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Bio Top Forum: The Way of Pharmaceutical R & D Strategy and Implementation of Chemical Injection

  2016-11-08

Guide: Suzhou suddenly entered into the winter after this autumn rain. Farewell to the second session of the DIA Drug Research and Innovation Conference, Bio-nano Park is about to usher in a new high-end course named The Way of Pharmaceutical R & D Strategy and Implementation of Chemical Injection. The course was introduced to Yeehong Business school of Shenyang Pharmaceutical University by Bio Top. As one of the excellent courses of Yeehong, it has been carried out for many years. This is the first time it carried out in Suzhou area and it is dedicated to helping the pharmaceutical enterprises’ employees in Jiangsu, Zhejiang and Shanghai. So that they can learn high-quality professional courses about the R & D and implementation of injection near their home. Therefore, they can help their company to follow the fast pace of development.

Shenyang Pharmaceutical University is a comprehensive pharmaceutical university with a long history. It has always been oriented by the demand of the development of pharmacy and related industries. It has 11 colleges including the School of Pharmacy, the School of Pharmaceutical Engineering and Yeeong Business school etc. . Yeehong business school was established in March, 2014. And it is committed to exploring a new model of management education and applied education in the field of medicine; cultivating advanced management and application talents rooted in China, with global vision and international standards for the pharmaceutical industry; conducting research on policies and industries of pharmaceutical industry; improving foreign exchange and cooperation in the field of pharmaceutical management and becoming an education training institution with a sense of social responsibility and the spirit of innovation. Over the years, they have been carried out a number of professional medical training programs in Beijing, Shenyang, Shanghai and other places. And they also invited experts and scholars from some well-known domestic and foreign authorities such as the former National Drug Review Center, the Canadian Ministry of Health and the US FDA Office of Generic Drugs (OGD) as the curriculum leader and lecturer. And all of these have won the favor and praise of some well-known domestic pharmaceutical companies, department heads and other students.

Course Name: Senior Manager Training Course-Pharmaceutical R & D Strategy and Implementation of Chemical Drug Injection

Time: 9:00-17:00, November 10th- 12th , 2016

Place: A1 Round Lecture Hall, Bio-Nano Park, Suzhou Industrial Park

Curriculum Objectives:

1. To systematic understand the theoretical knowledge, development ideas and the main research contents of the development of chemical injection;

2. to understand how use the new ideas of modern drug in the research and development of injection;

3. to grasp the research contents, ideas, methods and tools of the key issues in the R & D of chemical drug injection, so as to enrich the knowledge resources in R & D management decision-making;

4. to know the pharmaceutical technology requirements about registration of domestic and international chemical drug injection;

5. to understand pharmaceutical research and development characteristics of innovation and imitation of pharmaceutical injection.

Objects:

1. the middle/high-level technical management personnel of drug research and development institutions and production enterprises;

2. the technical management personnel of the registered agents;

3. the professionals related to research and development and teaching in high medical institutions and research institutions;

4. proposed medical-related undergraduate or above, more than 5 years related work experience about drug R & D and registration.

Schedule:

1. Day 1: Formulation Design and Process Study of Injections

The basic contents and research ideas of pharmaceutical research and development of injections - generic drugs and innovative drugs

The application of modern drugs’ development concept in the research and development of injection - prescription design and process research (combine with case studies)

Control strategies for injections

Panel discussion

2. Day 2: The Technology Transfer, Process Scale-up and Process Validation during the Development of Injections

Technology transfer of injections: basic processes and key issues

Process scale-up of injections: establishment of parameters and models

Process validation of injections: new ideas, processes and practices

3. Day 3: Stability Study of Injections and Compatibility Study of Packaging Materials

The main contents of stability study of injections

Study on compatibility of packaging , materials

Technical Requirements for Research of Pharmaceutical Injections in China

Three-dimensional rationality in the registration of injections

Basic technical requirements for the research of pharmaceutical injections (case study)

Panel discussion: common technical problems and solutions in the study of pharmaceutical registration of injections

Teacher Group

    1. Dr. Chen Zhen   The Professor of School of Pharmacy of Zhengzhou University

    Dr. Chen Zhen has rich experience in pharmaceutical technology review and a unique professional perspective in pharmaceutical research. He has served as the head of several technical review departments and sections at the National Drug Evaluation Center and has drafted more than 10 technical guiding principles and technical standards. He plays animportant role in the promotion of the required development of China's drug registration technology.

    2.Dr. Cui Yong   General Manager of Nanjing Pu Chen Pharmaceutical Development Co., Ltd

    Dr. Cui Yong has extensive experience in drug development and management. He worked as a team leader and senior scientist at VERTEX Pharmaceuticals and Genentech's R & D Division of Roche Group, and presided over the development of two innovative drugs, Twlaprevir and Erivedge. He also served as a long-term principal of the bulk drug crystal selection department at Roche Group - Genentech Company. And he is a senior expert in the field of pharmaceutical materials.

    3. Dr Yin Fangdong Director of Manufacturing Science & Technology, Lilly Suzhou Pharmaceutical Co., Ltd

    Dr. Yin Fangdong has rich experience in research and development of injection and now serving as the director of manufacturing science and technology at Lilly Company. He worked in the US pharmaceutical industry (Merck and Lilly) for twenty-six years. He served as Chairman of ISPE-China's First Chemical Products and Process Committee and Chairman of ISPE's Global Process / Product Development Steering Committee.

    4. Ms. Sun Yi  The Director of Infusion Division of Jiangsu Hengrui Pharmaceutical Co., Ltd. 

Ms. Sun Yi has a wealth of medical research and development and technical management experience. She once was the deputy chief engineer and research director of large state-owned pharmaceutical enterprises and the general manager and deputy general manager of the specialized transfusion production enterprises; and she was in charge of the new infusion production enterprises of plastic packaging. Since 2013, she has been responsible for the technical support about the drug package material of Hengrui Medicine’s new drugs project. And she has set up the Drug Compatibility Research Laboratory, which is responsible for organizing more than 100 research projects on drug compatibility.

Students’ Harvests :

1. enhanced the scientificity and targeted of the design of research and development programs;

2. understood the connotation of the new concept of modern drugs’ development and enhanced the ability to use it;

3. mastered the basic ideas, methods and tools to solute the key issues about the research and development of chemical drug injection, then enhanced the coordination and efficiency of R & D management;

4. understood the present situation and development trend of the pharmaceutical technical requirements for registration of pharmaceutical injections, and improved the compliance and registration efficiency of R & D.

Course Fee9800 RMB per person, including tuition, lunch, teaching materials, handouts, interpreting and translation fees, stationery and other related materials.

Application Information:You can call 0512-67995666 & 2704 or send an e-mail to zhoujing@biotop.com.cn for the inquiry.

Only 50 students are enrolled in this program, seats are limited, Sign Up Now!

Commands on Past Curses:

1. The design of this curriculum is unique! It starts from the scientific theory of injections, and ends in the analysis of registration review regulations of external injection. The interactive comments deepen the understanding and practice of the R and D and regulations of injections.

2. This course introduced new international advanced concepts and methods for the domestic R & D personnel. I have a more in-depth understanding of the requirements of guiding principles about the registration laws and regulations and technology after learned this course. I recommend the peers who dedicated to working on the research and development of new drugs to participate this course.

3. The arrangement of this course is reasonable, because it can make a good combination between theory and practice. And at the same time, we can understand the latest developments and technical development trends in professional technology. It can be a good guide to the realistic R and D work and the direction of future review in the national review policies. So it is very suitable for the enterprises’ R & D and technical theory and so on.

4. The course content is very rich, which greatly supplemented the processes and key points of new drug development and generic drug R & D of the injection.

5. I am often full of harvest after participated Yeehong’s training courses every time. The teachers always used the teaching method that combined with classic cases, which made us can understand the relevant concepts and course contents more deeply. I’m  very grateful to the teachers’careful arrangements.

About Yeehong Business School:

Yeeong business school, a secondary school of Shenyang Pharmaceutical University , was established in March 2014. It carries out the new type of colleges’management mechanism-Dean Responsibility System under the Council Management System. The School is committed to exploring a new model of management education and applied education in the field of medicine; cultivating advanced management and application talents rooted in China, with global vision and international standards for the pharmaceutical industry; conducting research on policies and industries of pharmaceutical industry; improving foreign exchange and cooperation in the field of pharmaceutical management and becoming an education training institution with a sense of social responsibility and the spirit of innovation.

About BioTop:

    Bio Top is an independent third-party technical service company located in Bio Bay. It provides services for testing related to biological medicine, GMP compliance verification, supply of reagents and consumables, specialized technical training and green channel for international transportation of bio-materials. It’s a one-stop service provider and a good partner in life science.