European Medicines Agency (EMA) requires the Marketing Authorisation Holders (MAHs) to register an Industry Single Point of Contact (i-SPOC). This is to inform the EMA… 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 »
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The FDA has published a new draft guidance to help Investigators comply with the safety reporting requirements in Clinical Trials 21-September-2021.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 »
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