Navigating Clinical Trials in Japan: From Regulatory Strategy to Operational Success
In today's dynamic global pharmaceutical landscape, understanding Japan's regulatory environment is crucial. This virtual session explores strategies for drug development in Japan, including its role in global Phase III studies and PMDA interactions. We examine unique aspects of Japanese clinical trials, addressing challenges and solutions. Through case studies participants will learn to navigate Japan's regulatory landscape and optimize clinical development in this key market.
This webinar covers:
- Navigating Japan's Regulatory Landscape
- Achieving Operational Excellence in Japanese Clinical Trials
- Featured Case Studies
Related Insights
Blog
Optimize your CMC strategy: Five steps to avoid regulatory setbacks
May 15, 2025
Whitepaper
How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Jun 28, 2023
Article
Five strategies for meeting the requirements of Project Optimus and improving the chances of approval
Nov 10, 2022
Playbook
Are you using real-world evidence?
Feb 1, 2023
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Webinar
How to navigate China’s regulatory environment
Feb 15, 2023
Whitepaper
The Chinese Pharmaceutical Market: Size, R&D, Regulations, Market Access and Innovations
Mar 9, 2023
Playbook
Mitigating risk, protecting potential: Practical strategies that position cell and gene therapy development for success
Mar 28, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Related Insights
Blog
Optimize your CMC strategy: Five steps to avoid regulatory setbacks
May 15, 2025
Whitepaper
How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Jun 28, 2023
Article
Five strategies for meeting the requirements of Project Optimus and improving the chances of approval
Nov 10, 2022
Playbook
Are you using real-world evidence?
Feb 1, 2023
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Webinar
How to navigate China’s regulatory environment
Feb 15, 2023
Whitepaper
The Chinese Pharmaceutical Market: Size, R&D, Regulations, Market Access and Innovations
Mar 9, 2023
Playbook
Mitigating risk, protecting potential: Practical strategies that position cell and gene therapy development for success
Mar 28, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023