Trial / data amendments. Use of eCRFs: raw data / final report ... to paper submissions, but may change (CVMP is paperless: a first for the vets!) 10 ...
Presented by: Isabel Chicharo MDMS Lead Data Officer Controlled Term Lists in use by eAF Container category; Country Quantity operator; Units of Measurement; MRL ...
Requirements for manufacture. Manufacturing authorisation issued by national ... Inspection of manufacture. The European Medicines Regulatory Networking Model ...
A need for better harmonisation of criteria for analysis and assessment of cases ... how analysis should be carried out and to come up with harmonised criteria ...
Quality Risk Management ICH Q9 History Disclaimer: This presentation includes the authors views on quality risk management theory and practice. The presentation does ...
Quality Risk Management ICH Q9 History Disclaimer: This presentation includes the authors views on quality risk management theory and practice. The presentation does ...
Reliable clinical data. Animal welfare. Clinical personnel and owner safety ... Study documentation. Final report. Key issues for the implementation of GCP ...
Periodo largo para el registro en varios pa ses. Procedimiento Descentralizado: ... Un procedimiento para varios pa ses. Calendario predecible. RMS y CMS ...
... I dati raccolti serviranno per studi di farmacoepidemiologia e per la valutazione dell incidenza della SAR Consente la valutazione del bilancio rischio ...
Increased resistance due to 'non-human' antibiotic use (veterinary and ... resistance among S.aureus from clinical mastitis in cows and sales of penicillin ...
Head of Sector, Safety of Veterinary Medicines, EMEA. Veterinary ... MAH required to collect, evaluate & collate information on all suspected adverse ...
Mirror Groups. European Technology Platform for Global Animal Health (ETPGAH) 6 July 2006 ... European Technology Platform for Global Animal Health ...
le syst me fran ais de pharmacovigilance organisation, missions bonnes pratiques de pharmacovigilance autres syst mes de pharmacovigilance dans le monde
Title proposal for a regulation of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of ...
Email Lists of Interest. PDA Pharmaceutical Sci-Tech Discussion Group ... Discussion of the environment of the Sterility Test, and the protective function ...
Yokohama. November 2004. Draft for consultation. March 2005. Chicago ... ICH Q9 document or used as training material - Decision to be made in Yokohama ...
New Zealand. Endorsement by an Advisory Council. Publication in the regular news letter ... new scientific knowledge requires changes or amendments ...
The application for renewal of the MA was assessed in parallell with the re ... The Marketing Authorization was renewed by the EU-commission in July 2006, based ...
European Union Risk Evaluation Process on Safety of Chemical Additives used in Animal Nutrition PROFESSOR EU Risk Expert Sulhattin Yasar : sulhattinyasar@ ...
... and IT support group (Telematics) Enforcement. Communication. Homeopathics ... Recognises the importance of good telematics and efficient use of EU resources ...
Descripci n Detallada del Sistema de Farmacovigilancia ... Adoptar medidas para alentar la notificaci n. SEF-VET - Desarrollar y gestionar VIG A-VET. ...
European Partnership for Alternative Approaches to ... Paediatrics. Orphans. 141/2000. Legal framework for medicinal products. Pharmaceutical legislation ...
... are in the domain of the chemical engineer, plant manager, and quality group. ... Decisions are made in the plant and through various engineering groups. ...
La Legislaci n de EU en el tema residuos. EU legislation on residues ... Formic acid. II. none considered necessary. Lactic acid. II. none considered necessary ...
2 years if Paediatrics Investigational Plan (PIP) results included in the MA and ... PDCO Paediatric Committee - CAT Committee for Advanced Therapies ...
INAP Jornada Participaci n Espa a e-Goverment Uni n Europea 10 de ... EUDRA = European Union Drugs Regulatory Authorities. Estrategia telem tica de la EMEA ...
As adjuvant in the symptomatic treatment of diarrhea ... Herbal medicinal product used as adjuvant in the symptomatic treatment of minor articular pain. ...
Benchmarking the Competitiveness of the European Animal Health Industry. A Report by ... Limited Survey of Animal Health Companies in Europe and the USA' (2006) ...
Rational Dosing of Antimicrobial Drugs in Animals ... against which activity to be claimed Plasma ... PK measurements Determination of disease outcome ...
Cr e en 1995, constitue un des 3 p les de l'AFSSA. Ses sp cificit s : valuation et ... Administratifs. 4 M en 2005 (3/4 de redevances) Organisation int gr e, centr e sur les ...
(Institute for Honey Analysis) Bremen, Germany. Quality ... The flavour and aroma vary, but are derived from the plant origin. African Honey Trade Workshop ...
... 5 members with specific areas of complementary expertise ... Therapeutic e.g. New alternative to patients in treating, preventing or diagnosing a disease ...
Flea and Tick Products Market, by Product Type (Oral Pill, Powder, Spray, Collar, Spot On, Shampoo and Others), by Pet (Cat, Dog and Others) and by Distribution Channel (Convenience Stores, Hypermarket, Supermarket, Specialty Stores, Online Stores and Others) - Global Industry Insights, Trends, Outlook, and Opportunity Analysis, 2017-2025