Quality Digest

This Webinar will discuss the Marketing Authorization Processes – Filings & Registrations in Japan. How and when to influence the regulatory process and how to use regulations to your advantage.

Areas Covered in the seminar:

* Marketing Authorization Processes – Filings & Registrations
o Pharmaceutical Affairs Law (PAL) & Drug Registration
o Medical Devices
o Biologic Considerations
o Developing Combination Products; Classification and Licensing Review
o Drug Master File (DMF) Use in Japan
o Labeling Requirements
o Package Insert Requirements
* Variations: Changes to Marketed Products
o Types of Variations
o Variation Filings and Typical Review Times
* License Renewals
o Japan’s Process; What has recently changed?
o License Terms
o Maintenance Responsibilities
* Comparing and Contrasting Japan’s Procedures vs. U.S. FDA
o Comparison of Processes
o Agency Interactions
o Accepted Practices
* How and When to Influence the Regulatory Process
o Japanese Way of Thinking / Coming to Agreement
o Important Cultural Issues for Consideration
o The Do’s and Don’ts of Regulatory Involvement in Japan
* How to Use Regulations / Regulatory Contacts to Your Advantage
o Agency Interactions
o Business Impact Within and Outside of Japan
o Professionalism in Regulatory Affairs

More Info

Please contact Customer Care to avail 15% Christmas Offer on Regular Pricing (650-620-3937)