Drug-Device Combination Products

The Drug-Device Combination Products Masterclass is an advanced two-day training program designed for professionals involved in the development, regulation, quality, manufacturing, and lifecycle management of combination products. This intensive course provides practical guidance on navigating global regulatory requirements, including FDA regulations, EU MDR Article 117, and international approval pathways. Participants will explore key topics such as classification strategy, design controls,

The Drug-Device Combination Products Masterclass 2026 is an advanced training program designed for professionals involved in drug-device combination product development, regulatory affairs, quality assurance, medical device compliance, and pharmaceutical innovation. Taking place in Basel, Switzerland, this intensive two-day masterclass provides a comprehensive understanding of the global regulatory landscape governing combination products and equips participants with practical strategies for successful product development and market approval.

Participants will gain in-depth knowledge of FDA regulations, EU MDR Article 117 requirements, design controls, risk management, human factors engineering, manufacturing processes, supplier controls, and regulatory submission strategies. The program explores critical topics such as product classification, primary mode of action determination, technical integration of drug and device components, quality management systems, process validation, and lifecycle management.

Through expert-led presentations, real-world case studies, interactive discussions, and practical workshops, attendees will learn how to avoid common regulatory and development challenges that can delay approvals or increase project costs. The course also covers IND, NDA, BLA, and MAA submissions, post-market surveillance requirements, CAPA management, complaint handling, global rollout strategies, and change management throughout the product lifecycle.

This masterclass is ideal for professionals working in pharmaceuticals, biotechnology, biologics, medical devices, regulatory affairs, quality assurance, quality control, CMC, manufacturing, process development, risk management, and project management. Attendees will leave with actionable tools, industry best practices, and practical knowledge to support successful development, regulatory approval, commercialization, and lifecycle management of drug-device combination products in global markets.

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