Glossary
BCG
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Bacillus Calmette–Guérinvaccine

BOT
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Bill of Testing

CDP
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Clinical Development Plan

CL
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Clinical

CMC
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Chemistry, Manufacturing, and Controls

COG
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Cost Of Goods

CPP
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Critical Process Parameters

CQA
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Critical Quality Attributes

CTA
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Clinical Trial Application

CTM
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Clinical Trial Material

DP
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Drug product

DS
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Drug substance

EC
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Ethics Committee

EMA
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European Medicines Agency

FIH
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First In Human

GAVI
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Global Alliance for Vaccines and Immunisation

GMO
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Genetically Modified Organism

GMP
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Good Manufacturing Practice

HEOR
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Health Economics and Outcome Research

IB
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Investigational Brochure

IP
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Intellectual Property

KOL
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Key Opinion Leader

MTA
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Material transfer agreement

Mtb
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Mycobacterium tuberculosis

NHP
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Non Human Primate

NIP
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National Immunization Programs

NRA
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National Regulatory Authority

P-CL
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Pre-clinical

PDP
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Product Development Plan

PDP
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Product Development Plan

PI
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Prinicipal Investigator

PM
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Project management

POI
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 Prevention of Infection (endpoint)

PoC
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Proof of Concept

QC test
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Quality Control test

RA
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Regulatory Authority

RMP
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Risk Management Programme

SGC
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Stage Gate Criteria

TB
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Tuberculosis

TPP
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Target Product Profile