- Improving the Regulatory Review Process: Assessing Performance and Setting Targets[electronic resource] / edited by Neil McAuslane, Stuart Walker.
- McAuslane, Neil., editor., Walker, Stuart., editor.
- SpringerLink (Online service)
- XIX, 163 p. : online resource.
- CMR Workshop Series
- 1 Assessing performance and setting targets -- 2 Current regulatory reforms and improvements in the review process -- 3 Current regulatory reforms: CBER -- 4 Improving the review process: The view of the Japanese MHW -- 5 Comparing the performance of the Canadian TPD with other regulatory authorities -- 6 Measuring performance: The view of the TGA -- 7 Why have targets for the review process? The view of the EMEA -- 8 Why have targets for the review process? An individual viewpoint -- 9 Key milestones in the regulatory review process -- 10 How do you measure the quality of the scientific assessment and the review process? The view of the MCA -- 11 Ensuring the quality of the scientific assessment and the review process: The FDA?셲 good review practice initiative -- 12 Outcome of syndicate discussions -- Meeting participants.
Medical laws and legislation.
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- Springer eBooks
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- Printed edition: 9789401060424