Relevant units:

In order to thoroughly implement and enforce the new "Drug Administration Law" and "Drug Registration Management Measures", effectively establish a drug research and development quality management system, help drug research and development companies solve problems and confusions encountered in establishing a quality system, do a good job in drug research and development project management and registration document submission, and make preparations for drug development and registration production site inspections. We are scheduled for 20212021 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 19px;">year6 

1. Meeting Arrangement

Meeting location: Nanjing (the specific location will be notified to the registered personnel)

Conference time: June 21-23, 2021 (full day check-in on the 21st)

 

2. Main discussion content and lecturers of the conference

This course was originally designed by Li Yongkang. Since2018year12021The annual update includes:1) Added solutions to problems encountered in the establishment, implementation and maintenance of the drug research and development quality management system;2) Added the application of R&D quality management system in project management and registration application (see Chapter 2 for details); 3 padding: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 19px;">) Combined with the experience and models of advanced domestic and foreign companies, a large number of case sharing has been added (see Chapter 3 for details). The updated content is more scientific, the concept is more advanced, the implementation is simpler, and the operation is clearer.

Day 1: June 22 (Tuesday) 9:00-12:00 am   14:00-17:00 pm

Chapter 1 In-depth understanding and application of laws and regulations

Section 1: How to accurately distinguish between laws, regulations, rules, standards and guidelines and their effectiveness relationship

Section 2: How to distinguish between the red line and the bottom line in laws, regulations and rules

Section 3: How to prevent the risk of unconsciously appearing fake and inferior drugs

Section 4: The relationship and control between non-compliance, compliance and over-complianceSection 5: How to accurately understand the connotation and essence of the GXP clause requirements

Chapter 2 Basic principles and operation strategies for the establishment and implementation of the quality management system for drug research and development

Section 1: Basic principles for the top-level design of the drug R&D quality management system;

Section 2: What is GMP-like/reason for generation/accurate range;

Section 3: How to implement segmented management in different sections of the three stages of non-GMP/GMP-like/full GMP;

Section 4: Example of Phased Management of cGMP in BeiGene's Development Process

Section 5: Design and Compliance Assessment of Pharmaceutical R&D Organizations;

Section 6: How to accurately divide and identify the responsibilities of R&D QA (case analysis);

Section 7: How to quickly and compliantly establish a file system for the R&D quality system;

Section 8: How to correctly draft a highly operational R&D SOP

Section 9: How to Conduct Quality Control in Drug R&D

Section 10: How to maintain and improve the R&D quality management system through auditing

Section 11: New ideas and new paths for excellent operation of drug R&D quality management;

The next day: June 23 (Wednesday ) 9:00-12:00 in the morning  14:00-17:00 in the afternoon

Chapter 3: Application of R&D Quality Management System in Project Management and Registration Application

Section 1: How to look at the relationship and role of R&D quality management and project management from a macro perspective (including goals/decision-making/angles of thinking about problems/principles of handling problems, etc.);

Section 2: How to integrate project management into R&D quality management;

Section 3: How to control the relationship, balance, promotion and restriction between R&D quality and R&D efficiency;

Section 4: How to implement key node assessment and quality release;

Section 5: How to deeply understand the essence and connotation of the legal and regulatory requirements for drug production management;

Section 6: Principles for writing registered production processes and quality standards (meeting the application requirements and meeting the operation of the enterprise)

Section 7: How to write the production process and quality standards for chemical drug registration;

Section 8: How to write the manufacturing process and quality standards for biological product registration (including traditional Chinese medicine)

Section 9: How R&D QA and registration departments review registration documents;

Chapter 4: Case Study on Establishing and Implementing Quality Management System for Pharmaceutical R&D

Section 1: How to unify the ISO quality manual and the R&D quality management manual

Section 2: How to accelerate the progress of project management under the premise of compliance (WuXi Biologics case sharing);

Section 3: The inspiration from BeiGene's experience in implementing MAH quality management;

Section 4: How to carry out change control and case sharing in the GMP-like stage;

Section 5: How to conduct deviation investigation and case sharing in the GMP-like stage;

Section 6: How to perform OOS adjustment and case sharing in the GMP-like stage;

Chapter 5: New Features, New Trends and Key Control Points of Drug Registration Verification

Section 1: New trends in drug registration, verification and supervision

Section 2: Interpretation of key points of the new "Key Points and Judgment Principles for Drug Registration Verification";

Section 3: Compliance Judgment Principles for Future Process Consistency     

Section 4: Analysis and inspection of the characteristics of drug registration data reliability issues;

Section 5: How to manage data reliability issues that have occurred;

 

3. Participants

1.1. Professionals in pharmaceutical companies, R&D companies, scientific research institutes, etc. engaged in drug R&D, production and registration; 2. R&D quality management personnel, R&D analysts and management personnel; 3. Drug R&D management and technical personnel, production operations and production management personnel; 4. Drug registration and application personnel, R&D project management personnel; 5. Personnel engaged in pharmaceutical regulations education and drug research institutions;

 

 4. Meeting description

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

2、The speakers are all senior experts in the industry, welcome to call for consultation

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

 

5. Conference fees

Conference fee: 2500 yuan/person (conference fee includes: training, seminars, materials, etc.); board and lodging are arranged uniformly, and the cost is borne by the participants., Board and lodging are arranged uniformly, and the cost is borne by the participants.

 

6. Contact information

tie人: beamred        

mobile/WeChat:13241056626

       QQConsultation:2672283518    

              Email:yiyaolianghong@163.com

 

 

Attachment 1: Meeting schedule

Attachment 2: Participation registration form

 

Beijing Huaxia Kaisheng PharmaceuticalTechnology Center

medicine training online live broadcast

April 2021