ABHI Conference London 23 March 1999

6/1/99

Copyright Gertjan Reichman 1999. This presentation has ben reproduced with kind permission from
Gertjan Reichman and the ABHI Conference organisers.

Click here to start

Table of Contents

ABHI Conference London 23 March 1999

Outline (continued)

Some definitions

Some definitions (cont..)

Some definitions (cont..)

Some definitions (cont..)

A SIMPLIFIED RELATIONSHIP BETWEEN RISK ANALYSIS AND OTHER RISK MANAGEMENT ACTIVITIES

Understanding the Risk Management process

Understanding the Risk management process

Understanding the Risk management process

Understanding the Risk Management process

Understanding the Risk management process

Understanding the Risk management process

Where do risk analysis and risk management fit in the regulations (Europe)?

Essential requirements

Standards which address “risk-activities”

Standards which address “risk activities” (cont.)

Text of the EU mandate on Risk management

The development of ISO/CD 14971

The 10 paragraphs of ISO/CD 14971 (1998-05-21)

The Annexes of ISO/CD 14971 (1998-05-21)

The Annexes of ISO/CD 14971 (cont.)

Highlighting some critical points (1)

Highlighting some critical points(2)

Highlighting some critical points (3)

Highlighting some critical points (4)

Author: E. Dekkers

Email: admin@biomateria.com

Home Page: http://www.biomateria.com

All text and representations on this site © L P M Lloyd-Evans & BioBridge 2000-2005
mlloydevans@biobridge.co.uk.
Designed and managed by BioPortfolio Ltd on behalf of L P M Lloyd-Evans & BioBridge Associates.

The foundation and maintenance of this site was made possible by EC funding in project BRRT-CT97-5008 1997-2000