SOURCE: Xtalks

Xtalks Webinars

October 03, 2014 07:05 ET

The Critical Role of CMC in Your IND Submission, Live Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - October 03, 2014) - This webinar featuring esteemed speaker Dr. Glenn Petrie, Senior Scientific Advisor at ABC Laboratories, will focus on the primary CMC requirements for a biopharmaceutical IND submission. Join this webinar to learn more on Wednesday, October 15, 2014 at 1:00pm EDT. 

Early stage drug developers generally have their sights firmly set on the initiation of clinical trials, focusing on toxicological and pharmacological studies. Often, the importance of Chemistry, Manufacturing and Control (CMC) data is underestimated. But the CMC package is critical to IND approval, and meeting all FDA requirements demands careful planning and sound execution.

This discussion will cover the risk/reward criteria for determining the level and degree of method validation, reference standard characterization and formulation, as well as potential pitfalls and ways to streamline the entire development process.

To learn more about this event visit: The Critical Role of CMC in Your IND Submission

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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Contact Information

  • Contact:
    Michelle Tran
    Tel: +1 (416) 977-6555 ext 352
    Email: mtran(at)xtalks(dot)com