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Pattern of USA Inc. | Regulatory Affairs Outsourcing ft Pattern of USA Inc. Homepage, FAQ
510(k) – Premarket Notification for Medical Device aka PMN AADA – Abbreviated antibiotic drug application ACTD – ASEAN common technical dossier ADR – Adverse drug reaction AE – Adverse event AIM – Active ingredient manufacturer AIMD – Active implantable medical device ANDA – Abbreviated new drug application API – Active *** ingredient AR – ***sment Report (European Union) ASMF – Active Substance Master File ATMPs – Advanced therapy medicinal products BA – Bioavailability BAP – Biotechnology Action Program BIND – Biological investigational new drug BLA - Biologic License Application BWP – Biotech Working Party (EMA) C&P – Chemistry and *** CA – Competent authority CANDA – Computer assisted new drug application CAP – Centrally authorized product CAPA – Corrective action and preventive action CAPLA – Computer Assisted Product License Application CCDS – Company core data sheet CD – Controlled drug CDSCO – Central Drug Standard Organization (India) cGLP – Current good laboratory practice cGMP – Current good manufacturing practice Cl – Total body clearance CLO – Clinical overview CLS – Clinical summary CMC – Chemistry – manufacturing – controls CMP – Certificate of Medicinal Product COA – Certificate of ***ysis CoFS – Certificate of Free Sale CP – Centralized procedure (European Union) CP – Comparability protocol (USA) CPP – Certificate of *** product CQA – Clinical quality assurance CR – Controlled release CRO – Clinical Research Organization CSI – Core safety information CSP – Core safety profile CSR – Clinical study report (European Union) CT – Clinical trial CTA – Clinical trial application CTA – Clinical trial authorization CTD – Clinical Trials Directive CTD – Common technical do***ent/dossier CTMS – Clinical trial management system CTS – Common technical specification CVM – Center for Veterinary Medicine (US) DACS – Detailed and critical summary DAE – Discontinuation due to an adverse event DDPS – Detailed description of pharmacovigilance system DMF – Drug master file DMS – Do***ent management system DP – Drug product DS – Drug substance DSUR – Development safety update report EA – Environmental ***sment EC – Ethics committee eCTD – Electronic common technical do***ent EDMF – European drug master file EDT – Electronic data transfer ENS – Early notification system EPA – Environmental Protection Agency EPL – Effective patent life ePSUR – Electronic periodic safety update report ERB – Ethical review board ESPAR – Executive Summary Pharmacovigilance ***sment Report EUA – Emergency Use Authorization EWG – Expert Working Group EWP – Efficacy Working Party FAR – Final ***sment report FMEA – Failure mode and effects ***ysis GCP – Good clinical practice GDP – Good distribution practice Generic - Generic drug GGP – Good guidance practice GLP – Good laboratory practice GMP – Good manufacturing practice GMP – Good management practice GPP – Good pediatric practice GPP – Good pharmacoepidemiology practice GpvP – Good pharmacovigilance practice GRB – Global Regulatory Board GRP – Good regulatory practice GSL – General sales list GSP – Good statistics practice GVP – Good pharmacovigilance practice HCP – Healthcare professional HEOR – Health economics and outcomes research HREC – Human Research Ethics Committee HTA – Health technology ***sment IB – Investigator’s brochure IC – Informed consent ICD – Informed consent do***ent ICSR – Individual case safety report IDE – Investigational Device Exemption IDMP – Identification of medicinal products IEC – Independent ethics committee IM – Issue management IME – Important medical event IMI – Innovative Medicines Initiative IMP – Investigational medicinal product IMPD – Investigational medicinal product dossier IMRDF – International Medical Device Regulatory Forum IMS – Information management strategy INDA – Investigational new drug application (USA) INDC – Investigational New Drug Committee IP – Intellectual property IPO – Intellectual Property Office IPR – Intellectual property rights IQM – Integrated quality management IRB – Institutional review board IRD – International registration do***ent IRN – Incident Review Network IS – Internal standard ISE – Integrated summary of efficacy ISRB – Integrated summary of risk benefit ISS – Integrated summary of safety KIT – Key intelligence topic KM – Knowledge management KOL – Key opinion leader LCM – Lifecycle management LLL – Lifelong learning MA – Marketing authorization MAA – Marketing authorization application (EU) MAH – Marketing authorization holder MAIL – Medicines Act Information Letter (UK) MAL – Medicines Act Leaflet (UK) MDCG – Medical Device Coordination Group MDD – Medical Device Directive MDEG – Medical Device Expert Group MDLO – Medical Device Liaison Officer MDR – Medical device reporting MERS – Multi-agency electronic regulatory system MHRA – Medicines and Healthcare products Regulatory Agency (UK) ML – Manufacturer’s license (UK) MOU – Memorandum of Understanding MRA – Mutual recognition agreement NAP – Nationally authorized product NBE – New biological entity NCE – New chemical entity NCO – Non clinical overview NCS – Non clinical summary NDAC – New Drug Advisory Committee (India) NIMP – Non-investigational medicinal product NME – New molecular entity OD – Orphan drug ODA – Orphan *** Act (USA) ODD – Orphan drug designation OIA – Official action indicated OOS – Out of specification OTC – Over-the-counter *** P&R – Pricing and reimbur***t P – *** only P to GSL – *** to General Sales List PA – Product authorization PAI – Pre-approval inspection PAR – Preliminary ***sment report PASS – Post authorization safety study PAT – Process ***ytical technology PDE – Personal daily exposure PER – *** evaluation report PGD – Patient group direction PI – Prescribing information PI – Production information PIL – Patient information leaflet PIM – Product information management (EMA) PIP – Pediatric investigation plan PMS study – Post-marketing safety study PMS – Postmarket(ing) surveillance POM – Prescription-only medicine POM to P – Prescription-only medicine to *** PPI – Patient and Public Involvement (UK) PRSPH – Potential serious risk to public health PSMF – Pharmacovigilance system master file PTE – Patent term extension PUMA – Pediatric-use marketing authorization PV – Pharmacovigilance PVAR – Preliminary Variation ***sment Report QA – Quality assurance QbD – Quality by design QC – Quality control QMS – Quality management system QOL – Quality of life QoS – Quality overall summary QP – Qualified person QPPV – Qualified person for pharmacovigilance QRD – Quality review of do***ents [template] RA – Regulatory affairs RAPS - Regulatory Affairs Professionals Society RCFID – Registration Certificate for Import of Drug RCT – Randomized controlled trial RDE – Remote data entry RDS – Repeat dose study RDT – Rising-dose tolerance REACH – Registration, evaluation, authorization, restriction of chemicals RI – Regulatory intelligence RING – Regulatory Intelligence Network Group rINN – Recommended international non-proprietary name RMM – Risk minimization measure RMP – Reference medicinal product RMR – Reaction monitoring report ROI – Return on investment RoW – Rest of world RP – Responsible person RPS – Regulated product submission Rx – Prescription S+T – Sampling and testing SAG – Scientific Advisory Group SAP – Scientific advice procedure SAWP – Scientific Advice Working Party SI – Statutory instrument SLA – Service level agreement SME – Significant medical event SMF – Site master file SMO – Site management organization SMQ – Standardized MedDRA query SOP – standard operating procedure SPIN – Special interest network SSC – Scientific Steering Committee TAG – The***utic Advisory Group TLV – Threshold limit value TOC – Table of contents TOD – Table of decisions TOPRA – The Organization for Professionals in Regulatory Affairs TPP – Target product profile USDA – United States Department of Agriculture VAI – Voluntary action indicated WC – Written confirmation WL – Wholesale dealer’s license WRAC – Worldwide Regulatory Affairs Committee WHO - World Health Organization

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