Essentials of European Medical Device Regulatory Affairs

PR – Pulse rate PRAC – Pharmacovigilance Risk Assessment Committee (EMA) PRAG – PSUR Repository Advisory Group PRD-PRV – Pediatric rare disease priority review voucher (US)

PREA – Paediatric Research Equity Act (US) PREG – Pandemic Response Expert Group PRIME – Priority medicines scheme P-RMS – PSUR reference member state (also see PSUR) prn – as needed (Latin: pro re nata) PRO – Patient reported outcome PRO-AE – Patient-reported outcomes in adverse event reporting PROM – Patient-relevant outcome measure PROSPER – Patient - reported outcomes safety event reporting PROTECT – Pharmacoepidemiological Research on Outcomes of Therapeutics PRR – Proportional reporting ratio

PRS – PIM review system (EU) – also see PIM PRSPH – Potential serious risk to public health PSA – Parallel scientific advice PSM – Pre-submission meeting PSMF – Pharmacovigilance system master file PSP – Paediatric study plan PSUR – Periodic safety update report PSUSA – PSUR single assessment PtC – Points to consider PT time – Prothrombin time PTD – Protection of technical documentation PTE – Patent term extension PUL module – Performance of the Upper Limb module PUMA – Paediatric-use marketing authorisation PV – Pharmacovigilance PVAR – Preliminary Variation Assessment Report PXRD – Powder xray diffraction PSR – Product safety reference PSS – Personal social services

QA – Quality assurance QALY – Quality-adjusted life year QbD – Quality by design QC – Quality control qd – once a day [Latin: quaque die] qds/qid – four times a day [Latin:quater die sumendum/quater in die] QIDP – Qualified infectious disease product (US) QMS – Quality management system QOF – Quality and Outcomes Framework (NICE, UK) QOL – Quality of life QoS – Quality overall summary QP – Qualified person QPPV – Qualified person for pharmacovigilance QR(C) – Quick response (code) (EU) QRD – Quality review of documents [template] (Q)SAR – Quantitative structure activity relationships QSE – Quality, safety and efficacy QSIT - Quality System Inspection Technique (US FDA)

QTPP – Quality target product profile QUAMED – Quality Medicines for All QWP – Quality Working Party (EMA) R&D – Research & development R4BP – Register for Biocidal Products RA – Rapid alert – but also: RA – Regulatory affairs

RADAR – Risk assessment of drugs analysis and response RAMA – Remote access for marketing authorisations (MHRA) RAPS – Regulatory Affairs Professionals Society (US) RAS – Rapid alert system