FDA Compliance 2011 - South Korea: Navigating the Regulatory and Clinical Trial Environment
Date2011-12-09
Deadline2011-12-09
VenuePalo Alto, USA - United States
KeywordsSouth 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
Topics/Call fo Papers
This 6-hr virtual seminar will focus on the regulatory compliance requirements and procedures for conducting Clinical Trials on Pharmaceutical Products in South Korea. It will also cover topics relating to pre-clinical and clinical requirements and address the structure of the regulatory agencies in South Korea.
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.
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.
Other CFPs
- Incorporate FDA's New Process Validation Principles into Company Verification and Validation Planning
- The International Conference on Cultural Diplomacy in the EU
- China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations)
- SOPs for Clinical Trials ? Regulatory Requirement and Key to Effective Management
- FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program
Last modified: 2011-11-15 20:11:09