'Post approval' presentation slideshows

Young Innovators 2011

545 views • 46 slides

Pharmacovigilance in Japan. ? Overview & Specific drug safety issue ?

Pharmacovigilance in Japan. ? Overview & Specific drug safety issue ?. Tomoko Okudaira Office of Safety ? ,Office of New Drug ? Pharmaceuticals & Medical Devices Agency ? PMDA ? ,JAPAN. Disclaimer. Translation note English and Japanese are not a perfect match

1.09k views • 28 slides

Pharmacovigilance in Japan. ? Overview & Specific drug safety issue ?

Pharmacovigilance in Japan. ? Overview & Specific drug safety issue ?. Tomoko Okudaira Office of Safety ? ,Office of New Drug ? Pharmaceuticals & Medical Devices Agency ? PMDA ? ,JAPAN. Disclaimer. Translation note English and Japanese are not a perfect match

287 views • 28 slides

Andrew Smith

Andrew Smith . Consultant, Navitas BioPharma Consulting Non-Exec. Director : Alliance Pharma. Previously NHS Institute for Innovation and Improvement; Chairman Fishawack Communications President, Parexel Medical Marketing Division, USA (5 yrs)

489 views • 26 slides

Division of Bacterial, Parasitic and Allergenic Products OVRR/CBER/FDA

Division of Bacterial, Parasitic and Allergenic Products OVRR/CBER/FDA. Laboratory Mission and Functions. Assure Safe and Effective Products for Immunological Control of Bacterial, Parasitic and Allergenic Agents Affecting Human Health. Research Review Post-licensure surveillance

463 views • 19 slides

Post Approval Monitoring Program

Post Approval Monitoring Program. by Louisa Gay Post Approval Monitoring Officer. What is Post Approval Monitoring Why should we do this Who will be involved Logistics Questions. Discussion Areas.

154 views • 15 slides

Post Approval Monitoring Program

Post Approval Monitoring Program. by Louisa Gay Post Approval Monitoring Officer. What is Post Approval Monitoring Why should we do this Who will be involved Logistics Questions. Discussion Areas.

338 views • 15 slides

Recast Clinicals

Recast Clinicals. Dr. Wolfgang Ecker CIE. Recast Clinicals. CIE has set up Task Force for Recast COM, FR, DE, IR, AT, PT, SE, UK; EUCOMED Presentation to COM: Autumn 2010. Recast Clinicals Clarification of Concepts. State of the art Sponsor of a Clinical Investigation PMCF

193 views • 6 slides

V Vannappagari, 1,2 J Albano, 3 N Koram, 1 H Tilson, 2 AE Scheuerle , 4 M Napier 2

Prenatal Exposure to Zidovudine and Risk for Ventricular Septal Defects and Congenital Heart Defects: Data From the Antiretroviral Pregnancy Registry (APR). V Vannappagari, 1,2 J Albano, 3 N Koram, 1 H Tilson, 2 AE Scheuerle , 4 M Napier 2.

114 views • 3 slides