Our support covers the following aspects:
- Identification and selection of Japanese KOLs. Development of communication and engagement plan with KOLs.
This is a key activity for the following reasons:
– Develop clear understanding of Unmet need/Medical practice in JP
– Suitable Clinical positioning of the drug in Japan
– Commercial insights
– Support during PMDA consultation
- Regulatory and Clinical Development Strategy for Japan
Yakumed will build a detailed independent assessment report including recommendations and potential risks
- Support and maintain the relationship with Japanese KOLs and relevant Patient Advocacy Group(s) in Japan
Support includes all areas related to orphan designation (Strategy, Preparation of Docs and F2F meetings with MHLW).
- Support referral to study sites to boost recruitment
Exploring eligibility for conditional approval, Strategy, Preparation of Docs and F2F meetings with PMDA. Etc.