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Page 1: · Sistema di Qualità Aziendale in accordo alle UN EN ISO 9001:2008; ... PSUR, CES, ccsl, CTD, SEA ecc). Definizione ed implementazione di un piano di formazione annuale per il

Page 2: · Sistema di Qualità Aziendale in accordo alle UN EN ISO 9001:2008; ... PSUR, CES, ccsl, CTD, SEA ecc). Definizione ed implementazione di un piano di formazione annuale per il

Page 3: · Sistema di Qualità Aziendale in accordo alle UN EN ISO 9001:2008; ... PSUR, CES, ccsl, CTD, SEA ecc). Definizione ed implementazione di un piano di formazione annuale per il

Page 4: · Sistema di Qualità Aziendale in accordo alle UN EN ISO 9001:2008; ... PSUR, CES, ccsl, CTD, SEA ecc). Definizione ed implementazione di un piano di formazione annuale per il

Page 5: · Sistema di Qualità Aziendale in accordo alle UN EN ISO 9001:2008; ... PSUR, CES, ccsl, CTD, SEA ecc). Definizione ed implementazione di un piano di formazione annuale per il

Page 6: · Sistema di Qualità Aziendale in accordo alle UN EN ISO 9001:2008; ... PSUR, CES, ccsl, CTD, SEA ecc). Definizione ed implementazione di un piano di formazione annuale per il

Page 7: · Sistema di Qualità Aziendale in accordo alle UN EN ISO 9001:2008; ... PSUR, CES, ccsl, CTD, SEA ecc). Definizione ed implementazione di un piano di formazione annuale per il

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PSUR Repository user guide for MAH submissionsesubmission.ema.europa.eu/psur/docs/psur_docs/PSUR...Wasif Sabir 1.1, 1.2 05/11/14 Added “Create delivery file” screens and annotation

Submissions to the PSUR Repository via EMA Gateway…esubmission.ema.europa.eu/psur/docs/PSUR Repository Gateway we… · Ensure you are using the correct version of Java (version

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CCSL FCA e CNHI 2015 - AQCF-R · 2017. 10. 31. · Title: CCSL FCA e CNHI 2015 Author: sararinaudo Created Date: 7/8/2015 2:59:00 PM

PSUR Repository - API Specification - Europaesubmission.ema.europa.eu/psur/api/PSUR-Repository... · PSUR Repository - API Specification EMA/224103/2015 Page 1/45 19 August 2015

Verifying MARTE/CCSL Mode Behaviors using UPPAAL · MARTE provides CCSL – a time model and a clock constraint speciﬁcation lan-guage. CCSL is an expressive language that supports

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PSUR Repo Release Notesesubmission.ema.europa.eu/psur/docs/PSUR Repo Release... · 2021. 1. 1. · Release Notes PSUR Repository . Table of Contents ... Version 01.08.00 (Release

General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appelskog

New PharmacovigilanceLegislation: PSURs& Renewals - Psur… · A. PSURs: from the preparation of the PSUR to the implementation of European Commission decision/national actions 1

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The New PSUR/PBRER - bioforumconf.combioforumconf.com/isop/Files/HOT TOPICS PSUR 9 March14.pdf · The New PSUR/PBRER Dr Irene FERMONT, MD, MSc, EUQPPV ISOP ISRAEL Coordinator IFC

PSUR Submissions in Single Assessment via EMA ...esubmission.ema.europa.eu/gateway/eSubmissions of PSUR...Safety Update Reports” - stLegally binding since 1st April 2013 (1 publication

Lead Member State PSUR updated preliminary assessment reportjannel.se/methylphenidatePSUSA2015.pdf · PSUR – Periodic Safety Update Report . RMP – Risk Management Plan . RR –

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SCOPE Work Package 8 Lifecycle Pharmacovigilancewalkgroveonline.com/scope_training/WP8/Practical Guide on PSUR... · pects of PSUR / PSUSA assessment and the drafting of ... (SOP)

1994 2007 Ccsl Introduction Poster

1.1.1 New EU Guidance published on PSUR Submission (10 ...safetyobserver.com/download/free_access/SafetyObserver125.pdf · → Link to EMA News Release → Link to EMA PSUR Page →

ICH Guidance for PSUR

PSUR Submissions in Single Assessment via EMA …esubmission.ema.europa.eu/gateway/eSubmissions of PSUR via EMA... · PSUR Submissions in Single Assessment via EMA Gateway Webclient

PSUR Repository user guide for MAH submissions - …esubmission.ema.europa.eu/psur/docs/PSUR Repository user guide for... · list and products for which the active substance has been