The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course" training has been added to ResearchAndMarkets.com's offering.

This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and PMCF studies with particular emphasis on the adverse event reporting requirements during these studies.

The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period. It also covers the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance.

Certification:

• CPD: 12 hours for your records
• Certificate of completion

Who Should Attend:

• Regulatory affairs specialists
• Quality assurance specialists
• Clinical research associates
• Junior clinical research associates
• Professionals involved in reporting adverse events during pre- and post-market clinical studies

Key Topics Covered:

Clinical evaluation - An overview

• What is a clinical evaluation?
• How do you conduct a clinical evaluation?
• The regulatory requirements pertaining to clinical evaluation

Clinical investigations - An overview

• What is a clinical investigation?
• When are clinical investigations needed?
• The regulatory requirements

PMS and PMCF

• What is PMS?
• What is PMCF?
• When are PMCF studies necessary?

Quiz on clinical evaluation, clinical investigation and PMCF

New requirements of the MDR

• Summary of safety and clinical performance
• Periodic safety update report (PSUR)

The competent authority and the Notified Body

• What is their role in the above processes?
• What are the responsibilities of the manufacturer?
• What to communicate and when

Workshop on the new requirements of the MDR

Vigilance reporting

• What is vigilance?
• The requirements for vigilance reporting during medical device studies

How to define and classify adverse events

• Definitions
• Types of events
• Determining categories

Vigilance workshop

The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies

• MEDDEV guidance document
• ISO 14155 harmonised standard
• Responsibilities
• Templates

The MDR - clinical elements

• Focus on changes in the clinical arena
• Chapter 6: clinical evaluation and investigation
• Annex 14: clinical evaluation and post-market clinical follow-up

For more information about this training visit https://www.researchandmarkets.com/r/ggefrq

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