Month: <span>February 2021</span>

Month: February 2021

Understanding E2B

The electronic transmission of adverse event information to stakeholders, using International Conference on Harmonization (ICH) E2B standard, is an essential component of global drug safety and pharmacovigilance operations. E2B(R3) is the current version of the International Standards Organization (ISO) Individual Case Safety Report (ICSR) standard. What is E2B? E2B doesn’t …

TGA – Pharmacovigilance obligations of medicine sponsors

The TGA has published answers to FAQ’s relating to the pharmacovigilance obligations of sponsors of medicines on the ARTG. The aim is to support understanding of the pharmacovigilance responsibilities of medicine sponsors. The following topics are covered in the FAQ: Collecting and reporting adverse drug reactions. Post-registration studies and post-marketing …

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