Don’t Miss it ― a Regulatory Discussion with our Experts

 

Complimentary Webinar — Clinical Trials in Support of a U.S. Drug Submission

Did you know that first-in-human (FIH) clinical trials conducted in Canada can accelerate regulatory approvals from the EMA and the U.S. FDA?

For an overview of foreign health authority requirements for approval to conduct a FIH clinical trial, including a comparison of Health Canada’s and the EMA’s Clinical Trial Authorization (CTA) processes and the U.S. FDA’s Investigational New Drug (IND) submission process, watch this complimentary webinar.

Topics covered include:

• Ensuring timely FIH clinical trials when planning your early phase drug development strategy
• Utilizing foreign clinical trials for U.S. FDA drug submissions and approvals 
• Differences in the quality and nonclinical data submission requirements to gain EMA, FDA, and Health Canada approval to conduct FIH trials 

Contact us to discuss the additional benefits of conducting FIH trials in Canada.

You may also be interested in the following:

• Webpage: Scientific, Regulatory, and Strategic Guidance
• Fact sheet: Clinical Sample Collection Kits
• Fact sheet: First-in-Human (FIH) Studies

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.