As a European biopharmaceutical company, did you know that conducting your first-in-human (FIH) clinical trials in Canada can help accelerate EMA and FDA approvals?
In this complimentary webinar, we discuss the additional benefits of conducting FIH trials in Canada.
Topics covered will include:
1. The similarities and differences between Health Canada CTA, EMA CTA, and FDA IND submission processes
2. Pre-submission meeting and submission process
3. Content required for Health Canada, EMA, and FDA
4. Timelines and milestones - Health Canada, EMA, and FDA FIH clinical trial approval
Presenters:
- Dr. Beatrice Setnik, PhD, Chief Scientific Officer at Altasciences
- Paul Sidney, Senior Director, Compliance and Regulatory Affairs at Altasciences
Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements.
Altasciences… helping sponsors get better drugs to the people who need them, faster. Visit our website to learn more: www.altascienc...
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