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"
7-8 Nov 2022
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:
In 2003 David established PharmaDelivery Solutions Ltd as a specialised consultancy service in the field of drug delivery combination products (especially respiratory) device technology. This has led to involvement in projects with focus in pulmonary, nasal and other delivery routes, with an international client base. Much of the activity of PharmaDelivery Solutions Ltd is focused in the area of development programme support, regulatory GAP analysis and generation of documentation supporting development and test programmes, together with data review and contingency evaluation.
David has over 35 years experience in the development, industrialization and approval of inhalation drug delivery systems, combination products and medical devices.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
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
* 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 expert Aleksandra Beer 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: