"Tongxieyi" Forum 41: Road to excellent Pharmaceutical analysis manager
November 23rd to 26th, 2015
The Chinese (Beijing) global elite club
The career road of a pharmaceutical analysis manager usually begins with sample test to quality study, and then from the familiar quality studies to an effortless and efficient phase, covering from "qualified" to "good", followed by "excellent"; during which, in addition to mastering the basic skill of establishment and verification of chromatographic method and physical testing and chemical analysis, whether the analysis and research of the impurity profiling or the comparison of dissolution curves are nothing but big mountains that stand in your way. You have no choice but only climb over them one by one.
Adhering to the "first-line and first-class", here, Tongxieyi selects the "old referees" who are much experienced in application evaluation and research, and the "old drivers" who are working in the first line of research and development guide us towards an excellent a pharmaceutical analysis manager. These “old referees" and "old drivers", greatly impressive and well known persons, are most frequently inquired after each "Tongxieyi" BBS.
"Tongxieyi" Forum 41 "Road to excellent Pharmaceutical analysis manager" lasts for 4 days, and 7 invited reporters are greatly impressive and well known experts. The topics are all key points in quality research of drug R&D, being analysed concretely and practically, which change the previous case that distinguished guests were gathered but only views,and opinions were proposed, causing the audience indigestion.
Two masters of Zhou Li-chun and Yu Li have spent up to two months on carefully cooking a big meal for you to enjoy the whole day.
Of course, you will have unexpected surprises.
We believe that you will be the star of tomorrow in the field of pharmaceutical analysis after the four days experience.
If you are engaged in pharmaceutical analysis for more than three years and if you have your own experience and comprehension for pharmaceutical analysis, you'll be honoured to come to the front and deliver a 5-minute speech in "Super analysis director", sharing your experience with the participants. Please contact the secretariat of Tongxieyi
New Drug Elite Club of Tongxieyi
Undertaken by Beijing Zitan Management consulting co., LTD
Impurity research and regulatory requirements
9:00-12:00, November 23rd
Establishment, optimization and problems analysis of chromatography system in impurity research
◆Establishment, optimization and problems analysis of chromatography system in impurity research
◆What is the "Ghost peak" in pharmaceutical analysis?
◆It is not so difficult in the analysis of impurity profiling
◆How to carry out the relevant substance research on standard or non-standard generic drugs?
of analytic method
Dr Xiao Baiming, executive technical director of Jiangsu Simcere Pharmaceutical R&D Co., Ltd.
He was engaged in new drug quality study for 10 years in BMS, designing and implementing the research on the stability sample missing materials of entecavir tablets, and on the establishment, validation and transfer o fthe formation mechanism and the final method for their degradation, thus ensuring the success of the entecavir tablet NDA. Xiao Baiming, as the project header or successor took part in several cooperative projects of Simcere's BMS.
How does pharmaceutical R&D meet the needs of new drug regulatory requirements in different stages?
◆Analysis on the problems of medicine releasing.
◆Data requirements for IND stability
◆Difference of drug research requirement between IND and NDA
◆Focus on evaluation in the different stage of new drug
Chief consultant of APEX China Co., Ltd.
As an "athlete", Zhang Ming-ping was responsible for pharmaceutical and regulatory affairs in Novartis and BeiGene As a "referee", Zhang worked in CDE for six years, evaluating more than one thousand drug applicaionts.
15:15-15:30 Tea break
Consideration on the research of chemical generic impurities
◆8 doubtless failures in evaluations for chemical generics
◆Four major issues in impurity research: spectral analysis of impurities, targeted detection method, impurity limitation confirmation, impurity research and other associated researches
◆Five factors associated in impurity researches: synthetic processes, structural feature， forced degradation, real testing and reference Information
◆Three necessary matters: source analysis of impurities, tracing analysis of impurities and determinants of impurity limitation
◆ Checking of several responses under the new normal situation
◆Communication ability for analysis manager
Li Junde，vice director of R&D centre of Eastern China Pharmaceutical Co., Ltd.
Having worked in the first-line for 22 years, Li Junde has already been quite familiar with the quality study of the generic drugs. This time, Li wants to share his experience with you in the impurity research of the generic drugs.
On Nov. 24th,
QbD concept based new drug quality research is a kind of conscious action.
◆Intensive analysis and project management based on sample material balance as the main line
◆Case study on the key issues to control the quality research
◆Analysing researchers of their leading roles and values in drug synthesis, formulation development, safety evaluation and first phase I clinical trials
◆Daily training of pharmaceutical analysis personnel and orderly efficient management of laboratories
Dr. Chen Dongying，researcher of Shanghai Institute of Materia Medica, CAS
Dr. Chen Dongying has served in new drug quality research in Shanghai Institute of Materia Medica, CAS for more than 16 years. Her scientific research results have proved that the quality research is not in a supporting role in new drug research and development, but can often reflects a powerful professional role, it is not a R&D stage for sample synthesising, but running throughout the whole process of new drug research and development.
The basic thinking and crucial problems of the research of drug quality control
◆Thinking and strategy of quality control
◆Material control and source control
◆Production technology and process control
◆Study on standards and end point control
Zhang Zhefeng，scientific director and
chief medical adviser Beijing innovative pharmaceutical biotechnology
Zhang Zhefeng worked in Heibei Institute for Drug Evaluation for more than 10 years and engaged in drug evaluation for more than 10 years in CDE He will give a deep analysis on the key link in quality control and the vital issues, assisting pharmaceutical analysis managers to carry out pharmaceutical research based upon the quality control, and develop effective system of quality control strategies.
Part 2 Methodology validation and dissolution curve contrast
On Nov. 25th, 09:00-17:30
Getting a thorough mastery of analytic methodology validation
◆Modification of Chinese Pharmacopoeia 2015 in terms of methodology validation
◆How to carry out methodology validation in pharmaceutical research?
◆Correction of methodology validation
◆Standardising conventional physical and chemical tests (determination of melting point and solubility, and test of chlorine and heavy metals, etc.)
Assistant director of Beijing Institute for Drug Control
She has working in Beijing Institute for Drug Control for about 30 years, serving as director of Chemical Lab, Biochemical Lab and Antibiotics Lab. She served as a national and Beijing municipal drug evaluation expert to participate in numerous drug registrations and verifications. As a member of Chinese Pharmacopoeia Commission, much of her work was involved in the compiling of the new pharmacopoeia. At the same time, Zho li-chun was an honourable reporter of "Tongxieyi" Forum for two times. This time, Zhou li-chun will compare the methodology validation modification in the old and new pharmacopoeia, making corrections for you in respect of the concept of methodology validation, technical requirements and the key points.
On Nov. 26th, 09:00-17:30
Talking about those troublesome issues of the dissolution curve contrast research
◆Is there any reason that you could not contrast your own reference preparation?
◆Some others used dissolution medium, why it is wrong for me to use it?
◆Why can't we completely follow determinate the methodology validation using the dissolution determination of the same content determination as that of chromatographic conditions?
◆Must it be a prescription process problem for f2 factor being less than 50?
◆What effects will the modification of dissolution determination in Pharmacopeia 2015 bring R&D?
Assistant director of Beijing Institute for Drug Control
As an "old drug analyst" working in CDE for more than 30 years, Yu Li is also a "Xieyi personage." In Tongxiwyi Forum 39, her one and a half hours report inspired the resonance of the participants. Drug consistency evaluation is depended on dissolution. We kindly invite Master Yu again to guide our pharmaceutical analysis managers to get rid off the puzzle of "the dissolution curve comparison research". This training will provide a complete solution to all the difficult problems generated in dissolution research. The above training training include lectures, video fault-finding, field demonstration, panel discussions and prize quiz etc., in a rich and varied but un-boring forms of activities.
Please sign up online through the registration link:http://tongxieyi41.eventdove.com or click here阅读原文 to read the original text. Seats are limited, and please register asap! Registeration time: from October 21st, 2015 - December 22nd, 2015
One activity (participating Part 1 or Part 2)
• RMB 2200/person（from October 21st
to October 31st, 2015）
• RMB 2400/person（from November 1st to November 10th, 2015）
• RMB 2600/person（from November 11th to November 22nd, 2015）
• RMB 3000/person（from November 23rd to On-site registration）
Package （ Part 1 + Part 2）
• RMB 4000/person（from October 21st to October 31st, 2015）
• RMB 4400/person（from November 1st to November 10th, 2015)
• RMB 4800/person（from November 11th to November 22nd, 2015)
• RMB 5500/person（from November 23rd to On-site registration）
The fee is inclusive of: the conference cost and lunch
membership of “Tongxieyi" （registered and dues paid
before November 11th）
Individual member: only for individual member him(her)self
Corporate membership: five people can enjoy the personal membership price
Members participating Part 1 or Part 2
• RMB 1400元/person（registered and dues paid before November 11th, 2015）
Those registering and paying dues after November 11th, 2015 will not enjoy the membership price
Contact: Liu Liting 13426307172
Chen Man 13718714943
EXPO booth and activity support: Zhou Yuhua 13827555575 Accommodation and traffic
The Chinese (Beijing) global elite club, Unit C, Yuhui Building,
73 Fucheng Road, Haidian District,
Beijing [Subway line
10:Xidiaoyutai Stop (North-west exit), 100m walk]
Yulong Hotel, Beijing, China
Address: 40 Fucheng Road, Haidian District, Beijing （eeting place）; room rate: RMB 370～688/room; contact: manager Su: 18901256668