Description
<strong>Course Schedule - March 9-11, 2009</strong><br/><br/>The content of this course is to present detailed components
of INDs/NDAs, BLAs, ANDAs, SNDAs, IMPDs and CTDs
(Modules 1–5). These regulatory submissions will be based
on the requirements of the US code of Federal Regulations,
EU Directives and ICH guidelines. Each of these regulatory
documents will be presented as they are related to safety,
quality and efficacy necessary for global submissions. Details
of non and pre-clinical data, clinical data, and CMC data
necessary to achieve new product approvals globally will be
presented and discussed. Recommendations for expediting
new product approvals will be correlated with the regulatory
procedures.<br><br>
Other topics presented that will help participants understand
the structure and bureaucratic demands will include:<br><br>
• FDAs internal structure, policies and procedures<br>
• Regulation requirements for new product submissions<br>
including SNDAs, CTDs and DMFs globally<br>
• Acceptance of international data for use in new product<br>
approvals<br>
• Similarities between EU directives and FDAs Code of<br>
Federal Regulations<br>
