ATM Talks | Getting to Regulatory Approval: Strategies To Move Your Discovery Forward

Regulatory approval is rarely as simple as looking up the rules. So, what does it really take to move a discovery forward?

You are invited to join the Academy of Translational Medicine for the first ATM Talk of the academic year with Karen Long, who brings more than 30 years of experience preparing regulatory submissions for Canada, the US, and Europe. She will unpack Regulatory Affairs, one of the most critical steps in the translational pathway from promise to practice.

Register now

What you’ll learn:

• How regulatory strategy fits on the path to patient access
• What goes into regulatory submissions
• How regulatory requirements should shape research
• How professionals navigate grey areas and incomplete information
• Key costs, timelines, and program risks

The session includes time for questions and requires no regulatory background. It is designed for researchers, trainees, clinicians, and spinout teams developing health innovations with a path to market.

Part 2, coming later this year, will explore health technology assessment and reimbursement, and why approval alone does not guarantee patient access.

About the Speaker

Karen Long has 30 years of experience in the pharma and medical device industries. She has primarily worked in regulatory and drug development roles, but also in project management, analytical and quality/compliance. She has US, EU, Canadian and Global Regulatory Affairs Certifications, and has written numerous successful regulatory submissions, most recently to support Phase 1 and 2 clinical trials in the European Union.