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Variations in the European Union: CMC/Quality Changes

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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.

Featured Topics 

  • 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

Learning Objectives 

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

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET

Questions about Archived Webinars
Carolyn Callahan
Phone +1.215.442.6194
Fax +1.215.442.6199

Technical Requirements 

Click here for minimum system requirements.


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Registration Fees 

Other Fees

Group Site
Group Plus


Member Government Individual
Charitable Nonprofit/Academia Member Individual
Member Individual


NonMember Government Individual
Charitable Nonprofit/Academia Nonmember Individual
NonMember Individual
Registration Information

Printable Registration Form

  • 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.

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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