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
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Latest ReleaseSafety Observer 178Draft ICH E6(R3) Principles
New MedDRA Mappings
ABPI updates Guidance
FDA Regulatory Action
COVID-19 Vaccines & Safety
Safety Observer 177EU Clinical Trial Regulation
FDA and E2B requirements
Health Canada & ePI
COVID-19 Vaccines & Safety
Servier and Mediator
Safety Observer 176EMA and ISO IDMP Standards
COVID-19 Vaccines & Safety
COVID-19 Vaccines & Virus Variants
MHRA & RSI in Clinical Trials
New FDA E2B Requirement
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Number of users
- 1 user
- 2 to 5 users
- 6 to 14 users
- 15 to 49 users
- 50 and + users
