Drug/device and device/drug combination products are becoming increasingly important in the medical industry. The development and manufacture of these products raises a number of complex issues and the quality and regulatory aspects are challenging. This interactive seminar will clarify the EU and US approach to drug/device and device/drug combination products, address the requirements for the device technical file/design file, explain the biological and synthetic drug regulations and look at the registration procedures for these products.
The programme will cover the regulatory strategy to adopt and the relevant aspects of GMP and quality processes, including the data expectations for the CTD. It will also review the key relationships between quality, regulatory, R&D and production. Delegates will find this a comprehensive overview of the requirements for these products and will have an opportunity to discuss the complexities with an expert in this field.
Benefits of attending:
- Clarify the definitions for drug/device and device/drug combination products in the EU and USA
- Consider the requirements for the device technical file/design file
- Comply with the biological and synthetic drug regulations
- Understand the registration procedures for devices and medicines in the EU and USA
- Determine the data required for the Common Technical Document (CTD)
- Consider the regulatory strategy depending on your product
- Gain practical advice on how to apply the ISO standards
Certification:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
Defining a drug/device and device/drug product
- EU approach
- US approach
Regulatory procedures for drug/device and device/drug products
- EU procedures
- US and Office of Combination Products
Understanding devices
- Medical Device Regulation - EU
- CE marking and Notified Body interactions
- CDRH definitions - US - 510(k) and PMA
- Labelling
- Vigilance requirements
Device technical file/design file
- What is required
- Structure
- Bench testing
- Potential clinical requirements
Workshop: Technical file/design file
Understanding the biological and synthetic drug regulations
- EU/US definition of medicinal product
- Labelling
- Pharmacovigilance
- Quality requirements
Registration procedures
- EU approach
- US approach
GMP and ISO standards
- Practical application
- Interpretation of the standards
The CTD
- Where to put data
- Data expectations
- Applying QbD (quality by design)
Workshop: CTD requirements - tracking critical documents
Key considerations for the regulatory strategy
- Deciding which regulatory route to take
- Device and product registrations
- Combination-only registrations
- Desired labelling
Workshop: regulatory strategy
Speakers
Mr Andrew Willis,
Consultant ,
IndependentAndrew 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. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and 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 has 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 currently has a total of 28 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. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.
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
