Видео ютуба по тегу Fda Dsur Guidance

FDA Development Safety Update Report (DSUR)
FDA Development Safety Update Report (DSUR)
Regulatory Shorts#2 | DSUR vs PSUR | Safety Reports | Drug Regulatory Affairs
Regulatory Shorts#2 | DSUR vs PSUR | Safety Reports | Drug Regulatory Affairs
How FDA Guidances Get Created and the Downsides Of Too Much Tech in Clinical Research
How FDA Guidances Get Created and the Downsides Of Too Much Tech in Clinical Research
FDA - Pharmacovigilance Post-Marketing Rules and Regulations Series 3
FDA - Pharmacovigilance Post-Marketing Rules and Regulations Series 3
Day 8 | Reviewing Aggregate Safety Reports in Pharmacovigilance (PSUR, PBRER, DSUR Review Guide)
Day 8 | Reviewing Aggregate Safety Reports in Pharmacovigilance (PSUR, PBRER, DSUR Review Guide)
FDA Center for Drug Evaluation and Research Regulatory Framework, Paul Brown, April 9, 2024
FDA Center for Drug Evaluation and Research Regulatory Framework, Paul Brown, April 9, 2024
Investigator Responsibilities - Safety Reporting for Investigational Drugs and Devices
Investigator Responsibilities - Safety Reporting for Investigational Drugs and Devices
Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies
Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies
What to be included in PADERs as per FDA
What to be included in PADERs as per FDA
FDA Form 483 and Warning Letter – The Basics & the Differences
FDA Form 483 and Warning Letter – The Basics & the Differences
Drug Safety Regulatory Requirements
Drug Safety Regulatory Requirements
Руководство FDA подвергается критике на фоне внутренних разногласий.
Руководство FDA подвергается критике на фоне внутренних разногласий.
Communicating Drug Safety Messages
Communicating Drug Safety Messages
Important Regulatory Updates from 2019 – Good Pharmacovigilance Practices
Important Regulatory Updates from 2019 – Good Pharmacovigilance Practices
Development Safety Update Report (DSUR) l Medical Writing
Development Safety Update Report (DSUR) l Medical Writing
Development Safety Update Report (DSUR) vs Periodic Safety Update Report (PSUR) | Pharmacovigilance
Development Safety Update Report (DSUR) vs Periodic Safety Update Report (PSUR) | Pharmacovigilance
Tofersen and the FDA Approval Process
Tofersen and the FDA Approval Process