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US Laws, Regulations and Industry Best Practices for Excipients



Part 1: Wednesday, October 20, 2021 - 9:00am to 11:00am EDT
Part 2: Thursday, November 4, 2021 - 9:00am to 11:00am EST


This webinar is intended to provide a road map for how the regulatory process in the US works relative to the use of excipients and will focus on requirements for:
1. Excipient manufacturers/suppliers
2. Drug manufacturer/excipient users
3. US FDA drug application reviewers

Learning/Awareness Objectives
1.
Understanding of responsible regulatory agencies and standards for excipients
2. Excipient information necessary for supporting drug applications
3. Requirements and resources needed for filing and maintain a US Type IV DMF
4. Regulatory considerations for Atypical Actives, colorants/flavors and biological adjuvants.
5. Evolution from bundling review, to registration to joint review of excipients used in drug
6. Emerging hot topics and challenges impacting excipients

Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs