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  • May 27 2018 - 17:20
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Draft of the guideline for pre-clinical studies of cell and gene therapy products was assessed

Draft of the guideline for pre-clinical studies of cell and gene therapy products was assessed

 

A meeting was held between experts of the country to evaluate the draft of the guideline for pre-clinical studies of cell and gene therapy products.

According to the public relations and information center of the Vice-Presidency for science and technology affairs, Amir Ali Hamidieh, secretary of stem cells sciences and technologies development headquarter, pointed out the proper cooperation between this headquarter and food and drug organization of the ministry of health, stating: one of the important responsibilities of the headquarter is cooperation with ministries to provide various guidelines and planning for stem cells, as well as preclinical and clinical studies.

Hamidieh pointed out that there is a need in designing the necessary guidelines for those who refer to clinics to be treated by gene and cell therapy. In this regard, he added: we hope that meeting with experts of this field be associated with designing the necessary guidelines based on global standards.

In addition, Mohammadnejhad, manager of the national network of animal modeling and in-body research, explained about the mission of the network, asserting: one of the most important goals of the network is developing a software for researchers of the country to commercialize their products and introduce them to global markets.

He pointed out the necessity of designing preclinical regulations, adding that the necessity of developing products in the international arena is designing guidelines based on GLP principles and by gaining the necessary standards from OECD.

Moreover, Hajizadeh presented the primary draft of guideline of the industry for preclinical evaluation of cell and gene therapy, which was then assessed by experts. In the end, it was decided that further studies be conducted to form the final draft and send it to the food and drug organization.

 

  • News group : NEWS
  • News code : 34751
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