a new academic program for medical device …...nov 05, 2017 · 2 11.05.2017 third who global...
TRANSCRIPT
www.fh-luebeck.de
A NEW ACADEMIC PROGRAM FOR MEDICAL DEVICE REGULATORY AFFAIRS PROFESSIONALS
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Folker Spitzenberger, Heike Wachenhausen, Stephan Klein University of Applied Sciences Lübeck Lübeck, Germany
3rd WHO Global Medices Devices Forum May 10th – 12th,2017 Geneva, Switzerland
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There is a Worldwide Need for Professional Competencies in the Medical Device Regulatory Field as Integral Part of the International Health Workforce.
Effective Regulatory Systems for Medical Products are Considered an Essential Component of Health System Strengthening
Considering the Variety and Application Types of Medical Devices, the Regulatory Framework for these Products is of Decisive Relevance for the Contribution to Health Standards.
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UNIVERSITY OF APPLIED SCIENCES LÜBECK - STUDIES AT THE BIOMEDTEC SCIENCE CAMPUS …
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SO FAR: … TRAINING COURSE REGULATORY AFFAIRS MANAGER (RAM)
• 3 Modules à 3 Months
• completely online
• Training types:
Online-Scripts
Web-Conferences
Excercises
Group Work
Tests
– 2013: 20 Members (Pilotphase)
– 2014: 102 Members
– 2015: 150 Members (Limitation)
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SOON: ONLINE-MASTER STUDY PROGRAM MASTER OF SCIENCE - REGULATORY AFFAIRS (MRA)
International market analysis
Analysis of the need for RA professionals
Industrial contacts (BVMED, Working Group Regulatory Affairs Life Science Nord)
Draft of a competence profile for MRA
Curriculum fro MRA
Qualified Teachers
Preparation of Accreditation (ECTS-System)
Since April 3rd, 2017: Pilot testing phase with 3 testing modules (over 100 participants from Germany, Switzerland, US)
Planned start: October 2017
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ONLINE-MASTER STUDY PROGRAM – MRA CURRICULUM
2 year study program
100% Online
Pre-Condition: Bachelor
level in sciences,
medical or
pharmaceutical
sciences, medical
engineering, …
Elective topics (Options)
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Medical device manufacturers and other economic operators
Certification Bodies/Notified Bodies
Competent authorities for registration and surveillance of
medical devices
Research and Standardization Organisations
Consultants
Users and operators of medical devices
ONLINE-MASTER STUDY PROGRAM – MRA CURRICULUM TARGET GROUPS AND ORGANISATIONS
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Medical
Management Medical
Engineering Constructional Infrastructure
Mai
nte
nan
ce
Qu
alif
icat
ion
Strategy and Aims
Innovation management
Policy Support
Technology
Innovation
Development
Qualification
Conception
Development
Transfer
„Relief“ Adjusted Technologies and Concepts
WH
O/U
N
Ad
visory B
oard
Prof. Rentzsch Prof. Framke
Prof. Klein Prof. Spitzenberger Prof. Wehrig
Institute IHRM (International Health Relief Management)
Prof. Rentzsch (Director) N.N. (Business management)
DIRECTORATE
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Thank you for your kind attention.
Prof. Dr. Folker Spitzenberger University of Applied Sciences Fachhochschule Lübeck Mönkhofer Weg 239 23562 Lübeck Tel. +49 451 300 5372 E-Mail [email protected] Website www.fh-luebeck.de