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Variations in the European Union: CMC/Quality Changes

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Overview 

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
CustomerService@diahome.org

Questions about Archived Webinars
Carolyn Callahan
Phone +1.215.442.6194
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Thursday, Jun 26, 2014

  • 1:00PM - 11:59PM

    Variations in the European Union: CMC/Quality Changes

    Speaker(s):

    • Yasmin de Faria Krim, PharmD, MSc
      Manager, Pharma Technical Regulatory
      F. Hoffmann-La Roche Ltd, Switzerland
    • Alberto Ganan Jimenez, PhD
      Head of Service, Procedure Management and Business Support Division
      European Medicines Agency, United Kingdom
    • Evangelos Kotzagiorgis
      Scientific Administrator, Quality of Medicines, Human Medicines Evaluation Div
      European Medicine Agency, United Kingdom
    • Pascal Venneugues
      Scientific Administrator, Quality of Medicines, Human Medicines Evaluation Div
      European Medicines Agency , United Kingdom
    • Susanne A. Winterscheid, PMP
      Head of Project Management of Licensing Division 3
      BfArM, Germany
    • Variations in the European Union: CMC/Quality Changes
      Presentation - All Speakers
      United States

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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