July 2020
SAFETY OBSERVER N169
22 PAGES
COVID-19 Guidance
New CIOMS DILI Guidance
FDA updates E2B Guidance
FDA updates REMS Guidance
EU PV Training Material
PUBLICATIONS / NUMBER 169
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Latest ReleaseSafety 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
Safety Observer 175Draft GVP Module XVI on RMMs
EMA CTIS Training
Post-Brexit Guidance
Canada ADR Reporting guidance
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Number of users
- 1 user
- 2 to 5 users
- 6 to 14 users
- 15 to 49 users
- 50 and + users
