GMP Webinar: The new Medical Device Regulation and its influence on Combination Products

GMP Webinar: The new Medical Device Regulation and its influence on Combination Products

Course No 17206


Costs

: EUR 199,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Peer Schmidt, AbbVie Deutschland GmbH & Co. KG

Peer Schmidt brings more than 15 years of experience in the development, manufacturing, registration and supervision of Medicinal Products, Medical Devices and Combination Products. As Senior Manager Global Quality Systems, he leads the AbbVie Center of Excellence for Quality Risk Management. He also acts as EU Authorized Representative and Management Representative for AbbVie´s Medical Devices. He holds a PhD in Molecular Biology and was previously the Head of Quality Assurance at Abbott Biotechnology Germany.

Background

In the EU, Medical Devices are regulated by two EU Directives (90/385/EEC, 93/42/ EEC) whereas in-vitro diagnostics are regulated by an independent directive. This will change in the near future. With the publication of the new Medical Devices Regulation (MDR) in the Official Journal of the European Union, a transition period has started which will end in May 2020. The MDR will supersede the two directives regarding the active implantable Medical Devices (AiMDD) and all other Medical Devices (MDD). The changes concern all classes of Medical Devices and will lead to distinct, detailed and extensive requirements. They will also apply to the Medical Device elements of Combination Products.

  • What do manufacturers of Medical Devices/Combination Products have to expect in the near future?
  • What are the crucial changes?
  • What has to be considered for implementation?
  • What should be done already now?
These questions will be clarified during the webinar.

Target Group

This training is intended for employees of enterprises who want to be informed about the requirements of the Medical Devices Regulation, especially manufacturers of Medical Devices. It also applies to drug manufacturers utilizing medical devices to administer their products (Combination Products) .

Technische Vraussetzungen

Wir nutzen für unsere Webinare Cisco WebEx, einen der führenden Anbieter für Online-Meetings.

Unter http://www.webex.de/test-meeting.html können Sie überprüfen, ob Ihr System die nötigen Anforderungen zur Teilnahme an WebEx- Meetings erfüllt sowie sich das erforderliche PlugIn gleich installieren lassen. Für den Test geben Sie bitte einfach Ihren Namen und Ihre eMail Adresse an. Falls die Installation aufgrund Ihrer Rechte im EDV System nicht möglich ist, kontaktieren Sie bitte Ihre IT Abteilung. WebEx ist heute ein Standard und die notwendigen Einrichtungen sind schnell und einfach zu machen.

Die detaillierten Systemanforderungen finden Sie in diesem Dokument.

Programme

The following issues around the new Medical Device Regulation will be addressed:

  • Background of the changes in medical device regulation
  • Transition periods
  • Changes in product classification
  • Conformity assessment of Combination Products according to MDR
  • New requirements regarding technical documentation
  • Identification of products by means of UDI: What is UDI, Differences/Similarities to US requirements
  • The person responsible for regulatory compliance („QP for Medical Devices“)
  • Requirement profile
  • Interim solutions
  • Medical Devices Coordination Group (MDCG)
  • Scrutiny procedure for specific Medical Devices
  • Clinical evaluation / studies
  • Supervision by competent authorities
  • EUDAMED data base
  • What to consider when getting ready for the new regulations?
  • Compatibility of the MDR, Quality System for Medical Devices (21 CFR 820) and GMP for Combination Products (21 CFR 4)

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