Dublin, May 07, 2026 (GLOBE NEWSWIRE) -- The "Development of Combination Products: Critical Interactions (Sept 16th - Sept 17th, 2026)" has been added to ResearchAndMarkets.com's offering.
The medical industry's evolving landscape has increasingly seen the amalgamation of drugs and devices, resulting in complex drug/device and device/drug combination products. These innovative solutions represent significant advancements but also pose intricate challenges in development, manufacturing, and meeting regulatory and quality standards.
This dynamic course is meticulously designed to provide an in-depth understanding of the nuanced EU and US frameworks concerning these combination products. Attendees will gain critical insights into the requirements for the device technical file/design file and receive comprehensive guidance on the biological and synthetic drug regulations. Furthermore, the course will elucidate the registration procedures essential for launching these products successfully.
A major focus of the program is on devising regulatory strategies and exploring essential aspects of Good Manufacturing Practice (GMP) and quality processes. Participants will be equipped with knowledge about the data expectations for the Common Technical Document (CTD) and will explore the pivotal relationships that intersect quality control, regulatory compliance, research and development, and production processes.
Serving as a robust platform for industry professionals, this course offers a holistic view of the standards and requirements necessary for successfully navigating the complexities of combination products. Participants will have the unique opportunity to engage with an expert in the field, ensuring a comprehensive understanding of the subject matter and the strategies to overcome related challenges.
This course is especially beneficial for professionals seeking to enhance their expertise in regulatory and quality elements of combination products, providing 12 Continuing Professional Development (CPD) hours to acknowledge the depth and breadth of learning offered.
Who should attend?
- All development, regulatory and quality personnel involved in the development of combination products (drug/device and device/drug products)
- Pharmacovigilance/vigilance personnel
- Device experts looking to expand their knowledge to medicines and vice-versa
Key Topics Covered:
- Day 1
- Defining a drug/device and device/drug product
- Regulatory procedures for drug/device and device/drug products
- Understanding devices
- Device technical file/design file
- Workshop: Technical file/design file
- Understanding the biological and synthetic drug regulations
- Day 2
- Registration procedures
- GMP and ISO standards
- The CTD
- Workshop: CTD requirements - tracking critical documents
- Key considerations for the regulatory strategy
- Workshop: regulatory strategy
Speaker
Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.
He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs.
He has over 30 years' pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.
For more information about this training visit https://www.researchandmarkets.com/r/s2u5jz
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