This webinar was intended to provide a road map for how the regulatory process in Europe works relative to the use of excipients with a focus on requirements for:
1. Excipient manufacturers/suppliers
2. Drug manufacturer/excipient users
3. European regulatory bodies and competent authorities
Learning/Awareness Objectives
Attendees will be provided with:
> Understanding of responsible European regulatory agencies and standards for excipients
> Understanding of local law/regulations for registration and/or import of excipients
> Excipient monograph regulatory and testing requirements
> Excipient information necessary for supporting drug applications
> General overview of Certificate of Suitability (CEP) process and when/how used
> Regulatory considerations for Atypical Actives and colorants
> Emerging hot topics and challenges impacting excipients
Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory Affairs
> Compendial Affairs
> Quality Affairs