In order to strengthen the talent cultivation of non clinical pharmacokinetics (PK) and toxicokinetics (TK) of drugs in China, improve professional technical level, master new technologies and methods, and further promote the implementation of the ICH "M10 Bioanalytical Method Validation and Sample Analysis" guiding principles officially implemented in China from July 29, 2023, the China National Institute for Food and Drug Control (hereinafter referred to as the Institute) will hold a training course on pharmacokinetics, toxicokinetics, and bioanalytical technology in Beijing on October 24-25, 2024.

1、 Host organization
China National Institute for Food and Drug Control
Release time: September 18, 2024
Original link:
https://www.nifdc.org.cn/directory/web/nifdc/xxgk/ggtzh/pxtzh/202409141438041239315.html

2、 Training instructor
This training invites senior experts from the China National Medical Products Administration, food and drug regulatory authorities, and the industry to give lectures.

3、 Training target
（1） Technical personnel from drug research and development institutions, manufacturing enterprises, colleges, research institutions, and other related fields;
（2） Professional technical personnel in the biological analysis laboratory;
（3） Personnel from food and drug regulatory authorities and inspection and testing institutions.

4、 Training Content
This training mainly focuses on key technologies and related guiding principles in non clinical pharmacokinetics, toxicokinetics, and biological analysis of drugs (listed below in non teaching order). The main content is as follows:
（1） Focus points for non clinical research examination and verification of toxicokinetics/pharmacokinetics;
（2） ICH M10 Guidelines for Validation of Bioanalytical Methods and Sample Analysis;
（3） Capacity building and inspection focus and experience sharing in biological analysis laboratories;
（4） Key technologies and case studies in pharmacokinetic research of traditional Chinese medicine;
（5） Key technologies and case analysis for the study of metabolites inside and outside the drug substance;
（6） Key technologies and case analysis of non clinical pharmacokinetics of antibody conjugated drugs (ADCs);
（7） Key technologies and case analysis of non clinical pharmacokinetics of nanomedicine;
（8） Key technologies and case analysis of non clinical pharmacokinetics of dual resistance drugs;
（9） Key technologies and case analysis of non clinical pharmacokinetics of cell and gene therapy drugs;
（10） Radioisotope labeling technology and case analysis;
（11） Key technologies and case analysis of non clinical pharmacokinetics of drugs.
Note: The specific training content shall be subject to the information published in the registration system.

5、 Training time and location
（1） Registration time: October 23rd (11:00 to 21:00)
（2） Training time: October 24-25 (ending at 12:00 on the 25th)
（3） Registration location: Lobby of Jinjiang Fuyuan Hotel, Beijing
（4） Training location: Grand Banquet Hall, 1st Floor, Jinjiang Fuyuan Hotel, Beijing

6、 Training methods
（1） Training format
The training will be conducted in the form of on-site lectures.
（2） Training certificate
After the training is completed, students can log in to the training system to view or download the training certificate.
Mobile terminal: trainees can view or download the training certificate on "China Drug Inspection" WeChat official account → "Education and Training" → "China Drug Inspection Cloud Class" → "My" → "My Certificate".
Computer end: Login https://zjyk.nifdc.org.cn Website → "My" → "My Certificates" to view or download training certificates.

7、 Registration Procedure
Training support team or individual registration.

（1） Mobile: Scan the QR code below on WeChat and log in to register for this training course. Or after following the WeChat official account of "China Drug Inspection", click → "Education and Training" → "China Drug Inspection Cloud Class" to view the information of this training class and register.

（2） Computer end: Login https://zjyk.nifdc.org.cn View the information of this training course on the website and register.

（3） The number of training spots is limited, please register as soon as possible, and the quota will expire once it is full.

（4） If the training course is delayed or cancelled due to force majeure factors, further notice will be given.

8、 Training expenses
（1） Training expenses
The training fee for this training course is 2500 yuan per person (including trainer fees, venue fees, material fees, certificate fees, lunch and dinner buffet fees during the training period, and other expenses).
（2） Payment method for training fees
Online payment students enter the order confirmation page after submitting the registration information in the official account, select the online payment method, click Submit to jump to online payment, and can view it in "Registered" or "My" - "My Registered" after completion. Online payment of training fees does not incur any transaction fees, and the confirmation of training registration is subject to the final payment time.
Unit payment supports both corporate to corporate and personal remittances (such as counter and online banking remittances). To ensure timely receipt of remittances, trainees are required to remit the funds before registration for the training and mark the remittance with "pharmaceutical training+trainee name". Unit payment requires uploading the unit payment voucher to the Zhongjian Cloud Course platform. After submission and review, it can be viewed in "Registered" or "My" - "My Registered".
Payee: China National Institute for Food and Drug Control
Account: 0200001509089202642
Bank of Deposit: Industrial and Commercial Bank of China Beijing Yongdingmen Branch
Account number: 10210000152
（3） This training course issues training fee invoices, which are divided into electronic invoices (regular invoices) and electronic invoices (value-added tax special invoices).
Students need to carefully select the invoice type and accurately fill in the invoice information when registering. After the China Inspection Institute confirms receipt of the training payment, the invoice will be issued no later than 5 working days after the training is completed. Students can check the invoicing status through the following methods.
Mobile terminal: trainees can view relevant information on the official account of "China Drug Inspection" → "Education and Training" → "CIQ Cloud Class" → "My" → "My Invoice".
Computer end: Login https://zjyk.nifdc.org.cn Website → "My" → "My Invoice" to view relevant information.

9、 Other matters
（1） Beijing Jinjiang Fuyuan Hotel (recommended): The accommodation expenses for this training will be borne by the trainees themselves, and they will settle with the hotel themselves.
Accommodation fee (discounted price for this training course): Standard King Room: 430 yuan/day/room (including breakfast) Standard Double Room Single Stay: 480 yuan/day/room (including breakfast) Standard Double Room Shared Stay: 240 yuan/day/bed (including breakfast)
Due to limited housing resources, if you need to book a hotel, you can call 010-67800531 or contact Manager Yang at 15910604673. By attending this training course, you can enjoy the discounted prices as agreed above.
（2） There will be no pick-up or drop off station arranged for this training. Students are required to go to the hotel on their own and bear the transportation costs.
Bus route:
At Beijing Railway Station, take Metro Line 2 Inner Ring (towards Chongwenmen) to Chongwenmen Station and transfer to Metro Line 5 (towards Songjiazhuang) to Songjiazhuang Station. Then transfer to Metro Yizhuang Line (towards Yizhuang Railway Station) and exit at A1 North Exit of Wanyuan Street Station. Walk 781 meters to the hotel.
From Daxing International Airport, take the Airport Line (towards Caoqiao) to Caoqiao Station and transfer to Metro Line 10 (towards Jiaomen West) to Songjiazhuang Station. Then transfer to Metro Yizhuang Line (towards Yizhuang Railway Station) and exit at A1 North Exit of Wanyuan Street Station. Walk 781 meters to the hotel.
10、 Contact Information
（1） Education and Training Center of China National Institute for Food and Drug Control
Teacher Pang, phone: 010-53851491,
Mobile phone: 15313386335
Teacher Wang, phone: 010-53851305,
Mobile phone: 18910892088
（2） Institute of Safety Evaluation, China National Institute for Food and Drug Control
Teacher Zhang, phone: 010-67872233-8215,
Mobile phone: 13716774679
（3） Training registration technology
Consultation on system registration and related issues
Teacher Li: 18834135839
（4） Beijing Jinjiang Fuyuan Hotel Address: No. 11 Ronghua Middle Road, Beijing Economic and Technological Development Zone
Manager Yang, mobile phone: 15910604673