Webinar - Comparison of US FDA and Health Canada CTA submission to Support First-in-Human Phase I

In this webinar Altasciences' Paul Sidney, Senior Director, Compliance and Regulatory Affairs, Scientific & Regulatory Affairs and Julie Forget, Director Safety Assessment
Seattle, WA discuss foreign clinical trial data accepted under the US Food and Drug Administration (FDA) regulations to support New Drug Application (NDA) (including 505 (b)(2)) and Abbreviated NDA (ANDA) submissions.
It is a common assumption that pharma and biotech companies are focused on these regulatory submissions to the US FDA. In fact, US-based contract research organizations often provide what they refer to as their “standard Investigational New Drug (IND)-enabling programme” when initiating discussions with new clients. However, for a variety of reasons, the drug development strategy of many companies is to conduct first-in-human (FIH) clinical studies outside of the US.
To ensure the safety of Phase I healthy trial subjects, the generation and conduct of suitable non-clinical toxicology studies is documented in the international harmonized guidance ICH M3 R2. However, the presentation of this data as a well-argued case, conforming to local regulatory expectations and standards, is key to a successful foreign regulatory authority submission.
This webinar will provide an overview of a foreign health authority’s requirements for gaining approval to conduct an FIH clinical trial by comparing Health Canada and European Medicines Agency (EMA) Clinical Trial Authorization (CTA) processes to that of the FDA IND submission. The presentation will cover the following:
Highlight similarities and differences
Provide an overview of the receiving divisions
Summarize each regulatory agency’s review process, submission process and content
Review timelines for CTA/IND submissions.
Key learning outcomes:
1. Understand current considerations for emerging biopharmaceutical companies to ensure timely FIH clinical trials when planning early-phase drug development strategies
2. Learn how foreign clinical trials can support FDA drug approval
3. Explore 505(b)(2) NDA submission and how foreign clinical trials support this drug development strategy
4. Review the differences in the quality and non-clinical data submission requirements to gain approval from EMA, FDA and Health Canada to conduct an FIH trial.
For your early phase research, our experts in clinical trial services ensure the design and conduct of clinical pharmacology and early efficacy studies generate the data that meets your objectives, leveraging preclinical data in the design of the programs that move your drug candidate to proof of concept. We have expertise in all the clinical pharmacology studies for regulatory submissions, in a wide range of therapeutic areas, for small molecules, biologics, and 505(b)(2) or Hybrid applications, on behalf of biopharmaceutical companies of every size.
Visit our website to learn more clinical trial monitoring and our CRO research support services: www.altasciences.com/clinical...
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