February 2021
SAFETY OBSERVER N175
16 PAGES
Draft GVP Module XVI on RMMs
EMA CTIS Training
Post-Brexit Guidance
Canada ADR Reporting guidance
And more...
PUBLICATIONS / NUMBER 175
Stay on top of all key Pharmacovigilance Regulatory requirements
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Latest ReleaseSafety Observer 181EU Clinical Trial Regulation
EU consults on Pharmacovigilance
EMA Signal Detection Pilot
Hong Kong updates PV Guidance
Safety Observer 180PSURs for COVID-19 vaccines
MHRA, Health Canada and DSURs
FDA Trial Safety Reporting
EMA consults on ePI
ANSM and PV in Compassionate Use
Safety Observer 179EMA Training on CTIS
Canada & Combination Products
New PV Guidance in South Africa
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