Found 147 presentations matching your search
INVESTIGATIONAL NEW DRUG ,�ORANGE BOOK,�UNDERSTANDING ON 505(b) (2) APPLICATIONS� prepared b...
regulatory affairs
All information about Drug Master File(DMF)
COMMON TECHNICAL DOCUMENT , its granularities, benefits, advantages, shortcomings.
medical devices
this ppt contains about 21 CFR part 312
GCP course material
In this slide contains Quality-by-Design in Pharmaceutical Development. Presented by: T. MOUSAMI BH...
Organizational structure and application forms
Drug Regulatory Affaira for B. Pharma and M. Pharma
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug wh...
Investigator roles
This presentation is prepared based on USFDA Guidance "Orange Book Questions and Answers" ...
ICH GUIDELINES Q8, QbD
The Common Technical Document (CTD) is a standardized format for regulatory submission of informatio...
System design
The pharmaceutical Quality by Design is a systematic approach to development that begins with prede...
This presentation explains in brief the process, types, requirements, and conditions where PAS is ne...
Slide deck for Pharmacovigilance students/beginners, Healthcare professionals, pharmacists, nurses. ...
- Whilst the realization of the CTD took many years, there is now a common format for the submission...
quality by design in pharmaceutical development ICH Q8 guideliness
Drug Discovery vs. Drug Repurposing and AI in Pharmaceutical Manufacturing Use of AI tools in manufa...
This presentation provides an overview of the regulatory guidelines established by the Organisation ...
Navigating Brazil's ANVISA registration process for Class IV medical devices can be complex. Thi...
