This 3-hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
The information presented will help you gain a comprehensive understanding of the Regulatory Structure, Product Classification, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals, GMP requirements and cultural working aspects within the Regulatory Environment in Japan. It will prepare you for regulatory approval processes, Agency meetings, the complexities of running clinical studies, the importance of partner selection and also add the cultural knowledge needed for success in-country.
The recent changes made by PMDA to be more sponsor and applicant-friendly, along with the impact this has had on dossier review times, will be shared. Real world experiences on actual interactions with the Agency, since these changes have been implemented, will also be discussed.
Attendees will leave this Course clearly understanding the Regulatory Procedures necessary to be successful in getting your products to market in a timely fashion. This Course has been updated to provide participants with competitive insight into:
- The impact of the PAL to PMDL Law change to applicants
- Who can legally register Life Science products in Japan
- If you want to be the legal License holder, what will you need: establishment office & personnel type
- When will additional clinical trials be needed on products and on which ones
- Will Japan accept global, clinically-developed data
- How does a Japanese CTD submission differ from ICH requirements
- What is required to register a Medical Device in Japan
- Japan's Medical Device classification procedures and regulatory pathways
- Can you expect a GMP inspection of your facility by PMDA staff; updates to GMP Regulation & Guidelines
- What are your post-marketing responsibilities as a License Holder
- How best to work with the Authorities from a Business and Cultural Aspect
- Overview of Healthcare Systems
- Regulatory Agencies Structure and Responsibilities
- Pharmaceutical Regulations
- Country Establishment Licensing & Procedures
- Japan and ICH (International Conference on Harmonization)
- Drug Development Process
- How to Apply for Clinical Trials
- The Clinical Trial Application
- Amending the CTA
- Conducting Meetings with the Agency
- Agency Review Process for Decision-Making
- Clinical Trial Start-up
- GCP Requirements
- Importing IMP into Japan
- Product Labeling Requirements
- Conducting Clinical Trials
- Marketing Authorization Procedures (Drugs & Devices)
- Considerations for Orphan Drugs, Biologics and Generics
- GMP Requirements
- Post-Marketing Responsibilities
- Aspects of Asian Business Culture
- Effectively Working with the Regulators
- Summary / Final Comments
- Wrap-Up Questions
Who Will Benefit
This webinar will benefit Project Team Members, whose specific functional discipline comes from:
- Global Business Development Personnel
- Commercial & Executive Management
- Country Managers
- Clinical Operations Staff
- Quality Assurance Personnel
- Monitors / CRAs
- Regulatory Affairs Personnel
- Pharmacovigilance Reporting Personnel
- Global Supply Chain Personnel
- Manufacturing Personnel
- CRO's, Consultants
Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.
His experience and knowledge span Healthcare Authority's requirements and regulatory processes across Life Science products.
For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries.
He holds a BS / MS in Chemistry.