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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.

8-9 Oct 2020

& 25-26 Mar 2021 , 7-8 Apr 2021 , 7-8 Oct 2021 , 14-15 Oct 2021

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

Andrew Willis (More...)

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, where 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 had 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 has over 30 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.

Book now

Book now

8-9 Oct 2020
Live webinar
8-9 Oct 2020
Live webinar
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
+ VAT @ 20.00%
Enrol now
to attend
Live webinar
25-26 Mar 2021
Live webinar
25-26 Mar 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 11 Feb 21*
Enrol now
to attend
Live webinar
7-8 Apr 2021
Face-to-face, (venue not yet confirmed)
7-8 Apr 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 24 Feb 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
7-8 Oct 2021
Live webinar
7-8 Oct 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 26 Aug 21*
Enrol now
to attend
Live webinar
14-15 Oct 2021
Face-to-face, (venue not yet confirmed)
14-15 Oct 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 2 Sep 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

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

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...

  • Abbott Healthcare Products BV
  • Abbott Laboratories Ltd
  • Allergy Therapeutics Ltd
  • Almac Group
  • Avon Automotive plc
  • Bayer Healthcare
  • Blau Pharmaceutical Services
  • BOC Ltd (part of the Linde Group)
  • Bristows LLP
  • Britannia Pharmaceuticals Ltd
  • Chiesi Limited
  • Co-Operative Pharmacy
  • Cyton Biosciences Ltd
  • Dechra Ltd
  • E.C. De Witt & Company Limited
  • Fresenius Kabi UK Ltd
  • Galderma International
  • JensonR+ Ltd
  • Karib Kemi Pharm Ltd
  • Labopharm Europe Ltd
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • NAPP PHARMACEUTICALS
  • Pierre Fabre Ltd
  • Rosemont Pharmaceuticals Limited
  • Sanofi Pasteur MSD
  • Sanofi Pasteur MSD Ltd
  • SCHERING-PLOUGH LABO NV
  • Shire Pharmaceutical Ltd
  • Sinclair IS Pharmaceuticals Ltd
  • Teva Pharmaceuticals Europe B.V.