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DUBLIN–(BUSINESS WIRE)–The “Variations to Marketing Authorisations” conference has been added to ResearchAndMarkets.com’s offering.

It is a key post-marketing responsibility of the marketing authorisation holder (MAH) to keep dossiers up to date, and changes must be submitted as variations to the appropriate regulatory authority.

This interactive event will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of various applications using the various European procedures. The course will cover the latest variation regulations and offer guidance from an industry expert on how to optimise your regulatory procedures to help achieve faster approval. The programme will include filing tips and strategies with information and advice on creating a global dossier and implementation periods.

Practical sessions throughout the two days will provide an opportunity to discuss different scenarios and strategies with other participants.

Benefits of attending:

  • Gain an overview of the EU system for variations
  • Assess how pharma companies are working in this evolving regulatory environment
  • Profit from practical advice on the preparation and submission of variation applications
  • Understand the impact of Module 3 on your variations dossier
  • Discuss filing tips and strategies to help achieve faster approval

Agenda:

Day one

Basis of EU Regulations 1234/2008 and 712/2012

  • Classification in accordance with the legislation
  • Understand the differences between type lA, type IB and type ll variations
  • Clarify foreseen and unforeseen variations

Special topics in variations

  • Handling active ingredient master files as variations
  • Submission of new clinical data

Practical session: Analysing and classifying the different changes Grouping and work-sharing

  • Understanding when grouping is appropriate
  • Clarifying what types of variations may be grouped
  • Guidance on assembling a grouped submission
  • Understanding when work-sharing is appropriate

Understanding Module 3

  • The dossier impact on variations
  • QbD
  • CQA pyramids

Practical session: Understanding reviewers Filing strategy

  • Creating a global dossier (gold/silver/ bronze versions)
  • Understanding implementation and grace periods
  • Fixed and rolling implementation strategy

Practical session: Plan the timelines/project management of a variation submission

Day two

Other procedures

  • Article 5
  • Urgent safety restrictions
  • Understanding when to use extension applications

Filing tips

  • Submitting type IA, IB and type II applications
  • Understand how to ensure that your dossier is complete
  • Find out what to do when your application is rejected

Submission planning

  • Identify and understand strategic considerations

Data requirements for type II variations

  • Learn how to identify and support a type II change

Practical session: Data requirements for more complex changes Variations through national procedures and differences from centralised procedure

  • Understand the procedures
  • Languages and translations
  • Explore the linguistic review process

Mutual recognition and decentralised procedures for variations

  • Understand the procedures and responsibilities of the MAH, RMS and CMS
  • Learn how to efficiently plan for and run an MR variation procedure

Practical session: A variation to an example MRP authorised product including planning timelines and impact of referrals Advanced compliance

  • Creating your own compliance requirements
  • SUPAC guidance

Speakers:

Andrew Willis

Consultant

Independent

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and he was head of a team of internal and external regulatory affairs consultants. He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He has 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He currently has a total of 28 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many Biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment. He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.

For more information about this conference visit https://www.researchandmarkets.com/r/hm4rjn

Contacts

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Laura Wood, Senior Press Manager

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