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Report of the PMDA-ATC Regenerative Medicinal Products Review Webinar 2021 for CDSCO, India

  On June 3, PMDA held a seminar entitled “PMDA-ATC Regenerative Medicinal Products Review Webinar 2021 for CDSCO, India“. A total of 39 regulators of Central Drugs Standard Control Organization (CDSCO), who are engaged in reviewing of pharmaceutical products including regenerative medicinal products, participated in the webinar.
The webinar opened with the remarks by Dr. SATO Daisaku (Chief Management Officer, PMDA) and by Mr. Sanjeev Kumar (Deputy Drugs Controller (India), CDSCO). In the webinar, the speakers from PMDA and CDSCO shared the information on the regulatory framework for regenerative medicinal products, and the speakers from PMDA introduced the experience in the review of cell therapy products and gene therapy products.

At the end of the webinar, Dr. FUJIWARA Yasuhiro (Chief Executive, PMDA) and Dr. V. G. SOMANI (Drugs Controller General, CDSCO) gave the closing remarks.

 


Top row from left: Mr. Kumar, (Deputy Drugs Controller, CDSCO), etc., Dr. Somani (Drugs Controller General, CDSCO), Dr. FUJIWARA Yasuhiro (Chief Executive of PMDA), PMDA lecturers and Dr. SATO Junko (Office Director, Office of International Programs of PMDA).

See attached program.