SQA

OCTOBER 18, 2023

The public consultation is open until 31 December 2023 and the topic will be further discussed during a joint HMA/EMA workshop scheduled for 20-21 November 2023. All interested stakeholders are invited to comment on the draft reflection paper and to identify potential opportunities and risks of AI in the field of medicines.

FDA 40

FDA Compliance Licensing World Health 40

SQA

OCTOBER 18, 2023

The public consultation is open until 31 December 2023 and the topic will be further discussed during a joint HMA/EMA workshop scheduled for 20-21 November 2023. All interested stakeholders are invited to comment on the draft reflection paper and to identify potential opportunities and risks of AI in the field of medicines.

FDA 40

FDA Compliance Licensing World Health 40

SQA

OCTOBER 18, 2024

The sponsor is also responsible for implementing a Quality Assurance system to ensure that the clinical trial is conducted and data generated, documented, and reported in compliance with the protocol and Good Clinical Practice (GCP) guidelines issued by the CDSCO Directorate General of Health Services Government of India.

FDA 52

FDA Compliance Public Health World Health 52

SQA

OCTOBER 18, 2024

The sponsor is also responsible for implementing a Quality Assurance system to ensure that the clinical trial is conducted and data generated, documented, and reported in compliance with the protocol and Good Clinical Practice (GCP) guidelines issued by the CDSCO Directorate General of Health Services Government of India.

FDA 40

FDA Compliance Public Health Governance 40