Considerations for Managing Clinical Trials and Regulatory Filing Strategy During COVID-19 By Elaine B. Taylor Vice President, Regulatory Strategy and Policy, Synchrogenix, a Certara company2 1 This guidanc e is agreed b y the Clinic al T rials Expert Group (C TE G) of the E uropean Commission support ed b y the EMA , the Clinic al T rials F acilit ation and Coordination Group (C TF G) of the Heads of Medicines Agencies (HMA) and the GCP Inspect ors’ W orking Group c oordinat ed b y the EMA Figure 1. Timeline of COVID-19 Regulatory and Government Responses During First Few Months of COVID-19 Crisis Key dates Mitigate the impact of COVID-19 on your clinical trials and regulatory filing strategy Regulatory Agencies across the world have quickly responded to the COVID-19 pa

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