Transcription of Risk Assessment in the Pharmaceutical Industry
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Risk Assessment in the Pharmaceutical Industry
Risk Assessment in the Pharmaceutical IndustryDorothea K ppeLiability Insurance: The Never-ending StorySeptember 9th, 2009 2009 Page 2 _10-Sep-09 Risk Assessment in the Pharmaceutical Industry - the 6 W WER WAS WANN WO WIE WARUM WHO WHAT WHEN WHERE HOW WHY 2009 Page 3 _10-Sep-09 Definitions 2009 Page 4 _10-Sep-09 Definitions Risk Analysis Risk Assessment A systematic process of organizing information to support a riskdecision to be made within a risk management process. It consists of the identification of the hazards, and the analysis and evaluation of risks associated with the exposure to these hazards (ICH Q9) Risk Communication Risk Evaluation Risk Identification Risk Management Risk Reduction 2009 Page 5 _10-Sep-09 Risk Assessment in the Pharmaceutical Industry -WHYM ission and Vision of a Pharmaceutical company We will bring to the world Pharmaceutical and health care products that improve livesand deliver outstanding value toour customers and shareholders 2009 Page 6 _10-Sep-09 Risk Assessment in the Pharmaceutical Industry -HOW Pharmaceutical Industry is driven by regulations and guidelines WHO ICH FDA / EMEA No formal risk management
Risk Assessment in the Pharmaceutical Industry Dorothea Köppe Liability Insurance: The Never-ending Story September 9th, 2009
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