Regulatory Affairs for Drug/Device Combination Products

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Course Overview

 

Drug/device combination products pose regulatory difficulties as the requirements of devices must merge with pharmaceuticals. Device companies are increasingly adding medicinal substances to improve products. Similarly, as the number of biotech and advanced therapeutics grows, so too does the need for specialised device delivery systems.

 

This drug/device combination training course provides you with the skills and knowledge to navigate both the pharmaceutical and device regulations. Importantly, you will learn how to merge the two regulatory systems in areas such as risk management and quality. Delivered by experts in both device and pharmaceutical regulations you will gain practical insights into developing a successful combination product strategy.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives

  • Examine the key differences in regulations between device and medicinal products
  • Review the regulatory landscape in the EU and US for drug/device combination products to ensure speedy market access
  • Understand specific design and development challenges for drug/device combination products to reduce delays
  • Analyse the clinical requirements for both devices and medicinal products to ensure you are aware of the overall combination landscape
  • Learn about the regulatory and quality framework for pharmaceutical products
  • Discover best practice to manage the two regulatory systems in unison to ensure compliance fast approvals
Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Module 1

Overview of the regulatory landscape for combination products

  • Review the definition of a combination product
  • Medicine-device borderline and classification
  • Examine the major differences in regulatory affairs between medicines and devices
  • Review the regulatory pathway for combination products in the EU and US
Module 2

Device regulations in the EU and US

  • Overview of the current regulatory framework for medical devices in the EU
    • Roles of Competent Authorities (CA) and Notified Bodies (NB)
    • Impact of the Medical Device Regulation (MDR) on combination products
  • Examine the regulatory framework for devices in the US
    • Review 21 CFR Part 3 and Part 4
    • Office of Combination Products (OCP)
    • RFDs (requests for designation) and Pre-RFDs (pre-requests for designation)
Module 3

Risk management and labelling

Examine risk management:

  • Overview of Standard ISO 14971
  • Risk management for a combination product

Review labelling:

  • Brief overview of labelling requirements
  • Labelling for combination products
Module 4

Design and development challenges

  • Expectations when designing and developing a medical device
  • Development consideration for a combination product
  • Perspectives by constituent part
  • Human factors
Module 5

Clinical and post market obligations

  • Clinical evaluation for devices
  • Clinical requirements for medicinal products
  • PMS requirements for medical devices
  • Pharmacovigilance requirements for medicinal products
Module 6

Regulatory affairs for pharmaceuticals

  • Overview of the regulations
  • Pharmaceutical quality management

Merging the two regulatory systems

  • Examine best practice to merge both regulatory systems together
  • Examine how to merge both quality systems

 

Richard Young has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to combination products. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

 

Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.

 

Richard has delivered both online and classroom training courses on drug/device combination products. He has supported many professionals with their understanding of the regulatory framework in both the US and EU. Drawing on his extensive industry experience, Richard provides examples and case studies during the training.

This course is suitable for professionals who work with drug/device combination products. It is ideal for pharmaceutical professionals who are combining a device with their medicinal product. Likewise, it is suitable for device professionals who are looking to add a medicinal element to their product.

 

These include medical device and pharmaceutical professionals in the following roles: Regulatory Affairs | Quality | Design & Development | Clinical | Management.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.