Drug-Device Combination Products DRUG DEVICE on October 20-21, 2026 in Basel, Switzerland

**Drug-Device Combination Products 2026: Regulatory Strategy, Design Controls, and Global Approval Masterclass**

The pharmaceutical and medical device industries are rapidly evolving, driven by innovation in drug delivery systems, smart medical devices, biologics, digital health technologies, and advanced combination products. Successfully developing and commercializing drug-device combination products requires a comprehensive understanding of global regulatory requirements, design controls, quality management systems, risk management, and post-market compliance.

The **Drug-Device Combination Products 2026 Masterclass** is a premier advanced-level training program designed for professionals involved in regulatory affairs, quality assurance, medical device engineering, pharmaceutical development, manufacturing, and healthcare compliance. This intensive two-day event provides practical guidance on navigating FDA regulations, EU MDR Article 117 requirements, global regulatory approval pathways, and combination product lifecycle management.

Participants will gain valuable insights into medical device compliance, design control implementation, human factors engineering, risk management strategies, GMP compliance, supplier management, and quality management systems. The program explores the integration of drug and device development, addressing critical challenges related to regulatory submissions, technical documentation, manufacturing controls, and post-market surveillance.

As healthcare continues to embrace AI-driven healthcare innovation, smart medical devices, digital therapeutics, and connected drug delivery technologies, regulatory expectations are becoming increasingly complex. This masterclass examines emerging trends and provides practical tools to support successful product development, regulatory strategy, and global market access.

Led by industry expert **Abha Raveau-Violette**, participants will benefit from real-world case studies, interactive workshops, and hands-on discussions covering FDA submissions, EU MDR compliance, Notified Body expectations, combination product development, pharmaceutical quality systems, and healthcare technology innovation.

Key topics include Drug-Device Combination Products, Regulatory Affairs, FDA Compliance, EU MDR Article 117, Design Controls, Human Factors Engineering, Medical Device Regulation, Quality Assurance, Risk Management, Drug Delivery Systems, Biologics Development, Medical Device Engineering, GMP Compliance, Lifecycle Management, Global Regulatory Strategy, Post-Market Surveillance, Healthcare Innovation, Pharmaceutical Manufacturing, and Quality Management Systems.

Join leading professionals from pharmaceutical, biotechnology, and medical device organizations to learn best practices, avoid costly regulatory delays, strengthen compliance strategies, and accelerate successful global product approvals.