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Variations in the European Union: CMC/Quality Changes

Jun 26 2014 10:00AM - Jun 26 2014 12:00PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)
2:00 PM to 4:00 PM GMT
3:00 PM to 5:00 PM BST
4:00 PM to 6:00 PM CET


This 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 and Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details
Melissa Buchanan, Content Lead
Phone +1.215.442.6158
Fax +1.215.442.6199
Melissa.Buchanan@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Presenter(s) 

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Continuing Education 

The Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer X.XX CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

DIA’s Certificate Program Statement
This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: 1 Elective Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Variations in the EU: CMC/Quality Changes IACET 1.50 0.200

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must participate in the live webinar, and complete the credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Thursday, July 10, 2014.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits are not available for participation in the archived version of the webinar.

Registration Fees 

Other Fees

Group Site
$899.00
Group Plus
$1599.00

Member

Member Government Individual
$175.00
Charitable Nonprofit/Academia Member Individual
$225.00
Member Individual
$300.00

Non-Member

NonMember Government Individual
$175.00
Charitable Nonprofit/Academia Nonmember Individual
$225.00
NonMember Individual
$400.00
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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