Planning, Evaluation and Reporting of Safety Data During Drug, Biologic and Vaccine Development
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*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.