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Development of Combination Products: Critical Interactions

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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Details

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

Programme

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

Customise

Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 5-6 May 2022
  • 7-8 Nov 2022

Book now

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Previous customers include...

  • AstraZeneca
  • Bespak Europe Ltd, Recipharm
  • Blue Reg Pharma Consult
  • Camurus AB
  • CHIESI FARMACEUTICI S P A
  • Cilatus
  • CROMA PHARMA
  • Elcam Medical ACA Ltd.
  • Foundation for Biomedical Research and Innovation
  • Galderma
  • Grifols, S.A
  • Guerbet
  • Instituto Grifols SA
  • Johnson&Johnson
  • McNeil AB
  • medac GmbH
  • Orion Corporation
  • Taro
  • TEVA
  • Teva Pharmaceuticals Ireland
  • Venn Life Sciences ED B.V.
  • Zealand Pharma A/S

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 20

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, Nov 20

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, May 19

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, Nov 18