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3-hr Virtual Seminar: South Korea - Navigating the South Korean Regulatory Compliance and Clinical Trial Environment

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This 3-hr training on South Korean regulatory compliance requirements for life science products will discuss about the regulatory structure, clinical trial requirements and the conduct of running clinical research in South Korea.

Speaker
Instructor: Robert J Russell
Product ID: 702153

Why Should You Attend:

This 3-hr session will help you gain a understanding of the regulatory structure, clinical trial requirements and the conduct of running clinical research in South Korea. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in South Korea, the importance of partner selection and the cultural knowledge needed for success. The recent changes made by KFDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agency since the changes, will also be discussed.

Note: A detailed, 6-hr training is available on the same topic. Click here to purchase that training

Areas Covered in the Seminar:

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 East Asian countries' 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 East Asian countries 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 = 3 hrs
$899.00 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