6-Hour Virtual Seminar on Phase I GMPs
View: 14
Website https://www.gcplearning.com/virtual-seminar/6-hour-virtual-seminar-on-phase-i-gmps-11674LIVE |
Edit Freely
Category
Deadline: April 01, 2021 | Date: April 01, 2021
Venue/Country: U.S.A
Updated: 2021-03-09 20:30:56 (GMT+9)
Call For Papers - CFP
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.
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.