organizer

Pharmaceutical and Chemical Industry Committee of China Chemical Enterprise Management Association

Pharmaceutical Materials Information Technology (Beijing) Co., Ltd.

all relevant units

Population pharmacokinetics and pharmacodynamics (PK-PD) analysis is currently the most widely used and mature quantitative pharmacology analysis method. It is the basic method for building a mathematical model of the dose-exposure-effect relationship of drugs. It can help solve drug development and key decision-making issues in supervision and improve the safety, effectiveness, economy and compliance of drug treatment. In recent years, domestic drug research and development has advanced by leaps and bounds, and the demand for precise clinical medication is growing. The "modeling and simulation" technology of population PK-PD has received more and more extensive attention and application. NONMEM is a gold standard software for modeling and simulation recognized by the U.S. FDA and China's CDE. However, problems such as difficulty in getting started and few learning resources have always plagued domestic researchers.

In order to promote the development and application of population PK-PD "modeling and simulation" technology in China and improve the competitiveness of pharmaceutical companies in new drug research and development and clinical drug treatment, we specially held the 2024 Population Pharmacokinetics-Fundamentals of Pharmacodynamics (NONMEM Software) Training class. The purpose of this training is to: introduce the basic theories and applications of classic pharmacokinetics and pharmacodynamics; introduce the basic theories and applications of population PK-PD research; and the standard process of modeling (software practice):Database, exploratory analysis, basic models, covariate models, interpretation of model results, model verification, model application; population PK-PD paper/report specifications; population PK-PD model optimization and complex model coding; population PK-PD application case analysis, etc.

This training will invite quantitative pharmacology experts as instructors, striving to enable each participant to master the basic ability to use NONMEM software, providing participants with a platform to deeply understand, communicate and learn about group PK-PD. Pharmaceutical company personnel who are engaged in or are interested in engaging in group PK-PD-related work are welcome to sign up.

meeting arrangements

meeting place:Tencent Meeting (notify the specific address to registered personnel)

meeting time:April 19 - 21, 2024 (three days)

training syllabus

Time 09:00-12:00 13:30-16:30

before the meeting

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Installation of NONMEM, PsN and other software (one week before training)

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the first day

09:00-12:00

13:30-16:30

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Basic theories and applications of classic pharmacokinetics and pharmacodynamics

Basic theory and application of population PK-PD research

Modeling Standard Process (1):Database, exploratory analysis, basic models (software practice)

the next day

09:00-12:00

13:30-16:30

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Modeling Standard Process (2):Covariate model, interpretation of model results, model verification (software practice)

Modeling Standard Process (3):Model application (software practice)

PK-PD Paper/Report Specifications

the third day

09:00-12:00

13:30-16:30

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PK-PD model optimization and complex model coding (software practice)

PK-PD application case analysis

You need to have your own notebook computer (Windows operating system) and need a certain foundation in pharmacokinetics or pharmacodynamics, mainly software operation and supplemented by theoretical knowledge.

Introduction to the lecturer

** Teacher Huang, ** Participated in more than 60 Phase I/II clinical studies as an investigator, most of which are new drugs, including COVID-19 vaccines, COVID-19, neutralizing antibodies, monoclonal antibodies, cell therapy, PET/CT research, aerosols, gels, powders, tinctures, etc., covering infection, nerve, spirit, tumor, skin, digestion and other fields. He is responsible for managing the implementation of 2 clinical trials and participating in 2 CDE communication meetings; He was the author of 7 reports related to quantitative pharmacology and participated in more than ten, including in vitro PK-PD, animal PK-PD, clinical PPK and PK-PD; participated in the establishment of a quantitative pharmacology system in a well-known 3A hospital and drafted 4 SOPs related to PPK-related; Published 8 PK-PD-related papers as the first author, participated in the writing of 1 expert consensus and 1 technical guide, and presided over 1 quantitative pharmacology related topic.

Dr. Liu Bo is a provincial expert in Hubei. Ph. D. graduated from Trinity College, Dublin, Ireland, majoring in pharmacy, and served as a research and development scientist at Simcyp Company in the UK. It is mainly engaged in vitro simulation research on pharmacokinetics and drug metabolism, and independently developed a "virtual bioequivalence" platform. Member of the Core Committee of the Drug Absorption Group of the American Federation of Pharmaceutical Scientists (AAPS); member of the Physical Pharmacy and Biopharmacy Content Committee of the American Federation of Pharmaceutical Scientists (AAPS); member of the British Academy of Pharmaceutical Sciences; and member of the International Federation of Pharmaceutical Engineering.

Wu Keheng, Director of the Modeling and Simulation Department of Yinghan Pharmaceutical Technology (Shanghai) Co., Ltd., has participated in and was responsible for more than 30 quantitative pharmacology modeling and development tasks, covering non-clinical to clinical PK/PD conversion, popPK/PD and ER analysis, PBPK-based ethnic sensitivity analysis, virtual bioequivalence assessment, and DDI simulation. He participated in the construction of the intelligent dissolution database and AI-PBPK platform of the B2O virtual drug development platform, and wrote and submitted 8 software copyright applications. Published 5 quantitative pharmacology articles.

Participants

Relevant personnel from administrative departments, scientific research institutes, pharmaceutical companies, drug clinical research institutions and other relevant personnel in drug research and development and management; researchers in clinical pharmacology, clinical pharmaceutical biostatistics, data management, clinical medicine and other aspects

meeting notes

1. Theoretical explanation, case analysis, special lectures, interactive Q & A

2. The keynote speakers are all senior experts in the industry. Welcome to inquire.

3. Enterprises need internal training and guidance, please contact the conference team

training costs

conference fee:4500 yuan/unit (conference fee includes:Training, Q & A, electronic materials, guidance, video reviews, etc.); in order to ensure the effectiveness of the guidance, this training is limited to 40 units.

remittance account

Please note for remittance: Practical training in pharmacodynamics

account name: Beijing Kaisheng Win-Win Enterprise Management Co., Ltd.
opening bank:Industrial and Commercial Bank of China Co., Ltd. Beijing Fangshan Branch Liangxiang Branch
(Note:Invoice shows bank:Industrial and Commercial Bank of China Co., Ltd. Beijing California Shuijun Branch)
account number: 020 031 690 910 006 9663

Registration method

扫描下方二维码或者点击“read the original”，登记信息后，会务人员将与您沟通培训相关细节。

This meeting is limited to 40 companies. Welcome发送公司名称+姓名+电话预登记。Sign up by SMS, WeChat, and email.

contact:Lu Yao 13910496728 (WeChat synchronization)

Scan the QR code and sign up

Click to read the original registration information

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