4 – 6 November 2026
TRAINING TIMES
Learn how to navigate regulatory expectations for drug-device combinations
Get clarity on how to integrate risk analysis, and GSPR requirements into your product development
Learn to create a clear strategy that aligns clinical, regulatory, and quality components
Learn how to anticipate regulatory expectations early and structure your submission to prevent setbacks during review.
Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
Learn how to navigate both drug and device regulations, including FDA, EMA, and Notified Body pathways
Discover how to justify design choices, risk strategies, and documentation that hold up under scrutiny
Develop an integrated plan covering clinical, quality, and design control elements to support product approval
Spot potential compliance issues early and learn how to prevent delays during review and approval
Designed for professionals who want to enhance their expertise and advance their careers
Health Sciences and Medical Devices Consultant
James Pink has over 25 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assuranceprograms for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.
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Take a sneak peek at the trainer's presentation.
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“James demonstrated deep subject-matter expertise and presented complex regulatory concepts in a clear and structured manner. The course was well-paced, with a good balance between theoretical content and practical insights. Thank you!”Halina Thivolle
“Fantastic training with a good overview on key regulatory topics. I loved the live interactions and the focus on real case scenario situations from the audience.”Alessandro Fammartino
“It has been a well-structured training, with clear and well-explained concepts. I can't say anything negative or anything to improve.”Lorena