What this course is about
Drug/device and device/drug combination products are becoming increasingly important in the medical industry. The development of these products raises a number of complex issues regarding the development process and their manufacture. The quality and regulatory aspects to consider are also challenging. This seminar will clarify the EU and US approach to drug/device and device/drug combination products. It will discuss the requirements for the Device Technical File/Design File and will explain the Biological and Synthetic Drug Regulation and the registration procedure for these products.
The programme will also cover the regulatory strategy to adopt for these products and the key aspects of GMP and quality processes applicable for drug/device and device/drug products, including the data expectations for the Common Technical Document.
Delegates will find this a comprehensive overview of the requirements for these drug/device and device/drug combination 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 Regulation and its requirements
- Understand the registration procedures for devices and medicines in the EU and USA
- Determine the data required for the Common Technical Document
- Consider the regulatory strategy depending on your product
n Gain practical advice on how to apply the ISO standards
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
Programme - Day one
Defining a drug/device and device/drug product
- Medical Device Regulation – EU
- CE marking and Notified Body interactions
- CDRH definitions – US – 510K and PMA
- Vigilance requirements
Regulatory procedures for drug/device and device/drug products
- EU procedures
- US and Office of Combination Products
Device Technical File/ Design File
- What is required
- Bench testing
- Potential clinical requirements
Workshop: Technical File/ Design File
Understanding the biological and synthetic drug regulation
- EU/US definition of medicinal product
- Quality requirements
Programme - Day two
- Devices EU/US
- Medicines EU/US
GMP and ISO standards
- Practical application
- Interpretation of the standards
Common Technical Document (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
An independent consultant with 32 years of experience with regulatory affairs and pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in co-ordinating, planning and running global development projects.
His experience is wide ranging, allowing fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management.
Since acting as an independent consultant his roles have included:
- Interim Strategic advice to major pharmaceutical company for roll-out and compliance strategies for Russia / CIS, MENA, ASEAN, LATAM, South Africa and Switzerland, including ensuring appropriate staff development and strategies which ensure protection of intellectual property whilst maintain patient focus.
- Orphan drug registrations of vaccine products and synthetic molecules
- NCE approved in US and Europe for urology product (Simultaneous NDA and EU Centralised submission)
- Support for NBE during clinical phases and CMC support for a Biosimilar, Biosimilar / Biologic CMC reviewer for major pharma. Biosimilar experience includes working on first EU biosimilar onwards.
- Oversight of Regulatory strategy for ATMP (Cancer vaccine) and CMC lead for Stem Cell treatment
- Training to major pharmaceutical companies for Chemistry and Pharmacy section of the dossier and Life Cycle Management. Additional lead training / presentations on Life Cycle Management for TOPRA.
Furthermore, his responsibilities have provided senior management oversight and direction in the following key areas: -
- Strategic management of ATMP products for Biotech start-up company
- Strategic Biosimilar team, developing a global biotech and biosimilar strategy for key biosimilar products.
- Global Quality Leadership Team, providing oversight and direction for global quality processes.
- Innovation Team, providing oversight and direction for the innovation.
Additional experiences reflect raising funds for new start-up companies and associated due diligence activities. Also he has substantial awareness of management of P & L performance, growth initiatives related to service expansion, geographical expansion and innovative business development approaches.