- Global Pharma News & Resources

Regulatory and Procedural Aspects of Variation Submission in Pharmacovigilance Webinar -

The "Regulatory and procedural aspects of variation submission in Pharmacovigilance" webinar has been added to's offering

A variation is a change to the terms of a marketing authorization. All the Pharmaceutical producers and importers in EU are required to provide information about variations to the regulatory authorities with their medicines. These variations can be minor with minimal or no impact or can be major' with significant impact related to the quality, safety and efficacy changes of the medicinal product.

Learning Objectives:

  • This webinar provides the guidance for marketing authorisation holders on the regulatory requirements and procedures for the different types of variations.
  • This WEBINAR will describe the regulatory requirement and procedures and processes for the different types of variations. A structured methodology presented in the WEBINAR shall provide the support to the Pharmaceutical companies and CROs for preparation and submissions of all VARIATIONS as per EU regulatory standards.
  • The aim of the webinar is to provide the practical know-how in terms of the most common issues experienced during processing of all types of VARIATIONS that will support applicants in the preparation of the submissions.

If you are involved in any aspect of pharmacovigilance and looking forward to strengthen your pharmacovigilance knowledge, this WEBINAR will help you to increase your knowledge base regarding the techniques and regulatory processes involved in variation submission in Pharmacovigilance in EU.

This will be a perfect learning opportunity in all areas of drug safety, pharmacovigilance, regulatory and quality compliance and will be a great addition to your knowledge in pharmacovigilance.

Who Should Attend:

  • Pharmacovigilance (including QPPV)
  • Clinical Research
  • Risk Management
  • Drug Safety Assessment Department
  • Safety Data Analysis
  • Pharmacoepidemiology
  • Information Technology
  • Regulatory Affairs
  • Pharmacovigilance consultancy
  • Quality and Compliance
  • Legal

Key Topics Covered:

  • Article 5 procedure: Regulatory and procedural guidance
  • Type IA variations and submissions
  • Type IB variations and submissions
  • Type II variations and submissions
  • Variation Submission and Documentation
  • Presenting IN change application and submission
  • Marketing Authorization Extension application and procedures
  • Presenting and handling of GROUPED Variation application
  • Checklist for high quality applications submission
  • New variations regulation: Regulatory and procedural guidance
  • Applications affecting an Active substance Master File (ASMF)
  • Work sharing Procedures
  • Timelines for submission, review and approval for various categories of variations
  • Special considerations
  • QA

For more information about this webinar visit

View source version on

Editor Details

Last Updated: 23-Oct-2018