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Documents DAIDS Safety Workshop: Part III Expedited Reporting via DAERS Albert Yoyin, M.D. and Archita...

Slide 1DAIDS Safety Workshop: Part III Expedited Reporting via DAERS Albert Yoyin, M.D. and Archita Chatterjee, M.S. DAIDS RSC Safety Office Johannesburg, South Africa 29…

Documents Pharmacovigilance and ICH guidlines

1. PHARMACOVIGILANCEPHARMACOVIGILANCE & ICH GUIDELINES& ICH GUIDELINES Prepared by Mr.C.STALIN.M.Pharm.,(Ph.D) Technical Associate, Adverse events Monitoring Centre,…

Documents This project has been funded in whole or in part with Federal funds from the Division of AIDS...

Slide 1 This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National…

Documents ICH E-5 Overview and Current Topics Mamoru Narukawa.

Slide 1ICH E-5 Overview and Current Topics Mamoru Narukawa Slide 2 World Drug Sales in 11 leading countries (IMS 2001) Slide 3 Origin of New Drugs in the World Market (Med…

Documents Expedited Reporting/DAERS May 13, 2011 Oluwadamilola Ogunyankin, M.D. Chinedum Abanobi, M.D. DAIDS.....

Slide 1Expedited Reporting/DAERS May 13, 2011 Oluwadamilola Ogunyankin, M.D. Chinedum Abanobi, M.D. DAIDS Regulatory Support Center (RSC) Oluwadamilola Ogunyankin, M.D. Chinedum…

Documents Manual v2.0 Changes and DAERS Lawrence Allan (HJF – DAIDS) Dr. Oluwadamilola Ogunyankin (RSC...

Manual v2.0 Changes and DAERS Lawrence Allan (HJF â DAIDS) Dr. Oluwadamilola Ogunyankin (RSC Safety Office) November 15, 2010 HVTN Network Meeting. Seattle, WA Objectives…

Documents Safety Workshop: Part II Expedited Reporting & Assessment Olu Ogunyankin, MD DAIDS Regulatory...

Safety Workshop Part II - Expedited Reporting - Durban 2011 Safety Workshop: Part II Expedited Reporting & Assessment Olu Ogunyankin, MD DAIDS Regulatory Support Center…

Documents Version 2 Expedited Reporting of Adverse Events to the DAIDS 1 Division of AIDS / NIAID.

DAIDS Planning Update Version 2 Expedited Reporting of Adverse Events to the DAIDS 1 Division of AIDS / NIAID 1 2 Objectives Expedited Reporting Policy Distinguish changes…

Health & Medicine Adverse Event Reporting Guidelines - Cancer Therapy Evaluation ...

1. Rev 7/06 JM 1 CTEP, NCI GUIDELINES: ADVERSE EVENT REPORTING REQUIREMENTS Effective ????? AdEERS Medical Help Desk Contact Information: Phone: 301.897.7497 Fax: 301.230.0159…