Important Training | KRB Consulting experts were invited as Speakers at NMPA Institute of Executive Development

2023-04-12

NMPA Institute of Executive Development is scheduled to hold a training course on 2023 Injection Registration Review and Conformity Evaluation in Beijing from April 24 to 27, 2023.

Through the training, it will help the participants accurately grasp the latest regulatory policy requirements of the injection industry, especially to understand the technical requirements of registration review, registration site verification requirements, as well as the quality requirements and testing methods related to the high-quality development of the injection industry in the Chinese Pharmacopoeia, and to enhance communication and share the latest practical experience on the technical difficulties of injection registration and development.

KRB experts are invited to give lectures

Ling Zhou

Vice General Manager of KRB Consulting, RA Expert

She has been engaged in drug registration work for 13 years and worked for two well-known CRO companies, and she is responsible for the international registration consulting of domestic formulations to FDA and EU. At the same time, she is also responsible for the registration regulations of domestic formulations and imported formulations to NMPA.

This training is an invited panel: Injectable development and registration filing
The similarities and differences of CMC studies and typical cases of issuing supplements for complex injectables in China and the US

Zhang Lei

Founder, General Manager of KRB Consulting

He is mainly engaged in FDA/EU/NMPA GMP compliance and third-party audits, and has led for 100+ GMP inspections in the past year, accumulating rich experience in quality culture construction and M&A compliance for pharmaceutical companies.

This training is an invited panel: Research, validation and declaration of aseptic and sterilization processes for injectables
The inspiration of the new EU sterile appendix 1 on China's sterile drug regulation
1) Systematic introduction of the new version of EU Appendix 1;
2) Detailed analysis of the core changes;
3) Analysis of EU regulatory thinking;
4) Insights on the regulation of aseptic drugs and self-improvement of enterprises in China;

Next —

Digitization of quality management, market access and related work

Related News