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Glossary

ANDA

abbreviated new drug application

API

active pharmaceutical ingredient

ASMF

active substance master file

BLA

biologics license application

CAPA

corrective and preventive actions

CEP

certificate of suitability to the monographs of the European Pharmacopoeia

CMC

chemistry manufacturing and control

CMO

contract manufacturing organisation

CPO

contract pharma organisation

CQA

critical quality attributes

CTA

clinical trial application

DSUR

development safety update report

eCTD

electronic common technical document

EMA

European Medicines Agency

eQMS

electronic quality management system

FSMP

food for special medical purposes

FTE

full time equivalent

GDP

good distribution practice

GMP

good manufacturing practice

GVP

good pharmacovigilance practice

HEOR

health economic outcomes research

HTA

health technology assessment

ICH Q3D

"INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE guidelines for elemental impurities"

ICER

incremental cost-effectiveness Ratio

IMPD

investigational medicinal product dossier

IND

investigational new drug

M&A

mergers and acquisitions

MAA

marketing authorisation application

MAH

marketing authorisation holder

NDA

new drug application

OOS

out of specification

OOT

out of trend

PBRER

periodic benefit-risk evaluation report

PIL

product information leaflet

PQR

product quality review

PSMF

pharmacovigilance system master file

PSUR

periodic safety update report

PV

pharmacovigilance

QMS

quality management system

QPPV

qualified person in pharmacovigilance

QA

quality assurance

QALY

quality adjusted life year

QC

quality control

QP

qualified person

R&D

research and development

RP

responsible person

SA

scientific advice

SMPA

Swedish Medicinal Products Agency

SmPC

summary of product characteristics

SOP

standard operating procedure

TPP

target product profile

WDA

wholesale distribution authorisation

Media

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.