The aim of the course is to identify similarities and differences between FDA´s and European regulations for Combination Products.
During the course, speakers will cover the various regulatory requirements for Medicinal Products/ Drugs and Medical Devices and present their similarities and differences. How to launch a Combination Product on the market will also be part of the presentations. Moreover, Case Studies about approval procedures of combination products will give practical orientation. It is also important to know which QM system fits the US and the EU requirements and what their similarities are. Also this topic will be discussed.
A Notified Bodies representative will explain the EU certification procedure for Medical Devices.
3 parallel workshops – concentrating on approval processes of Combination Products in the EU and the US and examples of Notified Body requirements on Combination Products will provide practical orientation.
Background
Combinations of Medicinal Products/Drugs, Medical Devices and/or Biologics are becoming more and more important for the market, e. g. for the delivery of a medication. Such “Combination Products” meet two worlds: the pharmaceutical regulation world and the world of the Medical Devices Regulations.
In the EU the GMP requirements for Medicinal Products are laid down in the GMP Guideline based on an EC regulation. The medical devices industry is regulated by three EU directives (90/385/EWG, 93/42/EWG and 98/79/EG) and one amending directive. The Medical Device Regulation will change this in 2020. The distribution of Medical Devices in Europe is based on a CE Certification. Medical Devices Inspections are primarily performed by Notified Bodies.
The basis for the approval process of Medicinal Products /Drugs is for both the EU and the USA the ICH Common Technical Document (CTD). Inspections are performed by authorities. In the USA, there are special approval processes for Medical Devices.
The US-FDA has developed own GMP regulations for Drugs (21 CFR 210/211) , Medical Devices (21 CFR 820), Biologics (21 CFR 600 – 680) and tissue-based products (21 CFR 1271) So far, there had been no standalone GMP regulations for combination products. This has changed only at the FDA since 22 July 2013 with the publication of FDA’s 21 CFR Part 4 (cGMP Requirements for Combination Products). An Office of Combination Products is responsible for this products in the USA. Until now, there is nothing comparable to 21 CFR 4 regarding Combination Products in the EU.
Target Group
This event has been especially designed for the manufacturers who are subject to Combination Products and want to become familiar with the practice-oriented implementation of the legal requirements in the USA and in Europe.
Date & Venue
Date Tuesday, 11 February 2025, 09.00 - 18.15 h (Registration and coffee 08.30 - 09.00 h) Wednesday, 12 February 2025, 08.30 - 15.30 h
Regulatory Requirements regarding Medical Devices in the USA
21 CFR 800ff
Guide to Inspections of/ Guidances for Industry
Classification EU vs USA
Marketing Authorisation in the USA
Classification of Medical Devices in the USA
How to classify Medical Devices in the USA
Examples
How to launch a Combination Product on the market?
“Combination product”- 21CFR 3.2 e in the US versus “combination products” in the EU
What do medical device companies need to know about medicinal products?
What does the pharmaceutical industry need to know about medical devices
The importance of the primary mode of action (US) and the intended use (Europe)
QM System for Combination Products
Quality Management System for Drugs
Quality Management System for Medical Devices
Similarities and differences
Qualifying of Suppliers
Quality Management System for the combination of Medicinal Products with a Medical Device
Workshop on Primary Packaging Material vs. Medical Devices
Case Studies: Approval Process for Combination Products in the EU
Case Study for a single entity “combination” product – a medical device containing a drug substance having an ancillary action
Case Study for an investigational medicinal product to be combined with a CE marked medical device (nebulizer)
Case Study – drug eluting stents – requirements regarding the in vitro- in vivo correlation of the sustained release drug substance in carrier
Human Factor Studies
Usability Norm EN 62399
Crossmatrix EU/USA
Comparision of EU/FDA Requirements
3 Parallel Workshops
Application of Quality Risk Management to Combination Products You discuss in the workshop risk management aspects regarding the medicinal product and medical device.
Approval of Combination Products in the EU The workshop is intended to lay down the basis for a strategy for a „combination product“ taking into account the fact, that in the EU the regulatory frames of medical devices, medical devices containing a drug substance having an ancillary action and medicinal products and the respective quality management systems have to be taken into consideration.
Two cases will be studied:
A medicinal product having a marketing authorization shall be combined with a medical device in development. How can this be accomplished? What needs to be done, where are possible pitfalls?
A medical device marked with a CE shall be combined with a medicinal product that is authorized for marketing. What needs to be done, where are possible pitfalls?
Notified Body requirements on Combination Products
The workshop is intended to assess examples of Notified Body audit findings and how to react.
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
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Seminar Programme as PDF