Variations To Marketing Authorisations Training Course Scheduled For November 11 - 12, 2026, Covering EU Regulatory Requirements And Submission Strategy
Dublin, Sept. 16, 2026 (GLOBE NEWSWIRE) -- "Variations to Marketing Authorisations Training Course (Nov 11th - Nov 12th, 2026)" has been added to ResearchAndMarkets.com's offering.
The Variations to Marketing Authorisations Training Course, delivered by IPI Academy, will take place online on November 11–12, 2026, providing two days of practical training on the EU system for variations and the preparation and submission of variation applications through European procedures. The programme addresses the ongoing responsibility of marketing authorisation holders to keep dossiers up to date and submit changes to the appropriate regulatory authority.
The course combines regulatory guidance with practical sessions covering the classification of Type IA, Type IB and Type II variations, grouping and work-sharing, Module 3, QbD and CQA pyramids, global dossier creation, implementation and grace periods, and variation submission project management. Day two addresses Article 5, urgent safety restrictions, extension applications, national procedures, mutual recognition and decentralised procedures, including MAH, RMS and CMS responsibilities.
Why You Should Attend
- Classify variations accurately: Examine the regulatory differences between Type IA, Type IB and Type II variations, including foreseen and unforeseen changes. Strengthen submission planning: Explore global dossier versions, implementation strategies and project timelines for variation submissions. Address complex changes: Review data requirements for Type II variations through a dedicated practical session. Understand European procedures: Examine national, mutual recognition and decentralised procedures and their associated responsibilities. Apply practical learning: Work through an example MRP-authorised product, including planning timelines and the impact of referrals.
The training is particularly relevant to professionals working in registration and regulatory affairs, as well as personnel involved in the variations process, including quality assurance, clinical safety and pharmacovigilance. Participants can receive 12 hours of CPD for their records and a certificate of completion.
Featured Course Expert
Mr Andrew Willis Independent Consultant: Willis provides expert advice and training on global regulatory solutions and pharmaceutical development. He previously served as VP Regulatory Affairs & Consulting Services at Catalent Pharma Solutions and has 28 years of pharmaceutical experience, including extensive European and US regulatory project experience.
With the online programme scheduled for November 11–12, 2026, professionals involved in marketing authorisation variations and European regulatory affairs can review the course and register their interest through Research and Markets.
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