As we talked about some pointers from ICH guidelines in my last post, to pick up from that points to move forword to understand or have a quick refresher of ICH guidelines. I agree they can be exhausting and cannot be so easy to be brief, as a novice i remember how it was difficult for me and still is sometimes. So let’s try and help people like me who struggle the same.
I was reading E2E guidelines and here are some interesting points i wanted to share that might also help you- For regulatory purpose for spontaneous report the relationship is unknown or is unclassified then also the event is considered as adverse drug reaction as opposed to event. To clarify in ICH guideline the definition of adverse event is where the causal relationship is not necessary, and reaction is where causal relationship is suspected. For seriousness too an important point put forward in guideline is…
