Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
19-20 Nov 2019
& 12-13 May 2020 , 17-18 Nov 2020
GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 4 Oct
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.
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.
|19-20 Nov 2019|
|19-20 Nov 2019||Cavendish Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
Until 4 Oct*
|12-13 May 2020|
|12-13 May 2020||Venue not yet confirmed||
+ VAT @ 20.00%
|17-18 Nov 2020|
|17-18 Nov 2020||Venue not yet confirmed||
+ VAT @ 20.00%
|Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.|
* Note the early booking discount cannot be combined with any other offers or promotional code