Combination products: From CMC and quality data to a submission-ready regulatory dossier - Practical preparation of compliant, sound documentation for

- Key guidelines and requirements (Focus: EU) - Marketing authorisation process for medicinal products - Conformity assessment of medical devices - Documentation strategy using quality related data as an example - Regulatory strategyand common pitfalls/solutions - Case studies/practical workshopThe EU regulatory landscape for drug-device combination products is highly demanding. This seminar walks you through the regulatory landscape, from MDR, EU GMP, and ICH guidelines to marketing authorisation and conformity assessment, equipping you with practical strategies for building compliant, submission-ready dossiers.LernzieleDrug-device combination products sit at the intersection of two highly complex regulatory worlds. Knowing how to navigate and combine the very different regulatory requirements for medicinal products and medical devices is becoming increasingly critical.In this seminar, you will gain a practice-oriented understanding of the EU regulatory landscape, from key guidelines and marketing authorisation to conformity assessment and documentation strategy.Through real-world case studies, you will learn how to structure compliant, submission-ready dossiers and confidently manage common pitfalls in your day-to-day work.ZielgruppenThis seminar is designed for regulatory affairs and quality professionals working in the pharmaceutical, medical device, or combination product industry, particularly those involved in marketing authorisation, conformity assessment, or CMC documentation.It is equally valuable for product managers, project leads, and legal/compliance specialists who need a solid understanding of the regulatory frameworks governing drug-device combination products in the EU and beyond.