Now in its 10th edition, the Summit brings together manufacturers, Authorised Representatives, Notified Bodies, regulators, legal experts, policy stakeholders, and industry leaders to discuss the practical realities of MDR and IVDR implementation.
This webinar will walk you through how to apply the FDA's CSA's risk-based principles to AI, and what that looks like in practice, using a validated requirement conflict detection AI agent as a real-world example.
A practical, two-day workshop that decodes the full ADC development journey — from CMC and analytical control through non-clinical, clinical and expedited pathways to global submissions and market access — using recently approved antibody-drug conjugates as working case studies.
In de afgelopen maanden zijn er diverse voorstellen gedaan vanuit de Europese Commissie voor aanpassingen in wet en regelgeving die impact (gaan) hebben op alle stakeholders die met medische hulpmiddelen en in-vitro diagnostica te maken hebben. Tijdens onze 43e sessie gaan we een dag wijden aan een selectie van de onderwerpen. Hierbij komen vertegenwoordigers van de overheden en Notified Bodies aan het woord, en wordt de impact voor fabrikanten en ziekenhuizen bekeken. Daartoe zijn panels en parallel sessies gepland.
RAQA Leadership Retreat 2026 Join the RAPS Switzerland Chapter RAQA Leadership Retreat 2026 in the Swiss Alps for two days of expert-led discussions, peer exchange, and practical insights designed for today's RA/QA professionals. 2000CHF, 1800CHF for early birds until end of July 2026
With dedicated programme streams for human medicines (pharmaceuticals), medical devices, IVDs and veterinary medicines, the Symposium is the must-attend event in the regulatory affairs calendar.
Join the TEAM-PRRC Annual Summit 2026 in Prague, the key European event dedicated to PRRCs (Persons Responsible for Regulatory Compliance) and regulatory affairs professionals in the medical device sector.
The ABHI UK HealthTech Conference returns in 2026, bringing together leaders from industry, government, the NHS, and regulation for two days of essential updates, market intelligence, and networking.
This three-day introductory workshop provides a practical foundation for understanding the regulatory landscape governing combination products in the US, European Union, and key global markets.