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PIMF 2022 6th Pharmaceutical Industry Microbial Technology Forum Notice

 Last Update: 2022-08-30
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The 6TH PHARMACEUTICAL INDUSTRY MICROBIOLOGY TECHNOLOGY FORUM of the 6th Pharmaceutical Industry Microbial Technology Forum in
PIMF2022 The 6TH PHARMACEUTICAL INDUSTRY MICROBIOLOGY TECHNOLOGY FORUM

August 25-26, 2022 Hangzhou, China

Relevant units:
August 25-26, 2021 New Century Grand Hotel Hangzhou 1.
Organization,
organizer,
co -organizer, co-organizer
2, time and place 3.
The main venue of the conference special forum:
Biopharmaceutical and microbial quality control sub-venue:
Microbiological safety control of traditional Chinese medicines and chemical medicines:
4.
Participants 5.
Participation fees

the same pharmaceutical company	registration fee	Remark
1st participant	free	See Participation Benefits (as of August 24)
Person 2 and above	￥2000/person	Including journal, certificate, lunch

2.
500 tickets for participation benefits

August 25	PIMF2022 The 6th Pharmaceutical Industry Microbial Technology Forum · Main Venue
Time/Time	Speech report / Topic	Speaker / Speaker
09:00-09:10	Forum speech	Tao Qiaofeng , Vice President of Zhejiang Institute of Food and Drug Inspection
09:10-09:50	Talking about the issues related to the microbial limit standard of the 2020 edition of "Chinese Pharmacopoeia" This speech focuses on how to control the microbial limit of raw materials and excipients, the expression of the bacterial count limit index, the limit standard of Chinese medicine decoction pieces, and the detection of pathogenic bacteria or conditions other than the corresponding standards in the control bacteria inspection. How to report pathogenic bacteria and other issues to analyze, and put forward their own thinking and suggestions .	Cao Xiaoyun , Vice-Chairman of the Microbiology Committee of the State Pharmacopoeia Commission
09:50-10:30	Key points to consider in microbial control in the production of risk-based biologics , Vaccine products have the characteristics of "long cycle, high investment, high risk and high income" . This speech will analyze the main risk considerations in the production of these three biological products, and focus on the key points of aseptic production and microbial control .	Jin Yulan President of Shanghai Pharmaceutical Quality Association Member of the Microbiology Committee of the State Pharmacopoeia Former General Manager of the Institute of Biological Products affiliated to China Biotechnology Expert of Shanghai Drug Administration
10:30-11:00	Coffee Break/Break
11:00-11:30	Application status and development trend of microfluidic chips in drug quality control microbial testing. Drug quality control microbial testing is an extremely important link in drug research and development and production. The basis and guarantee of sexuality . Microfluidic chip technology has the characteristics of high throughput, low consumption, low cost, less pollution, fast analysis and detection, small and portable, and low dependence on professionals. It can standardize the rapid microbial detection of the drug quality control process, solve the industrial "bottleneck" problem of lack of adaptable technical systems for drug testing and quality control, greatly improve the testing efficiency and quality control level, and promote the development of China's health industry . The report outlines the relevant characteristics of microfluidic chip technology and its application scenario analysis in the rapid detection of microorganisms, and shares the application status and development trend of microfluidic chips in the detection of microorganisms in drug quality control .	Zhao Ming Researcher/Professor/Ph. D. Supervisor Executive Director, Center for Cell Therapy Technology Research and Engineering, Institute of Oncology and Basic Medicine, Chinese Academy of Sciences
11:30-12:10	Biosafety management of pharmaceutical microbiology laboratories From SARS to COVID-19, we have made remarkable achievements, and the government, the public and related practitioners are paying more and more attention to environment, health and safety (EHS) . With the release and implementation of national biosafety laws and international documents, laboratory biosafety management has ushered in a new journey . This speech combines the "Biosafety Law of the People's Republic of China" (2021-04-15), the fourth edition of WHO "Laboratory Biosafety Manual" (2020-12-21), "National Hazardous Waste List" (2021-01- 01), "Medical Waste Classification Catalog" (2021-11-25) and related cases to discuss the biosafety management of pharmaceutical microbiology laboratories .	Cui Xuewen , Vice President of Sichuan Institute of Drug Control
12:00-13:20	Lunch / Lunch
13:30-14:10	Challenges and opportunities for the application of rapid microbial detection technology In the context of the establishment of personalized microbial detection methods for short-acting drugs and the development of quality control requirements for the whole process of drug production based on the concept of risk assessment, with the update of regulatory concepts and the formulation of regulations. Revised, Challenges and Opportunities for Rapid Microbial Detection Technology Application . The application progress of rapid microbial detection technology in the pharmaceutical industry is summarized, and the application scenarios, advantages and disadvantages of representative rapid microbial detection technology are shared .	Li Jue , Director of the Institute of Microbiology Inspection, Zhejiang Institute of Food and Drug Inspection, Member of the Academic Committee and Deputy Director of the Key Laboratory of Drug Microbiological Testing and Early Warning of the State Drug Administration
14:10-14:50	Considerations on the Pharmacy Review of Generic Drug Injections and Post-marketing Changes The quality of drug research directly affects the safety, effectiveness and controllability of post-marketing drugs . This speech focused on introducing the relevant laws and regulations, review thinking and case analysis of generic drugs for chemical injections on the market and post-marketing changes. Project quality management to ensure the quality and safety of drugs in the product development stage .	Sheng Yan Deputy Chief of Drug Evaluation Section of Zhejiang Drug and Cosmetics Evaluation Center (in charge of the work)
14:50-15:10	Coffee Break/Break
15:10-15:50	PDA TR88 Pharmaceutical Industry Microbiological Data Bias Survey Share the "PDA TR88 Pharmaceutical Microbiological Data Bias Survey" published in 2022 for the detection and monitoring of microorganisms generated during the testing of process water, gas, raw materials, intermediates and finished products in pharmaceutical production, such as: Microbial load, sterility testing, bacterial endotoxin testing, mycoplasma testing, environmental and personnel monitoring results that exceed product standards or acceptance criteria for registration approval, drug master file (DMF), official pharmacopoeia, GMP or manufacturer's internal controls, provide A survey framework illustrating how to conduct a microbial bias survey . In this lecture, I will share my experience and experience on this topic .	Wang Xiaoming , MD, MS Microbial Control, Sterility Assurance Expert
15:50-16:30	Aoya Bioinformatization System Construction Experience Sharing Enterprise informatization construction has been a hot topic in recent years. How to plan enterprise informatization construction, how to implement business system step by step, and what are the points to pay attention to in the implementation process . This speaker will talk about the experience of information system construction based on his own experience . .	Bei Liuluan Director of Information Center of Hangzhou Aoya Biotechnology Co. , Ltd.

August 26	PIMF2022 The 6th Pharmaceutical Industry Microbial Technology Forum·Traditional Chinese Medicine/Chemical Medicine Microorganism Sub-venue
Time/Time	Speech report / Topic	Speaker / Speaker
09:00-09:50	It has been nearly 80 years since the sterility inspection, sterility assurance and parameter release sterility inspection method was incorporated into the Pharmacopoeia. In the early stage, the production and preparation conditions of drugs were simple and the batches were small. As a destructive sampling test, sterility inspection played an important role in ensuring the safety of products. important role . With the development of the pharmaceutical industry, the production batch has expanded rapidly, the production process has become increasingly perfect, the representativeness of sterility inspection sampling and the rationality of inspection have attracted attention, and the parameter release method of sterile products based on strict process verification and high-level GMP management has begun to appear. . Due to various reasons, this "sterile inspection-free" method of releasing sterile products has not been implemented in China since the pilot program began in 2005 . Analysis of the changes in policies and regulations in recent years, especially the implementation of the ICH quality system in China, the shift from final product inspection to process control and even the whole life cycle focus on drug quality has become increasingly popular, and the research, practice, and verification of sterility assurance systems have continued to develop, and sterility inspection. The functional positioning in China may also face certain adjustments .	Ma Shihong Director, Microbiology Office, Institute of Chemical Medicine, China National Institute for Food and Drug Control
09:50-10:30	Accurate identification and evaluation technology of pharmaceutical microbial strains based on WGS technology The concept of "full life cycle" quality control of drugs requires identification and traceability of pharmaceutical raw materials, excipients, intermediate products, final products, pharmaceutical water, and microorganisms in the environment . Accurate identification and evaluation of microbial strains is an important prerequisite for pharmaceutical companies to carry out actual production . The 2020 edition of the "Chinese Pharmacopoeia" requires that whole genome sequencing (WGS) analysis is required for the production and verification of biological products and human gene therapy products, and WGS technology is included in the <9204 Guidelines for Microbial Identification> . This speech focuses on how to use the current cutting-edge WGS technology to serve the accurate identification and evaluation of pharmaceutical microbial strains .	Dr. Yao Su Director of China Industrial Microbial Culture Collection and Management Center Chairman of Industrial Microbiology Professional Committee of Chinese Society for Microbiology
10:30-11:00	/ Break
11:00-11:50	ISO14644 ，，，，，？？？ISO 14644，，，，，，，，。
12:00-13:20	/ Lunch
13:30-14:10	《》、《（）》，（）。，、。	GMP
14:10-14:50	、，，/(DET) 。，，/ 。
14:50-15:10	/ Break
15:10-15:50	“”，EGMP ，，，、、、，。，。
15:50-16:30	1421ISOPDA，。，。ISO、PDA，。，，，。	（） GMP

826	PIMF2022 ·
/Time	/ Topic	/ Speaker
09:00-09:50	USP ，、，，。USP，。
09:50-10:30	，。，。2020，2020，、。2020，。
10:30-11:00	/ Break
11:00-11:50	，，。，，。：1）1101《》，，；2）《》。
12:00-13:20	/ Lunch
13:30-14:10	，。ICH Q2 。，。
14:10-14:50	，，。MicroSEQ、，，、、，。
14:50-15:10	/ Break
15:10-15:50	《》，、、、，（DNA）。、。DNA 。
15:50-16:30	The relevant standards of USP host cell protein (HCP) analysis methods are mainly aimed at the current difficulties in the detection and analysis of host cell proteins in the biopharmaceutical industry. The content of USP General Chapter <1132> - Detection of Host Protein Residues in Biopharmaceuticals is interpreted, and USP is introduced. The development progress of related methods and reference materials in HCP detection and analysis .	Niomi Peckham , United States Pharmacopoeia (USP) Global Liaison Officer for Biologics Science and Standards

7.
Conference matters
1.
Accommodation and transportation 2.
Invoice matters 3.
Payment method 4.
Registration method
www.
cncimi.
org

August 24, 2022 8.

Contact www.
cncimi.
org zypx@cncimi.
org

Organizing Committee of the 6th Pharmaceutical Industry Microbial Technology Forum of PIMF2022June
15, 2022

Reference attachment: Participation Receipt Form

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