Singapore, Jan 25, 2008: Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, announced that its top executives will present at the 11th Annual Workshop for Clinical Data Management scheduled to held on January 31–February 1, 2008 in Tokyo, Japan.
Dr Barton Cobert, Vice President, Global Regulatory Initiatives & Pharmacovigilance will deliver speech in a session titled “The Importance of Reporting Adverse Effects.”
This annual meeting will deliver information to attendees about the clinical data management processes, as well as provide opportunities for clinical data management leaders to discuss the evolution of the industry.
In his presentation, Cobert will review the regulatory requirements for safety data reporting in the major regions. Additionally, Cobert’s presentation will address the areas critical to the success of clinical trials, including the requirements and mechanics of safety data collection. He will detail trends in clinical safety data collection, analysis and reporting, life cycle risk assessment, risk management, and risk management plans in the context of clinical trials. Cobert will also discuss clinical transparency in regard to registries of ongoing trials and safety data posted to internet registries, as well as privacy and data transmission issues.
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