Topics
- Conducting Clinical Studies in Japan
Likely Parameters Defining Clinical Trials; What to Anticipate, Japan`s Clinical Investigational Plan (CIP), Importing the IMP & Supplies into Japan, Clinical Trial Start-Up; GCP and GMP Requirements, Finding & Hiring CROs in Japan, Product Labeling Requirements, Special Product Considerations, Conducting Clinical Trials in Japan, CT Close-out and Reporting Requirements, Clinical Trial Pharmacovigilance Reporting and Cultural Aspects – Working in Japan - Japan Regulatory Compliance
Japan`s Regulatory Agency`s Structure and Responsibilities, Overview of Japan`s Healthcare System, Agency Review Process for Decision-Making, Japanese Drug Development Process, Japan and ICH (International Conference on Harmonization), Country Establishment Licensing & Procedures – Requirements for Conducting Clinical Research, Japan`s Desire for Innovative Products, Requirements for Clinical Trials in Japan, The Changing PMDA and How Japan Wants to be Involved in Clinical Trials
Who should Attend
Clinical Trial Project Managers, Clinical / Pharma & Device personnel, QA / QC Personnel, Monitors / CRAs, Regulatory personnel whose responsibilities require knowledge of Japan`s Regulatory and Clinical Trial environment, Pharmacovigilance reporting personnel, Manufacturing personnel, Global Supply Chain personnel, All personnel who need to understand the procedures and impact of placing Medical Devices on the Market across the EU and Global Business Development personnel.
