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Variations to Marketing Authorisations Training Course

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

26-27 Apr 2022

& 13-14 Oct 2022

Book now

Details

Course overview

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 variation 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

Who should attend?

This course will be particularly relevant for those working in registration and regulatory affairs. It will also be of interest to anyone with an involvement in the variations process including QA, clinical safety and pharmacovigilance personnel.

Programme

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

Other procedures

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

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

Presenter

Marloes van der Geer (More...)

Marloes van der Geer works as senior regulatory affairs scientist at Qdossier. Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier. Marloes’ areas of expertise are: eCTD, lean authoring, publishing, biopharmaceuticals (incl. biosimilars), clinical development, regulatory convergence & harmonization and facilitated registration pathways (incl. orphan drugs), local RA activities (e.g. product information management).

Book now

Book now

26-27 Apr 2022
Live webinar
26-27 Apr 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 22 Mar 22*
Enrol now
to attend
Live webinar
13-14 Oct 2022
Live webinar
13-14 Oct 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 8 Sep 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • Atnahs Pharma Nordics
  • Avon Automotive plc
  • Bayer Healthcare
  • Blau Pharmaceutical Services
  • Boehringer Ingelheim Ltd
  • Bristows LLP
  • Casen Recordati SL
  • Consilient Health
  • Cratian Agency for medicinal products and medical devices - HALMED
  • E.C. De Witt & Company Limited
  • Fresenius Kabi UK Ltd
  • Galderma (UK) Limited
  • Galen Ltd
  • Irish Patents Office
  • Karib Kemi Pharm Ltd
  • Mylan
  • Novartis Hrvatska doo
  • Novartis International AG
  • Novartis Pharmaceuticals UK Ltd
  • ObsEva
  • Procter & Gamble Technical Centres Ltd
  • Ranbaxy Laboratories Ltd
  • Reckitt Benckiser Healthcare (UK) Ltd
  • S A Consultancy Ltd
  • Sanofi Pasteur MSD
  • Shire Pharmaceutical Ltd
  • SHORE LTD
  • Teva Pharmaceuticals Europe B.V.
  • Teva UK Ltd
  • Waymade Plc

It was very interesting and informative.

Dubravka Božičević, Senior Advisor for Validation of Applications, Cratian Agency for medicinal products and medical devices - HALMED, Apr 21

Excellent webinar! [Speaker is] engaging and friendly.

Abhijit Nair, Regulatory Affairs Officer, Consilient health, Apr 21

Excellent, clear and interactive

Mohit Pandey, Morningside Healthcare Limited, Oct 20

Andrew is a good speaker and managed to keep our attention during these two days despite the fact that it was a webinar.

Chloë Braud, International Regulatory Affairs Pharmacist, Guerbet, Oct 20