BIO Submits Comments to EMA on Strategies to Identify and Mitigate Risks for First-In-Human and Early Clinical Trials with Investigational Medicinal Products
February 28, 2017
BIO submitted comments to the European Medicines Agency (EMA) on the guideline, Strategies to Identify and Mitigate Risks for First-In-Human and Early Clinical Trials with Investigational Medicinal Products.
BIO says it’s important the guideline acknowledges and differentiates the requirements for trials conducted in high-morbidity and high-mortality disease states such as advanced stage cancers, as in such settings more flexibility should be applied. This is already recognized by regulators in other guidance documents (e.g., ICH S9 guideline). Other comments include discussion of maximum doses in healthy volunteer studies, sentinel dosing, and more.
Download Full Comments Below
2017.02.28 BIO Comments On EMA First-in-human FINAL
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BIO submitted comments to the European Medicines Agency (EMA) on the guideline, Strategies to Identify and Mitigate Risks for First-In-Human and Early Clinical Trials with Investigational Medicinal Products.
BIO says it’s important the guideline acknowledges and differentiates the requirements for trials conducted in high-morbidity and high-mortality disease states such as advanced stage cancers, as in such settings more flexibility should be applied. This is already recognized by regulators in other guidance documents (e.g., ICH S9 guideline). Other comments include discussion of maximum doses in healthy volunteer studies, sentinel dosing, and more.