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Austria Trend Hotel Savoyen Vienna

2016 年 11 月 29 日 8:00 上午 - 2016 年 11 月 30 日 2:00 下午

Rennweg 16, 1030 Vienna, Austria

Information Day and Interactive Hands-on Workshop on The New European Medical Device Regulation: Change Management

This event will provide insight to the essential changes of the New Medical Device Regulation, such as the role of notified bodies and requirements in clinical and post-market requirements.

概览

This event will provide insight to the essential changes of the New Medical Device Regulation, such as the role of notified bodies and requirements in clinical and post-market requirements. Day One will be dedicated to key updates to MDR (Information Day), and Day Two will focus on developing skills to apply these regulation updates to attendees’ daily work (Interactive Hands-on Workshop).

Day One: MDR Information Day – Attendees will learn from key experts on the differences and new requirements within the new MDR.
Day Two: Hands-On Application Workshops – Attendees will work through practical application scenarios of the new updates with key subject matter experts.

谁应该参加？

This event is designed for regulatory professionals e.g. medical device – industry and SME:

  • QA/RA directors
  • QA/RA managers
  • Clinical trial managers
  • Implementation project leads
  • Product managers
  • Safety officers

It is also aimed at pharma industry companies who want to enter this market and have to learn about the upcoming changes in the regulatory framework, trade associations, notified bodies, authorities etc., who would like to be updated on the changes and implications of the new EU Medical Device Regulation.

学习目标

At the conclusion of this workshop participants will be able to:

  • Understand the differences between the previous and the new regulation
  • Return to their organisation with practical examples of changes required in key job areas
  • Implement the change management in their company

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