Regulatory Quiz

This quiz has 10 questions.

  • The pass mark is 50%.
  • For questions where there is more than one correct answer, no marks will be awarded for a part correct answer.
  • At the end of the quiz, you be awarded a mark without revealing the correct response(s) to each question.

 

#1. From this date, all new Clinical Trial Applications in the EU can only be submitted under the Clinical Trials Regulation (EU) 536/2014

#2. Which of the following regulatory agencies is NOT a member of the Access Consortium, collaborative initiative of the following governmental authorities that regulate human medicines and other health products

#3. Which of the following regulatory agency/ies don’t participate in Project Orbis, a programme coordinated by the US FDA to review and approve promising cancer treatments?

#4. In the UK, the International Recognition Procedure licensing route replaces which of the following licensing routes?

#5. Which of the following is the new regulation on Health Technology assessment in the EU?

#6. Which of the following does the proposed new EU Pharmaceutical legislation repeal and replace ?

Select all that apply:

#7. The proposed new EU pharmaceutical legislation includes which of the following?

Select all that apply:

#8. When does the Windsor Framework, an agreement between the UK and the EU on the way forward in Northern Ireland come into effect?

#9. Which of the following will the new EU Health Technology Assessment Regulation cover?

Select all that apply:

#10. On this date, the EU Clinical Trials Directive will stop becoming applicable to all Clinical Trial Applications submitted before or after the entry into application of the EU Clinical Trials Regulation.

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Results

The quiz pass mark is 50% , so you have passed!

The quiz pass mark is 50%, so better luck next time!