BioPort Atlantic CBV Knowledge Expansion Series - Regulatory Ready: Preparing for FDA & Health Canada Meetings

Regulatory meetings can be critical milestones in a biotech company’s development journey. In this session, CBV Expert-in-Residence, Dana Nohynek, will provide an overview of Health Canada and FDA pre-submission and pre-IND meeting pathways.

Designed for companies and academic teams developing a therapeutic product toward first-in-human (FIH) trials, the session will break down the regulatory meeting process, including:

• The different FDA and Health Canada pre-submission and pre-IND meetings

• When to use each meeting pathway

• What to include in your meeting request and briefing package

• How to prepare your team and questions

• The timeline from meeting request → package submission → meeting → meeting minutes

• How to turn regulatory feedback into actionable next steps

Whether you’re preparing for your first regulatory interaction or approaching a key development milestone, this session will give you practical guidance to help you prepare with confidence and make the most of your regulatory meeting.