DUBLIN--(BUSINESS WIRE)--The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting" conference has been added to Research and Markets' offering.
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting.
This seminar provides an essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting for medical device clinical studies complying with the European Medical Device Directive 93/42/EEC.
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.
Topics covered include:
- The regulatory requirements for monitoring and reporting adverse events during medical device studies
- How to define and classify adverse events
- Clinical investigations and evaluations
- PMS and post-market clinical follow-up studies
- Vigilance reporting
- The role of the Competent Authority
Agenda:
09.30 Welcome and introduction
09.45 Clinical investigations and evaluations - when is an investigation needed?
- How to perform a clinical evaluation
- When are clinical investigations needed
- The regulatory requirements
10.35 PMS and post market clinical follow up studies
- What is PMS
- What do the regulations entail
- When are PMCF studies necessary
11.00 Refreshments
11.15 Vigilance reporting
- What is vigilance
- The requirements for vigilance reporting
11.45 How to define and classify adverse events
- Definitions
- Types of events
- Determining categories
12.15 The regulatory requirements for monitoring and reporting adverse events during regulatory and post market clinical follow up studies
- MEDDEV guidance document
- ISO 14155 harmonised standard
- Responsibilities
- Post market clinical follow up studies
12.50 Discussion
13.00 Lunch
14.00 Vigilance workshop
14.30 The new Medical Device Regulations
- Structure and overview of the new regulation
- Some of the main changes
- Final provisions - transitional arrangements
15.30 Discussion
15.45 Refreshments
16.00 The new Medical Device Regulations - clinical elements
- Focus on changes in the clinical arena
- Chapter VI Clinical Evaluation and Investigation
- Annex XIV Clinical Investigations
16.40 The role of the Competent Authority (CA)
- What is the involvement of the CA
- Communicating with the CA
- What to communicate and when
17.00 Discussion and end of forum
For more information about this conference visit https://www.researchandmarkets.com/research/plcvrh/medical_device?w=4
