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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.

7-8 Jul 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

Pharmaceutical medicine

Legislation

Guidance

Case study

A close look at Module 3

ICH Q12

US, Canada, Australia variations

Global variation planning

Lean authoring

Trends and developments

Presenters

Marloes van der Geer (More...) (7-8 Jul 2022, 13-14 Oct 2022)

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).

Joanne Roza (More...) (7-8 Jul 2022)

Joanne Roza works as a senior regulatory affairs consultant at Qdossier. She is involved in regulatory affairs consultancy and has also expertise in regulatory operations for big- and small-sized pharmaceutical companies. Joanne holds a bachelor degree in Health Sciences from Maastricht University and a master degree in Health Economics, Policy and Law from the Erasmus University in Rotterdam. She started her career at Qdossier in 2016 and has been involved in a variety of regulatory operations and affairs projects. Joanne’s areas of expertise are: regulatory affairs (strategy and planning), preparation/creation and dispatch of different types of electronic submission formats (e.g. US FDA, CA, EMA, CH), lean/structured authoring and the creation of baseline (CMC) submissions.





Book now

Book now

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate
  • 40% off the 3rd delegate
  • 50% off the 4th delegate
7-8 Jul 2022
Live webinar
09:00-17:00
UK (London)
7-8 Jul 2022
Live webinar
09:00-17:00
UK (London)
GBP 1,299.00
EUR 1,859.00
USD 2,098.00
+ VAT @ 20.00%
Enrol now
to attend
Live webinar
13-14 Oct 2022
Live webinar
09:00-17:00
UK (London)
13-14 Oct 2022
Live webinar
09:00-17:00
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 8 Sep*
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. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

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...

  • Abbott Healthcare Products BV
  • Archimedes Pharma UK Limited
  • Avon Automotive plc
  • Bayer Healthcare
  • Blau Pharmaceutical Services
  • Cross Vetpharm Group UK LTD
  • Dechra Ltd
  • E.C. De Witt & Company Limited
  • Eli Lilly & Co Ltd
  • EVER Valinject GmbH
  • Fresenius Kabi AB
  • Gilead Sciences International Ltd
  • Intervet Nederland bv
  • Janssen-Cilag Ltd
  • Life Molecular Imaging
  • Lundbeck Limited
  • Mentholatum Co Ltd
  • Milpharm Ltd/Aurobindo Pharma Limited
  • Mylan
  • Novartis Pharmaceuticals UK Ltd
  • Procter & Gamble Technical Centres Ltd
  • Reckitt Benckiser Healthcare (UK) Ltd
  • S A Consultancy Ltd
  • Sanofi Pasteur MSD
  • Sanofi Pasteur MSD Ltd
  • SCHERING-PLOUGH LABO NV
  • Shire Pharmaceutical Ltd
  • Teva Pharmaceuticals Europe B.V.
  • Wrafton Laboratories Ltd, t/a Perrigo
  • Zentiva Group AS

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