Glossary

Bacillus Calmette–Guérinvaccine

Bill of Testing

Clinical Development Plan

Clinical

Chemistry, Manufacturing, and Controls

Cost Of Goods

Critical Process Parameters

Critical Quality Attributes

Clinical Trial Application

Clinical Trial Material

Drug product

Drug substance

Ethics Committee

European Medicines Agency

First In Human

Global Alliance for Vaccines and Immunisation

Genetically Modified Organism

Good Manufacturing Practice

Health Economics and Outcome Research

Investigational Brochure

Intellectual Property

Key Opinion Leader

Material transfer agreement

Mycobacterium tuberculosis

Non Human Primate

National Immunization Programs

National Regulatory Authority

Pre-clinical

Product Development Plan

Product Development Plan

Prinicipal Investigator

Project management

 Prevention of Infection (endpoint)

Proof of Concept

Quality Control test

Regulatory Authority

Risk Management Programme

Stage Gate Criteria

Tuberculosis

Target Product Profile