octobre 27, 2025 - octobre 28, 2025
Connect with us at DIA's Canada Annual Meeting
Hilton Lac-Leamy | 3 Boulevard du Casino, Gatineau, QC J8Y 6X4, Canada
Thursday, October 27, 3:00 PM | Session 4, Track A
Health Canada, the Industry, and the Future of Oncology Approvals
International collaboration is reshaping the regulatory landscape. This session will explore Health Canada’s evolving relationship with the FDA, examining key milestones, as well as current and future initiatives. Industry experts will provide their experience into the impact of Project Orbis on accelerating global oncology approvals across multiple countries as well as sharing data-driven perspectives on its effectiveness in streamlining access to innovative treatments.
My Dang, MBA
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.
Thursday, October 27, 4:25 PM | Session 5, Track A
Navigating Submissions Relying on Third Party Data (SRTDs)
Explore the Submissions Relying on Third Party Data (SRTD) pathway for drug registration in Canada. This session will cover Health Canada's requirements, the critical role of Systematic Literature Reviews (SLRs), and strategies for adapting foreign regulatory packages for Canadian filings. Attendees will gain essential knowledge to optimize their future SRTD submissions.
Vishal Oza, MPharm
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.
Friday, October 28, 10:30 AM | Session 7, Track A
Navigating the Novel: Multi-faceted Challenges in Rare Disease Treatment in Canada
This session will explore regulatory challenges in developing treatments for rare diseases, emphasizing pathways and expert advice to navigate these hurdles. Attendees will recognize diverse challenges associated with first-in-class treatments, analyze the impacts of small patient populations and novel manufacturing on submission strategies, and evaluate the benefits of early scientific engagement and interagency collaboration. Panelists will address unique challenges, share case studies, discuss evidence generation for approval, and highlight the importance of characterization and scientific exchange.
Meet the team
Regulatory Affairs
Innomar Strategies understands the hard work and effort you perform to get to the point of submitting dossiers to the authorities. Whether you are getting ready to submit for the first time and need help putting together a meeting request, or to submit a drug application, we can help. We prepare submission-ready documents based on regional and agency format requirements. We also keep on top of these submission changes, as they happen, so you don’t have to.
Our Regulatory Operations department is flexible and can offer a bespoke program tailored to your individual requirements. These services can be provided as a full service, or as individual activities.
We understand the Canadian healthcare landscape
Let's Connect
Fill out the form below to request a time to connect with our experts while attending DIA Annual Meeting or if you are interested to learn how our expert insights can guide your business decisions.
