Ich Fda Socra 09 2007

Where the FDA Regulations End and ICH GCP Begins The Differences & Similarities Between the Two Paul Below, CCRA GCP Trainer Medical Research Management, Inc. SoCRA 16 th Annual Conference Adams Mark Hotel, Denver, CO September 29, 2007

[object Object],[object Object]

[object Object],[object Object],[object Object],Learning Objectives

[object Object],[object Object],What is ICH?

[object Object],[object Object],[object Object],[object Object],ICH Purpose

[object Object],[object Object],[object Object],Importance of ICH to Industry

[object Object],[object Object],[object Object],[object Object],ICH History

[object Object],[object Object],[object Object],[object Object],ICH Categories

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Efficacy Guidelines

[object Object],[object Object],ICH Guideline for GCP (E6)

[object Object],[object Object],ICH GCP Objective

[object Object],ICH GCP Implementation in US

[object Object],[object Object],[object Object],FDA Guidance Documents

[object Object],[object Object],[object Object],ICH as FDA Regulation

Specific Differences Between ICH GCP and the FDA Regulations

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],ICH GCP Sections

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],IRB Responsibilities (ICH 3.1)

[object Object],[object Object],[object Object],[object Object],[object Object],IRB Composition (ICH 3.2)

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],IRB Composition cont.

[object Object],Investigator Agreements (ICH 4.1)

[object Object],[object Object],[object Object],Investigator Resources (ICH 4.2)

[object Object],[object Object],[object Object],Subject Medical Care (ICH 4.3)

[object Object],Protocol Compliance (ICH 4.5)

[object Object],[object Object],Investigational Product (ICH 4.6)

[object Object],[object Object],Informed Consent (ICH 4.8)

[object Object],[object Object],Informed Consent cont.

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Informed Consent cont.

[object Object],[object Object],[object Object],[object Object],Records and Reports (ICH 4.9)

[object Object],[object Object],Records and Reports (ICH 4.9)

[object Object],Sponsor QA/QC (ICH 5.1)

[object Object],[object Object],[object Object],Record Keeping (ICH 5.5)

[object Object],Compensation (ICH 5.8)

[object Object],[object Object],Financing (ICH 5.9)

[object Object],IRB Review (ICH 5.11)

[object Object],Supplying IP (ICH 5.14)

[object Object],[object Object],Monitoring (ICH 5.18)

[object Object],[object Object],[object Object],[object Object],Monitoring cont.

[object Object],[object Object],Protocol and IB (ICH 6 & 7)

[object Object],[object Object],[object Object],[object Object],Essential Documents (ICH 8)

[object Object],[object Object],[object Object],Essential Documents cont.

[object Object],[object Object],Contact Information

Ich Fda Socra 09 2007

Recomendados

Recomendados

Más contenido relacionado

La actualidad más candente

La actualidad más candente (20)

Destacado

Destacado (7)

Similar a Ich Fda Socra 09 2007

Similar a Ich Fda Socra 09 2007 (20)

Último

Último (20)

Ich Fda Socra 09 2007