ComplianceOnline

Course Description:

Course "Navigating the Japan and South Korean Regulatory Compliance and Clinical Trial Environment" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

This 2-day on-site Course will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan and South Korea. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in both countries, the importance of partner selection and the cultural knowledge needed for success. The recent changes made by PMDA and KFDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agencies since these changes, will also be discussed.



Who will Benefit:

This course will be beneficial to the following personnel whose responsibilities require knowledge of Japan and South Korea's regulatory requirements for Life Science products:

  • Regulatory Compliance personnel
  • Clinical / Pharma & Device personnel
  • Clinical Trial Project Managers
  • Monitors / CRAs
  • QA / QC Personnel
  • Pharmacovigilance reporting personnel
  • Regulatory personnel whose responsibilities require knowledge of Japan's and South Korea’s Regulatory and Clinical Trial environment
  • Global Supply Chain personnel
  • Manufacturing personnel
  • Global Business Development personnel




Course Outline:

Day 1: Japan

Day 2: South Korea

Part I: Japan Regulatory Compliance

  • Overview of Japan’s Healthcare System
  • Japan’s Regulatory Agency’s Structure and Responsibilities
  • Japanese Drug Development Process
  • Agency Review Process for Decision-Making
  • Country Establishment Licensing & Procedures – Requirements for Conducting Clinical Research
  • Japan and ICH (International Conference on Harmonization)
  • Requirements for Clinical Trials in Japan
  • Japan’s Desire for Innovative Products
  • How Japan Wants to be Involved in Clinical Trials
  • The Changing PMDA
  • Conducting Meetings with the Agency
  • Japanese Philosophy in Risk Evaluation
  • How to Apply for Clinical Trials in Japan; the CTA
  • Amending the CTA

Part II: Conducting Clinical Studies in Japan

  • Japan’s Clinical Investigational Plan (CIP)
  • Likely Parameters Defining Clinical Trials; What to Anticipate
  • Clinical Trial Start-Up; GCP and GMP Requirements
  • Importing the IMP & Supplies into Japan
  • Product Labeling Requirements
  • Finding & Hiring CROs in Japan
  • Conducting Clinical Trials in Japan
  • Special Product Considerations
  • Clinical Trial Pharmacovigilance Reporting
  • CT Close-out and Reporting Requirements
  • Cultural Aspects – Working in Japan
  • Effectively Working with the Regulators; Do’s and Don’ts, Practical Experiences Shared

Part I: South Korea Regulatory Compliance

  • Overview of South Korea’s Healthcare System
  • South Korea’s Regulatory Agencies Structure and Responsibilities
  • South Korean Drug Development Process
  • Agency Review Process for Decision-Making
  • Country Establishment Licensing & Procedures
  • Requirements for Conducting Clinical Research
  • South Korea and ICH (International Conference on Harmonization)
  • Requirements for Clinical Trials in South Korea
  • South Korea’s Desire for Innovative Products
  • How South Korea Wants to be Involved in Clinical Trials
  • The Changing KFDA
  • Conducting Meetings with the Agency
  • Korean Philosophy in Risk Evaluation
  • How to Apply for Clinical Trials in South Korea; the CTA
  • Amending the CTA

Part II: Conducting Clinical Studies in South Korea

  • Likely Parameters Defining Clinical Trials; What to Anticipate
  • Clinical Trial Start-Up; ICH GCP and GMP Requirements
  • Importing the IMP & Supplies into South Korea
  • Product Labeling Requirements
  • Finding & Hiring CROs in South Korea
  • Conducting Clinical Trials in South Korea
  • Priority Reviews in South Korea
  • Clinical Trial Pharmacovigilance Reporting
  • CT Close-out and Reporting Requirements
  • Cultural Aspects – Working in South Korea
  • Effectively Working with the Regulators
  • Do’s and Don’ts, Practical Experiences Shared
  • Summary / Final Comments
  • Wrap-Up Questions



Meet Your Instructor

Robert J. Russell
President of RJR Consulting, Inc

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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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ editor@complianceonline.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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Accreditation




The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.




After completion of course "Navigating the Japan and South Korean Regulatory Compliance and Clinical Trial Environment" RAPS certificate will be issued to attendee.






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