Infarmed Regulatory Training handouts - 14 Nov

Infarmed Regulatory training

14 November 2017, Lisbon, Portugal

Chair: Christopher Bailey, Regulatory Intelligence and Training manager, TOPRA

09:15 Registration

Tea and Coffee

09:30 Welcome from TOPRA and outline of the day – Christopher Bailey

09:40 Introductions from course delegates and what they wish to get out of the day

10:00 Stephan Buttron, Principal Medical Research Manager Regulatory Affairs , NAMSA, Germany

History of Risk Management

ISO 14971 Risk Management Process Overview

Differences between ISO and EN ISO Versions

Risk Management and Quality Management Systems

Risk Management Definitions and Terminology

Risk Management Plan & Risk Acceptance

11:00 Tea/Coffee break

11:15

Risk Identification - From Hazard and Harm to Risk

Risk Evaluation - Probability and Severity

Work Shop/Interactive Exercise 1:

Risk Management Deliverables in Design Projects

12:15 Lunch

13:15

Risk Controls & Residual Risk

Risk Management Report

Regulatory Compliance

14:45 Coffee/Tea break

15:00

Clinical Risk/Benefit Evaluation

Post-Production Risk Management – Post-Market Surveillance

Work Shop/Interactive Exercise 2:

Risk Based Incident Report Evaluation

16.15 Summary and Q&A Session

16:45 Close of day

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