FDA COMPLIANCE 2011 - South Korea: Navigating the Regulatory and Clinical Trial Environment

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Category South Korea Regulatory Compliance; Clinical Trial Requirements; Regulatory Structure in South Korea; KFDA regulations; Drug Development Process; South Korea CRO selection; IMD; Clinical Trials in South Korea

Deadline: December 09, 2011 | Date: December 09, 2011

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

Updated: 2011-11-15 20:11:09 (GMT+9)

Call For Papers - CFP

Why Should You Attend:

This 6-hr training will provide valuable insights into how regulations and compliance issues are culturally handled in Japan.

This course specifically focuses on the regulatory compliance requirements and procedures for conducting Clinical Trials on Pharmaceutical Products in Japan. The course will also cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in South Korea. Content will also include descriptions of the methods by which regulators in the Ministry of Health / KFDA process filings and registrations for new Clinical Studies and what is expected throughout the lifecycle of Phase I ? Phase IV studies in the country.

Who Will Benefit:

This course will be beneficial to the following personnel in Pharmaceuticals, Medical Devices, and Combination Products manufacturing companies:

- Clinical Trial/ Research Professionals

- Regulatory Affairs Professionals

- QA/ QC

- Manufacturing/ Production

- Global Business Development

- Senior Management

NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 7th December 2011.