Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.
22-23 Feb 2022 + 2 more dates
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:
22-23 Feb 2022
London venue TBC
09:00-17:00 UK (London)
Course code 11430
Until 18 Jan
5-6 May 2022
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 11628
Until 31 Mar
7-8 Nov 2022
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 11754
Until 03 Oct
The speaker was very clear and enabled participants to ask questions with a lot of patience and with clear answers.
Nov 17 2020
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