This webinar will provide valuable assistance to regulated companies which employ regulatory affairs associates, clinical specialists, internal auditors, audit managers and personnel of JPAL-regulated medical device or IVD companies.
With revisions to the Pharmaceutical Affairs Law (PAL) and GCP Ordinance 36, there is an increased focus on clinical data and how it is presented to the PMDA/MHLW. A comprehensive audit of relevant clinical investigations is now expected to determine if the clinical trials and clinical trial systems are effectively documented and implemented. This audit should be proceduralized and should be based on both Ordinance 36 as well as ISO 15144 parts 1 and 2.
Areas Covered in the seminar:
- Review of the requirement for clinical data per JPAL, Ordinance 169 and relevant notifications.
- Understanding the requirement to comply with Ordinance 36 Good Clinical Practice for domestic (in Japan) or foreign clinical investigations.
- Focus on the independent audit of clinical investigations to ensure compliance.
- Developing an audit procedure and checklist for GCP clinical investigations.
- Developing an audit checklist for GCP clinical investigations based on ISO 15144 Parts 1 and 2.
- The difference between clinical monitoring and the Japanese GCP audit of clinical investigations.
- Practical aspects of auditing foreign clinical trials for MHLW compliance.
Who will benefit:
This webinar will provide valuable assistance to regulated companies which employ regulatory affairs associates, clinical specialists, internal auditors, audit managers and personnel of JPAL-regulated medical device or IVD companies. The employees who will benefit include:
- Regulatory Managers and related personnel
- Clinical Investigation Managers
- Internal auditors and 2nd-party auditors who deal with assessments of clinical evaluation processes
- Internal process owners who will be audited to the requirements of risk management
- Consultants
Instructor Profile:
Phil Smart, is a founding member of RA/QA International LLC. He serves the medical device community as Consultant, Facilitator and Instructor to 21 CFR Part 820, CMDR/CMDCAS, MDD, MHLW/PMDA/Japanese PAL. He has been a European Notified Body Lead Assessor for over 15 years with auditing experience in a wide range of active and non-active medical device clinical evaluations and clinical monitoring. He was head of TUV PS Japan for several years and continues to provide consultation and independent audit support to ensure effective compliance to Japanese PAL and its ordinances.
