Índice

  • 01

    COURSE INFORMATION

  • 02

    Introduction

    • Introduction
  • 03

    PSUR Periodic Safety Update Report

    • PSUR

    • PSUR - EURD list

    • PSUR - Content

    • PSUR - Submission

    • PSUR - Assesment Report
  • 04

    DSUR Development Safety Update Report

    • DSUR
  • 05

    RMP Risk Management Plan

    • RMP

    • RMP - Format and Content
  • 06

    ACO Addendum to the Clinical Overview

    • ACO - Objective

    • ACO - Formatand Content