The Fifth Advanced Training Course for Drug Non-clinical Safety Evaluation

On August 16-19, 2019, sponsored by the Chinese Pharmaceutical Association Drug Safety Evaluation and Research Committee, China Food and Drug Control Research Institute, Shanghai Medicilon  (referred to as “Medicine”) sponsored the “No. 5 The “Advanced Training Course for Persons in Charge of Non-clinical Safety Evaluation of Drugs” successfully concluded in Shanghai. The training course lasted 2 days, 13 experts were invited to give lectures, and nearly 300 people signed up to participate.

At present, my country’s safety evaluation agency has entered a period of rapid development, and the staff and scale are constantly expanding. The growth and maturity of the new SD requires a platform for communication and development. In order to further promote the improvement of the level of SD talents in the field of drug safety evaluation in China, and to promote the improvement of the overall capability of the drug safety evaluation industry in China, this seminar takes “Non-clinical Safety Evaluation of New Drugs” as the theme, and focuses on new biological Authoritative experts in the field of non-clinical safety evaluation of drugs, experts from the drug review center, and senior domestic front-line SDs were invited to give special reports on product review and approval strategies, safety evaluation case analysis, and test normative concerns.
The opening ceremony of the training course was presided over by Dr. Xingchao Geng, Chairman of the Committee on Drug Safety Evaluation and Research of the Chinese Pharmaceutical Association. Zhang Hezhan, Director of the Institute of Safety Evaluation, China Food and Drug Control Institute, delivered a welcome speech on behalf of the organizer, emphasizing preclinical safety evaluation And I wish the conference a complete success. Professor Peng Shuangqing, vice president and head of the pre-clinical research department of Medicilon, delivered a speech on behalf of the organizer of the conference, expressing warm welcome and sincere greetings to the delegates. Medicilon is a professional preclinical drug development outsourcing service in the industry The company is honored to host this meeting.
The meeting also specially invited pharmacy experts to report to increase participants’ understanding of the design characteristics of new drugs and improve the rationality of the safety evaluation test design.

As the organizer of this training course, Medicilon organized meticulously, and Professor Peng Shuangqing, vice president and head of the preclinical research department, and Dr. Zeng Xiancheng, senior director of the toxicology research department, presented wonderful academic reports to the participants. Professor Peng Shuangqing’s report titled “Comprehensive Analysis of Drug Toxicology Research Data Based on Toxicity Mechanisms”, focusing on how to conduct human safety risk assessment based on drug non-clinical research data to ensure the safety of clinical users, and systematically introduced based on toxic effects The concept of the mechanism how to distinguish the “harmful effects” of data and how to apply it in risk assessment. Dr. Zeng Xiancheng’s report titled “Preclinical Safety Evaluation System of Antibody Conjugation Drugs and Its Application”, combined with Medicilon’s experience in the safety evaluation of antibody conjugate drugs (ADC), systematically introduced the characteristics of ADC drug safety evaluation, Difficulties, basic principles and main concerns. The content of the report was well received by the participants. At the same time, Medicilon arranged 14 SD leaders to participate in this training class, and conducted extensive and in-depth exchanges with industry colleagues on the spot.
With the rapid development of China’s innovative drug research and development industry, many new drug varieties have emerged, such as CAR-T cell therapy products, stem cell products, ADC monoclonal antibodies, oncolytic virus products, nano drugs, nucleic acid drugs, etc. These new drugs are preclinical Evaluation experience is limited, and there is also a lack of technical guidelines or technical standards that can be referred to. These new drugs also require special consideration and attention in preclinical safety evaluation trial design, data statistics, and result analysis. In addition, in recent years, as my country has joined the ICH organization, the implementation of the new version of the GLP specification has also put forward higher requirements for the subject in charge (SD) both technically and normatively.
After two days of training, according to the participation of the participants, the expert committee of the conference selected 8 outstanding students, and the pharmacological toxicology expert and Professor Yuan Bojun of Naval Military Medical University issued honorary certificates to the outstanding students.
During the training, experts and trainees fully interacted and communicated on the spot, and the atmosphere was very active. The person in charge of the project (SD) is the core of the preclinical safety evaluation study and is the person in charge of the entire process of the entire trial project. Especially after the new version of the GLP specification is promulgated and implemented, the responsibility of SD is more important and the task more difficult. The level of SD directly determines the level of drug non-clinical safety evaluation research. The training class provides an unprecedented opportunity for continuing education and training for domestic professionals engaged in safety assessment and related fields. Through seminars and exchanges, academic research and cooperation were expanded, which helped to improve the level of domestic drug safety evaluation, and was highly praised and praised by the participants.
Medicilon is a drug research and development outsourcing service company (CRO), which has established a compound synthesis, compound activity screening, structural biology, pharmacodynamic evaluation, pharmacokinetic evaluation, toxicological evaluation, formulation research and new drugs in Shanghai. Registered as an integrated technical service platform that meets international standards, and has been recognized by the international drug administration. Medicipua’s animal laboratory facilities have obtained AAALAC (International Association for Animal Evaluation and Certification) certification and National Medical Products Administration NMPA GLP certification, and have reached the US Food and Drug Administration GLP standard. Medicilon helps customers reach their goals faster with efficient and cost-effective one-stop professional services.