Startdate:
9 October 2012 - 10 October 2012

Purpose:
The module aims to provide students with a comprehensive knowledge of regulatory affairs within medical devices and drug/device combinations, and to enable students to:
• Offer regulatory strategic advice
• Compile adequate regulatory documentation
• Search for current and future regulations within the field

The module is targeted at regulatory employees from the medical device industry as well as from the drug industry. In particular, manufacturers/developers of medical devices used in combination with drugs (prefilled devices or devices, where the drug is ancillary to the device), or students with a special interest in this field will benefit from the module and gain a better understanding of the legal framework and its impact on such products.

By the end of this module, the student should be able to:

- understand the basic principles of medical device regulations, particularly in the EU, and to understand the basic requirements, when implementing a medicinal product - either as an ancillary drug substance to a medical device, or a drug product to be delivered by a medical device. Further, students will gain a better understanding of the consideration process behind various problems arising during the development of a combined product

- analyse and evaluate whether a combined product is regulated as a drug or as a medical device, and to be able to search for detailed information and provide proper input to projects regarding development of combined products. Further, students will be able to decide, whether a medical device used in combination with a drug should be registered in accordance with medical device legislation or drug legislation

- use best practices when evaluating whether a combined product is regulated as a medical device or as a medicinal product, and evaluate the documentation necessary to meet the regulatory requirements of a medical device

Content:
Key Topics:

• The module focuses attention on legal activities on the European market, but will provide a lecture on legal requirements in the US as well
• The considerations to be made for the different kinds of topics arising during the development of a combined product.
• This module will give you the ability to judge whether a medical device used in combination with a drug has to be registered according to the medical device or the drug legislation.

• Hilde Viroux, Assistant Director, EU Regulatory Affairs Medical Devices, Alcon Laboratories, Belgium
• Tove Kjær, Regulatory Affairs Manager, ORIGIO A/S, Denmark
• Irene Rebollo, Director, Medical Safety International, Alcon Laboratories, Spain
• Thomas Pedersen, Development Engineer, Novo Nordisk A/S, Denmark
• Elisa D. Harvey, DVM, PhD, Senior Regulatory Consultant, CardioMed Device Consultants, LLC, USA
  More international lecturers will be added...

Prerequisites:
In order to secure the professional level of the education. The participants must have a educational background at bachelor level within a relevant area and at least two years’ experience within Regulatory Affairs or equivalent qualifications. Please note that applications will be considered in order of receipt.

Literature:
A list of recommended literature will be send to the participants approx. 4 weeks prior to the start of the module.
The list will be divided into mandatory and optional reading. The mandatory references is part of the examination syllabus.
The participants are expected to study and be familiar with the mandatory references in advance of the module