Learn why requirements for plain-language summaries of clinical studies, aimed at a broad, non-technical audience, could create new risks for sponsors.
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So far Ed Ricketts has created 16 blog entries.
Reserve your place at our webinar to learn about Health Canada PRCI requirements, differences with EMA policy 0070 and how to bring synergies between the two regulatory requirements.
Reserve a place on our webinar to explore the current state of regulatory technology and how it isn't fit for the challenges of regulatory lifecycle management and new regulatory operating models.
With the UK set to leave the EU in the near future, Kinapse examines the potential implications for the EU QPPV