AESI or Adverse Events of Special Interest
Adverse Events of Special Interest is an important concept in management of safety risks for medicinal products and vaccines. The is no single definition of… Read more »
Read MoreAdverse Events of Special Interest is an important concept in management of safety risks for medicinal products and vaccines. The is no single definition of… Read more »
Read MoreMHRA has again issued inspection metrics which has a lot interesting information. Note that the number of for cause inspections is high The UK’s national… Read more »
Read MoreUsers are reminded that certain preparatory steps must be taken before it is possible to use CTIS. Sponsor organisations opting for the organisation-centric approach that… Read more »
Read MoreFDA began accepting IND Safety Reports in E2B format, November 21. In preparation for the receipt of IND Safety Reports, FDA has posted the following… Read more »
Read MoreThe FDA has published a new draft guidance to help Investigators comply with the safety reporting requirements in Clinical Trials 21-September-2021. Recently, the recommendations for… Read more »
Read MoreEuropean Pharmaceutical Market Research Association (EphMRA) has revised the Adverse Event Reporting (AER) Guidelines in September 2021 (click here). The guideline provide the recommendations for… Read more »
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