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Weekly GCP Challenge

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.


Challenge: Regulatory What Is It?

Question Number 1:

ISS - What is it?
A
 Regulatory Agency in Italy
B
 Summary of Safety data used for New Drug Applications to the FDA
C
 Indian version of GCP
D
 The Central Ethics Committee in Iceland

Question Number 2:

CTD - What is it?
A
 Canadian Regulatory Agency
B
 The equivalent of an Investigators Brochure for Medical Devices
C
 The Document detailing the Chemical Technical aspects of an investigational product
D
 A set of standards for new drug application dossiers

Question Number 3:

TPD - What is it?
A
 Document summarising the Tolerability Profile for New Drug Applications
B
 The Dossier detailing the Therapeutic Profile of a Pharmaceutical
C
 The Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use
D
 A type of blister packaging used to pack IMPs

Question Number 4:

SPC - What is it?
A
 A document providing information on the medicinal product, including therapeutic indications, posology and method of administration, contraindications, warnings and precautions for a marketed product in Europe
B
 Document detailing the Safety Profile for a New Drug Application
C
 Statement of Protection provided to subjects in specific trials
D
 A paediatric investigational plan within the EU

Question Number 5:

MRP - What is it?
A
 The Regulatory Agency of Mexico
B
 One of three possible methods for obtaining marketing authorisation in Europe
C
 A document detailing the manufacturing purity of a pharmaceutical product
D
 A Indian Guidelines for the content of Regulatory Packages

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