This 6 hour virtual seminar will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan.

It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in Japan, the importance of partner selection and add the cultural knowledge needed for success. The recent changes made by PMDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agency since these changes, will also be discussed.

Agenda: (All time in EST)

• 10:00 am EST to 12:00 noon (Session I)
• 12:00 noon to 1:00 pm (Lunch)
• 1:00 pm to 3:00 pm (Session II)
• 3:00 to 3:15 pm (Break)
• 3:15 to 3:45 pm (Conclusions and Final Comments)
• 3:45 - 4:00 pm (Q&A Session)

Areas Covered in the Seminar:

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.

This course will be beneficial to:

• 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 Regulatory and Clinical Trial environment
• Global Supply Chain personnel
• Manufacturing personnel
• Global Business Development personnel
• All personnel who need to understand the procedures and impact of placing Medical Devices on the Market across the EU

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.

Registration - Session Only: $749.00

CD Recording Only: $1,099.00