Webinar Recording

Regulatory Considerations Regarding IR Film Coating Post-Approval Changes

There are many reasons why one may need to consider a change in the film coating that is used on a marketed product.

Watch the available on-demand webinar to learn:

  • Understanding of the key technical considerations typically needed to support a film coating change, as well as the various regulations and guidance documents related to post-approval changes.
  • Learning the process for making a change to an IR (immediate release) film coating and what is needed in the U.S. and Europe to make the change in terms of technical studies and other information that may be required for FDA/EMA submissions.
  • Discovering what can be done to make these types of changes with minimal regulatory impact or approval delays.

Watch the webinar

Meet the speakers

Mr. David R Schoneker

David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns.

With over 43 years of experience working in these areas, Dave has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world. He is also an Adjunct Professor at Temple University's School of Pharmacy in their RA/QA Master's Program where he teaches courses in Global Excipient Regulations and the Regulation of Dietary Supplements.

Prior to August 2019, David R. Schoneker was the Global Regulatory Director – Strategic Relationships at Colorcon, Inc. His responsibilities included global coordination of Colorcon’s worldwide regulatory activities. He was at Colorcon from 1977 until 2019.

Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee serving as the Vice Chair for Science and Regulatory Policy, where he is actively involved with the development of Regulatory, Safety, Excipient GMP and Supplier Qualification related guidelines to improve Excipient Acceptability, Safety and Global Supply Chain Security.

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