Legal & Regulatory

EMA Releases Webinar On Regulatory And Procedural Aspects Of Applications For Type I Variations

November 5
6:07 AM 2016

The European Medicines Agency (EMA) is organising a webinar on 15 November 2016 to advise stakeholders on regulatory and procedural aspects of applications for type IA and IB variations submitted to the Agency.

The event will provide participants with a general overview of frequently identified validation issues in type I variation applications, as well as guidance on key aspects that marketing authorisation holders should consider when preparing their submissions. This aims to improve the quality of applications and reduce the number of issues raised during validation. The session will be of benefit for regulatory affairs professionals and other industry professionals working on the preparation of applications for type I variations to the Agency.

Main topics will include:

  • overview of Type Ivariationsprocedures;
  • electronic application form;
  • documentation requirements;
  • update of safetyproduct informationfor generics;
  • good manufacturing practice(GMP) and inspections-related documentation;
  • applications affecting anactive substance master file(ASMF).

This webinar will be broadcast live on the EMA's website between 13:30 - 16:00 (UK time).

Presentations will be available on the EMA's website prior to the event. A video recording will be published after the event.

In April 2015 EMA launched a survey to gather feedback from stakeholders and the Agency's staff on the performance of its post-authorisation procedures. A report on the outcome of the survey has been published, which outlines actions to further improve the quality of submissions, simplify procedures and provide additional guidance.

To summarize, this webinar will support applicants in the preparation of the submissions of Type IA and Type IB variations to the Agency. The aim of the webinar is to present the most common validation issues identified during validation and/or processing of type IA and type IB variations to the terms of the marketing authorisation, and to increase the awareness of relevant questions and answers and guidance documents that can support applicants in the preparation of the submissions. The webinar will cover important procedural and regulatory aspects associated with IA and IB variations including electronic application form, submission requirements, update of safety product information, GMP related documentation, ASMF and other relevant topics relevant for these procedures.

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