Back to On-demand Webcast: Case Study - Bringing Agility and Automation to New Drug Application (NDA) Development
1.00 RAC

On-demand Webcast: Case Study - Bringing Agility and Automation to New Drug Application (NDA) Development

An on-demand recording of “Case Study: Bringing Agility and Automation to New Drug Application (NDA) Development”, sponsored by VEEVA, originally recorded on 6 December 2017.

Credits:
1.00 RAC

  • List Price: $0.00

Item Details:

Sponsored by: 

Learn how to implement new operating processes and business systems that equip small regulatory teams to manage the demands and complexity of major submissions. This case study from Trevena will share how one innovative biotech designed and implemented their internal submissions...

Back to On-demand Webcast: Case Study - Bringing Agility and Automation to New Drug Application (NDA) Development
View More

» View the Table of Contents

Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design