Professional Training
4.6 (42 Reviews)

Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products

Length
2 days
Price
1,299 GBP 1,099 GBP
Next course start
17 September, 2024 (+4 start dates)
Course delivery
Virtual Classroom
Length
2 days
Price
1,299 GBP 1,099 GBP
Next course start
17 September, 2024 (+4 start dates)
Course delivery
Virtual Classroom
Leave your details so the provider can get in touch

Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products

Understand the regulatory frameworks governing drug/device and device/drug combinations in the European Union and the USA.

The demarcation between medicinal products and devices is becoming ever more important and, with the convergence of emerging novel technologies, the number of drug/device combination products and medical devices incorporating a medicinal substance is increasing. At the same time, cell therapy and tissue-engineered products are being combined with both pharmaceuticals and medical devices. This course will address the European and FDA regulatory requirements, help you define the regulatory route for your product and offer practical guidance on Notified Body expectations, clinical trial considerations and post-market surveillance of borderline products.

Participants will have an invaluable opportunity to discuss the complex issues involved with key regulatory experts in this field.

By the end of the course participants will have the knowledge and skills needed to navigate the complex regulatory landscape for drug/device and device/drug combinations in the EU and the USA effectively. They will be equipped to ensure compliance with the regulatory requirements and facilitate the successful development and commercialisation of these innovative products. 

PRE-SEMINAR READING - It is recommended that you have read the the EU Medical Device Regulation, particularly, Article 120 and the General Safety & Performance Requirements (Annex I) and Technical Documentation (Annexes II and III). For the US, review FDA’s Office of Combination Products website prior to attending this seminar.

Upcoming start dates

Choose between 4 start dates

17 September, 2024

  • Virtual Classroom
  • Online
  • English

21 January, 2025

  • Virtual Classroom
  • Online
  • English

19 May, 2025

  • Virtual Classroom
  • Online
  • English

10 September, 2025

  • Virtual Classroom
  • Online
  • English

Suitability - Who should attend?

Benefits of attending

  • Understand the European regulatory guidance
  • Know what your competent authority expects
  • Gain an insight into notified bodies considerations on drug/device products
  • Learn how to define the approval route for your product
  • Clarify the major differences in documentation and approval routes
  • Consider quality systems requirements for combination products
  • Discover the FDAs regulatory approach to combination products
  • Hear how to deal with human tissue engineered products
  • Stay up-to-date on post market surveillance for combinations products

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Reviews by course attendees

Average rating 4.6

Based on 42 reviews.
Reviews are published according to our review policy.
Write a review!
4/5
Sandra T
07 Nov 2022

Very precise wording and explanations were given on a complex subject

5/5
Pia M
07 Nov 2022

It was a very good programme!

4/5
Ricado T
07 Nov 2022

Very good speakers, very well prepared presentations and contents adequate to the expectations.

International Professional & Industry Academy
10-12 Rivington Street
EC2A 3DU London

About IPI Academy

International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...

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