Module 1 2021

25/06/2021

QUESTIONS?

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Abbreviations

AE

Adverse Event

PIP

Paediatric Investigation Plan

BLA

Biologic License Application

PM Project Management

CMC Chemical,Manufacturing and Controls

PMF

Plasma Master File

CMO

Contract Manufacturing Organization

PoC

Proof of Concept

CPP

Certificate of Pharmaceutical Product

PV

Pharmacovigilance

CTA(s) Clinical Trial Application(s)

QC

Quality Check/Control

DMF

Drug Master File

RA

Regulatory Affairs

DMA Data Management System

R&D Research & Development

(e)CTD (Electronic) Common Technical Document ROW Rest of World EMA European Medicines Agency R&R

Roles & Responsibilities

EU

European Union

RUT

Readability User Test

FTIH First Time In Human

SA

Scientific Advice

GMP

Good Manufacturing Practice

SWOT Strengths, Weaknesses, Opportunities, Threats

IV

Intravenous

TC(s)

Teleconference(s)

LCM Life Cycle Management

TOC

Table of Contents

LOI

Letter of Intent

TPP

Target Product Profile

MAA Marketing Authorisation Application

TT

Tech Transfer

Mgt

Management

xTPP

X Traget Product Profile (X= Clinical or Quality or Critical)

PAC

Post Approval Commitment

US

United States

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