs for Canada’s federal research funders. She also led the development of the CIHR's training and equity strategies where she received the Innovation Award. Dr. Croker has a PhD from Western University where she studied the molecular mechanisms of breast cancer metastasis and therapy resistance.

Dr. Salman Afsar, Senior Director and Signal Management Team Chair at Bristol Myer Squibb, is a distinguished physician specializing in Medical Safety Assessment. With a strong background in the pharmaceutical industry including notable positions at Sanofi and Astellas, Dr. Afsar brings extensive expertise to his role. Before transitioning to industry he made significant contributions in academia and clinical practice, earning him prestigious awards for his exceptional work.

As VP Clinical Research with the Centre for Neurology Studies and National Research Lead for MAPS Canada, Sonia is a neuroscientist, Clinical Research Professional, leader, and a long-standing research nerd. She has a wealth of experience in Phase II-IV trials in pharmaceuticals, medical devices, digital health, and psychedelics, and is passionate about finding efficient ways to bridge the gap between research and reality in clinically meaningful and accessible ways.

Munaza has 24 years of experience in the world of clinical trials. She is passionate about EDI principles, integrating them into all her work, with a special focus on the inclusion of immigrants in clinical trials. She is on Faculty at McMaster University, where she teaches in the Applied Clinical Research Program. She chairs the N2 Public Engagement Committee, where she champions many EDI initiatives. She is also on the executive board of ACRP Canada.

Stephanie Stankiewicz currently works with the Merck Pharmacovigilance (PV) Partner Strategy and Management team as a Director of Drug Safety and is based in the US. She currently leads a team responsible for the PV implementation and integration of business deals, such as acquisitions and in-licensing. She has over 25 years of experience in PV, with various roles within case processing, safety database support, as well as safety database configuration. Stephanie holds a Bachelor of science degree in Biology from the College of St. Elizabeth and MBA from Centenary University.

Dr. Bliu, a senior biostatistician at Health Canada, has over 22 years of expertise in statistics, pharmaceutical development, and regulations. With a Ph.D. in Biostatistics from McGill University, he has made significant contributions to oncology, vaccines, autoimmune diseases, pediatrics, and rare disorders therapeutic areas. His research interests include advanced study designs and methodologies, Bayesian approaches, causal inference methods, and real-world data applications. He has collaborated internationally on studies, forums, and policy guidance documents such as ICH. As a dedicated educator, he lectures at McGill University and contributes to workshops and conferences on statistical methodologies and clinical study design.

David Duguay is a scientific manager at the Marketed Pharmaceuticals Bureau, Marketed Health Product Directorate, in the Health Products and Food Branch, at Health Canada. He has over 10 years of regulatory drug safety experience with Health Canada. His work involves the post-market surveillance of prescription drugs including Risk Management Plans (RMPs), safety assessments, benefit-risk assessments, and signal detection involving the review of adverse event reports. David graduated from the Université de Montréal (Ph.D. Pharmacology) in 2007 with a focus on cardiovascular pharmacology, and he completed a postdoctoral fellowship in neurosciences at McGill University in 2010.

A Visionary Founder & Director of PV Operations at Zenith PV, a leading firm in PV. Under her leadership, Zenith PV excels in providing cutting-edge solutions to meet Health Canada stringent standards. With extensive experience across Canada & Europe, Manar brings unique blend of traditional and innovative practices to PV. Her commitment to advanced technology drove Zenith PV's rapid growth, supporting pharma and hospitals. Through her strategic acumen, Manar established robust operational framework and a culture of continuous improvement. She is recognized as a transformative figure in a typically conservative discipline, pushing boundaries to enhance patient outcomes, forward-thinker, and a sought-after thought leader and speaker in PV.

Gurpreet Singh is Vice President, Managing Director Integrated Safety at IQVIA. Based in UK, he has 18 years' experience in Pharma Industry of which 16+ years have been in Global Drug Development. He has had the opportunity to work with some top global companies like Cognizant, Tata Consultancy, Novartis and Parexel. At Novartis he was the Global Head of PV Operations managing all Global PV activities. At Parexel he was the Senior Director PV Operations responsible for managing PV projects of top Global Pharma and Biotech companies. Gurpreet is a certified Six Sigma and Project Management Professional. He has interest in Digital Transformation and Organization Culture and has led various projects during his tenure in the Pharma Industry.