Notice on holding the ICH Q8(R2)-Q12 Guidelines Online Training

In order to further promote the understanding and mastery of domestic reviewers and industry of the technical requirements related to the guiding principles of ICH "Q8(R2): Drug R&D", "Q9: Quality Risk Management", "Q10: Drug Quality System", "Q11: API Development and Manufacturing (Chemical Entities and Biotechnology/Biological/Bioentity Drugs)" and "Q12: Technical and Regulatory Considerations for Drug Life Cycle Management", and strengthen exchanges with other regulatory agencies and industry experts on review and enterprise registration application practices, The ICH Office of the State Medical Products Administration will hold a two-day online training
on ICH Q8(R2)-Q12 guidelines from November 29 to 30, 2022.
The training related matters are hereby notified as follows:

1.
Training time

November 29, 2022, 9:00-16:00

November 30, 2022, 9:00-17:00

2.
Organizational structure

Organizer: ICH Office of the State Medical Products Administration

Co-organizer: China Drug Administration Research Association

3.
Participants

The training is free and open to the public, with a total of 10,000 online places
.

4.
Teaching experts

This training will invite foreign experts and domestic experts with relevant practical experience from foreign enterprises, and relevant experts from the verification center will be invited as speakers
.

5.
Registration

1
.
There is no registration fee for this training, participants need to scan the QR code to enter the registration.
Places are limited and available while stocks last
.

Computer link: https://wx.
vzan.
com/live/pc/expo/index/1763?zbid=1772732231

2.
Participants who participate in the training are invited to submit questions that need to be answered by the corresponding experts through the question collection page after registration, and the experts will answer questions and discuss
after the lecture.

VI.
Contact Information

Conference organization: Teacher Zhang (010-82210382)

Technical Support:Teacher Guo(13810338321)

ICH Q8(R2)—Q12 Guiding Principles Online Training Agenda