Successful regulatory submissions are shaped long before the dossier is written. This educational session highlights the importance of proactive planning and demonstrates how decisions made during preclinical and early clinical development directly impact submission quality, timelines, and outcomes. Through a practical, submission-driven perspective, participants will learn how to anticipate CMC, non-clinical, and clinical requirements, avoid common gaps, and align development strategies with Health Canada expectations. The session is designed for a mixed audience, including students, academic innovators, early-career professionals, and biotech start-ups.
Attendees can join either virtually or in-person. In-person attendees will have an exclusive opportunity to tour CASTL’s state-of-the-art training facility, gain a practical understanding of all stages of the biomanufacturing process, and network.
Registration Fees & Deadlines
Member: $20 I Nonmember: $35
Learning Objectives
After attending this session, learners will be able to:
- Understand how early development decisions influence regulatory submissions
- Anticipate key CMC, non-clinical, and clinical requirements before submission
- Identify common gaps that lead to delays and regulatory questions
- Apply proactive regulatory thinking early to improve submission efficiency
- Align scientific development with regulatory expectations across development stages
Who Should Attend?
- Regulatory Affairs professionals supporting cell and gene therapy or combination product programs.
- CMC and Technical Development professionals contributing to global regulatory submissions.
- Device development and engineering professionals working on CGT delivery systems.
- Scientists responsible for potency assay development and regulatory justification.
- Quality and compliance professionals overseeing combination product requirements.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Agenda
- 1:00 pm – 2:00 pm (presentation, Q&A)
- 2:15 pm – 4:00 pm (for in-person attendees: tour of CASTL training facility, networking)
Speakers
Ibtissem Helal
Clinical Compliance & Licensing Specialist, Sandoz Canada
Ibtissem Helal is a Quality Assurance and Regulatory professional with over eight years of experience supporting pharmaceutical products from early development through regulatory submission and market launch. She holds two Master’s degrees in Genetic Engineering & Molecular Biology and Industrial Microbiology. Ibtissem has contributed to Canadian submissions for innovative products, injectables, and biosimilars and currently specializes in clinical compliance.
She is recognized for her proactive, submission-focused approach and is passionate about mentoring students, academic innovators, and biotech start-ups in building strong regulatory foundations early.
Location
CASTL Montreal Training Center
4100 Rue Molson
suite 120
Montreal, Quebec H1Y 3N1
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.