December 2020
SAFETY OBSERVER N173
20 PAGES
EU Clinical Trial Regulation
New FDA Draft Guidance
PV in the COVID-19 era
Product Safety News
PUBLICATIONS / NUMBER 173
Stay on top of all key Pharmacovigilance Regulatory requirements
We do the search and bring you the regulatory information you need to achieve compliancein your Pharmacovigilance operations.
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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Choose the number of users for this product
Number of users
- 1 user
- 2 to 5 users
- 6 to 14 users
- 15 to 49 users
- 50 and + users
