Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.
★★★★★ "The speaker was very clear and enabled participants to ask questions with a lot of patience and with... more"
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:
This course is part of our GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
12-13 February 2024
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 13486
Until 08 Jan
25-26 June 2024
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 13754
Until 21 May
7-10 October 2024
13:30-16:45 UK (London) (UTC+01)
14:30-17:45 Paris (UTC+02)
08:30-11:45 New York (UTC-04)
Course code 13949
Until 02 Sep
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
I was hoping to achieve more knowledge about combination product and the regulatory documentations needed for the market authorisation and this was completely accomplished.
May 5 2022
Analytical Scientist, Chiesi Farmaceutici
Nov 17 2020
The speaker was very clear and enabled participants to ask questions with a lot of patience and with clear answers.
Regulatory Affairs Specialist, Elcam Medical ACA Ltd.
Nov 17 2020
Overall content of the webinar was very good and covered a lot of topics.. The presentation was clear and included a lot of information. I believe this course was very informative and covered a breath of information in regards to combination product and i gained a lot of useful information and knowledge.
Regulatory Affairs Specialist , Bespak Europe Ltd, Recipharm
May 9 2019
The course was very good. The presentations were clear and included a lot of material. The workshops gave an idea how to think outside the box.
Regulatory Affairs Associate-Experienced, Taro
Nov 6 2018
The speaker and content was very good. It was clear there was a lot of knowledge and the content was aimed at the right audience
Associate Director Regulatory Affairs, TEVA
Korea, Republic Of
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: