6-Hour Virtual Seminar on Phase I GMP
Training
Online
*Indicative price
Original amount in USD:
$ 445
Description
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Type
Training
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Level
Advanced
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Methodology
Online
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Class hours
6h
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Duration
1 Day
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Virtual classes
Yes
The studies are generally in small number of healthy subjects and use lower doses of the drug product.
Reviews
Subjects
- Education
- Training
- Financial
- Medical
- Technology
- Best Practice
- Employees
- Risk
- Management
- Benefits
Teachers and trainers (1)
Event Manager
Traning Provider
Course programme
Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.
This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
Additional information
6-Hour Virtual Seminar on Phase I GMP
*Indicative price
Original amount in USD:
$ 445