GAIN REGULATORY INSIGHTS2025 BIOLOGICS & BIOSIMILAR SYMPOSIUM
Friday, March 28, 2025 | TORONTO
Friday, March 28, 2025 | TORONTO
Join CAPRA's Biologics & Biosimilar event with Health Canada and Industry Leaders.
This collaborative event represents a valuable opportunity to acquire insights and regulatory knowledge that will assist our regulatory professionals in navigating the complexities of scientific developments and advancements.
By attending, you will gain practical regulatory insights through in-person Q&A and panel discussions with all speakers by attending.
2025 Biologics and Biosimilar Symposium
Registration is now open - Don't miss the chance to enhancing your professional knowledge and skills!
Join CAPRA's Biologics and Biosimilar event with Health Canada and Industry leaders. This collaborative event represents a valuable opportunity to acquire insights and regulatory knowledge that will assist our regulatory professionals to navigate the complexities of scientific developments and advancements.
By attending, you will gain practical regulatory insights through in-person Q&A and panel discussions with all speakers.
- Opening remarks from BRDD Director General
- Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products
- Update on ICH M4Q (R2) CTD guidance
- Biosimilar Guidance Update
- Discussing the 15-day Clarifax timelines for submitting samples with HC
- Agile Licensing of Drugs and Medical Devices regulations
- BIOTECanada Overview
- Update on ATP
- From Foundations to Frontiers: The Evolving Landscape of Biologics Regulations
- Strategies to Overcome Development and Regulatory Challenges for Small and Medium Companies
Symposium Speakers
Sophie Sommerer
Health Canada
Director General, BRDD
Hugo Hamel
Health Canada
Associate Director, CBBB, BRDD
Denis Arsenault
Health Canada
Manager, Centre for Policy, Pediatrics and International Collaboration
Dr. Chris Ablenas
Health Canada
Senior Evaluator, CBBB, BRDD
Amy Tsung
Sanofi Canada
Head, Regulatory Affairs, CMC
Fiona Frappier
Health Canada
Manager, Centre for Policy, Pediatrics and International Collaboration
Ron Boch
BIOTECanada
Vice President, Biotechnology and Industry Affairs
Johanne Veenstra
Health Canada
Senior Regulatory Policy and Risk Management Advisor, Office of Advanced Therapeutic Products,
Jennifer Wilhelm
Merck Canada
Director, Regulatory Affair
Yatika Kohli
NoNo Inc.
Chief Regulatory
and Strategy Officer
Agenda
| Time | Description | Presentation Overview | Guest Speaker | Duration |
|---|---|---|---|---|
| 7:15 - 8:25 am | Registration and Breakfast | 70 mins | ||
| 8:25 - 8:30 am | Welcoming Remarks | 5 mins | ||
| 8:30 - 8:45 am | Opening Remarks | Sophie Sommerer, Director General, BRDD, Health Canada | 15 mins | |
| 8:45 - 9:30 am | Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products, followed by Q&A | The three CTD Guidance documents applicable to Conventional biotherapeutic products, Biotechnological/biological (Biotech) products, and Blood products have been merged into one document as they shared more than 95% of the content. The revised guidance document was posted in April 2024. An overview of the major changes will be provided during this session. | Hugo Hamel, Associate Director, CBBB, BRDD, Health Canada | 45 mins |
| 9:30 - 10:15 am | Update on ICH M4Q (R2), followed by Q&A | The CTD guidance document M4Q(R1) has been revised for the first time since 2001. It provides a harmonized structure and format for presenting CMC (Chemistry, Manufacturing, and Controls) information in a registration dossier. This session will present an overview of the revised guidance document. | Hugo Hamel, Associate Director, CBBB, BRDD, Health Canada | 45 mins |
| 10:15 - 10:25 am | Question and Answer Period | 10 mins | ||
| 10:25 - 10:45 am | Coffee Break | 20 mins | ||
| 10:45 - 11:20 am | Biosimilar Guidance Update, followed by Q&A | Health Canada’s Biologic and Radiopharmaceutical Drug Directorate (BRDD) has undertaken a review of its guidance document on Information and Submission Requirements for Biosimilar Biologic Drugs (Biosimilars guidance), which was last updated in 2016. A section-by-section review of the current guidance is being conducted, with the objective of proposing amendments to update the Biosimilars guidance. | Denis Arsenault, Manager, Centre for Policy, Pediatrics and International Collaboration, Health Canada | 35 mins |
| 11:20 - 12:15 pm | Discussing the 15-day Clarifax timelines for submitting samples with Health Canada, followed by Q&A | From an industry perspective, consistency sample requests for biologics based on Health Canada’s 15 calendar-day Clarifax timelines can be challenging to manage without advanced notice of the timing or samples required. This has resulted in review clock stops until all samples can be delivered to Health Canada. | Dr. Chris Ablenas, Senior Evaluator, CBBB, BRDD, Health Canada; Amy Tsung, Head, Regulatory Affairs, CMC, Sanofi Canada | 55 mins |
| 12:15 - 12:30 pm | Question and Answer Period | 15 mins | ||
| 12:30 - 1:30 pm | Lunch Break | 60 mins | ||
| 1:30 - 2:00 pm | Agile Licensing of Drugs and Medical Devices Regulations, followed by Q&A | In December 2022, Health Canada published a regulatory outlining new targeted provisions and regulatory amendments to the Food and Drug Regulations (FDR) and Medical Devices Regulations (MDR) for stakeholder consultation. Building upon regulatory agilities piloted during the pandemic, the proposed regulatory amendments would enable terms and conditions for higher-risk drugs. | Fiona Frappier, Manager, Centre for Policy, Pediatrics and International Collaboration, Health Canada | 30 mins |
| 2:00 - 2:20 pm | Strengthening Canada’s biomanufacturing capacity and life sciences sector through regulatory modernization, followed by Q&A | Canada’s ambition in the Biomanufacturing and Life Sciences Strategy of a modern and agile regulatory system is increasingly important for global and Canadian biotechnology companies. The presentation will highlight how this regulatory reform will position Canada as a global leader in biotechnology, fostering innovation and improving healthcare outcomes. | Ron Boch, Vice President, Biotechnology and Industry Affairs | 20 mins |
| 2:20 - 2:50 pm | Update on ATP, followed by Q&A | Some therapeutic products are so unique or complex that they need a different regulatory approach. The ATP framework provides the ability to authorize ATPs in a flexible and risk-based manner. Health Canada will provide an update regarding the implementation of the framework and current ATP candidates, report on public consultation, and lessons learned. | Johanne Veenstra, Senior Regulatory Policy and Risk Management Advisor, Health Canada | 30 mins |
| 2:50 - 3:10 pm | From Foundations to Frontiers: The Evolving Landscape of Biologics Regulation, followed by Q&A | Biologics continue gaining prominence as vital components of modern medicine, encompassing established therapies and cutting-edge innovations. This presentation will explore the evolving regulatory environment surrounding biologics, offering insights from an industry perspective. | Jennifer Wilhelm, Director, Regulatory Affairs, Merck Canada | 20 mins |
| 3:10 - 3:20 pm | Question and Answer Period | 10 mins | ||
| 3:20 - 3:50 pm | Strategies to Overcome Development and Regulatory Challenges for Small and Medium Companies, followed by Q&A | Small- and medium-sized enterprises (SMEs) often struggle to define “suitable” development paths and regulatory strategies for their products. This session will discuss approaches for development and regulatory strategies that make sense for SMEs. | Yatika Kohli, Chief Regulatory and Strategy Officer, NoNo Inc. | 30 mins |
| 3:50 - 4:00 pm | PM Break | 10 mins | ||
| 4:00 - 4:25 pm | Panel Discussion and Q&A for All Topics | All Topics | All Speakers | 25 mins |
| 4:25 - 4:30 pm | Closing Remarks | 5 mins |
| Time | Description |
|---|---|
| 7:15 - 8:25 am | Registration and Breakfast |
| 8:25 - 8:30 am | Welcoming Remarks |
| 8:30 - 8:45 am | Opening Remarks Sophie Sommerer, Director General, BRDD, Health Canada |
| 8:45 - 9:30 am | Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products, followed by Q&A Hugo Hamel, Associate Director, CBBB, BRDD, Health Canada |
| 9:30 - 10:15 am | Update on ICH M4Q (R2), followed by Q&A Hugo Hamel, Associate Director, CBBB, BRDD, Health Canada |
| 10:15 - 10:25 am | Question and Answer Period |
| 10:25 - 10:45 am | Coffee Break |
| 10:45 - 11:20 am | Biosimilar Guidance Update, followed by Q&A Denis Arsenault, Manager, Centre for Policy, Pediatrics and International Collaboration, Health Canada |
| 11:20 - 12:15 pm | Discussing the 15-day Clarifax timelines for submitting samples with Health Canada, followed by Q&A Dr. Chris Ablenas, Senior Evaluator, CBBB, BRDD, Health Canada; Amy Tsung, Head, Regulatory Affairs, CMC, Sanofi Canada |
| 12:15 - 12:30 pm | Question and Answer Period |
| 12:30 - 1:30 pm | Lunch Break |
| 1:30 - 2:00 pm | Agile Licensing of Drugs and Medical Devices Regulations, followed by Q&A Fiona Frappier, Manager, Centre for Policy, Pediatrics and International Collaboration, Health Canada |
| 2:00 - 2:20 pm | Strengthening Canada’s biomanufacturing capacity and life sciences sector through regulatory modernization, followed by Q&A Ron Boch, Vice President, Biotechnology and Industry Affairs |
| 2:20 - 2:50 pm | Update on ATP, followed by Q&A Johanne Veenstra, Senior Regulatory Policy and Risk Management Advisor, Health Canada |
| 2:50 - 3:10 pm | From Foundations to Frontiers: The Evolving Landscape of Biologics Regulation, followed by Q&A Jennifer Wilhelm, Director, Regulatory Affairs, Merck Canada |
| 3:10 - 3:20 pm | Question and Answer Period |
| 3:20 - 3:50 pm | Strategies to Overcome Development and Regulatory Challenges for Small and Medium Companies, followed by Q&A Yatika Kohli, Chief Regulatory and Strategy Officer, NoNo Inc. |
| 3:50 - 4:00 pm | PM Break |
| 4:00 - 4:25 pm | Panel Discussion and Q&A for All Topics All Speakers |
| 4:25 - 4:30 pm | Closing Remarks |
Registration and Ticket Pricing
(HST will be added at time of checkout)
(HST will be added at time of checkout)
| Category | In-Person Attendance | Online Access |
|---|---|---|
| CAPRA Members | $580 | $510 |
| Non-Members | $685 | $585 |
| CAPRA Student Members | $350 | $350 |
Important Deadlines
| Deadline | Date |
|---|---|
| Registration Deadline | March 19, 2025 |
| Hotel Reservation Deadline | March 06, 2025 |
Hotel accommodations are booked separately by following instructions below. Our sponsorship and vendor packages include registration tickets.
For further assistance, please contact CAPRA at administrator@capra.ca.
Registration
| Non Member In Person Non Member Rate to attend In Person. "Not a Member Yet? Join CAPRA Today and Save $105 on your ticket price! |
$685.00 + tax | |
| Non Member Online Access Non Member Rate to attend Online. Link to event will be sent one week prior. Save the date in your calendar! Not a Member Yet? Join CAPRA Today and Save $100 on your ticket price! |
$585.00 + tax | |
| BUNDLE: In Person Registration + CAPRA Membership Includes In Person attendance and Member Benefits until July 31, 2025. Enjoy year-round access to resources, free webinars, and a network of regulatory professionals. |
$655.00 + tax | |
| BUNDLE: In Person Registration + CAPRA Student Membership Includes In Person attendance and Student Member Benefits until July 31, 2025. Enjoy year-round access to resources, free webinars, and a network of regulatory professionals. |
$425.00 + tax | |
| Proceed to Checkout | ||
Sponsorship & Vendor Booth Opportunities
Please email the administrator@capra.ca for sponsorship registration with the package that provides the best value.
HST will be added at the time of checkout.
Platinum Sponsorship$2,355
Benefits:
- Two (2) attendee tickets
- Company logo and hyperlink on all event media broadcasts and the CAPRA event webpage
- Promotion of the company logo before and during the event
- One page of digital collateral material sent to all attendees by the event host
- excludes HST
Gold Sponsorship$1,975
Benefits:
- Two (2) attendee tickets
- Company logo and hyperlink on all event media broadcasts and the CAPRA event webpage
- excludes HST
Vendor Booth Options$1,705 | $1,105
Benefits
- Two (2) attendee passes: $1,705 + HST
- One (1) attendee passes: $1,105 + HST
Special Room Rates
& Hotel Reservation Information
& Hotel Reservation Information
CAPRA 2025 Biologics and Biosimilar Symposium
Friday, March 28, 2025
Westin Toronto Airport Hotel
950 Dixon Road, Toronto, Ontario
$239/night
(plus applicable tax and fees)
for the CAPRA Symposium are subject to availability.
- Guests making such reservations must identify as members of the CAPRA group
Includes complimentary wireless high-speed internet. - Make your reservation before March 6, 2025, or Call 1-866-837-5184 for individual Reservations.