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Management Forum

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.

★★★★★ "Excellent webinar! [Speaker is] engaging and friendly."

6-7 June 2023
+ 12-13 October 2023
from £1099

Need help? Enrol or reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

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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

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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.

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The Variations to Marketing Authorisations course will cover:

Day 1
Day 2

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

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6-7 Jun 2023

Andrew Willis
San Salvatore Training Ltd

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.

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12-13 Oct 2023

Marloes van der Geer
Qdossier

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).

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Book Variations to Marketing Authorisations Live online training

NEW higher discounts for multiple bookings - 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*

Please contact us for pricing if you are interested in booking 5 or more delegates

6-7 June 2023

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 12960

GBP 1,299
EUR 1,869
USD 2,129

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

12-13 October 2023

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 12374

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 07 Sep

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's Variations to Marketing Authorisations training course

Excellent presentations and course material. Always better face to face, but digital plateform worked well. All very clear. Alot was covered during two days. The case studies made me practise what we were taught.

Oct 13 2022

Louisa Dew United Kingdom
Regulatory Affairs Consultant, NDA Regulatory Science Ltd