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Pharmaopportunities has the
largest selection of
INDs/NDAs/CTDs
training courses online. Our training courses are provided by
the some of the best
Biotech
companies in the world.
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| Industry |
Biotech |
| Course Category |
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| Training Location |
Burlingame, CA USA
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| Training Date and Time |
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| Seating Capacity |
Not Applicable |
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Description |
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Course Schedule - March 9-11, 2009
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.
Other topics presented that will help participants understand
the structure and bureaucratic demands will include:
• FDAs internal structure, policies and procedures
• Regulation requirements for new product submissions
including SNDAs, CTDs and DMFs globally
• Acceptance of international data for use in new product
approvals
• Similarities between EU directives and FDAs Code of
Federal Regulations
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Who Should Attend |
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This course is directed to personnel involved in:
• New Pharmaceutical Product Development
• Pre-clinical and Clinical Research
• Regulatory Affairs
• Quality Assurance
Participants should have an understanding of the steps in new
product development and/or the responsibilities of regulatory
affairs in submitting new product applications worldwide. |
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Click here to Download Brochure
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Click here to View Registration Form |
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