Melanie Cote works as a Senior Manager, Global Regulatory Affairs at Otsuka and has been in the industry for more than 20 years. After graduating with a bachelor's degree in biochemistry, she worked for a few years in analytical development for various biotechnology companies. She later completed a DESS in drug development, focusing on CMC, and has a Master of Pharmaceutical Sciences from the Université de Montréal. In 2010, Melanie fell into the field of Regulatory Affairs and moved to the UK shortly after where she worked in European regulatory for 2 years. Back home since 2013, Melanie has focused on Canadian regulatory. She is thrilled to be part of DIA Canada Annual Meeting program committee for her second year.

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.

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.

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.

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).

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.

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. M? 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.

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.

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.

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.

Nadia Mian is currently working as the head of local pharmacovigilance 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.

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.

Kim McDonald-Taylor consults in project management, medical writing, training & teaching being in the clinical trials area for over 35 years, including 12 years with Endpoint Research. Her therapeutic experience includes most diseases & therapies. Kim has volunteered with CRAC since 1997. She is a member of Human Research Accreditation Canada Council since 2018. Kim teaches QA & Critical Thinking in Post-Graduate Clinical Research Program at Seneca. Kim earned her MSc from Ontario Veterinary College at Guelph University. She has presented & co-chaired sessions at DIA, ACRP and others. Kim was awarded the Excellence in Clinical Research award 2018 at the CTP conference & 2016 Volunteer of the Year for her work with Brain Injury Canada.

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. He is very excited to participate on the DIA Canada this year.

Sabrina Ramkellawan started her career as a registered nurse with critical care speciality. She has 25 years of clinical trial experience working for Pharma, CROs & research sites. Sabrina has experience conducting clinical trials with novel therapeutics, devices & digital health products. Sabrina is also the President/Board Director at Clinical Research Association of Canada. Through AxialBridge she is supporting a DIGITAL Supercluster Canadian Government award to develop an APP Technology to improve diversity in participant recruitment and retention in clinical trials. Sabrina is the COO at AxialBridge that supports biotech/pharma, CROs, & sites navigate regulatory, strategic advisory and clinical operations to conduct clinical trials.

Marcia Sam is a Senior Manager, Regulatory Affairs at Regeneron Canada Company. 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.