Module 5 Presentations

18/07/2024

Practical Considerations (1)

- Not required to have an affiliate in Japan during clinical development. Your agent/CRO can be your in-country care-taker (ICCT) - There are local cost-effective CROs for small biotech companies, but it is necessary to have experienced bilingual staff/agent to manage communication

- Consider carefully using the sites with deep expertise and experience

- Starting early is the key!

- Be mindful of GCP compliance to avoid issues during review of JNDA

Distribution to third parties is not allowed

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Practical Consideration (2)

- Investigators in Japan have less time and incentives than their Western counterparts to participate in Clinical Trials

- Contracts are made with the hospitals, not investigator; and many of the discussions go through the hospital administration

- The amount of documentation required in Japan is relatively higher than that which is required in Europe

- CRAs need to visit more frequently Japanese investigators and site staff to keep the investigators engaged and assist the sites with clinical trial administration - Some hospital networks have centralized IRB, but most sites don’t. Government has just issued a plan to promote the expansion of IRB.

Distribution to third parties is not allowed

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