When it comes to getting medicines to market—and keeping them there—regulatory red tape can be as challenging as drug development itself. ResearchAndMarkets.com has just added a new training course, “Variations to Marketing Authorisations” (Oct 15–16, 2025), designed to help pharma professionals navigate one of the industry’s most complex post-approval hurdles.

Why It Matters

For marketing authorisation holders (MAHs), filing and maintaining dossiers isn’t optional—it’s a legal responsibility. Every tweak, whether it’s a formulation change or a new safety restriction, must be filed as a “variation” with European regulators. And in a field where time is money, knowing how to classify, prepare, and submit the right type of variation can shave weeks off approval timelines.

The upcoming course provides a structured overview of the EU’s system for variations under Regulations 1234/2008 and 712/2012. More importantly, it promises practical, scenario-based training to help regulatory teams file smarter, not harder.

Inside the Course

Across two packed days, participants will dig into:

• Variation Types – Demystifying Type IA, IB, and II variations, along with foreseen vs. unforeseen changes.

• Filing Strategy – Tips for creating global dossiers and managing gold/silver/bronze versions.

• Grouping & Work-Sharing – When it makes sense to combine submissions and how to execute them.

• Module 3 Impact – How quality data (QbD, CQA pyramids) shape dossier decisions.

• Advanced Compliance – From urgent safety restrictions to SUPAC guidance.

Interactive case studies will let attendees apply concepts to real-world scenarios, from managing national vs. centralised procedures to handling linguistic reviews in mutual recognition processes.

The Expert

The course will be led by Andrew Willis, an independent regulatory consultant with nearly three decades of pharmaceutical experience. Formerly VP of Regulatory Affairs at Catalent, Willis has overseen major EU and US filings, including mutual recognition approvals across 26 countries. His background spans everything from biotech cancer treatments to sterile manufacturing—credentials that make him well-placed to decode regulatory complexity.

Beyond the Lecture

The event isn’t just about theory. Participants can expect hands-on discussions, peer exchanges, and 12 hours of Continuing Professional Development (CPD) credits. A certificate of completion will also be provided—useful currency for regulatory professionals looking to validate expertise in a competitive field.

Why Now?

The EU regulatory landscape continues to evolve, and pharma companies face mounting pressure to accelerate post-marketing changes without tripping over compliance hurdles. With new therapeutic classes—from cell therapies to mRNA vaccines—coming to market, regulatory affairs teams are dealing with an unprecedented mix of traditional and novel requirements. Training like this aims to close that knowledge gap, helping companies avoid costly delays.

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