16 - 20 June 2025
Mercure Hotel MOA Berlin, Berlin, GermanyHybrid Event I Attend In-Person or Digitally16 - 20 June 2025
Mercure Hotel MOA Berlin, Berlin, Germany,
Hybrid Event I Attend In-Person or Digitally
Mercure Hotel MOA Berlin, Berlin, Germany,
Hybrid Event I Attend In-Person or Digitally
20 June 2025
Post Market Surveillance and Vigilance
Accurately Determine Benefit-Risk. Increase Adaptability of Your PMCF. Optimise Adverse Event Reporting.
Advance Your PMS and Vigilance Systems with Real World Inspiration
Digest the latest updates to PMS requirements globally
- Uncover the current regulatory requirements for post-market surveillance in Europe to ensure compliance
- Understand UK post market requirements feedback from the chairman of the UK Responsible Person Association
- Identify where global requirements align to streamline global PMS processes
Ensure continuous device and IVD compliance with effective PMS planning
- Understand the combination products 'grey area' with help from UCB
- Ensure proactive PMS with best practices from Abbott
- Equip your teams with the skills to streamline vigilance reporting through multi-stakeholder discussions
Capitalise on learnings from industry peers
- Utilise the experience of Rehaler in determining and implementing benefit-risk in PMS plans
- Navigate the application of real-world evidence in PMS with examples from Human Care AB
- Apply Hoya Surgical’s learnings on adverse event reporting and ensure events are reported correctly
Ensure Post Market Surveillance Excellence with Insights From the Experts
SME Survival Guide Workshop
Monday 16 June
- Understand the EU regulatory landscape for innovation
- Identify key stakeholders to bring devices and IVDs to market
- Curate effective regulatory and clinical strategies
- Develop and complete technical files for submission
- Pinpoint funding pathways and develop pitches
- Navigate pricing and reimbursement options
