November 2020
SAFETY OBSERVER N172
17 PAGES
EMA issues Q&As on DMC
New CTFG contraception guidance
MedDRA PtC Companion Document
Brexit Guidance updated
PUBLICATIONS / NUMBER 172
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Latest ReleaseSafety 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
And more...
Safety Observer 178Draft ICH E6(R3) Principles
New MedDRA Mappings
ABPI updates Guidance
FDA Regulatory Action
COVID-19 Vaccines & Safety
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Number of users
- 1 user
- 2 to 5 users
- 6 to 14 users
- 15 to 49 users
- 50 and + users
