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.
Benefits of Attending this Seminar
- Gain an Overview of the Medical Device Industry
- Learn About Medical Device CE Marking
- Gain an overview of medical device and IVD regulation and the new legislative proposals
- Understand Clinical Trial Controls and Device Vigilance
- Discuss device/drug combination products
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 this sector. The course will be particularly relevant for regulatory staff, 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
- The role of the Competent Authority and Authorised Representative
- Brexit an update – what might happen
- 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
- Building a global approval strategy on an EU CE Mark Approval
- The key interface with digital technology