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Basic information for beginners...
SUPAC
shahnaz khatoon.
Introduction to Scale up and post approval changes. SUPAC Guidelines : 1.In component and compositio...
SUPAC - Pharma Technology Transfer
Scale Up And Post-Approval Changes
Drug safety reporting has a vital role in the pre-approval and post-approval phases. It is essentia...
Chemistry, Manufacturing, and Control (CMC) & Post Approval Regulatory Affairs; M. Pharmacy -Pha...
Safety data generation Pre clinical phase Clinical phase Post approval phase (PMS)
Safety data generation in pre-clinical phase, clinical phase and post approval phase
Scale up and post approval changes Immediate release tablets November 1995 US-FDA guidance
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Risk Management Plans (RMPs) are essential tools used by pharmaceutical companies and regulatory aut...
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited report...
Master formula record, DMF (Drug Master File), Distribution records. Generic drugs product developme...
documentation in pharmaceutical industry, master formula record (MFR), DMF (drug master file), distr...
Transfer of processes to an alternative site occurs at some stage in the life-cycle of most products...
Clinical trials are critical in the development of novel medications and cures, advancing medical sc...
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration proces...
This presentation will cover introduction of QbD, benefits & misconception about QbD. Nowadays, ...
Drug regulatory agencies play a critical role in ensuring the safety, efficacy, and quality of pharm...
