On November 20-21, 2019, as a part of the 2019 World Conference on Access to Medical Products, a side meeting on the Current Global Regulatory and Ethical Landscape for CHIM studies including Regional/Global Collaborative Guidance was organised in New Delhi, India.
Regulators in India recognize the value of such studies and are contributors to and supportive of the draft guidance being developed.
Guidance which is India specific should take into consideration global best practice and include the Indian regulatory processes.
Important areas that need to be covered in guidance are clear and unambiguous informed consent, participant recruitment and payment and compensation in the Indian context. CHIM studies in India require regulatory and clinical capacity building, training and collaborations (both at regional and global levels).
Summary of the workshop could be found here: USEFUL RESOURCES.
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