Clinical Trial Disclosure – Keeping Ahead of the Wave; A Webinar Presented by Dechert LLP and Hyman, Phelps & McNamara, P.C.June 18, 2013
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 (see our previous post here). 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, titled "Clinical Trial Disclosure: Keeping Ahead of the Wave," 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
David B. Clissold, Director, Hyman, Phelps & McNamara, P.C.
Hope S. Freiwald, Partner, Complex Commercial Litigation/Life Sciences, Dechert LLP
David A. Kotler, Partner, White Collar and Securities Litigation/Life Sciences, Dechert LLP
Jonathan A. Schur, Partner, Corporate and Securities/Life Sciences, Dechert LLP
Roger C. Thies, Director, Hyman, Phelps & McNamara, P.C.
Tuesday, June 25, 2013, from 12:45 PM – 1:45 PM EDT. Please confirm your attendance by Monday, June 24. Further details, including how to connect to the webinar, will be provided closer to the program. Application for Continuing Legal Education ("CLE") credit is currently pending in California, New Jersey, New York and Texas. Please email Pamela Lashbrook (firstname.lastname@example.org) with any questions, or if you require CLE credit in another jurisdiction.