Gather your strength and create a new chapter in the industry. On April 13th, the online forum of "Big Charity Cloud Forum- -WHO Vaccine Pre-Certification (PQ)" jointly hosted by Times Group and Yunzhi Pharmaceutical Technology was held as scheduled. Mr.Christian Bachofen, an internationally renowned biomedical design and planning expert, director of The Group and chief technology officer of biomedicine, shared the special topic of "WHO Pre-certification Product Review Document Architecture and Good Document Specification". Nearly 3,000 professional guests of r & D, verification, quality management from biomedical enterprises across the country watched it online.

Mr.Christian Cloud Forum live course live

At present, a total of 7 Chinese enterprises have passed the WHO vaccine pre-certification, 5 of which are professional services provided by Mr.Christian, and they have rich practical experience in Chinese localization in the WHO-PQ field. At the same time, Mr.Christian explained the system document system of WHO pre-certification products in combination with his concept of serving international and Chinese pharmaceutical enterprises in nearly 20 years. He pointed out that WHO drug pre-certification is a service provided by WHO to evaluate the quality, safety and effectiveness of drugs, and explained the operation process mode of WHO pre-certification from seven steps, including the pre-submission meeting, application letter and pre-certification documents.

Mr.Christian shared the special topic of "WHO Pre-certification Product Review Document Architecture and Good Document Specification" in the cloud forum

First of all, we introduced the basic situation of WHO-PQ, he pointed out that the WHO drug pre-certification is a service provided by the WHO, used to evaluate the quality, safety and effectiveness of drugs, after he from the pre-submission meeting, application letter, pre-certification documents and other seven steps to explain the operation process mode of WHO pre-certification.

WHO pre-certification process mode explanation

Electronic general technical document (eCTD), as the current internationally recognized drug declaration data preparation format, has replaced the previous product master document (PSF). Mr Christian detailed the general technical documents (eCTD) in the specific content of the five modules, for the more important quality, the clinical trial report and clinical trial report the three plates, Mr Christian listed each plate need to write content and need to pay attention to the technical difficulties, for you to effectively solve the file writing questions and confusion.

Explanation of eCTD Electronic General Technical Document course

Good document processing specification (GdP) is an indispensable part of the WHO pre-certification process. Mr.Christian started with an overall overview of how to record, data entry and recording notes, and the integrity and reliability of the data, and stressed that the more important aspect now is to ensure the source of information while ensuring the traceability and consistency of the document.

First appearance, connect to the world

In this online forum, we also released the "Pharmaceutical Professional English Vocabulary Manual" jointly produced by Times Group and Yunzhi Pharmaceutical Technology. The pocket book is classified by five parts: quality management (Quality Assurance), monitoring and analysis (Monitoring & Analysis), facilities (Facility & Equipment), production process (Production & Process), and registration and research and development (Registration & R & D), with a total of 2,000 + professional words. Each vocabulary includes Chinese, English, English phonetic symbols and vocabulary application examples. Under the wave of globalization of Chinese pharmaceutical enterprises, the Pharmaceutical Professional English Vocabulary Manual will also become a necessary professional "English dictionary" for pharmaceutical professionals.

Connect with the world and build the future of the industry. As the leader of pharmaceutical engineering EPC, The Group always takes science and technology as the source power of development, shares cutting-edge information in the pharmaceutical and environmental protection industries, spreads international cutting-edge ideas, and promotes the rapid development of the pharmaceutical industry.

Character link：ChristianBachofen

Mr.Christian Bachofen is an internationally renowned biomedical design and planning expert, with a bachelor in bioengineering at Zurich, and a founder and chief designer of CB Consultancy AG. He has served as a visiting professor at Basel and Jilin University in Switzerland. Mr.Christian has rich experience in the planning and design of pharmaceutical factory facilities, GMP clean room and HVAC system design, pharmaceutical water system design, quality management system, etc. As a project leader participated in several international famous biomedical design projects, including Johnson & Johnson pharmaceutical freeze-dried antibody production plant and mab-Xilin bottle packaging line design project, novartis pharmaceutical research and development park office building and for laboratory building design project, baekje shenzhou Suzhou pilot production workshop and Guangzhou commercial production workshop design project and sheng group new crown vaccine production workshop, and many other projects. The F2P2-Centocor's New R & D Fill Finish Pilot Plant project won the best project of the International Association of Pharmaceutical Engineering (ISPE). Christian In the design and implementation of the project, it proposed and realized a highly integrated unique design concept, cleverly balanced the requirements of flexibility, efficiency and compliance, and ISPE awarded it the best engineer.

Learning is like rowing upstream: not to advance is to drop back.

——To all the students

On January 22nd, the two-month International Bioengineering English Training camp was officially closed in the Yue Zongli conference room of Times Group. Under the guidance of Teacher Monica, an English expert in the pharmaceutical industry, the students have completed 12 bioengineering English courses and mastered 100 daily English dialogue exercises.

The Special training camp college and the Monica teacher took a group photo together

At the closing ceremony, the students finished the class in English and fully demonstrated the harvest in the past two months. The jury team composed of the lecturer Monica, Zhang Xinqiao, director and vice President, and Song Xiaohui, director and vice President, made targeted comments on each student's presentation.

The students are conducting daily professional English communication training

Finally, Teacher Monica issued the certificate of completion to each student, and said that the end of the special English training camp is not really the end, but the beginning of English learning. I hope you can continue to persist and break through the difficulties encountered in the learning road together. Students also said that through this period of English learning, they had regained their confidence and interest in English learning, and believed that they could truly apply it skillfully in their work through continuous consolidation and learning.

With the advancement and deepening of the internationalization strategy of all business divisions, it is necessary for employees to have more comprehensive and professional quality and ability. International talent training is an important part of talent team construction. We will always adhere to the core values of "creating value for customers and creating value for employees", so that more high-quality projects can meet with the world, so that all employees can realize their personal value.

In August this year, The Times Group and CB Consultancy AG carried out strategic cooperation to jointly build an international biomedical project consulting, design and construction team, making English gradually become an essential tool for communication. In order to further improve the staff's oral skills and professional English ability, the Talent Development Center specially invited Liang Jie (Monica), a senior English translation expert, to customize a two-month international biological engineering English training camp for the biomedical engineering marketing and designers of the Group.

On November 26 and 27, accompanied by the English song "Hello", the International Bioengineering English Special Training Camp was successfully opened in the 2416 training room of the Sunday headquarters. More than 40 employees from the day Group participated in the training and study.

Opening warm-up Opening the camp message-is the language is a bridge Before the official opening camp, Zhou Lanxia, deputy general manager of biomedical Division and general manager of biomedical engineering design Company, made a speech in the opening camp. She said that the Intramodern biomedical team is an international team, and the customers served also have international characteristics, so it is very necessary to strengthen English learning. We hope to further improve your professional and oral English and communication skills, and better serve international customers. Learning- -to break through the barrier with enthusiasm Be good at teaching students in accordance with their aptitude. Monica teacher in two days of course, first of all from how to learn English efficiently, lead you from the words, phonetic symbols let everybody for how to learn English has the system of cognition, after the daily language practice and Chinese and English cut formula and other methods to break the students concerns about English learning, encourage everyone to dare to speak out. Finally, in order to understand the English level and ability of each student, Teacher Monica conducted an English test on the students through English translation, English listening and English expression, and put forward different suggestions on English learning. Einstein once said that "Love is the best teacher". After two days of learning, the students all said that their initiative in English learning has improved a lot, but also found that language learning is not without rules at all. As long as there is passion and dare to speak out, the progress in language will become increasingly significant.

Language has always been an important tool to recognize all kinds of cultures and feel the charm of various countries. In order to expand the business communication of the international bioengineering English training camp, we not only develops the international bioengineering English training camp, but also opens up a new path for everyone to understand different cultures and master language skills. I believe that when the process of globalization is becoming more significant, heaven will always adhere to the core value of "creating value for customers and employees", so that more high-quality projects can meet the world.

The students of biomedical Engineering took a group photo with Teacher Monica [Lecturer's Introduction] Liang Jie (Monica), who graduated from Beijing Foreign Studies University in 2007, majoring in English, and has been committed to English translation in the pharmaceutical industry for a long time. Specialized in the interpretation and translation of FAT, SAT, IOQ, trial operation, process technology, biomedical project consulting and design of vaccine production equipment. In recent years, he has mainly participated in the translation of WHO pre-certified data and the interpretation of WHO on-site inspection of Hualan Biology, Beijing Institute of Biological Products, Changchun Institute of Biological Products and other units.

On November 26-27, the university EMBA2021 class third course began, the group director, President, central Europe international business school master Wu Yafeng and director, executive vice President, Shanghai jiaotong university in business administration Dr Chen ping respectively as "innovation and entrepreneurship" and "supply chain management" two subject lecturer, lead the university EMBA2021 class students to study and discussion.

EPC project general contracting is a project organization mode vigorously advocated by the state at present. Its advantages lie in clear responsibilities, reasonable connection of all stages of design, procurement and construction can shorten the construction period, and the investment is controllable. As the domestic EPC engineering general contracting mode of early practitioners, relying on technology and talent advantage, has gradually formed the unique technology as the leading engineering general contracting mode, but how to further improve the management level, promote enterprises to achieve secondary entrepreneurship, will build the company into the world's first-class engineering technology enterprises, should be considered at this stage. The course theory of the two teachers is connected with enterprise management practice, good at giving guidance, and developed at different levels.

Meet customer needs and optimize cost configuration

Scientific management of supply chain is crucial to increase the competitive advantage of enterprises, especially for EPC projects. Due to the main equipment, various kinds of materials, long order cycle, the inventory management cost is high, so how to use scientific methods classified docking owner, technical personnel, designers, personnel, purchasing personnel, construction personnel, suppliers, how to use big data, scientific inventory management to achieve the optimal efficiency, the shortest advance period, the optimal price, the least inventory to enhance enterprise competitiveness is crucial.

Chen Ping respectively described the course of Supply Chain Management from ten aspects: supply chain concept, inventory management, supply contract, procurement and outsourcing, product design and supply chain, information value, customer value, pricing, process management informatization and standardization, and supply chain finance. In the inventory management section, Chen Ping explained the problem of inventory and the principle of minimum inventory cost and maximum profit by explaining the two basic models of economic batch model and single period model. In the product design section based on the whole supply chain, Chen Ping vividly explained the balance between inventory and customization and the economy of Dell computer, Panasonic bicycle, IKEA and Leberumi.

Chen Ping discussed with the students After the course explanation, Chen Ping led the students to analyze the existing problems and solutions in the modern supply chain management mode. Students for time supply chain management of technical management, material management, supplier management, approval process and cycle management, price fluctuation management of the five parts, actively spoke and discussed, day university EMBA2021 students, time control center general manager Miao Zhengxu in the "reduce procurement costs" discussion said "centralized procurement is one of the current group effective reduce procurement costs", but "how to maximize integration is a difficult problem, all kinds of materials is different, construction is different, big differentiation". Peng Xiaohui, a student of The University EMBA2021 class and deputy general manager of the University Automatic Control Division, believes that "accelerating the development of information technology and implementing a more accurate dynamic inventory management mode may solve this problem to a certain extent".

There is no future for innovative enterprises, and the more difficult innovation, the greater the value brought by innovation. However, innovation is not blind, let alone easy. For enterprises in different stages of development, the focus and difficulties of innovation are also different. Wu Yafeng brought a wonderful "Innovation and Entrepreneurship" course to the 2021 EMBA students. The course analyzes the three stages of technological innovation and technology innovation, management innovation and service innovation. Wu Yafeng pointed out that the development stage of the enterprise should match with the development stage of the industry, so that the enterprise can survive and survive better. For example, in different stages of development of the enterprise, the enterprise will focus on different priorities. For start-ups, research and development and technology practice are the most important, only good technology and products can drive the development of enterprises; for the development to a certain extent, increasing the business volume, scale growth is the key; for large enterprises, how to achieve the agile response to the market and policy is the key. The content of the course is simple, enlightening wisdom and thought-provoking.

Wu Yafeng shared innovative cases with the students In the case discussion section, combined with the cases of "51.com" and "Apple" shared by Wu Yafeng, the students explored the unprecedented "second entrepreneurship mode of business division" together. Modern university EMBA2021 class students, group vice President, biomedical division chairman Song Xiaohui thinks, "the group is now in the 'from 1 to N' stage of development, how to use the" index thinking "to achieve" compound interest growth "is our core logic, at the same time we should be on the basis of the mainstream business, adopt the model of'division development", refine more business sector, realize the lean transformation of the enterprise ". Hearing wide is smart creation, win friends and learn easy to become. The third course of EMBA Times Group strengthens the students' ability in project management and improves the awareness of enterprise innovation through the two words of "control" and "innovation". An EMBA lecturer will bring ideological and cognitive enlightenment will always guide the day forward.

The sole purpose of an enterprise is to create customers, with and with only two basic functions, namely marketing and innovation.

——, Peter Druke, the father of modern management

From December 11th to 12th, the third course of EMBA2020 of University was successfully concluded. Mr.Zhuang Zhimin, a famous Chinese marketing combat and brand research expert and practical trainer, and Wu Yafeng, group director, president and chief technical officer, respectively served as the course lecturers of "Key Customer Marketing and Customer Relationship Strengthening" and "Innovation and Entrepreneurship". In the two-day course, we discussed marketing and innovation together.

In the fierce market economy conditions, we are experiencing the era of marketing, we must establish a market-oriented operation mechanism to make the enterprise invincible. Mr.Zhuang Zhimin, a famous actual marketing combat and brand research expert and practical trainer in China, taught the course of "Big Customer Marketing and Customer Relationship Strengthening". The course is conducted from four dimensions: marketing thinking training and customer experience, and Chinese marketing and marketing methodology; it introduces three causes of Chinese marketing selective management, relational culture and its development process, and analyzes the marketing differences between state-owned enterprises and private enterprises. From the four elements of customer stickiness, customer loyalty, brand reputation and unexpected, we analyze how to strengthen customer relationship, and conclude that strengthening user experience is the hard truth of marketing. From the most important initial visit to the number of transaction visits (duration), we introduce the six skills of customer communication, marketing process and business transaction skills of in-depth visit combined with examples. At the end of the course, it points out that the best marketing way for enterprises is to walk together with customers, to create value for customers, and not to make excessive commitment, but to seek excessive value delivery.

With the development of The Times, many industries have been very different from their birth, or even subversive changes. This is not only has the needs of the new era, but also the active innovation and bold change of practitioners. Wu Yafeng, director, President, and Chief Technology Officer and master of China Europe International Business School, teaches the course of Innovation and Entrepreneurship. The course analyzes the three stages of industry evolution and enterprise development: technological innovation, management innovation and service innovation, and domestic and foreign industry trends and innovation direction and disruptive innovation, promote innovation, realize innovation and curiosity through insight and logic. Course the second part from the two modes of entrepreneurship-rocket launch and lean entrepreneurship, system introduces the contains the content of the lean entrepreneurship, lean entrepreneurship must adhere to the five principles, theory with practice image explains the principle of the entrepreneurial problem, entrepreneurial methods, entrepreneurship through three stages, concluded that the essence of lean entrepreneurship is trial-and-error learning, the essence of trial-and-error learning is induction. The course ends up returning to the founder himself to develop sensitivity, beauty and inspiration. Perfect lean entrepreneurship is inseparable from the traction of values.

Marketing and innovation, which is the requirement of the era of knowledge economy, but also to meet new challenges and adapt to the new environment changes. Through the two-day wonderful course study, the students have a deeper understanding of marketing, innovation and entrepreneurship, and will actively apply the theories and knowledge they have learned into practical work, constantly improve their ability and level, and contribute to the development of the company.