CLINICAL COMPLIANCE 2011 - Webinar On Differences between ICH-GCP and FDA regulations - Webinar By ComplianceOnline

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Category Clinical Webinar ,conference,event.

Deadline: March 10, 2011 | Date: March 10, 2011

Venue/Country: Palo Alto, U.S.A

Updated: 2011-02-14 17:53:38 (GMT+9)

Call For Papers - CFP

The biopharmaceutical industry is also targeted by globalization. Biopharmaceuticals companies are running clinical trials all over the world and in order to lower the costs data is transferred between countries. In order to reduce time, to lower costs and to avoid delays in submission and market approval clinical professionals need to know the similarities and differences between the FDA and ICH-GCP requirements. . This presentation will help with preparing better for submitting data obtained from outside US countries to the FDA and from US to outside FDA regulated countries. All these are done with the primary goal in mind: lowering companies’ costs and speeding data transfer for quicker regulatory submission and approval.

Areas Covered in the Seminar:

ICH guidelines and Good Clinical Practice (GCP).

FDA regulations.

Similarities between FDA regulations and ICH-GCP.

Differences between FDA and ICH-GCP.

Practical aspects.

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