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Conference Directory
Nonclinical Drug Safety Evaluations in Drug Development
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Venue Name: Online Webinar
Country: United States of America
City: Palo Alto
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Project team members from preclinical and clinical development,Project management,Regulatory Affairs,Drug safety,Registration and data management,Management team members
Start Date of Conference:: 01-21-2010
End Date of Conference: 01-21-2010
Description of Conference: This course is designed to provide a detailed overview of the role of toxicology in Drug Development. Participants will obtain an overall understanding of the principles of non-clinical safety evaluation with emphasis on application and interpretation of non-clinical safety data as it relates to and is integrated into the multi-disciplinary development plans and how it affects decision-making at each stage of the development process.
Areas Covered in the seminar:
* Principles of toxicology as they apply to drug safety assessment.
* Best practices in toxicology testing by drug development stage.
* Determination and use of safety margin calculations at different stages of drug development: case studies.
* Details of drug regulatory submissions: what the regulators want to see in terms of safety assessment.
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