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Full-day Virtual Seminar - South Korea: Navigating the Regulatory and Clinical Trial Environment

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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.

Speaker
Instructor: Robert J Russell
Product ID: 702547

Course "Full-day Virtual Seminar - South Korea: Navigating the Regulatory and Clinical Trial Environment" has been pre-approved by RAPS as eligible for up to 6 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

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

This course specifically focuses on the regulatory compliance requirements and procedures for conducting Clinical Trials on Pharmaceutical Products in South Korea. 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.

Learning Objectives:

This course is designed to provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with The Ministry of Health, the KFDA and Institutional IRBs in organizing and implementing Clinical Trials in South Korea. It will provide training on:

Agenda:

Part I: South Korea Regulatory Compliance

Part II: Conducting Clinical Studies in South Korea

Who Will Benefit:

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

This training will benefit personnel whose responsibilities require knowledge of South Korea’s regulatory, clinical, quality and import / export requirements.

Administrative staff responsible for ensuring compliance with IRB's Ethics Applications, Clinical Trial Applications overall GCP, GMP and GLP compliance requirements will also find this training highly relevant.

Global business development and general management requiring an understanding of how regulations and compliance issues are culturally handled along with how best to consider South Korea into one’s Global Business Strategy will profit from attending.

Instructor Profile:

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.

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Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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Training Options Training Duration = 6 hr
$999.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days