Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
9-10 May 2019
& 19-20 Nov 2019
GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 15 Mar
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:
Defining a drug/device and device/drug product
Regulatory procedures for drug/device and device/drug products
Device Technical File/ Design File
Workshop: Technical File/ Design File
Understanding the biological and synthetic drug regulation
GMP and ISO standards
Common Technical Document (CTD)
Workshop: CTD requirements – tracking critical documents
Key considerations for the regulatory strategy
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:
Furthermore, his responsibilities have provided senior management oversight and direction in the following key areas: -
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.