uncertainty, design-control gaps, supplier documentation weaknesses and incomplete devic(BASEL, Switzerland – June 19, 2026) Regulatory divergence, EU MDR Article 117 e evidence continue to expose drug-device combination products to submission delays and lifecycle risk. As FDA OCP interactions, PMOA-based pathway selection, Notified Body Opinion expectations, 21 CFR Part 4 and FDA QMSR alignment with ISO 13485 reshape planning, sponsors must connect regulatory submissions with design controls, risk management, human factors and usability engineering.
Fleming will hold the advanced-level masterclass “Drug-Device Combination Products – Practical Strategies for Design Controls, Regulatory Submissions and Global Approval” on 20 & 21 October 2026 in Basel, Switzerland, now also available via online live stream. The two-day programme addresses classification strategy, US and EU pathways, device constituent integration, container closure and delivery performance, manufacturing and assembly strategy, supplier controls, critical documentation and technical evidence.
The course is led by Abha Raveau-Violette, founder of CPMD Consulting Ltd, a regulatory, quality and technical expert with more than 17 years of experience in drug-device combination products across pharmaceutical and medical device environments. Her background includes senior roles at AstraZeneca, Sandoz and Teva, supporting development from early design through global approval and lifecycle management.
Case studies and workshops examine control strategy, process validation, tech transfer, CPV, bridging approaches, post-approval changes, lifecycle management, post-market surveillance, complaint handling, CAPA and global rollout considerations for regulatory affairs, quality, CMC, device development, manufacturing, human factors, usability, risk management and programme teams.
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Contact Karthik Naik
E: [email protected]
T: +421 257 272 100
W: fleming.events