Dublin, May 28, 2024 (GLOBE NEWSWIRE) -- The "An Essential Overview of the Medical Device Industry Training Course" conference has been added to ResearchAndMarkets.com's offering.
The concept of 'Life Sciences' is with us as we see the convergence of pharmaceuticals, medical devices and diagnostics. We are seeing the evolution of combination products, companion diagnostics, novel delivery systems, digital medicines and the introduction of artificial intelligence-enabled products.
This training course has been designed to provide you with an up-to-date overview of the medical device industry, and will be beneficial for anyone working in the pharmaceutical industry who requires an understanding of the medical device sector and the interface between the two. It will also be beneficial for those new to medical devices and those who require a refresher on recent changes in this fast moving sector.
- How are the regulations changing?
- What are the new rules for devices and diagnostics in the UK post-Brexit?
These key questions and many others will be answered by our experts in this focused programme and will provide an excellent opportunity to discuss the complexities involved.
Benefits of attending:
- Gain a better understanding of the medical device industry
- Be aware of the changing regulatory landscape
- Lean about the evolving interfaces between pharmaceuticals and medical devices
- Gain insights into the regulation of digital medicines
- Learn the new rules for devices and diagnostics in the UK post-Brexit
- Benefit from an opportunity for your questions to be answered
This course is a must for:
- Personnel from the pharmaceutical industry who want to learn more about the devices and diagnostic sectors
- All those who want to understand the interface between devices and pharmaceuticals
- Those who require a refresher on recent changes in the medical device sector
Agenda
The Convergence of Pharmaceuticals, Medical Devices and Diagnostics:
- What is a medical device and an In-Vitro Diagnostic (IVD)?
- How is the device market developing?
- The emergence of the 'Life Science' industry, digital medicine and AI-enabled products
- The challenges for regulation
An Overview of the MDR and IVD Directives and the Regulations:
- Update on the MDR implementation
- Update on the IVDR implementation
What are the Key Differences in Approach from Pharmaceuticals?
- Who are the key players?
- The role of the Competent Authority and Authorised Representative
Brexit Update:
- Impact on the medical device industry
Notified Bodies:
- What is a Notified Body?
- How to work with a Notified Body
How are Medical Devices and IVDs Evaluated?
- What are the data requirements?
Review and Summary of Role of Notified Bodies:
- How to work with Notified Bodies
- Role in changes to the device post-approval
- Future developments for Notified Bodies
Clinical Trial Requirements for Medical Devices:
- The control of trials for MDs and IVDs
- Phased introduction of the new EU system
- Controls for combination products
- Device and IVD Scientific Advice
Medical Devices Vigilance versus Pharmacovigilance:
- The Regulatory System
- Adverse event report - Vigilance
- Post marketing surveillance
- User reporting systems
- Human factors requirements
Device/Drug Combination Products and Companion Diagnostics:
- The Operation of Article 117 and Latest Guidance
Post Brexit MD and IVD controls in the UK
Future Changes, Influence of the Pharmaceutical Package, Role of the EMA, Regulation of Digital Devices and Global Harmonisation
For more information about this conference visit https://www.researchandmarkets.com/r/ccvxsb
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