'Adverse event reporting requirements' presentation slideshows

Adverse Event Tracking as mandated by the Best Pharmaceuticals for Children Act

Adverse Event Tracking as mandated by the Best Pharmaceuticals for Children Act. March 3, 2003. Dr. Solomon Iyasu Medical Team Leader Division of Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration. Outline.

397 views • 22 slides

Reporting Adverse Events in Research to ORO

299 views • 17 slides

260 views • 13 slides

Part 15 Public Hearing FDA Regulation of Combination Products November 25, 2002 Rockville, MD

Part 15 Public Hearing FDA Regulation of Combination Products November 25, 2002 Rockville, MD. Michael Gross, Ph.D., RAC Vice-President Worldwide Compliance Aventis Behring King of Prussia, PA michael.gross@aventis.com. PERSONAL EXPERIENCE. Inhalation device [510(k)]

306 views • 9 slides

U.S. Cosmetic Regulations and New Legislation

This webinar will cover laws and regulations for successful marketing and compliance of cosmetics in the U.S. It will help clarify what claims and product labeling are appropriate for cosmetics to market them successfully and avoid regulatory issues and problems with FDA compliance and competitive challenges. Current FDA Warning letters to cosmetic firms will be reviewed. Adverse Event Reporting requirements for cosmetics will be discussed with focus on how these requirements will change under newly proposed legislation for cosmetics: The Personal Care Products Safety Act.

140 views • 5 slides

Before enrolling patients

Last reviewed October 5, 2010 Relevant Extramural SOPs: Human Subject Resources. Clinical Trial Safety Monitoring and Reporting Requirements. After peer review NIAID commits funds. Before enrolling patients

92 views • 1 slides