Part 1: Introduction
With the country join ICH and the rapid improvement of clinical research related laws and regulations, regulatory authorities have put forward new requirements for the quality management of drug clinical trials, and pharmacovigilance has also faced in new challenges. In order to implement the "Drug Administration Law of the People's Republic of China", standardize pharmacovigilance during clinical trials, and do a good job in the management and evaluation of safety information in drug clinical trials. CSC's Pharmacovigilance Department will carry out a series of special activities related to safety management during clinical trials, the topics covering: product risk management essentials, how to write regular safety reports during clinical trials, and how to standardize the management of safety data Report etc. Part 2: Key points The entire phase of clinical trials is full of various risk factors, which are always related to the safety of the subjects. How can we effectively prevent and control potential risks, minimize risks, protect subjects’ safety, and ensure smooth clinical trials? test?
We will discuss the following key points in the Webinar:
- Risk management summary
- Safety related risk management in clinical trials
- Safety related risk management plan and protocol evaluation in clinical trials
Part 3: Time
May 13th 14:00-15:00
Part 4: Speaker
Part 5: Speaker’s introduction
Lily LI, graduated from the Academy of Military Medicine of the Chinese Academy of Military Sciences (formerly the Academy of Military Medical Sciences of the Chinese People’s Liberation Army), served as the pharmacovigilance manager of CSC and Meta Clinical Technology Co, Ltd., Years of pharmacovigilance experience, once worked in a global pharmaceutical company to implement pharmacovigilance work. Familiar with the pharmacovigilance regulations of China, the United States, Europe, Japan and other countries and regions. Has abundant experience of pharmacovigilance system establishment, clinical trials and post-marketing pharmacovigilance practice, participated in more than 50 domestic and foreign clinical trials and post-marketing pharmacovigilance projects, therapeutic areas include immunology, orthopedics, circulation, urology, breast cancer, and entities Tumors, advanced non-small cell lung cancer, gastric cancer, relapsed or refractory inert B-cell malignant hematological tumors, refractory or relapsed non-Hodgkin’s lymphoma, diabetes, liver and gallbladder, rheumatism, skin, breathing, etc., with abundant drugs Vigilance related materials writing experience.
Part 6：How to join the Webinar
Scan the bar code in below and join the Webinar for free