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ICH E6 Questions & Correct Answers Pack | Grade A+
ICH E6 Questions & Correct Answers Pack | Grade A+
[Show more]ICH E6 Questions & Correct Answers Pack | Grade A+
[Show more]Adverse Drug Reaction 
: All noxious and unintended responses to a medicinal product related to any dose; i.e. a 
causal relationship between a medicinal product and an adverse event is at least a reasonable 
possibility. 
Adverse Event 
: Any untoward medical occurence in a patient or clinical in...
Preview 2 out of 15 pages
Add to cartAdverse Drug Reaction 
: All noxious and unintended responses to a medicinal product related to any dose; i.e. a 
causal relationship between a medicinal product and an adverse event is at least a reasonable 
possibility. 
Adverse Event 
: Any untoward medical occurence in a patient or clinical in...
How long should essential documents be retained? 
: At least 2 years after the last approval of the marketing application in an ICH region; 
until there are no pending marketing applications or at least 2 years from formal 
discontinuation of the clinical development of an IP. 
Who should make ava...
Preview 3 out of 22 pages
Add to cartHow long should essential documents be retained? 
: At least 2 years after the last approval of the marketing application in an ICH region; 
until there are no pending marketing applications or at least 2 years from formal 
discontinuation of the clinical development of an IP. 
Who should make ava...
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