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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.
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
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7-8 Jul 2022 Live webinar 09:00-17:00 UK (London) |
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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 |
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13-14 Oct 2022 Live webinar 09:00-17:00 UK (London) |
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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 |
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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.