'Pharmacovigilance' trends

Domains containing the tag 'Pharmacovigilance'

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1nextrials.com Nextrials Nextrials is an innovative, award-winning , ileader in web-based software solutions for the clinical research industry. Prism®, the Company’s clinical trial management software, brings together sophisticated trial management and electronic data capture (“EDC”) in a single package enabling clinical researchers to derive more value from trial data, accelerate time to market and substantially lower development costs. ... Clinical trial data collection and management software, services, CTMS, Safety, and Electronic data capture. Innovative leader in EDC to EHR Integration: n/a 54.00 n/a
2pharmacorama.com Pharmacorama - Connaissance des médicaments - Pharmacologie Pharmacorama - Connaissance des médicaments - Pharmacologie: n/a 2.00 n/a
3cato.com
Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
A full-service, privately held contract research organization provides expertise in the development of ***, biologics, medical devices, and nutrition products across a variety of the***utic areas.
Cato Research is a full-service contract research and development organization (CRO) with international resources dedicated to helping *** and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new ***, biologics, and medical devices to the people who need them.: n/a 1.20 n/a
4nextpharmajob.com drug development jobs: n/a 1.30 n/a
5clinicalleader.com
Clinical Leader - Helping clinical research professionals connect and collaborate
Clinical Leader offers the latest expert insights, trends, and thought leadership in clinical research that enables *** companies, contract research organizations, and supporting providers to build strong, collaborative relationships.: 50.18 1.60 00:52
6pharmazet.com
PharmaAZet - Your partner for solution of the challenges in regulatory affairs, pharmacovigilance, quality assurance in ***s, generics OTC, medical devices, food supplements and cosmetics – Europe, Central and Eastern Europe, Russia.
Throughout the Europe PharmAZet offers wide services in regulatory affairs services, pharmacovigilance, product development, quality assurance and marketing expertise in the field of generic, WEU, THMP, originators and biological/biotechnological products as well as medical devices, food supplements and cosmetics.: n/a 3.00 n/a
7sfpt-fr.org
SFPT, Société Française de Pharmacologie et de Thé***utique
Société Française de Pharmacologie et de Thé***utique: 33.61 1.87 00:18
8assured.co.uk Assured | Cyber Insurance Broker | Cyber Broker Assured is a trusted cyber insurance broker that helps businesses protect against cyber risks. Our team of experienced cyber brokers offer customised solutions to fit your unique needs. Contact us today.: 34.39 0.70 01:49
9apmhealtheurope.com
Real Time Newswire for *** & Healthcare news - APM Health Europe
Unique newswire producing pan-European healthcare & *** news in real time. It delivers breaking news on clinical trials, regulatory, pricing & reimbur***t, health economics, pharmacovigilance as well as covering the regular products and companies via its News in Brief….: n/a 1.00 n/a
10ams-europe.com
AMS Advanced Medical Services GmbH
Pharma- und HealthCare-Dienstleistungen, Klinische Forschung, CRO, AMNOG, Medical Science, Nutzendossiers, Marketing & Sales, Leasingaußendienst, Clinical, Research, Pharmacovigilance, Biostatistic, late stage, development, ***sment, Safety, Update, Report, Audit: 44.61 2.26 01:09
11gratisol.com Best Institute for Clinical Research in Hyderabad - Gratisol Life Sciences Best Institute for Clinical Research in Hyderabad - Gratisol Labs. Clinical Research Courses: Pharmacovigilance, Medical Writing, Clinical SAS, Medical Writing & Pre Placement Training.: 100.00 1.00 n/a
12doctinews.com Doctinews - Le magazine d’information médicale de référence au Maroc Doctinews est un support d’information destiné aux professionnels de santé et qui leur permet d’être au fait de l’actualité du secteur médical au Maroc.: 74.58 1.26 00:19
13regulatory.com.ua
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: 42.26 1.01 n/a
14meddeviceregulatorysummit.com 8th Annual Medical Device Regulatory and Quality Summit 2024 | Inventicon The only conference in India to create an exclusive platform for regulators, industry stalwarts to come under one roof to discuss and share ideas that would not only benefit their organisations, but the industry at large.: 43.14 1.01 n/a
15ecronacunova.com ECRON ACUNOVA Ecron Acunova is the leader in Clinical Research, Outsourcing Clinical trials, Clinical Data Management, Biostatistical services, Central reference lab services, BA/BE Services and Phase I to IV clinical trials: n/a 3.00 n/a
16acunovalife.com ECRON ACUNOVA Ecron Acunova is the leader in Clinical Research, Outsourcing Clinical trials, Clinical Data Management, Biostatistical services, Central reference lab services, BA/BE Services and Phase I to IV clinical trials: n/a 3.00 n/a
17thewritingjobs.com The Writing Jobs | Categories A job market site for writers, proofreaders, editors and copywriters. The Writing Jobs offers the resources and information you need to ist in your search for employment in the writing and editing fields.: n/a 3.00 n/a
18rapofarm.pl Rejestracja leków | Pharmacovigilance | Badanie czytelności ulotki Pharmacovigilance | Badanie czytelności ulotki | Usługi z zakresu doradztwa dla przemysłu farmaceutycznego, dokumentacja rejestracyjna produktów leczniczych.: n/a 0.00 n/a
19regenold.com Dr. Regenold GmbH Dr. Regenold GmbH is specialised in development, international regulatory affairs and market access. Founded in 1994, we have helped many clients gain marketing authorisations for their product developments both nationally and internationally.: n/a 0.00 n/a
20hiropharmaconsulting.com HiroPharmaConsulting ファーマコビジランスの未来を支えるコンサルテーション。「ファーマコヴィジランス」(Pharmacovigilance)、「有害事象安全性情報システム」。専門特化したコンサルテーションの提供。: n/a 0.00 n/a
21crcpharma.com CRC Pharma clinical research organization pharma, healthcare, biotechnology, crc pharma, pharmacovigilance, clinical study, clinical trials, manoj jadhav, cdisc solutions: n/a 0.00 n/a
22epimed.nl 404 Not Found Epimed.NL - For Epidemiologists!: n/a 3.00 n/a
23planimeter.hu Planiméter: Planiméter kft. Planiméter: Planiméter kft.: n/a 3.00 n/a
24optimuspharmaconsulting.com Optimus | Drug Development | Medical Devices | Consulting | Solutions Optimus Pharma Consulting is a Consulting Solutions and Service Provider to the Drug and Medical Devices industry. Biologics, Vaccines, rDNA products, Small molecules, Biotechnology products, NBE’s, NCE’s, NME’s, Medical devices, Diagnostics, API’s (Chemistry & Biotechnology), Generics and Formulations, Stem Cells, Oncology, Immunology, Endocrine disorders (Diabetes), Cardiovascular, Central nervous system, Anti-infective, Gastrointestinal, Genito-urinary, Respiratory, Blood disorders, Ophthalmology, Nutraceuticals, Specialty products: n/a 3.00 n/a
25drugee.com Drugee - pharmacovigilance Web 2.0 Drugee est une société développant des services de santé électronique innovants dans le domaines des vigilances sanitaires: n/a 0.00 n/a
26mrchouston.com MRC - Medical Research Consultants - Providing Medical Record Retrieval and ysis, Nurse Review, Legal Nurse Consultants, Litigation and M Tort Support, and Lien Resolution Founded in 1983, MRC offers a comprehensive support solution for legal, healthcare, and insurance professionals, including nurse review of medical records, record retrieval and management, lien research and resolution, coding audit and education, and call center services. MRC has supported some of the largest m torts on record, including toxic tort and products liability litigations, but also offers expertise in Pharmocovigilance, HCC Management, and individual personal injury cases. MRC is a certified woman-owned business, and is a preferred vendor for several major manufacturers and companies.: n/a 3.00 n/a