Day Five – 20 June 2025Friday, 20 June 2025 - CEST Time Zone

• Current regulatory landscape and expectations for post market surveillance and vigilance in Europe

• Have there been any notable changes?

• Are there any areas under review to watch out for?

• Which sections of PMS guidance consistently trip people up?

• Solutions to overcome

• With UK PMS regulations having come into force in 2024, what are our first experiences?

• Do expectations align with Europe?

• Can manufacturers streamline PMS activities for both regions?

• Are there common pain points which need addressing?

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• Role of PMS in the Benefit-Risk Framework

• Regulatory Expectations for PMS Data Collection

• Risk Identification and Management via PMS

• Impact of Post-Market Data on Benefit-Risk Decisions

• Cross-Functional Collaboration for Effective Benefit-Risk and PMS

• How do you decide what Continuous PMCF activity is appropriate for each class of device?

• What systems and tools are key for creating?

• How do you implement?

• Set up a decision tree to help guide your decisions in the PMCF World

• Can you Create a Proactive and Maneuverable PMS/PMCF System to be globally supportive

• Understanding Real-World Evidence

• Integration of RWE in Post-Market Surveillance

• Regulatory Landscape

• Case studies

• Challenges and Opportunities

• Future directions

• Outline of a Practical Approach to Integrating MDCG 2022-21 Requirements: Effective integration into the Quality Management System to meet regulatory demands.
• Utilization of the PSUR Structure for Streamlined Input Templates: Developing department-specific templates to ensure consistent, compliant data collection across teams.
• Breaking Down Silos Through Direct Involvement: Enhancing cross-departmental collaboration by focusing on a unified PSUR project goal, rather than on isolated task completion.
• Fostering a Collaborative Environment: Bridging perspectives across departments to promote a cohesive approach to quality management.

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• What are the current regulatory expectations for adverse event reporting?

  • How are notified bodies assessing this?

• Industry experiences of reporting adverse events

  • Can current processes be more standardised?

  • Streamlining stakeholder interactions

  • Can AI be used to alleviate workload?