Discussion on concept of risks and benefits in the context of an application for the new drug as a very complex process that requires significant evaluation of a large amount of data of patients, particularly those related to security.
Areas Covered in the seminar:
* Why is a Benefit-Risk Assessment necessary.
* What information is collected to obtain the Benefit-Risk Assessment.
* Pharmacovigilance concepts for the Benefit-Risk Assessment.
* From where does the information come from to obtain the Benefit-Risk Assessment?
* How is used the information to obtain the Benefit-Risk Assessment.
* How is the Benefit-Risk Assessment reported to Regulatory Authorities.
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