Variations to Marketing Authorisations Training Course: An Invaluable Overview of the EU System for Variations, with Practical Advice on the Preparation and Submission of Variation Applications

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Jan 31, 2024, 14:45 ET

DUBLIN, Jan. 31, 2024 /PRNewswire/ -- The "Variations to Marketing Authorisations Training Course" conference has been added to ResearchAndMarkets.com's offering.

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

Certifications

CPD: 12 hours for your records
Certificate of completion

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.

Key Topics Covered:

Day 1

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

Day 2

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

Speakers:

Marloes van der Geer
Senior Regulatory Affairs Scientist
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).

For more information about this conference visit https://www.researchandmarkets.com/r/l3npaq

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