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Practical Applications of the ICH, OECD and other relevant regulatory guidance's in D

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Practical Applications of the ICH, OECD and other relevant regulatory guidance's in D

Venue Name: Online Webinar
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
City: Palo Alto
Country: USA
Start Date of Conference: 02-11-2010
End Date of Conference: 02-11-2010
Intended Audience/Keywords: Project management,Project team members from preclinical and clinical development,Management team members,Regulatory affairs Drug Safety,Registration and data management
Description of Conference: Detailed review of the components of ICH, OECD and other key regulatory guidances as they relate to drug safety, quality and efficacy for global submissions. The specific data sets and timing of studies needed at each stage of drug development process will be presented and discussed.

Areas Covered in the seminar:

* Overview of ICH and other key regulatory guidances.
* The "What", "When" and Hows" of proper implementation of ICH and other key regulatory guidance’s as they relate to overall drug safety assessment.
* Details on nonclinical, preclinical, quality and CMC data necessary to achieve approval at each stage of drug development.
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Practical Applications of the ICH, OECD and other relevant regulatory guidance's in D

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