Episode 1: “What you need to know about U.S. and EU Proposed Legislation: New Regulation Requirements and Assessing Systemic Risk”
Listen to Kelli Moll, partner, Schulte Roth & Zabel LLP discuss the proposed hedge fund regulations and their approach to systemic risk.
Pharma companies are seeking to bolster pipelines and cut costs more than ever before in preparation for looming patent expirations of blockbuster drugs. In this environment global collaborations are increasing while budgets are shrinking, and as a result Internet-based communication has taken a prominent position in clinical development.
The return on investment from using a clinical trial portal to manage document exchange and communication with investigative sites versus using traditional paper-based methods is clear. From reducing study start-up cycle time to expediting document distribution and management during conduct and close-out, the time and money savings are measurable. In addition, there are added benefits of security and control that come with using a portal that contribute to ROI.
Major changes are underway in the reporting and enforcement environment for drug safety, with new regulations now in place in the US and Europe that require sponsoring companies to provide timely, comprehensive and accurate information to authorities, virtually on demand. REMS, RMPs, RiskMAPS, the Sentinel Initiative and other FDA programs geared to identifying product safety risks before they emerge as public health challenges raise the bar on what the sponsors must do to comply.
Leading M&A practitioners discuss the findings of IntraLinks’ Global Corporate Development study and assess the attitude for dealmaking in North America, Europe and Asia-Pacific. The webcast also examines how relationships between stakeholders have been affected during the economic crisis, and who is now in the driving seat when it comes to getting a deal done.