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Management Forum

Development of Combination Products: Critical Interactions Training Course

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 + 3 more dates

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Format: Live online, Classroom
CPD: 12 hours for your records
Certificate of completion

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What this course is about

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:

Clarify the definitions for drug/device and device/drug combination products in the EU and USA
Consider the requirements for the device technical file/design file
Comply with the biological and synthetic drug regulations
Understand the registration procedures for devices and medicines in the EU and USA
Determine the data required for the Common Technical Document (CTD)
Consider the regulatory strategy depending on your product
Gain practical advice on how to apply the ISO standards

Who should attend

All development, regulatory and quality personnel involved in the development of combination products (drug/device and device/drug products)
Pharmacovigilance/vigilance personnel
Device experts looking to expand their knowledge to medicines and vice-versa

Enrol or reserve

The Development of Combination Products: Critical Interactions course will cover:

Defining a drug/device and device/drug product

EU approach
US approach

Regulatory procedures for drug/device and device/drug products

EU procedures
US and Office of Combination Products

Understanding devices

Medical Device Regulation – EU
CE marking and Notified Body interactions
CDRH definitions – US – 510(k) and PMA
Labelling
Vigilance requirements

Device technical file/design file

What is required
Structure
Bench testing
Potential clinical requirements

Workshop: Technical file/design file

Understanding the biological and synthetic drug regulations

EU/US definition of medicinal product
Labelling
Pharmacovigilance
Quality requirements

Registration procedures

EU approach
US approach

GMP and ISO standards

Practical application
Interpretation of the standards

The CTD

Where to put data
Data expectations
Applying QbD (quality by design)

Workshop: CTD requirements – tracking critical documents

Key considerations for the regulatory strategy

Deciding which regulatory route to take
Device and product registrations
Combination-only registrations
Desired labelling

Workshop: regulatory strategy

Enrol or reserve

Andrew Willis

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.

More details

Book Development of Combination Products: Critical Interactions Live online/Classroom training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

7-8 Nov 2022

Live online

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

GBP 1,099 1,299
EUR 1,579 1,859
USD 1,786 2,098

Until 03 Oct

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

20-21 Feb 2023

Live online

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 12141

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 16 Jan

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

27-28 Jun 2023

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 12384

GBP 1,299 1,499
EUR 1,869 2,149
USD 2,137 2,449

Until 23 May

2 days classroom-based training
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

9-12 Oct 2023

Live online

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 12403

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 04 Sep

4 sessions of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* 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.

Reviews of IPI's Development of Combination Products: Critical Interactions training course

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

Greta Ferrari Italy
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.

Yaniv Menachem Israel
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.

Rebekah Coke United Kingdom
Regulatory Affairs Specialist , Bespak Europe Ltd, Recipharm