Title:
Training course on Good Management of Medical Devices
Date(s) And Time(s):
Apr 26 2010 8:00AM - Apr 28 2010 5:00PM
Location:
Marriott Rive Gauche
17 , Boulevard Saint Jacques
75014 Paris
France
Interest Area(s):
Clinical Safety/Pharmacovigilance,Clinical Research,Project Management,Quality Assurance/Quality Control,Regulatory Affairs,Research & Development,Pharmacology
Overview:
Day I
Day I will deliver the knowledge base for the subsequent days. It will give an overview of the EU device legislative system and the principles and philosophy behind it. It will explain the definition of a medical device and the demarcation between medical devices and pharmaceuticals. It will also explain risk classification of medical devices and the relation between risk classification and conformity assessment procedures. The first day will highlight the role of the notified bodies and the legal basis for the requirements for clinical evaluation and clinical investigation. Also the regulatory route for different types of combination products with pharmaceuticals will be explained. An overview of the regulation of in vitro diagnostics and a comparison of the EU and US regulatory systems will conclude day I.
Day II
The course will give a clear guide how to develop practically a medical device. It will show how to identify the correct development path. For medical devices which need to be tested clinically, the process of planning, conducting and reporting a clinical investigation with medical devices will be explained to the course attendees. The practical differences between the development of pharmaceuticals and medical devices will be trained and the challenge of developing a drug device combination product should be sketched.
Day III
Responsibility in post marketing surveillance of medical devices (and drug devices combination products) according to the Medical Device Vigilance System will be explained and illustrated by examples. Differences between risk management of medical devices and pharmaceutical products will be pointed out.
Emphasis that 2007 47 comes into force in 2010.
Key Topics
- Medical device regulation: philosophy, content and structure
- Risk-classification of medical devices
- Drug-device combination products
- In Vitro Diagnostics
- CE mark
- ISO 14155
- 93/42/EC, as amended by 2007/47/EC
- Clinical Evaluation and Clinical Investigation
- Medical devices vigilance system
Learning Objectives:
At the conclusion of this course, participants should be able to:
- Apply the principles of medical device regulation
- Classify medical devices according to rules for risk classification
- Identify the applicable conformity assessment procedure
- Understand the issues surrounding combination products of devices and pharmaceuticals (including ATMPs)
- Develop a medical device
- Conduct a medical device trial according to ISO14155
- Understand ethical and regulatory considerations of medical device trials
- Understand the practical differences between medical device and drug development
- Realise responsibilities in Post-marketing Surveillance
- Evaluate risks and handle incident reports
Target Audience:
This course is designed for persons with the challenging task of developing medical devices.
This course is designed for experienced and starting professionals in industry and regulatory bodies, who would like to get acquainted with all aspects of medical device regulation in a quick and broad way.
This course aims at professionals in pharmaceuticals (e.g. regulatory affairs, clinical development), who would like to obtain an overview of device regulation, or who are involved in drug-device combinations and for professionals involved in medical devices.
Participants are expected to have a relevant master’s degree and be working in pharmaceutical or medical device area.
CANCELLATION POLICY
Cancellations must be made in writing and be received at the DIA Europe office five working days prior to the course start date.
Cancellations are subject to an administrative fee:
Full Meeting Cancellation:
Industry (Member/Non-member) = € 200.00
Government/Academia/Non-profit (Member/Non-member) = € 100.00
Registrants who do not cancel five working days prior to the course start date and do not attend, will be responsible for the full registration fee. DIA Europe reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA Europe is not responsible for airfare, hotel or other costs incurred by registrants. Registrants are responsible for cancelling their own hotel and travel reservations.
Transfer Policy
You may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute registrants will be responsible for the non-member fee, if applicable. Please notify the DIA Europe office of any such substitutions as soon as possible.
Event Code:
10543
Contact Information:
DIA Europe
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL
SWITZERLAND
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG