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 works as a Senior Manager, Regulatory Affairs at Otsuka Canada Pharmaceutical Inc. and has been in the industry for more than 20 years. After graduating with a bachelor 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.

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, M? 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.

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 leading the Good Pharmacovigilance Practices inspection Program within the Regulatory Operations and Enforcement Branch (ROEB) at Health Canada. She previously was appointed as a pharmacovigilance manager in the Health Products and Food Branch (HPFB) and 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.

Sabrina Ramkellawan started her career as a registered nurse with critical care speciality. She has 25 years of clinical research experience working for Pharma, CROs and Research sites. Sabrina has experience conducting clinical trials with novel therapeutics, vaccines, biologics, NHPs, cannabiniods and psychedelics. Sabrina is also the President of the Clinical Research Association of Canada and Board of Directors for MAPS Canada. She has been actively involved in education including building & teaching clinical research programs. She is currently the COO at AxialBridge with a focus on emerging therapeutics and helping biotech/life science companies navigate regulatory, and clinical operations to conduct clinical trials.

With 29 years of experience in clinical research, Ted Trafford leads Feasibility, Business Development, and Site Relationship teams as Director of Business Development at Probity Medical Research, a clinical trial site administrative support company with a consortium of 70 sites across four countries. As a writer and speaker, Ted contributes to thought leadership and strategic initiatives in the clinical trials industry, leveraging his extensive experience and creative approach to drive meaningful discussion and progress for Sponsors, CROs, Sites and Technology Vendors. Ted recently launched a podcast called Innovating Clinical Trials for clinical research professionals eager to deepen their understanding of clinical trials.

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. In her current role Aneta leads 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.

Andrea is a Senior Clinical Evaluator in the Office of Clinical Trials (OCT) at the Pharmaceutical Drugs Directorate at Health Canada. Andrea completed an Honours Bachelor of Science in Biochemistry and Immunology at the University of Ottawa, followed by a Masters of Science in Cancer Therapeutics at the Barts Cancer Institute in London, United Kingdom. Upon moving back to Ottawa in 2015 and prior to joining OCT in 2020, Andrea's experiences include clinical research at the Ottawa Hospital Cancer Center, clinical review at Canada's Drug Agency, and quality review at the Biologic and Radiopharmaceutical Drugs Directorate.

Lama Abi Khaled joined Innovative Medicines Canada in April 2018. She is responsible for all matters related to the industry's ethical standards, regulatory and legal affairs. Lama holds a Biochemistry degree, a master’s in business administration and a Juris Doctor from the University of Ottawa. Prior to becoming a lawyer, Lama worked for over 10 years in pharmaceutical pricing and market access both in the private and public sectors. Prior to joining IMC, Lama was In-House Legal Counsel and Compliance Officer at a weight loss company. She also worked at a national Intellectual Property firm in Ottawa and completed her clerkship at the Federal Court of Canada.

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.

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. Silas holds a Bachelor’s degree in Biomedical sciences and a Master’s degree in Pharmaceutical Sciences with specialization in Drug Development from the University of Montreal.

Utkarsh is an Associate Professor in the Department of Health Sciences at Carleton University. He is a biostatistician and data scientist who works in health outcomes, clinical trials, biomarkers, and statistical/machine learning. Utkarsh's work in health outcomes is on understanding phenotypic, genotypic, and treatment response variability in two progressive diseases: Duchenne and Becker muscular dystrophy.

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.

Benny Ling is a senior scientific reviewer in the Marketed Pharmaceuticals Bureau in Health Canada. He holds a Master's degree in Pharmacology and Toxicology from the University of Western Ontario and has been working in Health Canada for over 20 years. Benny is the Health Canada representative at the on the CIOMS Working Group XIV on Artificial Intelligence in Pharmacovigilance and the LLM Taskforce.

Flora began her pharmaceutical career working as a bench microbiologist. In 1991 she Health Canada’s drug inspection unit where she inspected companies manufacturing importing, testing and wholesaling drugs for human and veterinary use for GMP compliance. In 2008 she joined the Clinical Trial Compliance Program where she planned and conducted inspections of sponsors, investigators and CRO establishments. She represented Health Canada on a PIC/s GCP joint inspection group. As part of Health Canada’s project to modernize the Health Canada GCP Program, Flora was assigned to conducting clinical trial inspections of bioequivalence studies. In May 2022 Flora joined BioAcuity Consulting Inc. providing quality, compliance and regulatory services

Andrew Raven joined Health Canada in 2004. He holds a Bachelor of Science in Molecular Biology and Genetics and a Master of Science in Mathematics and Statistics both from the University of Guelph. He has previously worked as a biostatistician and senior biostatistician, assessing study design and conduct as well as statistical methodologies and analyses in pre-market prescription drug submissions at the Pharmaceutical Drugs Directorate (PDD) (formerly TPD). He has been manager of the Biostatistics, Epidemiology, and Pharmacometrics Unit of PDD since 2015.

Roel Schlijper-Bos is the Clinical Trials & Research Unit Manager at BC Cancer – Prince George and is an uninvited guest on the traditional, ancestral, and stolen lands of the Lheidli T’enneh First Nations. After completing his residency program in Radiation Oncology in the Netherlands, he completed a 2-year Radiation Oncology fellowship at BC Cancer. He has been the CRU manager since early 2021 and has been involved in growing the clinical trials & research program at Centre for the North. His focus lies on expanding the systemic trials program in Prince George, improve Indigenous Cultural Safety both in- and outside clinical trials, and creating a team culture that is inclusive, meaningful, innovative, and encouraging.

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.

Kristin Willemsen is the Vice President of Scientific & Regulatory Affairs for CGPA. She works with CGPA members advocating for the implementation of regulatory, policy and guidance changes to increase access to safe, effective, and affordable generic medicines for Canadians. A key part of her role as an industry association professional over the past 15 years has been developing productive, collaborative relationships with governments and stakeholders to drive impactful regulatory outcomes. Kristin is also a Certified Association Executive and has earned a MSc from University of Ottawa.

Myriam is a seasoned professional with over 25 years of experience across commercial and medical roles in the CRO and pharmaceutical industries. She currently serves as the Global Head of the PPD FSP Regulatory Business Unit, leveraging her vast experience, dual BSc. in Biochemistry/Chemistry and MBA. Prior to her current role, she led the Global Regulatory Affairs team at IQVIA Biotech, and held significant positions at PPD and Pfizer. Myriam is recognized for her positive presence, adaptive leadership style, and people-focused approach. She has a proven track record of assembling, engaging, and developing high-performing global teams, applying her originality, insight, and interpersonal warmth to unify, inspire and teach others.

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.

At the Clinical Trials Transformation Initiative (CTTI), Ms. Hanger leads strategic planning and new initiatives. Previously, she was vice president of the online patient research network PatientsLikeMe, where she oversaw programs utilizing patient-generated health data in life sciences and regulatory settings. She has advised pharma/biotech, professional societies, and health tech companies on innovation partnerships and operations, practical applications of novel data, and late-stage research strategies. Ms. Hanger graduated summa cum laude from New York University with a degree in politics, and holds a Master’s degree in public policy from the University of California, Berkeley.

As Principal & Chief Patient Officer at Patient Voice Partners, Ursula leads stakeholder engagement conversations within healthcare to develop innovative solutions and advance service care delivery/evaluation across every aspect of disease management and treatment. In the role of Global Patient Engagement Officer for Patient Voice Connect by Patient Voice Partners, Ursula supports matching patients and caregivers to patient voice activities of interest. She also holds the position of Board Member & Executive Managing Director with the TOWWERS Institute, a not-for-profit that advances value-based healthcare for faster access to innovative therapies by centering on the patient, value, and affordability with multi-stakeholder engagements.

Susan Marlin is the President and CEO of Clinical Trials Ontario (CTO), an organization established in 2012 to improve the environment for conducting clinical trials. Prior to joining CTO she was the Associate Vice-Principal of Research at Queen’s University and worked for many years with the National Cancer Institute of Canada Clinical Trials Group. Susan has engaged in research ethics over the years serving on research ethics boards. She was President of the Canadian Association of Research Ethics Boards and is currently a member of several boards and committees supporting clinical research and innovation in health care.

Kim Meeking is the co-lead for Queering Cancer, a grassroots partnership dedicated to improving cancer care for sexual and gender diverse (SGD) individuals. Kim holds a Master’s in Clinical Health Research and is a radiation therapist by background. They have over 10 years of experience managing oncology clinical trials at the site level and with CROs, along with 5+ years in the non-profit sector. Kim’s interests focus on fostering inclusivity in clinical trials and enhancing cancer care for SGD populations through collaborative partnerships, rigorous research, and innovative knowledge mobilization.

Dr. Rania Mouchantaf is A/Executive Director at the Marketed Health Products Directorate at Health Canada with over 17 years of experience in the area of pharmacovigilance. Before entering the public service she worked in the private sector, however her interest in pharmacovigilance and 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.

An influential and data-driven executive professional with a robust background in the Pharmaceutical and Public Health sectors, bringing a unique blend of expertise in leading digital transformation initiatives and leveraging data to guide corporations through complex business changes. Recognized as a thought leader/industry expert in the data, digital health, and AI ecosystem, excelling at understanding industry trends and developing strategic perspectives to guide digital health and AI partnerships and investments. High-level analytical skills and deep expertise in drug development, clinical, safety and regulatory processes, data management, digital innovation, and governance.

Patricia Oliveira Pereira Tagliari holds a master’s degree in Public Health (Global Health and Health Diplomacy) from the National School of Public Health (2014), specializations in Health Regulation and Surveillance (2010) and Health Law (2007), both from Fiocruz, and a degree in International Affairs from the University of Brasilia (2004). She is currently a government employee, specialist in health regulation and surveillance, at the Brazilian Health Regulatory Agency - Anvisa. From April 2020 to the present date, Ms. Tagliari has served as Associate Director at Anvisa. Prior to that, she served as Advisor at Anvisa’s Office of Inspection and Health Surveillance and as the Head of Anvisa's International Affairs Office.

Dawn Richards, PhD, is the founder of Five02 Labs Inc., and Director of Patient and Public Engagement at Clinical Trials Ontario. With a PhD (Analytical Chemistry) from the University of Alberta and experience in different roles over 25 years, it is her diagnosis with rheumatoid arthritis in 2006 that led her to combine her passion for science with making the most of her diagnosis. In her role at CTO, Dawn is charged with executing on CTO’s strategic pillar of patient and public engagement.

Michael Barr has worked for Apex Trials for 7 years. During this time he lead a medical diagnostic device development project as the director of R&D. This project received over $2 million dollars of public and private funding. This diagnostic project lead to Michael's designing and being the lead Sponsor of an observational study during the peak of COVID. Not only was it the peak of COVID, the patients were nursing women. It was a complete success. Michael now leads business development for Apex Trials. Prior to Apex, Michael worked for a cider start-up in Toronto as employee number one. Michael also worked for Sanofi Pasteur at the Connaught campus manufacturing the vaccine for whooping cough. Apex Trials is based in Guelph, ON.

Chris Colwell is Vice President, International Government & Regulatory Affairs at the United States Pharmacopeia (USP). He leads a team that develops USP’s position on public policy and regulatory affairs issues related to its mission to improve global health through public standards.Chris’ prior experiences span technical and policy work across pharmaceuticals and medical devices in government, private sector and NGO sectors. He has worked at the US FDA, Merck & Co., Inc (known as MSD outside of the U.S. and Canada), Becton Dickinson (BD) and the Biotechnology Innovation Organization (BIO). Chris received his Masters in Public Policy from Georgetown University and a B.S. in Chemical Engineering from the Pennsylvania State University.

Julie Holtzople is a seasoned Clinical Trial Transparency professional. She spent 10 years building Clinical Transparency and Data Sharing at AstraZeneca, becoming an expert in Plain Language Summaries, Clinical Document Anonymization and Clinical Data Sharing. She also led the implementation and readiness for EU CTR Transparency requirements. Julie has been an active member of numerous CTT working groups and organizations contributing to CTT standards and best practices. Prior to AstraZeneca, she started her career as a management consultant working at Ernst & Young and then Booz Allen. Julie has recently returned to consulting as an independent. She specializes in Clinical Trial Transparency, process optimization and program delivery.

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.

Carrie Ku has been at Sanofi since 2014. Her team is responsible for the regulatory filings for the Specialty Care, General Medicines and Vaccines business units. Carrie has over 25 years experience in the pharmaceutical industry, mostly in regulatory affairs, but also in quality assurance, medical affairs, medical information and drug safety. Carris has a Master of Science (pharmacy) degree and a Bachelor's of Pharmacy degree, both from University of Toronto.

Dr. Thierry Lacaze received his medical degree from the University Paris 5 in 1993 and a PhD in biological sciences from the University Paris 7 in 1995. He was appointed professor of Pediatrics at the University Paris Saclay in 1997. He moved to Alberta in 2003 to become the inaugural Scientific Director of the Women and Children Health Research Institute in 2006. He is currently Clinical Professor of Pediatrics at the University of Calgary. He became the Scientific Director of MICYRN in 2018. Since March 2024, he is the Principal Investigator of the Pediatric Rare Disease Clinical Trial and Treatment Network, an initiative funded by the CIHR Institute of Genetics, as part of the Rare Disease Drug Strategy of the Government of Canada.

Melissa is a trained educator and has been working with families for more than 20 years. She began advocating for improved safety after the loss of her 8-year-old son, Andrew, from a community pharmacy medication error in 2016. Since that time, Melissa has been working with organizations to advance continuous quality improvement programs in community pharmacy, including error reporting. She is an active member of Patients for Patient Safety Canada and continues to advocate for patient safety, and more specifically medication safety, across the country and internationally. Melissa has delivered presentations on medication safety to local, provincial, national and international audiences.

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.

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.

Rachel has 13+ years of experience in regulatory operations and helping sponsors achieve their eCTD submission goals. She has led the eCTD submission publishing of a variety of application types for different regions, from small amendments to large-scale original marketing applications, as well as mentored and trained others in eCTD publishing and submission management. She has also spoken at industry conferences on topics pertinent to investigational and marketing related submissions and produced a variety of blogs, presentations, and other materials to share valuable industry insights.

Beginning my career as a Registered Nurse, I later shifted to research before joining GSK as a Clinical Research Associate, working in diverse therapeutic areas. After 20 years, I progressed to Site Engagement Lead, and most recently, National Site Engagement Lead, overseeing a team of CRAs. Outside of work, I enjoy spending time at our cabin with family and friends, either golfing or relaxing by the lake.

Emily has a Ph.D. in Biomechanics from the University of Guelph. Her use of primary research to make complex health decisions helped save her life when she was faced with a brain cancer diagnosis. She now guides other patients through their diagnoses and is passionate about research translation and health equity.

With more than 20 years of experience in Clinical Research, I have occupied various positions at IQVIA, in Clinical Operations (CRA, Clinical Lead), project management (Project Lead) and now within the Strategic Site Solutions team, working closely with IQVIA partner sites to support them in their current studies and to identify the best possible study opportunities for the PIs of their network. I mainly specialized in CNS studies (Alzheimer's Disease, Parkinson's Disease) in my last few years in Site Management but participates in multiple international trials across all phases and across a large variety of therapeutic areas.

Breanne Stewart is the Network Director for RareKids-CAN: Pediatric Rare Disease Clinical Trials and Treatment Network, where she provides strategic leadership, oversees operations, and fosters collaboration within the network. With a background as a registered nurse, Breanne has dedicated 10 years to the clinical trial field, supporting both investigator-initiated and industry-sponsored trials. For the past 6 years, she has served with the Maternal Infant Child and Youth Research Network as the inaugural Associate Director of Clinical Trials, where she played a key role in developing an Academic Research Organization.