· SOP No. Revision No. Effective Date To be Reviewed Replaces Revision ... This section of PSUR...

5

Transcript of  · SOP No. Revision No. Effective Date To be Reviewed Replaces Revision ... This section of PSUR...

Page 1:  · SOP No. Revision No. Effective Date To be Reviewed Replaces Revision ... This section of PSUR should capture the brief summary of clinically important emerging
Page 2:  · SOP No. Revision No. Effective Date To be Reviewed Replaces Revision ... This section of PSUR should capture the brief summary of clinically important emerging
Page 3:  · SOP No. Revision No. Effective Date To be Reviewed Replaces Revision ... This section of PSUR should capture the brief summary of clinically important emerging
Page 4:  · SOP No. Revision No. Effective Date To be Reviewed Replaces Revision ... This section of PSUR should capture the brief summary of clinically important emerging
Page 5:  · SOP No. Revision No. Effective Date To be Reviewed Replaces Revision ... This section of PSUR should capture the brief summary of clinically important emerging

MDCG GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR ...

MDCG GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR ...

PSUR-Repository-API-Specification - Europaesubmission.ema.europa.eu/psur/api/PSUR-Repository-API... · Web viewThe requirements for the API specify a subset of the search terms used

PSUR-Repository-API-Specification - Europaesubmission.ema.europa.eu/psur/api/PSUR-Repository-API... · Web viewThe requirements for the API specify a subset of the search terms used

clinically isolated syndromes

clinically isolated syndromes

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

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

Structuring Clinically Integrated Networks: Legal, …media.straffordpub.com/products/structuring-clinically...2015/07/23  · A Clinically Integrated Network (CIN) is a selective

Structuring Clinically Integrated Networks: Legal, …media.straffordpub.com/products/structuring-clinically...2015/07/23  · A Clinically Integrated Network (CIN) is a selective

PSUR Repository user guide for NCA users - Europaesubmission.ema.europa.eu/psur/docs/PSUR Repository user guide f… · This document serves as a simple guide for NCA users to help

PSUR Repository user guide for NCA users - Europaesubmission.ema.europa.eu/psur/docs/PSUR Repository user guide f… · This document serves as a simple guide for NCA users to help

Das neue PSUR-Format (Periodic Benefit-Risk Evaluation … · Online PHARMA FORUM, 28. August 2013 Dr. Thomas Grüger 1 Das neue PSUR-Format (Periodic Benefit-Risk Evaluation Report)

Das neue PSUR-Format (Periodic Benefit-Risk Evaluation … · Online PHARMA FORUM, 28. August 2013 Dr. Thomas Grüger 1 Das neue PSUR-Format (Periodic Benefit-Risk Evaluation Report)

PSUR Repository - API Specification - Europaesubmission.ema.europa.eu/psur/api/PSUR-Repository-API-Specification.pdf · Users of the API are typically systems which will require a

PSUR Repository - API Specification - Europaesubmission.ema.europa.eu/psur/api/PSUR-Repository-API-Specification.pdf · Users of the API are typically systems which will require a

PSUR Repo Release Notes - eSubmission: Projectsesubmission.ema.europa.eu/psur/docs/PSUR Repo Rele…  · Web viewThis release also contains some fixes which are not ... is incorrect

PSUR Repo Release Notes - eSubmission: Projectsesubmission.ema.europa.eu/psur/docs/PSUR Repo Rele…  · Web viewThis release also contains some fixes which are not ... is incorrect

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

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

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

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

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 →

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 →

Periodic Safety Update Report (PSUR)

Periodic Safety Update Report (PSUR)

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

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: The TGA Approach...TGA requirements for PSUR • . • • • The TGA applies the requirement to submit PSUR as a condition of registration PSURs are not required for all registered

PSUR: The TGA Approach...TGA requirements for PSUR • . • • • The TGA applies the requirement to submit PSUR as a condition of registration PSURs are not required for all registered

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 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, PSUSA und EURD-Liste - ein Update · Dr. Irmgard Resch . Abteilung Begutachtung Pharmakovigilanz . PSUR, PSUSA und EURD-Liste - ein Update . AGES Gespräch 13.6.2017

PSUR, PSUSA und EURD-Liste - ein Update · Dr. Irmgard Resch . Abteilung Begutachtung Pharmakovigilanz . PSUR, PSUSA und EURD-Liste - ein Update . AGES Gespräch 13.6.2017

Fit for the PSUR repository? · •Qualified Person for PHV (QPPV) for each MAH ... Users should continue to report any issues they may have with the system through the PSUR Repository

Fit for the PSUR repository? · •Qualified Person for PHV (QPPV) for each MAH ... Users should continue to report any issues they may have with the system through the PSUR Repository

A CLINICALLY SILENT PHEOCHROMOCYTOMA · PDF filea clinically silent pheochromocytoma combined with subclinical cushing ’s ... feokromosİtoma ... a clinically silent pheochromocytoma

A CLINICALLY SILENT PHEOCHROMOCYTOMA · PDF filea clinically silent pheochromocytoma combined with subclinical cushing ’s ... feokromosİtoma ... a clinically silent pheochromocytoma

PSUR Requirements

PSUR Requirements