Live Online Training: Combination Products
Im Auftrag der ECA Academy

Live Online Training: Combination Products Im Auftrag der ECA Academy

Seminar Nr. 18610

 

Kosten

ECA-Member: EUR 1290,--
Non ECA Member: EUR 1490,--
EU/GMP Inspectorates: EUR 745,--
APIC Member Discount: EUR 1390,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Harald Rentschler, mdc, medical devices certification GmbH
Dr Peer Schmidt, AbbVie GmbH & Co., Germany
Dr Andrea Weiland-Waibel, Explicat GmbH

Zielsetzung

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.

Hintergrund

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 now by an EU Medical Device Regulation (2017/745) 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.

Zielgruppe

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.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

Regulatory Requirements regarding Medicinal Products / Drugs 
  • European Directive about GMP
  • EU GMP Guide
  • Guide to Inspections of/ Guidances for Industry
  • Office of Combination Products
  • Marketing Authorisation
  • Regulatory Supervision
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
Q & A sessions
 
Three  Q &A sessions (two on day 1 and one on day 2) ensure interaction and that your questions are answered.

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