e-Learning

Question 1

What is Regulatory Science?

Answer 1

Scientific and technical foundations upon which regulations are based in various industries – particularly those involving health or safety.

~ Wikipedia

Question 2

What is pharmaceutical regulatory affairs?

Hint: Regulation is a profession

Answer 2

Pharmaceutical regulatory affairs is a PROFESSION which acts as the interface between pharmaceutical industries and drug regulatory authorities around the world.

Industries - Regulatory Affairs - Regulatory Authorities

Question 3

What is ICH?

Answer 3

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

Question 4

ICH’s mission is:
To achieve greater ________ worldwide to ensure that ____________ medicines are developed and registered in the most __________ manner.

Answer 4

harmonisation;
safe, effective and high quality;
resource-efficient

Question 5

Which year was HSA accepted into ICH?

Answer 5

2017

Question 6

What are the implications of HSA’s acceptance into ICH?

Answer 6

1. HSA earned international recognition as a country with an advanced regulatory system for pharmaceutical products.
2. SG’s views will be represented when developing ICH guidelines.
3. Facilitate entry of local pharmaceutical and biotech industries into other markets.
4. Faster development of drugs and quicker access to new therapies for Singaporeans.

Question 7

What are the 4 categories of topics in the ICH guidelines?

Hint: Q-SEM

Answer 7

1. Quality
2. Safety
3. Efficacy
4. Multidisciplinary

Question 8

What is QSEM in the ICH guidelines?

Answer 8

1. Quality
2. Safety
3. Efficacy
4. Multidisciplinary

Question 9

How does harmonisation lead to better health?

Answer 9

1. Prevent unnecessary duplication of clinical trials and post-market clinical evaluations.
2. Development & manufacturing of new medicines
3. Registration & supervision of new medicines
4. Reduction of unnecessary animal testing without compromising safety & efficacy.