The “Development of Combination Products: Critical Interactions Training Course” has recently been added to ResearchAndMarket’s offerings. This specialized program offers valuable insights into the development and regulatory aspects of drug/device and device/drug combination products, an increasingly prominent field within the medical industry.
In today’s rapidly evolving medical landscape, the development and manufacturing of combination products bring forth complex challenges, particularly related to quality assurance and regulatory compliance. The training course aims to provide comprehensive guidance on navigating these challenges successfully, addressing the specific requirements for both European Union (EU) and U.S. approaches to handling combination products.
Key topics covered in the course include:
1. Defining Combination Products: Understanding the distinct definitions and regulatory approaches for drug/device and device/drug products in both the EU and the USA.
2. Regulatory Procedures: Exploring the regulatory procedures governing drug/device and device/drug products, including those in the EU and the U.S., with a focus on the Office of Combination Products.
3. Understanding Devices: Delving into the EU’s Medical Device Regulation, CE marking, and the U.S.’s CDRH definitions, such as 510(k) and PMA, along with vigilance requirements and labeling.
4. Device Technical File/Design File: Providing insights into the requirements, structure, bench testing, and potential clinical requirements for these crucial files.
5. Biological and Synthetic Drug Regulations: Understanding the regulations governing medicinal products, with an emphasis on labeling, pharmacovigilance, and quality requirements in the EU and the USA.
6. Registration Procedures: Covering the registration procedures for devices and medicines in both the EU and the USA.
7. GMP and ISO Standards: Practical application and interpretation of Good Manufacturing Practices (GMP) and ISO standards.
8. The Common Technical Document (CTD): Guidance on where to place data, data expectations, and the application of Quality by Design (QbD).
9. Key Considerations for Regulatory Strategy: Exploring the decision-making process for regulatory routes, device and product registrations, combination-only registrations, and desired labeling.
The course will be led by seasoned consultant Andrew Willis, who brings a wealth of expertise in global regulatory solutions and pharmaceutical development. With over 28 years of experience in the pharmaceutical industry, Mr. Willis has a diverse background that spans manufacturing, analytical roles, and regulatory affairs. He has been involved in the development and clinical registration of pioneering medical products, including genetically modified live bacteria for cancer treatment.
The “Development of Combination Products: Critical Interactions Training Course” promises to be a valuable resource for professionals in development, regulatory, and quality roles within the pharmaceutical and medical device industries. It offers a comprehensive guide to navigating the complexities of combination product development successfully, ensuring regulatory compliance, and understanding the critical interactions in this dynamic field.