TGA
TGA has adopted the following 3 international scientific guidelines:
- ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
- Guideline on quality documentation for medicinal products when used with a medical device.
- Guideline on good pharmacovigilance practices (GVP) Module I - Pharmacovigilance systems and their quality systems.
Enquiries
/Public Release. This material from the originating organization/author(s) might be of the point-in-time nature, and edited for clarity, style and length. Mirage.News does not take institutional positions or sides, and all views, positions, and conclusions expressed herein are solely those of the author(s).View in full here.
