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
Agenda
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
Ms Marloes van der Geer,
Senior Regulatory Affairs Scientist ,
QdossierMarloes 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).
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.
