'Clinical trial data' diaporamas de présentation

US FDA Foreign Inspection s; Clinical Investigators

US FDA Foreign Inspection s; Clinical Investigators. At: Mahidol University Date: 1 MAR 2013 By: Pravich Tanyasittisuntorn, MD, EMBA, MSc. in Pharm Med. Overview. Organizations Involved. Center headquarters :

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Improving Stroke Prevention in Patients With Atrial Fibrillation

Improving Stroke Prevention in Patients With Atrial Fibrillation. Acknowledgement. Disclosures. Disclosures (cont.) . This presentation will not include any non-FDA approved or investigational uses of products or medical devices. Learning Objectives.

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Research Infrastructures to boost R&D in the field of rare Diseases

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Off-Label Communications and the Public Health Presentation to the Pharmaceutical Compliance Forum November 8, 2007

Off-Label Communications and the Public Health Presentation to the Pharmaceutical Compliance Forum November 8, 2007. Paul E. Kalb, M.D., J.D. With appreciation for the contributions of Joan McPhee and Alan Bennett of Ropes & Gray and Dan Troy of Sidley Austin. Overview. Introduction

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Gender Aspects in Drug Development and Approval The American Experience

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Monitoring and Special Considerations for Multi-Center Trials

533 views • 41 slides

Regulatory Application of Quantitative Analysis: Impact of Biomarker Data

Regulatory Application of Quantitative Analysis: Impact of Biomarker Data. Yaning Wang, Ph.D. yaning.wang@fda.hhs.gov Team Leader, Pharmacometrics Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration.

749 views • 40 slides

459 views • 31 slides

Comparative Effectiveness Research Plan Science board meeting November 15, 2010

Comparative Effectiveness Research Plan Science Board Meeting November 15, 2010 Comparative Effectiveness Research Plan Science board meeting November 15, 2010 Comparative Effectiveness Research Patient-Centered Health Research

973 views • 24 slides

Comparative Effectiveness Research Plan Science board meeting November 15, 2010

Comparative Effectiveness Research Plan Science Board Meeting November 15, 2010. Comparative Effectiveness Research Plan Science board meeting November 15, 2010. Comparative Effectiveness Research Patient-Centered Health Research.

460 views • 24 slides

Milan Smid, MD, PhD

Demonstration of bioequivalence for TB medicines . Milan Smid, MD, PhD. Tutorial: Quality of Pharmaceutical Ingredients, TB medicines, Beijing, 31 March, 2010.

477 views • 22 slides

Building a Strong Research Team

Building a Strong Research Team. Melissa Adde, INCTR. What Do We Mean by a Strong Research Team?. Research Team : A group of people working together in a systematic and scientific manner to establish facts

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The Food and Drug Administration Amendments Act of 2007: Implications of the Drug Safety Provisions

The Food and Drug Administration Amendments Act of 2007: Implications of the Drug Safety Provisions. Carolyn D. Jones, J.D., MPh Director, Regulatory Policy Biogen Idec Inc. November 30, 2007. What is FDAAA?. New legislation that Was signed into law on September 27, 2007

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GCP for Investigators

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FDA Standards Development and Implementation

Pharm Toxicology Advisory Subcommittee Meeting June 10, 2003. FDA Standards Development and Implementation. Randy Levin, M.D. Director, Office of Information Management Center for Drug Evaluation and Research Food and Drug Administration. Overview. Standards organizations

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Data Warehousing for the Reporting and Management of Clinical Data Robert Ellison, ICON CLINICAL Research Plc

Data Warehousing for the Reporting and Management of Clinical Data Robert Ellison, ICON CLINICAL Research Plc. Data Warehousing - Agenda. Why Use a Single Central Data Repository? Implementation of a Data Warehouse Hardware & Software Requirements Data Management Processes & Procedures

379 views • 14 slides

Good Clinical Practice GCP overview

Good Clinical Practice GCP overview. Research for Better Health Outcomes - Workshop March 9, 2011. Content. Historical perspective Origins of ICH / GCP Principles of GCP Informed consent. Historical Perspective. Nuremberg Code (1948) Kefauver-Harris Amendment (1962)

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BDMC Report and Perspective

BDMC Report and Perspective. Constantine Gatsonis, PhD ACRIN Biostatistics and Data Management Center Brown University. BDMC 2009 -2010: Highlights. Developing and launching new studies: Cancer : 6681 , 6685, 6686, 6687, 6688, 6689, 6690, 6691, 6692, 6693, 6694, 6695, 4006

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Pharmacology Training Programs in the Future

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ARS Question #1

ARS Question #1. Which treatment for MM should be avoided in patients wishing to pursue autologous peripheral blood stem cell transplant but is often used in elderly? A. Bortezomib B. Lenalidomide C. Melphalan D. Prednisone . ARS Question #2.

114 views • 2 slides