Flexible date

A 2-day practical & interactive training:

Combination products

A course to be offered in-house to pharmaceutical and medical device companies wanting to gain some insight into how to register combination products. It will give attendees a complete practical understanding of the regulatory framework of combination products in the EU and US.
Combination products
The CPD Certification Service
Continuing Professional Development (CPD) combines different methodologies to learning, such as training workshops, conferences and events, e-learning programs, best practice techniques and ideas sharing, all focused for an individual to improve and have effective professional development.
For more information visit the CPD website


  • Topics covered include variations, pharmacovigilance/vigilance,
    packaging and labelling requirements, format and content of the CTD/STED
  • Attendees will gain insight into the complex regulatory environment involving combination products
  • Suitable for both pharmaceutical/Biotech and/or medical device manufacturers


9am - 5pm

Overview of regulatory affairs for Combination Products EU/US

This module sets the context for the Regulation of Combinations in the US.
  • Introduction to Combination Products EU/US
  • Overview EU Medical Devices
    • Classification and Intended use
    • CE marking and duties of the manufacturer
  • Overview Medical Devices US
    • Device classification and Regulations US
    • DOverview of Device Regulations US
    • D510K/PMA
  • Combination Products EU, Comparison with US
    • Medical Device Regulations EU, Review key concepts and definitions
    • Brief comparison of definition of Combination Products US vs EU
    • Define/classify Horizon Products per EU (compared to US)
    • Design control, change management, design verification – EU
    • Quality oversight – EU
    • Supply Chain
    • Batch release
    • Post-approval changes
  • Device Development and Quality Issues
    • Examining the Design Control Process, Change Management, Design Verification
    • Human Factor Validation (IND and NDA)
    • Impact of the Development pathway on Regulatory Filings
    • Quality management system for the combination of medicinal product with a medical device
    • Identify key requirements for quality and manufacturing activities oversight and control in the US and the EU
  • CASE STUDY - 1
  • Clarifying the Labelling Requirements of Combination Products
    • Examining the Labelling requirements for Combination products
    • Identifying each of the Labelling Requirements
  • Purchasing Control and Batch release for Combination products
    • Purchasing control/design control and change management
    • Batch release US
    • Vendor management – who releases what/control of entire combination
    • Case specific Horizon products, related to FDA questions
  • CASE STUDY - 2
9am - 5pm

Post Approval Issues for Combination Products

This module focuses on EU, post approval changes and documentation.
  • Dealing with Post-approval Changes of Combination Products
    • Gaining a clearer understanding of when Variations should be submitted
    • Clarifying the Variability of the Requirements for different Product Types
    • Timelines and fees (in brief)
    • Streamlining the variation approval process (in brief)
  • Updating documentation CTD/STED for Combination Product Submissions
    • Case where there are CE marked devices
    • Case where devices are not CE marked
    • Case where the Combination is a Drug – CTD requirements
    • Case where the Combination is a Device – STED requirements
  • EU Medical device Regulation and effect on Combination Products
    • General update to the regulation
    • Main changes
    • Timelines (in brief)
    • Case scenarios specific to Horizon combination products
  • CASE STUDY - 3
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