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Regulatory Strategy For Pre Ind Meetings
Found 2 free book(s)Regulatory Strategy for Pre-IND Meetings with FDA: Why ...
www.biologicsconsulting.comRegulatory Strategy for Pre-IND Meetings with FDA: Why Meet and What to Ask Authors Ronald A. Salerno, PhD Kerin Ablashi, MS Debra Barngrover, PhD, RAC Kelly Reich, MS, RAC Acknowledgements David Lin, PhD Christopher Bussineau, PhD …
Clinical Development Plan Guide 110613 - Biostrategics
www.biostrategics.comRegulatory Considerations • Pre-IND meeting planning • IND documentation • Regulatory communications and meetings • Regulatory trends and intelligence • International regulatory planning Strategic Planning • Milestones and critical information availability • Key decision points • Go/no-go criteria