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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"

25-26 June 2024
+ 3-4 October 2024 »

from £1099

Need help?  Enrol or reserve

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

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

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


  • 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

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Andrew Willis
San Salvatore Training Ltd

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

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

25-26 June 2024

Live online

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

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

Until 21 May

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Not ready to book yet?

for 7 days, no obligation

3-4 October 2024

Live online

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 13949

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

Until 29 Aug

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; and apply only when booking multiple delegates on the same date.

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
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
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
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.

Chen Rozilyo
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

Rina Joshi
Associate Director Regulatory Affairs, TEVA


  • Alexion
  • BlueReg
  • DBV Technologies
  • Guerbet

United Kingdom

  • AstraZeneca
  • AstraZeneca (Macclesfield)
  • Bespak Europe Ltd, Recipharm
  • Chiesi Farmaceutici SpA
  • TEVA


  • Camurus AB
  • Johnson&Johnson
  • McNeil AB
  • Orexo AB


  • Octapharma AG
  • Octapharma Pharmazeutika


  • Alfred E. Tiefenbacher
  • Bayer AG
  • Medac GmbH


  • Cilatus
  • Endo Pharmaceuticals
  • Teva Pharmaceuticals Ireland


  • Chiesi Farmaceutici
  • Chiesi Farmaceutici S.p.A.
  • Chiesi Farmaceutici SpA


  • DADA Consultancy B.V
  • Sever Pharma Solutions
  • Venn Life Sciences ED B.V.


  • Grifols S.A
  • Grifols S.A.
  • Laboratorios Grifols


  • Ardena Gent
  • PhaRA+


  • NovoNordisk A/S
  • Zealand Pharma A/S


  • Elcam Medical ACA Ltd.
  • Taro


  • Galderma
  • Idorsia Pharmaceuticals Ltd


  • Janssen-Cilag Farmacêutica Ltda


  • Pliva Croatia Ltd.


  • Orion Corporation

Korea, Republic Of

  • AJOU University


  • argenx

Enrol or reserve

Run Development of Combination Products: Critical Interactions Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online


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:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749