About this Webinar
As UK life sciences companies expand operations into the European Union, quality management systems face unprecedented pressure. What once worked within a single regulatory environment must now adapt across multiple jurisdictions, partner networks, and inspection standards, often exposing critical gaps in process ownership, data visibility, and cross-site consistency.
In this joint webinar, quality and compliance experts from Scilife and Rephine bring together consulting expertise and system-based methodology to help organizations scale confidently, without losing control.
What You’ll Learn
- How expanding from UK-only to combined UK + EU operations fundamentally reshapes quality governance
- The most common failure points during international scale-up: visibility gaps, fragmented SOPs, and unclear accountability
- What EU and UK regulators and your partners, expect when assessing inspection readiness
- How to build a connected quality loop across events, CAPAs, changes, SOPs, and training for end-to-end cross-site consistency
Who Should Watch
Quality directors, regulatory affairs managers, and operations leads at UK-based pharmaceutical, medical device, or biotech companies preparing for or actively managing EU market entry.
Featured Experts
- Alex Pagès: QMS Consulting Line Director, Rephine
- Àngel BuendÃa: Knowledge Manager, Scilife
- Jordi Ametller:Â Senior Account Executive, Scilife
Watch the full webinar and close your compliance gaps.
Agenda
05:55
Expanding quality operations into the EU
14:50
Scaling up Quality Management
19:25
Risks and Considerations for proper transition
24:30
Change Management
36:22
How to build a connected quality loop for cross-site consistency
55:30
Q&A
Ready to take the next step?
Whether you need expert guidance on your QMS or want to see how Rephine supports life sciences teams scaling internationally, we’re here to help. Contact us here
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