DUBLIN--(BUSINESS WIRE)--The "An Essential Overview of the Medical Device Industry" conference has been added to ResearchAndMarkets.com's offering.
This one day workshop aims to give all the key information necessary to understand the regulation of Medical Devices and Diagnostics and to appreciate the key differences from Pharmaceutical regulation.
This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics, and to appreciate the key differences from pharmaceutical regulation. The workshop will highlight the transition to the new Medical Device Regulation (MDR) and discuss the new rules and approaches to developing combination products. The key interface with digital technology will also be discussed.
Why you should attend
The Pharmaceutical Industry is increasingly developing Device combination products and looking to use novel methods of drug delivery.to enhance the performance of medicine and as a part of life cycle management. Medical Devices are also being employed to monitor compliance in clinical trials and post-marketing as well as being used to monitor patients in trials. This one day workshop aims to give all the key information necessary to understand the regulation of Medical Devices and Diagnostics and to appreciate the key differences from Pharmaceutical regulation.
Who Should Attend:
The course has been specifically designed to meet the needs of those working in pharmaceuticals and in allied business functions who need to understand the medical device sector. The course will be particularly relevant for regulatory staff and those in clinical research, medical affairs, and business development.
- What is a medical device?
- What are the differences in approach from pharmaceuticals?
- How is the device market developing?
- An overview of the medical device and in-vitro diagnostics legislation, including the implementation of the 2017 Medical Device and IVD Regulations
- Preparation for the May 2020 Medical Device Regulation deadline
- The role of the competent authority and authorised representative
- Brexit update - impact on the medical device industry
- What will the 31 October 2019 deadline mean?
- What is a Notified Body and how are medical devices and IVDs evaluated?
- What are the data requirements?
- How to work with a Notified Body
- Clinical trial controls for devices
- Device vigilance versus pharmacovigilance
- Device/drug combination products and companion diagnostics
- The operation of Article 117 and the latest guidance
- Building a global approval strategy on an EU CE mark approval
The key interface with digital technology
For more information about this conference visit https://www.researchandmarkets.com/r/whkcxs