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 seminar will clarify the EU and US approach to drug/device and device/drug combination products, address the requirements for the device technical le/ design le and explain the biological and synthetic drug regulations and the registration procedure for these products.
The programme will also cover the regulatory strategy to adopt and the relevant aspects of GMP and quality processes, including the data expectations for the Common Technical Document. Delegates will nd 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 eld.
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 regulations
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.
Andrew 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, where 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 had 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 has over 30 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.