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
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