Module 6

02/10/2024

Abbreviations

Regulatory

Disease-specific

DSUR

Development Safety Update Report

DMT

Disease modifying therapy

EPAR

European Public Assessment Report

mCRPC

Metastatic castration resistant prostate cancer

GxP

Good……. (manufacturing/laboratory/documentation/clinical ) Practice

MDD

Major depressive disorder

MAA

Marketing Authorisation Application

MTX

Methotrexate

ODD

Orphan Drug Designation

NSCLC

Non small cell lung cancer

OTC

Over-the-counter

PAH

Peripheral arterial hypertension

PAES

Post-authorisation Efficacy Study

SoC

Standard of Care

PASS

Post-authorisation Safety Study

Type II DM Type II Diabetes Mellitus

PIP

Paediatric Investigation Plan

PSUR

Postmarketing Safety Update Report

PUMA

Paediatric use marketing authorisation

RMP

Risk Management Plan

SmPC

Summary of Product Characteristics

TPP

Target Product Profile

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

67

Abbreviations

Regulatory Abbreviations

AR

Assessment Report

PAM

Post-authorisation measure Post-authorisation safety study

B/R CDS

Benefit Risk

PASS PDCO

Core Datasheet

Paediatric Committee

CHMP

Committee for Medicinal Products for Human Use

PhV

Pharmacovigilance

Coordination Group for Mutual Recognition and Decentralized Procedures (Human)

CMDh

PIP

Paediatric Investigation Plan

CMS

Concerned Member State

PL

Patient Leaflet

CSR

Clinical Study Report

PRAC

Pharmacovigilance Risk Assessment Committee

DHPC

Direct Healthcare Professional Communication

PSUR

Periodic Safety Update Reports

DLP

Data lock point

PUMA

Paediatric-use Marketing Authorisation

EC

European Commission

RDP

Regulatory Data Protection Risk Minimisation Measures Risk Management Plan Reference Member State Reference Safety Information

EdTs EMA EURD

Educational Tools

RMMs

European Medicines Agency

RMP RMS RSI SAG

EU Reference Dates

HTA NCA

Health Technology Assessment National Competent Authority

Scientific Advisory Group

OE

Oral explanation

SmPC

Summary of Product Characteristics

PAES

Post-authorisation efficacy study

USR

Urgent Safety Restrictions

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

68

34