Phase IV Clinical Trials and Publications: Regulatory and Compliance Considerations in Challenging Times
Tuesday, June 10
2:00 PM EDT (18:00 GMT)
1 CPE Credit: Regulatory Ethics*

With increasing regulations, compliance requirements, and congressional interest in issues surrounding Phase IV clinical trials and publication strategies, life sciences companies must work to maximize their product development efforts while minimizing risks. What do you need to know? We'll discuss:

• The current environment and drivers for change.
• Regulatory and compliance considerations for Phase IV trials and investigator-initiated studies.
• Regulatory and compliance considerations – such as publication strategies, trial registration, ghost writing, authors, and publication selection – for publishing and distributing reprints.

Learn about the issues driving change in this rapidly evolving area and how they impact product life-cycle strategic planning.