Practical new drug R & D project management platform

New drug research and development management platform

The platform takes experienced technical backbones as the core , According to the requirements of drug laws and regulations , Develop drug research programs , The main R & D backbone will review, discuss and finalize the research plan and submit it to the company's project management platform , The tester conducts research according to the proposed scheme , Problems that cannot be solved are encountered during the experiment , The technical backbone shall solve it independently or through negotiation in time . During the test , Each test record and results shall be submitted to the company's project management platform ; The one-on-one teaching method is basically adopted for inexperienced newcomers , also , In order to make full use of personnel at various technical levels , Adopt different teaching methods for newcomers of different degrees , If the test cannot be carried out independently, the operator shall be taught by a person who is rigorous and skilled , Those who can operate independently but cannot solve the problems encountered in daily tests are taught by experienced technicians, etc . After the completion of the experimental research , By preparation 、 analysis 、 The person in charge of the synthesis module test collates and writes the pharmaceutical application materials according to the established research plan and the requirements of pharmaceutical research application materials , The data Department will search, translate and write the pharmacological, toxicological and clinical research literature , The person in charge of the project will review the collected set of research data 、 Check and be responsible . after , The person in charge of the review shall assign relevant technical backbones to complete the set of application materials and records 、 Atlas, etc , The review comments are summarized to the project leader , After the project leader draws up the modification plan , The review personnel and project participants form a discussion group on the revision of the scheme , Discuss and determine the modification plan , The project leader will review the comments 、 Submit the modification plan and modification to the company's project management platform , Then copy and bind the materials , Before the application, the person in charge of the review will again transfer relevant technical backbones for centralized review , At the same time, discuss and determine the modification scheme , The project leader will review the comments 、 Submit the modification plan and modification to the company's project management platform , At the same time, the review sheet shall be submitted to the deputy general manager of the company for signature before application . Last , The registration department shall coordinate and cooperate to complete the declaration of varieties 、 On site verification, etc , The final application materials shall be submitted to the company's project management platform .