ICH Guidelines definition
Examples of ICH Guidelines in a sentence
The medical records or other Source Documents, as defined by ICH Guidelines, that support the Study Results shall remain the property of Institution.
The medical records or other Source Documents, as defined by current ICH Guidelines, that support the Study Results shall remain the property of Institution.
IntelGenx shall provide Par with copies of any Form FDA 483 or other correspondence from the FDA or other applicable Governmental Authority regarding the compliance with Applicable Laws, including cGMP and ICH Guidelines, within one (1) business day of receipt by IntelGenx of such correspondence.
Application, shall comply in all material respect with ICH Guidelines (or other comparable regulation and guidance of any Regulatory Authority in the Territory), and, if and as applicable, the regulations and guidance of the FDA that constitute GLP and GMP.
Rhythm shall be responsible for reporting all adverse events (as defined in the then current edition of ICH Guidelines and any other relevant regulations or regulatory guidelines or any other safety problem of any significance, hereafter “Adverse Events”) relating to the Product to the appropriate regulatory authorities in the countries in the Territory in accordance with the appropriate laws and regulations of the relevant countries and authorities.