CRP 113 Lecture 2

Question 1

The need post-Belmont Report

Answer 1

-foreign clinical trial data, duplicated CTs loss of time and money
-regional variability in regulations for CTs
-need a standard for the EU, Japan and USA regions to facilitate mutual acceptance of CT data by regional regulatory bodies

Question 2

ICH

Answer 2

international council for harmonization
-joint initiative of reg authorities,academia, pharma industry, as equal partners to ensure and assess safety, quality and efficacy of drugs
-1990: Tripartite ICH guidelines on Quality (Q), Safety (S) and Efficacy (E)

Question 3

purpose of ICH (5)

Answer 3

-prevent unnecessary dupliation of CTs and post marke evaluations
-development and manufacturing of new drugs
-registrtion and supervision of new drugs
-reduce unnecessary animal testing without compromising safety and efficacy
-promote public health through harmonization

Question 4

Quality guidelines

Answer 4

-stability, purity, and GMP risk management

Question 5

Efficacy guidelines

Answer 5

-design, conduct, safety and reporting of clinical trials.
-also inludes pharmacogenetics, genomics, and techniques for targeting drugs

Question 6

Safety guidelines

Answer 6

-carcinogenicity, genotoxicity, reprotoxicity
-typically nonclinical studies

Question 7

Multidisciplinary guidelines

Answer 7

-medical terminology, common technical document, electronic standards for transfer of regulatory information (ESTRI)

Question 8

what is GCP(3)

Answer 8

-international ethical and scientific qualiy standard for designing, conducting, recording and reporting of trials involving human participants
-reported results are credible and accurate
-ensure rights, integrity and confidentiality of participants

Question 9

ICH GCP key objectives (3)

Answer 9

-describe key responsibilities of all individuals in the conduct of clinical trials
-describe approaches to CT design, conduct, oversight, recording, monitoring, reporting and archiving while ensuring subject protection and reliabiltiy of results
-describe electronic records and essential document standards to increase CT quality and efficiency

Question 10

ICH GCP Purpose (4)

Answer 10

-unify registration requirements for new IP
-reduce drug development costs, more economical use of animal, human and material resources
-accelerate drug product licensing times, avoid repeat testing
-increase patent protection times