Planning, Evaluation and Reporting of Safety Data During Drug, Biologic and Vaccine Development
View Presentation *Brenda Crowe, Eli Lilly and Company Keywords: safety, harms, safety analysis plan, data collection, analysis, reporting I will present recommendations for enhanced safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development. These include creation of a Program Safety Analysis Plan and a proactive, systematic approach for collecting and evaluating safety data. They are based on the recommendations of the Safety Planning, Evaluation, and Reporting Team (SPERT), a cross-company, multi-disciplinary team. SPERT’s recommendations are based on our review of relevant literature and on consensus reached in our discussions. SPERT’s recommendations may benefit the regulatory review process by applying predefined and more standardized safety evaluations to characterize the safety profile of a compound, which could help to provide more reliable and complete safety information to patients and health care providers at the time of new product marketing.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC