American Conference Institute's 6th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials

The American Conference Institute’s 6th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials will take place February 27-28, 2007 at the Roosevelt Hotel in New York. Legal and compliance experts from pharmaceutical and medical device companies, Contract Research Organizations (CROs), and hospital and research institutions, as well as attorneys will provide an intensive and thorough review of the critical issues that arise in ensuring proper management of protocols, contracts, consents, and other documents.

On February 27, Securities Litigation, Enforcement & Regulation senior counsel Elizabeth Gray will present Reacting to Scrutiny of Clinical Trial Disclosures by the SEC which will review the following:

• How FDA and SEC cooperation (Referral Process and Centralized Procedures) have affected scrutiny of clinical trial disclosures
  
• Complying with SEC reporting requirements pre- and post-approval
  
• Reconciling FDA/SEC disclaimer requirements
  
• Factoring in recent enforcement activities by the SEC and FDA
  
• Lessons learned from ImClone, TKT, ICN, and NY Executive Law 63(12)
  
• Disclosing clinical trial information that has been made available to the FDA but not publicly disclosed
  
• Determining what FDA actions to disclose and how to disclose them for accurate interpretation by the securities market
  
• Alleviating securities concerns: whether databank entries constitute “forward-looking statements” for investor reliance
  
• Controlling and monitoring material inside information