Clinical Trial Disclosure: Keeping Ahead of the Wave

Transparency and data disclosure are this year’s hot issues for pharmaceutical companies. On the clinical trial front, Europe is leading the way, with initiatives from the European Medicines Agency and the European Parliament that will impact drug research and development world-wide. The proposed TEST Act and FDA initiatives concerning disclosure of safety and efficacy data signal that the United States is not far behind. Mandatory disclosures concerning the details of trial protocols and results, if required, will have significant practical and strategic ramifications, particularly if retroactive disclosure is imposed.

Please join partners from Dechert’s Life Sciences practice and regulatory attorneys from Hyman, Phelps & McNamara, P.C. for a webinar on where these initiatives stand, what to expect and how reforms could impact pharmaceutical companies.

Seminar Topics:

• Update on EU and US legislative and regulatory proposals for clinical trial disclosures:
  - overview of current EU and US disclosure framework 
  - who is driving the push for expanded disclosure and how industry is or is not responding 
  - what is being proposed 
  - timeline for change impacting companies inside and outside the EU
• The real-world effects on current and future clinical development programs:
  - considerations regarding clinical trial design and management
  - implications for compliance and reporting programs
• Other immediate and long-term business impacts:
  - on securities-related disclosures and securities litigation risk
  - on IP protection
  - increased product liability risks

To listen to a recording of the presentation, click here.