regulatory framework 1

Question 1

Why do we need rules and regulations?

Answer 1

To ensure the Quality, Safety, Efficacy of medicinal products (QSE)

Question 2

What’s a Medicinal product?
German Medicinal product Act Definition

Answer 2

Substances that are used to treat diseases, to relieve complaints, or to prevent such diseases or complaints in the first place (Human or animals)

Question 3

EMA

Answer 3

European Medicine Agency

Question 4

FDA

Answer 4

Food and Drug Agency

Question 5

WHO

Answer 5

World Health Organisation

Question 6

PEI

Answer 6

Paul Ehrlich Institute

Question 7

RKI

Answer 7

Robert Koch Institute

Question 8

BfARM

Answer 8

Bundesministerium für Arzeimittel und Medizinprodukte

Question 9

ICH

Answer 9

International Conference on Harmonisation

Question 10

EDQM

Answer 10

European Directorate for the Quality and Medicines and Healthcare

Question 11

Ph. Eur

Answer 11

European Pharmacopeia

Question 12

USP

Answer 12

United State Pharmacopoeia

Question 13

cGMP

Answer 13

current Good Manufacturing Practice

Question 14

AMG

Answer 14

Arzeimittelgesetz (Medicinal Product Act)

Question 15

SOP

Answer 15

Standard Operating Procedure

Question 16

Medicinal Product definition
According to European Medicine Agency (EMA)

Answer 16

Substances that intended to treat, prevent or diagnose a disease or to restore correct or modify physiological functions by exerting pharma