Japan: Regulatory Compliance Requirements for Life Science Products 2018 is a seminar that covers topics such as:
- Who can legally register Life Science products in Japan
- The impact of the PAL to PMDL Law change to applicants
- When will additional clinical trials be needed on products and on which ones
- If you want to be the legal License holder, what will you need: establishment office & personnel type
- How does a Japanese CTD submission differ from ICH requirements
- Will Japan accept global, clinically-developed data
- Japan`s Medical Device classification procedures and regulatory pathways
- What is required to register a Medical Device in Japan
- What are your post-marketing responsibilities as a License Holder
- Can you expect a GMP inspection of your facility by PMDA staff; updates to GMP Regulation & Guidelines
- How best to work with the Authorities from a Business and Cultural Aspect
Japan: Regulatory Compliance Requirements for Life Science Products 2018 brings together:
- Quality Assurance
- Clinical Operations Staff
- Regulatory Affairs Personnel
- Monitors / CRAs
- Global Supply Chain personnel
- Pharmacovigilance Reporting personnel
- Global Business Development personnel
- Manufacturing personnel
- Country Managers
- Commercial Management
- CRO`s, Consultants