European Congress on Regulatory Affairs for Combination Products

About This Event

*One product. Multiple regulatory frameworks. Multiple owners. One patient.* ReCAP2027examines what happens when a medicinal product and a medical device become one therapeutic product, while the regulatory frameworks, quality systems, safety processes, and (internal) organisations behind them remain separate. Across two days, experts from industry, regulators and notified bodies will explore where combination products create gaps in responsibility, information and safety — and what can be done about them. *Learning Objectives* After ReCAP2027, participants will be better equipped to: See the whole product Understand how various global regulatory frameworks interact, and anticipate classification and borderline issues before they become development problems. Follow the risk across the lifecycle Understand how responsibility for benefit-risk decisions changes as a combination product moves from design and development through manufacturing and post-market surveillance. Connect the safety signals Recognise how drug-related, device-related, and use-related signals can become separated across different surveillance systems, and how to reconnect them. Close the organisational gaps Identify where internal silos, suppliers, responsibilities, and information flows can create blind spots in change control, complaint handling and risk management when dealing with combination devices. Leave with an action list Consolidate two days of insights into concrete first steps for your organization and a view on what must change at industry and regulatory level. *Who Should Attend?* ReCAP2027 is designed for experienced professionals working with drug-device combination products, including: - Regulatory affairs and regulatory policy professionals - Quality assurance and quality systems leaders - Pharmacovigilance, patient safety and device post-market surveillance specialists - Medical-device and combination-product engineers - Risk management and benefit-risk experts - Human factors and usability engineering specialists - Clinical development and medical affairs professionals - Post-market surveillance and product complaint teams - Supplier quality, alliance management and lifecycle management professionals - Pharmaceutical, biotechnology and medical-device manufacturers - Consultants working in these fields - Representatives from regulatory authorities and notified bodies