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American Course on Drug Development and Regulatory Sciences (ACDRS)
Department of Bioengineering and Therapeutic Sciences
UCSF Schools of Pharmacy and Medicine
[email protected]

"Although I have career experiences from basic science research to pharmaceutical clinical trial support and development, I sought a formal course that could fill the gaps between on the job training and experience in drug development. The ACDRS course, highly recommended by a colleague, provided an A to Z experience which ranged from early to final stages of development. An intensive resource library for self-readings and expert in depth presentations and critical discussions were the foundation for a full exposure to progressive steps in developing a drug. Authors of books and FDA guidance documents, pharmaceutical executives and clinical and foundation professionals were the instructors. The pairing of these expertise with team discovering through case studies resulted in a dynamic learning process that both engaged and fortified my knowledge in statistical modeling, identifying a potential molecule for development, strategies for planning each phase of clinical trials, interpretation of results, go-no go decision-making and a number of other topics. Also this included multi-countries marketing applications and agency policies for a more expansive view of drug development and research planning. The course for me was an amazing experience from instruction and content to fellow participants and self-development that was both demanding and rewarding. The result is I am a more confident and engaged contributor with global understanding of drug development components when I sit at the planning and decision table at my pharmaceutical company. ACDRS did not disappoint. I have a lasting body of knowledge, resources and colleagues to reference and achieved the goal of filling gaps in my drug development knowledge. Thanks ACDRS!"
Deena Kegler-Ebo, Associate Director, Clinical Development, Medical Affairs, Acorda Therapeutics