CDER Adds to Online Regulatory Learning Program - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

CDER Adds to Online Regulatory Learning Program


ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA’s Center for Drug Evaluation and Research (CDER) has been running an educational, regulatory-based forum since 2005 to engage its international regulatory counterparts. This forum includes online learning courses on how the Center organizes its drug-review process in the US.

This month, CDER added a new program in drug safety to its “CDER World” platform for training and education. The new program includes information about the agency’s Office of Surveillance and Epidemiology. The forum meetings, held twice a year, are held through CDER World in a “live” format via the Internet in order to reach as many people as possible.

“The interest in these ‘live’ meetings has grown exponentially with FDA working in harmonization with countries around the world,” states the CDER World website. “Many more people than can be accommodated at these small meetings want to learn about the science, technology, regulations and processes CDER uses to accomplish its complex and challenging work.”

Other eLearning programs focus on compliance, generic drugs, and new drugs. Each educational session includes a list of Frequently Asked Questions from international forums. These questions are updated by CDER periodically.

 

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
20%
Attracting a skilled workforce
28%
Obtaining/maintaining adequate financing
12%
Regulatory compliance
40%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here