Company Logo
Dublin, Nov. 03, 2022 (GLOBE NEWSWIRE) -- The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course" league has been added to ResearchAndMarkets.com's offering.
This seminar provides an indispensable overview of aesculapian instrumentality objective evaluations, objective investigations and PMCF studies with peculiar accent connected the adverse lawsuit reporting requirements during these studies.
The people volition ore mostly connected the caller Medical Device Regulations (MDR) with immoderate references to the existing Medical Device Directives.
It volition supply a bully instauration to aesculapian instrumentality objective studies and service arsenic an update for those with acquisition who request to support abreast of the regulatory changes and the methods of handling adverse events during the survey period.
It besides covers the caller requirements regarding periodic information update reports (PSURs) and the summary of information and objective performance.
Who Should Attend:
Regulatory affairs specialists
Quality assurance specialists
Clinical probe associates
Junior objective probe associates
Professionals progressive successful reporting adverse events during pre- and post-market objective studies
Key Topics Covered:
Clinical valuation - An overview
What is simply a objective evaluation?
How bash you behaviour a objective evaluation?
The regulatory requirements pertaining to objective evaluation
Clinical investigations - An overview
What is simply a objective investigation?
When are objective investigations needed?
The regulatory requirements
PMS and PMCF
What is PMS?
What is PMCF?
When are PMCF studies necessary?
Quiz connected objective evaluation, objective probe and PMCF
New requirements of the MDR
Summary of information and objective performance
Periodic information update study (PSUR)
The competent authorization and the Notified Body
What is their relation successful the supra processes?
What are the responsibilities of the manufacturer?
What to pass and when
Workshop connected the caller requirements of the MDR
Vigilance reporting
What is vigilance?
The requirements for vigilance reporting during aesculapian instrumentality studies
How to specify 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 - objective elements
Focus connected changes successful the objective arena
Chapter 6: objective valuation and investigation
Annex 14: objective valuation and post-market objective follow-up
Speakers
Janette Benaddi
Director of Clinical & Consulting Europe
NAMSA
Janette Benaddi is simply a concern mentor, planetary speaker/trainer and advisor to the aesculapian instrumentality industry. Janette has implicit 25 years' acquisition of managing pre and station marketplace objective studies successful some devices and pharmaceuticals. Janette has worked with respective multinational organizations successful assorted clinical, regulatory and selling roles. She has extended acquisition of conducting objective studies with aesculapian instrumentality products arsenic good arsenic regulatory expertise for CE marking of devices. Specifically she has been progressive successful penning and reviewing hundreds of Clinical valuation reports for the aesculapian instrumentality industry, she ahs besides provided grooming to Notified bodies successful this subject.
Janette qualified arsenic a registered caregiver successful 1984, she has a BSc successful Management studies, a Diploma successful Company Direction, and a Diploma successful Management studies, holds a teaching certificate and is simply a Chartered Scientist and Chartered Director. Janette sits connected respective committees successful the instrumentality assemblage and manufacture and has been an instrumental advocator of improving and advancing aesculapian instrumentality probe successful the UK. Janette has published respective articles relating to aesculapian instrumentality regularisation and objective studies.
For much accusation astir this league sojourn https://www.researchandmarkets.com/r/waw533
/cdn.vox-cdn.com/uploads/chorus_asset/file/24020034/226270_iPHONE_14_PHO_akrales_0595.jpg)
English (US)