Webinar: Getting your global, small molecule CMC regulatory strategy right from the start

Drug development is dynamic and engages CMC regulatory input at each step. It’s common to focus on the high-level, current tasks, without thinking more holistically about the CMC regulatory process and your molecule’s lifecycle. With a high-level focus, important steps and regulatory requirements are often missed, which can cause lengthy delays or additional costs to your project. As a result, it’s important to proactively plan and develop CMC regulatory strategies early on in your development process.

Attend this webinar to learn more about:

  • Navigating a variety of regulatory CMC issues in product development to ensure market application readiness
  • Key considerations for product development to ensure global CMC requirements are met for clinical trial and marketing applications 
  • Regional specific CMC data to support clinical trials for key countries: US, EU, UK, Australia, Canada and China

Featured Speakers

Betty Thompson

CMC Regulatroy Affairs

Thermo Fisher Scientific

Betty Thompson provides expertise in small molecule drugs, oral solid, oral solutions, and sterile injectable dosage forms across all product life cycle stages as part of Thermo Fisher Scientific’s North American Regulatory Affairs team. Betty is a CMC regulatory affairs professional with seventeen years of experience in a consulting environment. She received a Bachelor of Science in Applied Chemistry- Cooperative Program from University of Waterloo, Ontario, Canada. In addition to this, she also has a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.

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