Audioconference Title

Adverse Event Reporting SOPs for Drugs & Biologics
Audioconference Date Thursday September 24, 2009. 1:00 pm to 2:30 pm
Audioconference Description A discussion about SOPs that organize and improve FDA compliance of drug and biologic safety reporting efforts.
Instructor information

Contact me for assistance
regarding the application of this information		 Joshua Sharlin, Ph.D.
Sharlin Consulting
Tel +1-301-570-1107
jsharlin@pipeline.com
www.speedupfda.com
These documents supplement information presented in the audioconference
Document Title Pages Check here to Download
1 FDA Reviewer Guidance - Conducting a Clinical Safety Review of a New Product Application 84
2 FDA Guidance for Industry - Postmarketing Safety Reporting for Human Drug and Biological Products 50
3 FDA Guidance for Clinical Trial Sponsors - Clinical Trial Data Monitoring Committees 27
4 FDA Guidance for Industry - Providing Regulatory Submissions in Electronic Format 12
5 FDA summary of proposed new regulations requiring electronic submission of postmarketing safety reports 2
6 FDA proposed rule - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements 20