Development of Combination Products: Critical Interactions Training Course to Address Regulatory, GMP, and CTD Requirements
ResearchAndMarkets.com has announced the addition of the “Development of Combination Products: Critical Interactions Training Course”, scheduled to take place on February 9–10, 2026, to its global training portfolio.
The two-day interactive seminar is designed to address the increasingly complex challenges surrounding the development and regulation of combination products—medical innovations that blend drugs and devices into a single therapeutic solution. With the growing integration of drug/device and device/drug products in healthcare, this course aims to provide professionals with a clear understanding of the regulatory, quality, and technical requirements across both the European Union (EU) and the United States (US).
Growing Importance of Combination Products
Combination products, which merge the functionalities of pharmaceuticals and medical devices, have become a cornerstone of innovation in the global medical industry. From drug-eluting stents to prefilled injectors and inhalation systems, these products address pressing clinical needs while offering patient-friendly treatment solutions.
However, with innovation comes complexity. The development and manufacture of such products raise a unique set of challenges, as companies must simultaneously navigate drug regulations, medical device requirements, and the interplay between them. Both the EU and US regulatory landscapes have distinct procedures, and understanding how to align with them is crucial for market success.
This training course seeks to demystify the overlapping regulatory pathways, clarify definitions, and highlight practical considerations to ensure compliance, safety, and quality.
Key Learning Outcomes
The program provides a comprehensive overview of combination product requirements, ensuring participants leave with practical knowledge that can be applied to ongoing and future projects. Attendees will gain:
- A clear understanding of EU and US definitions for drug/device and device/drug products.
- Insights into the device technical file and design file, including structural requirements, testing protocols, and clinical considerations.
- Knowledge of how to comply with biological and synthetic drug regulations.
- Familiarity with the registration procedures for both devices and medicines in the EU and the US.
- Guidance on data requirements for the Common Technical Document (CTD).
- Strategies to build a tailored regulatory approach depending on product classification and intended use.
- Practical advice on the application of ISO standards and GMP compliance.
By combining expert instruction with interactive workshops, the course will help participants not only understand the regulatory framework but also apply it effectively in real-world development scenarios.
Certification and Professional Development
Participants completing the training will receive Continuing Professional Development (CPD) accreditation, equivalent to 12 hours, along with a certificate of completion. This certification adds value for regulatory, quality, and development professionals seeking to advance their careers and demonstrate specialized expertise in combination product development.
Target Audience
This training course is particularly valuable for professionals across the pharmaceutical, biotechnology, and medical device industries who are directly involved in the lifecycle of combination products. Specifically, it is designed for:
- Regulatory affairs and quality assurance personnel working on combination product submissions and compliance.
- Development and R&D teams responsible for designing and validating new drug-device integrations.
- Pharmacovigilance and vigilance experts monitoring safety and reporting requirements.
- Device specialists expanding their expertise into pharmaceuticals, and vice versa.
The cross-functional nature of combination products makes collaboration between teams essential. This course will equip participants to understand not only their own role but also the broader interdependencies between quality, regulatory, R&D, and production.
Course Structure and Content
The two-day seminar covers a wide range of topics critical to the development and registration of combination products. Each day blends regulatory insights, practical workshops, and case-based discussions.
Day 1 Highlights:
- Defining Combination Products: Clear distinctions between drug/device and device/drug products under EU and US frameworks.
- EU and US Regulatory Approaches: Key differences in classification and procedures.
- Device Regulations: EU Medical Device Regulation (MDR), CE marking, and notified body interactions; US CDRH definitions, 510(k) and PMA pathways, labeling, and vigilance requirements.
- Device Technical File/Design File: Structure, required content, bench testing, and clinical documentation. Includes a hands-on workshop to build familiarity with technical documentation.
- Biological and Synthetic Drug Regulations: Covering EU and US definitions of medicinal products, labeling, pharmacovigilance expectations, and quality standards.
Day 2 Highlights:
- Registration Procedures: Comparative analysis of EU and US approaches.
- Good Manufacturing Practices (GMP) and ISO Standards: Practical application and interpretation, with examples of how they apply to combination products.
- The Common Technical Document (CTD): Where to place data, meeting expectations, applying Quality by Design (QbD) principles, and a workshop on CTD requirements.
- Regulatory Strategy Considerations: How to decide on the most appropriate pathway, manage device and product registrations, address labeling, and navigate combination-only registrations. Includes a strategic workshop on building regulatory plans.
Expert Instructor
The course will be led by Andrew Willis, an independent consultant with nearly three decades of pharmaceutical development and regulatory experience.
Willis has an extensive background in global regulatory solutions and has held senior roles in the pharmaceutical sector, including Vice President of Regulatory Affairs & Consulting Services at Catalent Pharma Solutions, one of the world’s leading contract manufacturers and distributors of pharmaceuticals.
He began his career as a chemist, working in research with Parke Davis, before moving into regulatory affairs. Over the years, he has gained in-depth experience in sterile, oral solid, inhalation, topical, and biotech pharmaceutical products. His expertise spans not only conventional medicines but also biotech innovations, including growth hormones and cancer therapies. Notably, he contributed to the development and clinical registration of the first genetically modified live bacterium used in cancer treatment.
Willis has successfully managed numerous European and US regulatory projects, guiding submissions through both clinical and marketing authorization stages. He has coordinated meetings with European and US health authorities and has overseen complex projects such as a large European Marketing Authorization Application (MAA) that required full clinical data, followed by mutual recognition across 26 European countries—a project considered highly successful in terms of regulatory outcomes and timelines.
His broad regulatory expertise, combined with practical industry knowledge, makes him well-positioned to deliver valuable insights to delegates.
