Date(s) And Time(s):
Oct 27 2010 8:00AM - Oct 29 2010 5:00PM
Rue de Zurich 19
Clinical Research, Clinical Safety/Pharmacovigilance, Pharmacology, Project Management, Professional Education, Training & Development, Public Policy/Law/Corp. Compliance, Quality Assurance/Quality Control, Regulatory Affairs, Research & Development
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.
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.
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.
Medical device regulation: philosophy, content and structure
Risk-classification of medical devices
Drug-device combination products
In Vitro Diagnostics
93/42/EC, as amended by 2007/47/EC
Clinical Evaluation and Clinical Investigation
Medical devices vigilance system
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
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
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52