The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) topics are divided into four categories and ICH topic codes are assigned according to these categories. The ICH ‘Statistical Principles for Clinical Trials’ Guideline is part of:

What type of analysis would you use to address and communicate unmet need?

What is one major decision criterion for a positive HTA recommendation?

What is the denominator in a cost-utility analysis?

The following list contains descriptions of study designs and their names. Which name does NOT match the description?

Which of these statements are true? [2 correct answers] Identify Corrective Actions:

Which answer is correct about New vs. Existing data?

In the view of the G-BA, which trial durations are suitable for showing additional benefit in chronic diseases? Twelve weeks  Eighteen weeks 6 month   12 month  24 month

Quality Control… [2 correct answers]

In simple words, GMP means… [3 correct answers]