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Documents 1 The CDISC-HL7 Standard An FDA Perspective Armando Oliva, M.D. President, Avilo Consulting LLC...

Slide 11 The CDISC-HL7 Standard An FDA Perspective Armando Oliva, M.D. President, Avilo Consulting LLC Former Deputy Director for Bioinformatics Office of Critical Path Programs…

Documents Informa Atmp Gert Bos Nov 2009 Final

1. Regulatory challenges for combination-ATMP products Gert Bos BSI HealthcareDrug device Combination ProductsInforma, Prague, CZ17 November 2009 2. This presentation …

Documents Reducing the Medicalization of Maternal and Newborn Care July 2013.

Slide 1 Reducing the Medicalization of Maternal and Newborn Care July 2013 Slide 2 Session Objectives The objectives of this session are to:  Introduce the concept of…

Documents Roadmap of stability studies for Biosimilar product development Dr. Rashbehari Tunga Head Biotech...

Slide 1 Roadmap of stability studies for Biosimilar product development Dr. Rashbehari Tunga Head Biotech Stelis Biopharma 1 Slide 2 Index Introduction Regulatory guideline…

Documents FEEDBACK FROM SAPRAA WORKSHOP WITH PPB DR DORCAS PETA 18 NOVEMBER 2011.

Slide 1 FEEDBACK FROM SAPRAA WORKSHOP WITH PPB DR DORCAS PETA 18 NOVEMBER 2011 Slide 2 QUESTIONS RECEIVED CTD GMP Inspections Analysis of Samples Product Retention and Fees…

Documents Unsafe Abbreviations: MultiCare Health System Will Barnes, Celeste Derheimer and Margo Forstrom...

Slide 1 Unsafe Abbreviations: MultiCare Health System Will Barnes, Celeste Derheimer and Margo Forstrom Washington Patient Safety Coalition May 25, 2005 Teleconference Slide…

Documents An Interactive Approach to Good Clinical Practices (GCPs) Brandi N. Ring, M.A. Boston University...

Slide 1 An Interactive Approach to Good Clinical Practices (GCPs) Brandi N. Ring, M.A. Boston University School of Medicine Slide 2 Good Clinical Practices (GCPs)  ICH…

Documents Reducing the Medicalization of Maternal and Newborn Care

July 2013 Session Objectives The objectives of this session are to: Introduce the concept of “medicalized” care Provide examples of maternal and newborn health (MNH)…

Documents General Overview of Code of Federal Regulations 21 Part 58 Good Laboratory Practices.

General Overview of Code of Federal Regulations 21 Part 58 Good Laboratory Practices Why GLP regulations ? SAFETY Non-clinical safety studies are to protect the safety of…

Documents Louisiana Hospitals

In the Beginning... 2004 State of the Union Address President Bush called for electronic health records for most Americans within 10 years. In an executive order, he created…