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Navigating the Japan Regulatory and Clinical Trial Environment; Conducting Clinical Studies in Japan
Friday, July 13, 2012 from 7:00 AM to 1:00 PM (PDT)
Palo Alto, CA
This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities, its review process for decision-making and approval, requirements for clinical trials in Japan and the procedures for conducting clinical studies in the country and reporting them.
Why Should You Attend:
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.
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.
Who Will Benefit:
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
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.