Presented by
Management Forum

Development of Combination Products: Critical Interactions

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

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

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

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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

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

22-23 Feb 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11430

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 18 Jan

  • 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

In your basket 

5-6 May 2022

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 11628

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

Until 31 Mar

In your basket 

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

In your basket 

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


The speaker was very clear and enabled participants to ask questions with a lot of patience and with clear answers.

Nov 17 2020

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

UK

  • AstraZeneca
  • AstraZeneca (Macclesfield)
  • Bespak Europe Ltd, Recipharm
  • TEVA

Sweden

  • Camurus AB
  • Johnson&Johnson
  • McNeil AB

France

  • BlueReg
  • Guerbet

Ireland

  • Cilatus
  • Teva Pharmaceuticals Ireland

Israel

  • Elcam Medical ACA Ltd.
  • Taro

Spain

  • Grifols S.A
  • Grifols S.A.

Austria

  • CROMA PHARMA

Denmark

  • Zealand Pharma A/S

Finland

  • Orion Corporation

Germany

  • Medac GmbH

Italy

  • Chiesi Farmaceutici S.p.A.

Netherlands

  • Venn Life Sciences ED B.V.

Switzerland

  • Galderma

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Multiple colleagues?
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
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy