Variations in the European Union: CMC/Quality Changes
Continuing Education credit is not available for archive webinars.
This archive will be available for purchase through June 15, 2015
Duration: 2 hours 10 minutes
This archived webinar will provide to those working in the CMC (Chemistry, Manufacturing, and Controls) area an in-depth discussion on post-approval changes in the European Union (EU). It will cover both chemicals and biologicals.
- Classification of CMC/Quality changes and updates as per 2013 guideline
- Common mistakes in submissions
- Particularities for Mutual Recognition/ Decentralized Procedures (MRP/DCP) and National procedures
- Post-approval change management protocols
Who should attend?
Professionals involved in:
- Regulatory Affairs, Regulatory Compliance
- Technical/Scientific Writing
- Quality Compliance/Quality Assurance
- CMC Life Cycle Management
- CMC Project Management
At the conclusion of this webinar, participants should be able to:
- Discuss the CMC post-approval system in the EU
- Classify changes with regards to the EU variation system
- Identify how to handle variations in the centralized procedure
Ways to register
- Individual registration is a license for ONE internet login allowing one viewer.
- Group site registration is a license for ONE internet login allowing multiple viewers from one location.
- Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.
Cancellations: No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.