Foundations of US Pharmaceuticals and Biologics

When:  May 17, 2016 from 08:00 to 17:00 (ET)

Foundations of US Pharmaceuticals and Biologics is an informative, full-day, expert-led program that helps you build a solid foundation of the regulatory competencies needed today. Take advantage of bonus content to expand your learning opportunity beyond the workshop.

During the program, you will learn about pharmaceuticals and biologics: drugs, biologics, quality essentials, non-clinical essentials, early clinical development, late clinical development, registration essentials, approvals and post-marketing, drug safety, and advertising, promotion and labeling essentials.

In addition to the live, face-to-face program, we offer a special, blended learning opportunity with four online courses and relevant chapters from the just-released 9th edition of RAPS’ Fundamentals of US Regulatory Affairs. 

Bonus materials include:

Online Course #1: Role of the Regulatory Professional

Online Course #2: Pharmaceuticals: Definition & Lifecycle

Online Course #3: Pharmaceuticals: US Regulations (access will be provided during program)

Online Course #4: Global Regulatory Strategy for Pharmaceuticals (access will be provided during program)

Textbook: Selected pharmaceutical chapters from Fundamentals of US Regulatory Affairs (access will be provided during program)