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 and Global regulatory. She is thrilled to be part of DIA Canada Annual Meeting program committee for her third year.

As the Head 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.

Nadia Latif 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.

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 her career as a cancer researcher and, over the past 15 years, has held a range of leadership roles dedicated to strengthening health research capacity within Canada. She specializes in building sustainable systems that enhance research excellence, while fostering meaningful engagement. Prior to joining N2 Canada, Rebecca played a key role in leading in leading the Canadian Tissue Repository Network and advancing research engagement by managing the CIHR SPOR initiative for the Vancouver Island region. Most recently, she served as Director of the Office of the Vice-President Research and Innovation at the University of Victoria. Rebecca holds a BSc in Biology and a Master’s in 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.

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.

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.

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.

Randy Levitt is the Director, Pharmacovigilance, Medical Information and Patient Support at Knight Therapeutics Canada. He recently joined Knight from Paladin Pharma, where he worked for 13 years, most recently as Director, Pharmacovigilance and Medical Affairs. He is currently a Board Member of the Pharmacovigilance and Medical Information Network (PVN-MI) – Canada and Ethics Advisory Team Member at Innovative Medicines Canada. Randy completed his undergraduate and graduate degrees at McGill University, graduating with his PhD in Experimental Medicine.

Kim McDonald-Taylor consults in project management, medical writing, training & teaching being in the clinical trials area for over 37 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 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. In her spare time, Kim enjoys photography, birding, genealogy, music and downhill skiing.

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.

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.

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.

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).

Amber McLeod has held the role of Head of Immunology, Virology, and Specialty at AbbVie since May 2020. In this role, she leads a team of Regulatory Affairs professionals focused on filing and obtaining approval for biopharmaceutical drug submissions with Health Canada, spanning clinical development and commercial products in the fields of Immunology, Virology, Neuroscience, and Specialty Care. Amber joined Abbott in January 1999. Over her 25-year tenure with Abbott/AbbVie, she has held various roles of increasing responsibility, leading and managing numerous regulatory filings, approvals, and product launches across diverse therapeutic areas. Amber holds a Doctorate in Pharmacology and Therapeutics from McGill University.

Prof. Yola Moride has a strong track record of methodological expertise in pharmacoepidemiology and therapeutic risk management. She is Research Professor at Rutgers University and President of YolaRX Consultants. She received a PhD in Epidemiology from McGill University and a Post-doctoral Fellowship in Pharmacovigilance from the University of Bordeaux (France). She was President of the International Society for Pharmacoepidemiology (ISPE) and Vice-President of the International Society of Pharmacovigilance (ISoP). She also served on the Steering Group of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) at the European Medicines Agency, and was a member of CIOMS Working Group IX on risk min.

Dr. Rania Mouchantaf is A/Executive Director at the Marketed Health Products Directorate at Health Canada with over 20 years of experience in academic, industry and regulatory experience . Before entering the public service she worked in the private sector, however her interest in public health led her to join the federal government at Health Canada where she has assumed different roles in assessment, management and strategic policy development from both a pre and post market perspective in the area of safety, efficacy and quality Her education includes a Bachelor degree in Microbiology and Immunology and a doctorate degree in Pharmacology and Therapeutics from McGill University.

Todd has been working in Drug Development for more than 30 years. He has extensive experience in clinical operations and also participated in and led many large-scale change and process improvement initiatives. Todd is currently Product Owner for implementation of a new Protocol authoring. Prior to his current role, he was Roche’s Program Lead for TransCelerate.

Suzie Talbot is the President and Founder of DIEX Recherche, a Canadian private clinical research organization with 6 sites across Quebec. With nearly 30 years of experience in clinical research, she brings deep operational expertise and a strong site perspective to trial execution. Suzie is a passionate advocate for early, meaningful site engagement and for impactful research that improves patient health. She is also a founding member of the Canadian Clinical Research Coalition, which promotes Canada as a premier destination for clinical trials. Her leadership is driven by a commitment to operational excellence, strong collaboration between stakeholders, and research that truly makes a difference in people’s lives.

Visagine Vijayakulasingam is the Regional Head of International Patient Safety for Roche Europe, formerly having led Patient Safety for Roche Canada. She was a contributor to the Operation Glasswing working group, which partnered with Health Canada to enhance the efficiency of the CanadaVigilance database. Visagine is a passionate advocate for data-driven patient safety. She believes that leveraging data enables a proactive approach to identifying risks earlier in treatment, minimizing harm, and strengthening real-time collaboration with Healthcare Professionals (HCPs).

Indy Ahluwalia is a PV professional who has been in the industry for 15 years. Working in different aspects Indy first started out as a Drug Safety Associate, then moved to the technology side. He has previously worked for Eisai, Amgen, Gilead and Perficient he then moved to work in software companies My Meds and Me and then PVAI. He know works for management consulting firm Eliquent Life Sciences.  

Craig Anderson, Director of Data Standards & Continuous Improvement at Pfizer, oversees global Labeling projects, focusing on electronic labeling, drug product details, AI, digital health, and data standards. With industry experience and a regulatory background from Health Canada, he led projects on Structured Product Labeling, IDMP, and AE reporting. Craig also co-leads HL7 FHIR initiatives, including ePI, PQI, Structured Regulatory Correspondence, and API Exchange of Medicinal Product Information.

Jasmine Bhathena is the Acting Manager of the Self-care Products section at the Marketed Health Products Directorate, Health Canada. With over 16 years of combined academic and regulatory experience, she has held diverse roles in health product assessment and vigilance, regulatory management, and policy support across multiple product lines. Jasmine holds a Bachelor's degree and two Master's degrees in Microbiology, as well as a Ph.D. in Biomedical Engineering from McGill University.

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.

Josée Brisebois, PhD is a senior biopharma and life sciences consultant with over 30 years of experience driving innovation to improve patient outcomes. She has held leadership roles in Medical Affairs, Medical Information, Clinical and Regulatory at Incyte, Gilead/Kite, and Merck in Canada, spanning diverse therapeutic areas including oncology, cell therapy, infectious diseases, HIV, inflammation, dermatology, vaccines, and rare diseases. Josée has helped launch transformative therapies and brings deep expertise across the pharmaceutical ecosystem—from discovery to commercialization. She collaborates with stakeholders across academia, industry, public health, and patient advocacy, serves on the Board of BioCanRx, and has lectured at McGill

Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the convergence of clinical care and clinical research. Before joining TransCelerate, Allison was Senior Vice President of Strategy and Product Innovation for Optum Life Sciences, held a variety of leadership roles at the Advisory Board Company, and provided strategic guidance to biotechnology, medical device and health services companies. Allison has an MBA in healthcare management from the Wharton School and received her undergraduate degree from Dartmouth College.

Silas Leitao da Graca is currently the acting manager of the Adverse Reaction Monitoring and Information Section within the Marketed Health Products Directorate of Health Canada.

Fraser Gibson is a clinical research professional with extensive experience spanning global drug development, clinical operations, and regulatory compliance. Drawing on over a decade in the industry, he has led complex, multi-therapeutic studies and worked closely with sponsors, CROs, and investigators to improve trial delivery and patient engagement. Fraser has explored the theme of public trust in the pharmaceutical and clinical research sectors in depth in his forthcoming book, Bench to Bedside: The Business of Clinical Research and Drug Development, which examines how transparency, communication, and patient involvement can rebuild confidence in the industry.

Bassam Haidar is the Manager of the Metabolic and Musculoskeletal Drugs Division in the Pharmaceutical Drugs Directorate at Health Canada. With more than 20 years of experience in pharmaceutical evaluation and regulatory affairs, he leads the evaluation of therapies for metabolic and musculoskeletal diseases, including treatments for rare conditions. Bassam’s expertise spans endocrinology, cardiovascular diseases, venous disorders, dyslipidemia, diabetes, obesity, and autoimmune conditions. He holds a PhD in Biomedical Science from Université de Montréal and completed postdoctoral training at the University of Ottawa Heart Institute.

Dr. Sophie Hamel is a Senior Clinical Evaluator at Health Canada’s Office of Clinical Trial (OCT). She joined the Public Service under the Management Training Program, gaining experience in risk management, emergency drug access, and health crisis management. She previously was the New Drug Officer at the Special Access Program and acting manager of the OCT Medical Group during the COVID pandemic. She holds a Master in Experimental Medicine from McGill University, a PhD in Cellular & Molecular Medicine from the University of Ottawa, and completed a postgraduate pharmacovigilance externship at Harvard University. She is an Action Canada alumni, having completed a national policy internship focused on public leadership and policy development.

Rob Henderson is President and CEO of BioTalent Canada, where he’s led the organization’s growth into a national leader in bioscience talent development. With over 30 years of executive experience, Rob has helped connect thousands of Canadians to careers, championed workplace diversity, and advised governments on HR strategy. He’s a bilingual Quebec native, a biology graduate, and a passionate advocate for inclusion and the life sciences.

Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada she has been a Scientific Evaluator and a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau within the Marketed Health Product Directorate (MHPD), as well as a member of the core team for the Health Products and Food Branch "Regulatory Review of Drugs and Devices" initiative. Since 2018 she has held the position of Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Pharmaceutical Drugs Directorate.

Jean-François Léger, Site Engagement Lead, Clinical Study Unit, Canada at Sanofi. Mr. Léger brings more than three decades of clinical research expertise to his current role as Site Engagement Lead within Sanofi's Clinical Study Unit. With a master's degree in microbiology and immunology, he has dedicated 20 years of his career at Sanofi, where he continues to leverage his extensive experience in pharmaceutical clinical development.

Ursula Mann is the Principal & Chief Patient Officer at Patient Voice Partners, a life sciences team dedicated to integrating multi-partner perspectives into innovation development, research, and healthcare services. She also supports matchmaking patients and caregivers with initiatives to inform healthcare initiative as Global Patient Engagement Officer for Patient Voice Connect, an affiliate of Patient Voice Partners and is the Co-Founder of the EvidaHealth Foundation, a non-profit data registry organization. Her personal journey as a caregiver ignites her passion for advocacy and drive the work she leads today.

Katrina F. Mateo, PhD MPH, is a public health researcher, interventionist, and strategist bringing evidence-based, human-centered solutions to complex challenges. She leverages qualitative/mixed-method research methodology, human-centered design thinking, systems-thinking, behavioral science, and implementation science to drive meaningful impact in clinical trials, digital health, and public health initiatives. At Regeneron, she identifies & leads innovation opportunities to optimize clinical trial speed, efficiency, and quality. Her educational journey includes a BA from Vassar College, MPH from Columbia School of Public Health, PhD from CUNY School of Public Health, and MBA (in progress) at Boston University's Questrom School of Business.

Laura Muranyi is the Manager at Health Canada and leads the team responsible for the receipt, data entry and triage, quality assurance and maintenance and support of the Canada Vigilance Database. She has been working at Health Canada for over 18 years and has a vast knowledge of the complete health product lifecycle.

Meena N. Muthiah is the Director of Regulatory Intelligence and Policy at AstraZeneca and has been part of the pharmaceutical/biotech industry since 2009. Her expertise has been in regulatory strategy that focuses on spearheading strategies that accelerate drug approvals. Strategic thinker, and an effective communicator with expertise in regulatory intelligence tools development, driving collaboration across cross-functional teams, developing regulatory landscapes, solving complex regulatory strategic questions and proactive regulatory policy development. Pharmacist by training, with a Public Health degree in Health Policy and Clinical practice from Dartmouth.

Dr. Torrey M. Parker earned her medical degree from the University of Ottawa in 2009 and completed her Pediatrics residency at CHEO in 2015. Her clinical work has spanned both community and hospital settings, and she continues as a part-time consulting pediatrician. In 2020, she joined Health Canada’s Health Products and Food Branch, Pharmaceutical Drugs Directorate as a Medical Evaluator in the Bureau of Medical Sciences (BMS). She is currently Acting Director of BMS, leading teams in pre-market drug evaluation and risk management. Dr. Parker also holds a cross-appointment as Assistant Professor at the University of Ottawa Faculty of Medicine.

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 fostering alignment between HC and HTAs, enhancing international collaboration through platforms such as Access and ORBIS, and co-chairing the International Coalition of Medicines Regulatory Authorities (ICMRA) Working Group on Real-World Evidence.

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.

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.

Nicole van der Lee is the Associate Director in the Centre for Policy, Pediatrics and International Collaboration (CPPIC) within Health Canada's Biologic and Radiopharmaceutical Drugs Directorate (BRDD). Nicole has been with CPPIC since 2020, where she began as a senior policy analyst, driving the development and implementation of the Advanced Therapeutic Products Pathway and contributing to pediatric policy, regulatory modernization, and international policy initiatives at CPPIC. With nearly 15 years of federal government experience—including roles at the Canadian Food Inspection Agency and Health Canada—Nicole brings expertise in biotechnology, program and policy development, project management, and drug and device regulation.

Aneta Woroniecka-Osio has obtained her Medical Doctor degree from Medical University in Wroclaw, Poland. Upon completing her postgraduate training in Clinical Research she has joined Medical and Scientific Affairs at Bayer Canada. Aneta has over 15 years of industry experience, has held global roles of increasing responsibilities leading large phase III programmes in Clinical Development and Operations. Aneta also has experience in ICH-GCP study audit and regulatory inspections. Aneta has led development of operational framework focusing on DCT metrics; DCT implementation and advancing acceptance of DCT globally. She is passionate about science and innovative solutions to enable participation in clinical trials.

TARRY AHUJA, PhD is currently the Director of the new Post-Market Drug Evaluation Program at CADTH, the leading HTA agency for Canada. Prior to this he was a senior medical real-world evidence scientist for Eli Lilly for Europe and Canada. He has worked for over 10 years in the hospital setting in the area of sleep disorders and he has over 10 years of clinical research in the areas of otolaryngology, Alzheimer’s, stroke and ischemia with the National Research Council of Canada. He holds a PhD in Neuroscience with a specialty in electrophysiology and pharmacology, and has been a lecturer at Carleton University teaching “Biological Foundations of Addictions” and “Health Psychology” for over 15 years.

Mark is Chief Product Officer at RxPx, an award-winning AI-powered SaaS platform for life sciences. He leads product vision and strategy to support patients, caregivers, researchers, and HCPs while helping customers deliver differentiated value. With 20+ years as an entrepreneur and product leader in health, education, AI/ML, and connected devices, his products have reached 30M+ users worldwide. He has guided companies from startup to acquisition, with expertise in fundraising, culture building, product development, marketing, and scaling growth. Mark believes technology can drive personal and collective improvement and is committed to making that potential real.

Annie Bergevin is a Regulatory Affairs Franchise Lead at Novartis Pharmaceuticals Canada Inc. With more than 20 years of experience in the pharmaceutical industry, she has held progressively senior roles in Regulatory Affairs and has led a wide range of regulatory activities across the product development life cycle. Her experience spans multiple therapeutic areas, including neuroscience, ophthalmology, and oncology, as well as innovative platforms such as gene therapy and radioligands. Annie holds a Master’s in Pharmacology, a Master’s in Pharmaceutical Sciences, and a Bachelor’s in Biology from the Université de Montréal.

Jenny Buckley has more than twenty years of health systems and policy experience across the continuum of health care at the provincial, national, and international level. At Innovative Medicines Canada, Jenny is responsible for the regulatory affairs portfolio, working closely with a team of regulatory experts from IMC member companies on the Regulatory Advisory team. She also works closely with internal and external partners to explore ways to improve Canada’s clinical research infrastructure to increase Canada’s attractiveness for clinical trials and research investment. Jenny is a graduate of the University of Western Ontario (MA History) and the University of London (MSc Public Policy and Management).

Clint is Associate Program Director at TransCelerate BioPharma Inc., a nonprofit advancing biopharma collaboration. He has led and supported patient safety initiatives, including ICSR automation and modernization. Previously, he held senior roles at ICON plc and PRA Health Sciences, managing late-phase and RWE protocols and progressing through Clinical Research Associate and Project Management roles. He has contributed to 20+ peer-reviewed publications in patient safety and health sciences through writing support or co-authorship. Clint holds an MA in Experimental Psychology from Middle Tennessee State University and completed undergraduate studies at Lipscomb University.

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 ePILs.

Andrea is an innate leader that designs, delivers and realigns strategic and transformation plans in multiple, complex arenas including finance, technology, energy and climate, and health and the economy. She consistently achieves desired outcomes by maximizing partnerships and true collaborations, understanding risks, and unleashing the power and talent of the BAM team to support and elevate the Bioscience industry.

Alison Orth is the Director of Clinical Trials British Columbia, part of Michael Smith Health Research BC. With over 25 years of leadership experience in both the private and public sectors, she has guided major system change initiatives to strengthen BC’s clinical trials ecosystem. Alison has played a key role in developing a collective vision for clinical trials in BC, advancing a provincial single ethics review service, and contributing to a national clinical research workforce strategy. She is passionate about strengthening clinical trial ecosystems, making trials more accessible, and improving the clinical trial experience for patients and communities across British Columbia and Canada.

Vishal Oza is the Manager of Regulatory Affairs at Cencora, Innomar Strategies Inc., Canada, with over 15 years of experience in the global pharmaceutical industry and consulting, including 14 years specializing in regulatory affairs. His expertise lies in successfully managing a broad spectrum of U.S. regulatory submissions for both innovative and generic pharmaceuticals across diverse therapeutic areas. In addition, he has acquired substantial experience in managing Canadian regulatory submissions relying on third-party data and conducting Cochrane-style literature reviews. Vishal has a Master of Pharmacy degree in Pharmaceutical Analysis from Nirma University, India.

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.

In her current role, she provides strategic leadership and oversight for activities related to Medical Information and Medical Information Digital solutions. She began her career as a community pharmacist, before joining the Pharmaceutical Advertising Advisory Board (PAAB) as an Assistant Commissioner. She joined Lilly, 25 years ago, first supporting Medical Information before holding various roles in Legal, Sales, Compliance and Medical Affairs. Joanna obtained her B.Sc. in pharmacy from the University of Toronto and her MBA from the Schulich School of Business. Joanna is also a board member of the Pharmacovigilance and Medical Information Network (PVN-MI) Canada.

Dr. Soltys is the Executive Director of the Office of Clinical Trials in the Pharmaceutical Drugs Directorate of the Health Products and Food Branch at Health Canada. In this role, she oversees all activities related to the approval and pharmacovigilance of clinical trials involving pharmaceuticals in Canada, as well as Health Canada’s Special Access Program. She also represents Health Canada internationally as a member of ICH and the ACCESS Consortium. In addition to her regulatory work, Dr. Soltys maintains part time clinical practice at The Ottawa Hospital Cancer Centre where she participates in the care of patients with lung cancer and gastrointestinal cancer.

Stephen has over 25 years of experience in clinical trial operations and health programs’ leadership. His clinical research expertise includes roles in pharma, CRO and academic settings involving the conduct of drug, biologic, and device trials across a wide range of therapeutic areas. 3CTN, the Canadian Cancer Clinical Trials Network, maintains a Portfolio of 850 multi-centre academic cancer clinical trials and mobilizes and supports a pan-Canadian community of investigators, clinical research professionals and patient partners across its 53 pediatric- and adult-member Cancer Centres in improving shared aims for equitable access, accrual and the efficient, high-quality conduct of trials.

Anand Tamilarasan is a life sciences technology leader with over 25 years of experience aligning IT strategy with business goals to drive digital transformation. He delivers ROI through cloud platforms, data integration, and AI adoption, enabling operational efficiency and regulatory compliance. Anand has led enterprise initiatives across Regulatory, Quality, and Safety domains for global pharma and biotech organizations. He holds a Bachelor of Engineering in Electronics and Communication from Bharathiar University, India.

Dr. Heiko Waldmüller, MD is a medical informatics specialist and physician with deep expertise in digital health transformation and interoperability. He has played a pivotal role in shaping Germany’s national eHealth landscape—advising on large-scale initiatives like the ePA für Alle (Personal Health Record for all citizens) and the European Health Data Space. Combining medical insight with technical acumen, Heiko bridges the gap between healthcare practice and IT innovation. His projects span from AI-driven hospital workflows to data standardization with HL7 FHIR and SNOMED CT. Passionate about connecting medicine, data, and people, he brings strategic clarity to complex health IT ecosystems.

Dr. Heather Ward is an epidemiologist with over 15 years of experience, specializing in real-world pharmacoepidemiology studies focusing on safety and effectiveness. She completed a PhD in Epidemiology at the University of Cambridge (UK) and an MSc in Nutritional Sciences (Canada). Within the Safety Surveillance Research group at Pfizer, she is responsible for FDA- and EMA-committed post-authorization safety studies. Previously, Dr. Ward developed data collection methods for national cohort studies in Singapore and Qatar, and coordinated an international cohort for studies of diabetes and cancer. She has published more than 50 peer reviewed publications and authored a chapter in the 2019 International Diabetes Federation Atlas.

Jonathan Zaslavsky works in Regulatory Affairs at AstraZeneca for the Canadian business, focusing on oncology. He holds an MSc in Pharmaceutical Sciences from the University of Toronto, where he explored data-driven approaches, an interest he brings to regulatory strategy and innovation.

Kristen Zorn joined Health Canada over 25 years ago after completing her degree in Biology at the University of Waterloo. She has spent her career in PDD and worked extensively in Regulatory Project Management with the Bureau of Gastroenterology, Infection and Viral Diseases and the Bureau of Metabolism, Oncology and Reproductive Sciences. Kristen was the Associate Director in the Bureau of Cardiology, Allergy and Neurological Sciences and then in the Bureau of Policy, Science and International Programs, where she currently works as a Manager of Policy Development.

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.

Denis Arsenault is a manager in the Office of Policy and International Collaboration within Health Canada's Biologic and Radiopharmaceutical Drugs Directorate (BRDD). In this capacity, Mr. Arsenault leads policy development initiatives for BRDD on a number files including regulatory modernization and biosimilar biologic drugs.

Alex has been a federal public servant for 26 years. He has been Health Canada’s National Director of Clinical and Border Compliance Programs for the last 7 years. In his current capacity he has been responsible for providing executive leadership in supporting, influencing regulatory program priorities including the delivery of large and complex national operations, namely clinical trial and biological products compliance as well as importation of health products at the Canadian border ports of entry. In addition, in this leadership role and along with his team he has focused efforts on modernizing the activities of his national programs, ensuring that the transformation of Programs is based on adoption of a ri

Dr B. started as a Health Res. Scholar and Asst-Prof. (Medicine) at Université Laval, Scientist at Hôpital Laval-QC Heart & Lung Inst. He occupied positions in the private sector (CSO, VP, Dir.), served as President/CEO/Sc. Dir. of NBHRF, Co-Chaired NAPHRO and CIHR-led Forum of Health Res. Funders. Over 30 years, he fostered strategic planning, new programs/value demonstration initiatives, alliances with charities, federal/national agencies, fostering health/medical Rx&D/Innovation in the public/private sector, and investment in the Health Res. Enterprise. He serves on advisory/peer-review committees/boards, chairs oversight cttees and lectures at uSherbrooke and is an Adjunct-Prof. at uOttawa.

Mauricio is a senior professional with more than 20 years’ experience in Clinical Development and Medical Affairs and an established track-record of leading diverse teams through pre- and post-launch activities, clinical development, regulatory approvals, and Medical Affairs at Country, Regional and Global levels across multiple therapeutic areas, including rare diseases, immuno-oncology, immunology, cardiovascular and metabolic, women’s health and infectious diseases. Mauricio earned his MD degree in Brazil; his PhD at University of Manitoba in Canada and has post-doctoral training in Cardiac surgery from University of Ottawa; he completed his fellowship at Hôpital Européen de Paris, in Paris, France.

Brenda Gryfe is a Regulatory Affairs Consultant with over 30 years’ experience. Ms. Gryfe has a business-focused understanding of Regulatory Affairs, gained from experience across several mid-sized pharmaceutical companies, and over ten years in consulting. 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 & Cochrane-style literature reviews. Since her research as a pharmacist at U of Toronto, in seniors’ understanding of prescription drug labels, Ms. Gryfe retains a particular interest in labeling and patient education materials.

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.

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.

Agnes is an industry leader with over twenty years of experience in pharmacovigilance (PV) and medical information (MI) both in the pharmaceutical industry as well as in the consulting environment. She is a Vice President of Pharmacovigilance at ClaroPV whose team includes experienced and dedicated PV & MI professionals. Agnes in an expert PV auditor and a recognized pharmacovigilance educator engaged in teaching pharmacovigilance courses and presenting on various PV topics. Agnes holds a graduate degree in Pharmacology & Toxicology and, prior to joining the pharmaceutical industry, was involved in academic research.

Neil McAuslane PhD, Scientific Director of the Center for Innovation in Regulatory Science (CIRS) overseeing the scientific content of both CIRS regulatory and HTA programmes. Key research areas of work include regulatory strategy and strengthening, building quality into regulatory processes, the utilization of decision frameworks and the development of multistakeholder workshops which bring companies, patients, and agencies (Regulatory and HTA) together to discuss major areas of interest.He is currently involved in specific research on how best to measure the performance of agencies, risk-based approaches in the assessment of new medicines, building quality into the review process, decision making and HTA and regulatory alignment.

Sabrina is currently a Director in Regulatory Affairs at Merck Canada and has been with the company for over 20 years. Prior to joining the Pharmaceutical Industry, she was at Health Canada for 2 years as a Regulatory Project Manager. Sabrina holds a Bachelor's degree in Medical Biology and a Masters in Pharmaceutical Sciences.

Michael joined ICES (formerly Institute for Clinical Evaluative Sciences) as an Epidemiologist in 1992 and became an ICES Scientist and Research Program Lead in 2008. He is an Assistant Professor in the Department of Family Medicine at McMaster University and the Institute of Health Policy, Management and Evaluation at the University of Toronto. He holds a Bachelor's degree in Human Biology from the University of Guelph and a Master’s degree in Physiology from the University of Toronto. In addition to his work with ICES, Michael is a core member of the Ontario Drug Policy Research Network (ODPRN, odprn.ca) and Ontario Site Lead and Steering Committee member for the Canadian Network for Observational Drug Effect Studies (CNODES, cnodes.ca).

Perry is the late-stage Global Head of Compliance, Process, and Vendor Oversight at Hoffmann-La Roche Limited, with over 30 years of experience in Clinical Research and Pharma Technical domains. She leads a global team ensuring process efficiency, compliance, and effective vendor oversight across Roche. She started her career as as a nurse, fueling her ongoing passion for innovative study delivery and creating a patient-centric culture, dedicated to simplifying the patient journey and access. She is excited about the future of Clinical Research and how technology will advance innovation. She currently serves as Roche/Genentech's Industry Lead for TransCelerate in the Good Clinical Practice (GCP) space.

Adriana Rodriguez-Cruz, PhD in Biomedical Sciences, finished her academic pathway with two postdoctoral fellowships, one at McGill University and the second at Université de Montréal. Her field of research is in Infectious Diseases, primarily HIV, focusing on Epidemiology and patient-oriented research in Clinical Trials. She has 6+ years of combined experience both, in biomedical laboratory and clinical research. Having worked in the public healthcare system and Clinical Research Organizations broadens her understanding of Clinical Research. She advocates for Global Health Equity and promotes Patient-Centric Clinical Research by strengthening the role of medical service dogs and contributing to scientific knowledge and global health.

Pooja has more than 13 years’ professional experience in the pharmaceutical and biopharmaceutical industry, spanning regulatory strategy, clinical research, medical writing, health authority engagement, and lifecycle management across Canada, US, EU and other semi-regulated markets. As a Senior Scientist, Regulatory Affairs at Allucent, she is responsible for writing, evaluating, and reviewing technical documents, managing health authority interactions, preparing and leading regulatory submissions, and advising internal teams and clients on complex regulatory pathways.

Dr. Elana Cherry is the Director of the Centre for Blood, Blood Products and Biotherapeutics at Health Canada's Biologics and Radiopharmaceuticals Drugs Directorate. She has a wealth of regulatory, operational, and policy experience with almost 20 years at Health Canada and the Public Health Agency of Canada. After obtaining a Ph.D. in Microbiology and Immunology (HIV/AIDS) from McGill University and working in biotech and academia, Dr. Cherry joined Health Canada and has been working in roles of increasing responsibility in health product regulation (medical devices, pharmaceuticals, biologics, and COVID-19 vaccines) as well as in interdepartmental COVID-19 Border Measures and modernizing Canada’s biosecurity oversight framework.

Kevin completed his PhD in the Dept. of Laboratory Medicine and Pathobiology, University of Toronto. His research described how bacteria interact with the gut to contribute to health or illness. At Health Canada he served as a pharmacovigilance evaluator and later became a scientific advisor that involved communicating about these evaluations and contributing to the department’s transparency initiatives. Currently, he serves as an advisor that works closely with inspectors and industry to navigate GCP compliance & enforcement processes as well as risk management.

Jessy, a graduate in Political Science and Marketing Communications, brings over 18 years of experience in organizational and cross-sector communications, having worked across non-profits and within Quebec’s healthcare system. In her current role, she leads the development of advocacy and educational initiatives for patients and caregivers. She also plays a key role in shaping strategies for new community services and advancing Myeloma Canada's mission to transform cancer care for all Canadians. Recently, Jessy co-authored research focused on improving access to top-tier care and treatment, including refining assessment processes and promoting informed consent through effective information dissemination.

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.