Drug-Device Combination Products 2026

Drug-Device Combination Products 2026

The Drug-Device Combination Products Masterclass 2026 is a premier advanced-level training program designed for professionals involved in pharmaceutical, biotechnology, biologics, and medical device development. Led by renowned regulatory, quality, and technical expert Abha Raveau-Violette, who brings over 17 years of industry experience from AstraZeneca, Sandoz, and Teva, this intensive two-day course provides practical strategies for navigating the complexities of drug-device combination products.

Attendees will gain valuable insights into FDA regulations, EU MDR Article 117 requirements, design controls, risk management, human factors engineering, regulatory submissions, manufacturing strategies, supplier controls, and post-market surveillance. Through expert-led presentations, interactive workshops, and real-world case studies, participants will learn how to avoid common development challenges, reduce regulatory risks, and accelerate global approvals.

The event will take place on 20–21 October 2026 in Basel, Switzerland, with both onsite and online participation options available.

Scientific Sessions

Regulatory Framework & Classification Strategy
FDA Combination Product Regulations
EU MDR Article 117 Requirements
Drug-Device Integration & Technical Development
Design Controls for Combination Products
Risk Management & Human Factors Engineering
Manufacturing & Process Development
Supplier Control & Quality Systems
Regulatory Submissions (IND, NDA, BLA, MAA)
Post-Market Surveillance & Vigilance
Lifecycle Management & Change Control
Global Regulatory Approval Strategies
Technical Documentation & Compliance
Classification & Regulatory Strategy Workshops
Combination Product Case Studies 

Important Dates
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