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Risk Management

Risk Management
established methods of risk analysis
incl. ICH Q9

 
 
ICH Q8, Q9, Q10
GMP Pocket Guide Volume 4
ICH Q8 – ICH Q9 – ICH Q10

The ICH guidelines Q8, Q9 and Q10 represent the current thinking on the development of quality systems across the lifecycle of a product.

 
 
Risk-Based Compliance Handbook
This book covers all stages of the drug lifecycle from R&D, to the clinical phases, the launch and pharmacovigilance stages, and the discontinuation step.

 
 
Risk Assessment and Risk Management in the Pharmaceutical Industry
Clear and Simple

This book explores the phases of the risk management process in detail and examines how the various tools can be applied in identifying hazards and evaluating their potential impact and affects.

 
 
 
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