Webinar On Differences between ICH-GCP and FDA regulations

ComplianceOnline, Online Event
2011-03-10

Why Should You Attend: 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.

Who Will Benefit:

• Healthcare providers interested in exploring the field of Clinical Research
• Clinical professionals involved in clinical trial planning and management
• Administrative managers in charge of Clinical Research
• Regulatory Compliance Associates and Managers

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