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.
Objectives
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 (GMP) and the world of the Medical Devices Regulations (MDR).
In the USA there are own GMP regulations for Combination Products (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.
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.
Regulatory Requirements regarding Medical Devices in the USA
CE Certification
Standards
MedDev Document for Borderline Products
21 CFR 800 ff
Guide to Inspections of/ Guidances for Industry
Classification EU vs USA
Marketing Authorisation in the USA
Notified Bodies
Regulatory Supervision
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/Application of Usability Engineering to Medical Devices EN 62366-1
Usability Norm EN 62366
Crossmatrix EU/USA
Comparision of EU/FDA Requirements
Q & A sessions
Three Q &A sessions (two on day 1 and one on day 2) ensure interaction and that your questions are answered.
Further Information
Technical Requirements Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT) ECA Members EUR 1,890 APIC Members EUR 1,990 Non-ECA Members EUR 2,090 EU GMP Inspectorates EUR 1,045 The conference fee is payable in advance upon receipt of invoice.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
You cannot attend the Live Event? Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
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