Module 5 Presentations

18/07/2024

Tips to enhance communication (2)

Avoid staring & strong eye-contact

Avoid interruptions

Rephrase and/or repeat what you have heard to ensure you understood the message

Don’t take answers at face-value. Always ask questions to clarify and confirm (A yes doesn’t always mean yes!).

Distribution to third parties is not allowed

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Conclusion

Japan has been changing its regulations to attract global clinical programs

Relaxation of ODD rules and waiver of Ph.1 requirement

There are several differences with US/EU despite the commonalities

Understanding and respect of cultural differences are crucial for success

Distribution to third parties is not allowed

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