filmov
tv
FDA meetings Drug Development process | Regulatory affairs |

Показать описание
This video lecture describes in details about the Meetings Between the FDA and Sponsors or Applicants during drug development process including
-Importance of FDA meetings
-Types of Meetings Type A, B, C
-Meeting request
-Meeting package
-Assessment of the meeting by FDA
-Documentation of the meeting
Biology Lectures is a research organization with the mission of providing a free, world-class education for anyone, anywhere. We offer quizzes, questions, instructional videos, and articles on a range of academic subjects, including biology, microbiology, pharmacology, bioinformatics, immunology, biochemistry, anatomy and physiology, and many more.
Support us at:
#Biologylectures
-Importance of FDA meetings
-Types of Meetings Type A, B, C
-Meeting request
-Meeting package
-Assessment of the meeting by FDA
-Documentation of the meeting
Biology Lectures is a research organization with the mission of providing a free, world-class education for anyone, anywhere. We offer quizzes, questions, instructional videos, and articles on a range of academic subjects, including biology, microbiology, pharmacology, bioinformatics, immunology, biochemistry, anatomy and physiology, and many more.
Support us at:
#Biologylectures
FDA meetings Drug Development process | Regulatory affairs |
Formal FDA Meetings
The FDA Drug Development Process: GLP, GMP and GCP Regulations
GDUFA II Training - Pre ANDA Product Development Meetings, Robert Lionberger
Complex Innovative Trial Designs Pilot Meeting Program: The Process
How to Make an Impact at the FDA’s Drug Development Meeting for Long Covid — Hosted by Solve M.E....
Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017
Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018
Session I: Regulatory Compliance: A Complex but Essential Component in the Pharmaceutical Industry
The Drug Development Process
FDA Patient Focused Drug Development Meeting - Overview of FDA PFDD Initiative
FDA Approval Considerations with Dr. Paul Kluetz
Opportunities to Engage With the FDA About Qualification During Biomarker Development
Worried about Your Next FDA Meeting? Key Tips to Make It a Success
Formal Meetings for PDUFA Products and Communication Best Practices (4of14) REdI 2018
OTC Monograph Reform Overview of Draft Guidance for Formal Meetings
FDA Communication During Drug Development (4/14) REdI 2017
Public Meeting: Using Methods from PFDD Guidance 1 and Guidance 2 Meeting #2
Meetings: Pre-submission and Special Programs (4of15) REdI Annual Conference – May 29-30, 2019
Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017
FDA Webinar on the Infant Formula Transition Plan (Part 3)
Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine
What Is A Type B Meeting With FDA? - CountyOffice.org
Preparing for the FDA Patient-Focused Drug Development Meeting on Alopecia Areata
Комментарии