This webinar was 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