scholarly journals Regulatory Аffairs in the pharmaceutical industry – insights

2021 ◽  
Vol 66 (2) ◽  
pp. 41-52
Author(s):  
Filip Cvetanovski ◽  
Rubin Zareski
Keyword(s):  
Pharmaceutical Industry ◽  
Professional Growth ◽  
New Products ◽  
Pharmaceutical Product ◽  
Information Organization ◽  
Everyday Activities ◽  
Regulatory Affairs ◽  
Market Launch ◽  
Goals And Objectives ◽  
Individual Professional

The Regulatory Affairs as a field in the pharmaceutical industry has a lot of potential for individual professional growth. Formerly viewed as a clerical profession, growing requirements from competent authorities for a more regulated pharmaceutical industry resulted in growing interest and demand for regulatory proffessionals. The pharmacists working in a modern regulatory department unit are today viewed as key figures in obtaining the company’s goals and objectives. Their expertise can undoubtedly contribute to improving the strategy for the eventual market launch of a pharmaceutical product and provide for a better overall process in developing new products as well as maintaining ones that are already registered. In this essay we delve inside the image surrounding this department, and try to bring forward what is actually behind it. We then look inside the organizational structure and everyday activities of a regulatory department, and offer our thoughts into making the processes in that department more efficient consulting the latest insights from leading experts on this subject. Ultimately, we try to include the application of technological advancements into the picture and what their contribution would mean for managing information and thus an efficient way of functioning in such departments. Keywords: Regulatory Affairs, technology, information, organization, efficient

The Drug Lag: A 20-Year Analysis of Six Country Markets

1994 ◽  
Vol 13 (2) ◽  
pp. 290-299 ◽  
Author(s):  
Kathleen M. LaFrancis Popper ◽  
Robert W. Nason
Keyword(s):  
Public Policy ◽  
New Products ◽  
New Product ◽  
Pharmaceutical Product ◽  
Effective Drug ◽  
Drug Products ◽  
New Product Introductions ◽  
Drug Lag ◽  
The Cost ◽  
The Relationship

The sensitive nature of pharmaceuticals and the high cost of research and commercialization to introduce new products have led to numerous regulations intended to ensure the availability of safe and effective drug products. An unintended result has been to increase the cost of product introductions into various markets. The authors empirically test the relationship among the types of regulation, pharmaceutical product introductions, and the timing of their entry into the six largest country markets from 1970 to 1989. Surprisingly, the findings show that the type of regulation affects timing more than the number of new product introductions. The authors address the drug lag across the largest country markets on a product level over a period of 20 years. They discuss important potential implications for public policy and society.

scholarly journals PRIORITIZATION OF THE LAUNCH OF ICT PRODUCTS AND SERVICES THROUGH LINGUISTIC MULTI-CRITERIA DECISION-MAKING

2018 ◽  
Vol 24 (3) ◽  
pp. 1231-1257 ◽  
Author(s):  
Andr´es CID-LÓPEZ ◽  
Miguel J. HORNOS ◽  
Ram´on A. CARRASCO-GÓNZÁLEZ ◽  
Enrique HERRERA-VIEDMA
Keyword(s):  
Decision Making ◽  
New Products ◽  
Information And Communications Technology ◽  
Practical Case ◽  
Multi Criteria Decision Making ◽  
Technology Sector ◽  
Linguistic Model ◽  
Market Launch ◽  
The Right ◽  
Decision Making Model

The market launch of new products and services is a basic pillar for large and medium-sized companies in the ICT (Information and Communications Technology) sector. Choosing the right moment for it is usually a differentiating factor in terms of competition, since it is a source of competitive advantage. There are several mechanisms and strategies to address this problem from the market perspective. However, the criteria of the different actors involved – managers, sales representatives, experts, etc. – coexist in the corporate sphere and they often differ, causing difficulties in priority setting processes in the launch of a product or service. The assessment of the prioritization of these criteria is usually expressed in natural language, thus adding a great deal of uncertainty. Fuzzy linguistic models have proved to be an efficient tool for managing the intrinsic uncertainty of this type of information. This paper presents a linguistic multi-criteria decision-making model, able to reconcile the different requirements and viewpoints existing in the corporate sector when planning the launch of new products and services. The proposed model is based on the fuzzy 2-tuple linguistic model, aimed at managing linguistic data expressing different corporate criteria, without compromising accuracy in the calculation of said data. In order to illustrate this, a practical case study is presented, in which the model is applied for scheduling the launch prioritization of several new products and services by a telecommunications company, within the deadlines set in its strategic planning.

CMPC® Certification as a Milestone, Not a Millstone: A Response to Scherzer and Reel

2019 ◽  
Vol 13 (3) ◽  
pp. 345-350
Author(s):  
Robin S. Vealey ◽  
Nick Galli ◽  
Robert J. Harmison
Keyword(s):  
Professional Growth ◽  
Historical Context ◽  
Certification Program ◽  
Mental Performance ◽  
Certification Exam ◽  
Individual Professional

In this commentary, we respond to Scherzer and Reel’s concerns over the Certified Mental Performance Consultant® (CMPC®) certification program requirements, particularly the certification exam. A reframing is suggested, in which the exam and recertification requirements are viewed as exciting historical milestones and an opportunity for individual professional growth as opposed to a personal inconvenience. In addition, some historical context and rationale for specific aspects of the CMPC certification program are provided, including the rationale for the CMPC credential.

THE ROLL OF GENERIC DRUGS– QUALITY AND ECONOMIC ASPECT IN TREATMENT

2016 ◽  
pp. 5-11
Author(s):  
Huu Dung Tran ◽  
Phuoc Bich Ngoc Nguyen
Keyword(s):  
Pharmaceutical Industry ◽  
Generic Drugs ◽  
Pharmaceutical Product ◽  
Economic Aspect ◽  
Assessment Centers ◽  
Expiry Date ◽  
Innovator Product ◽  
Bioequivalence Assessment ◽  
Innovator Company

Generic drugs have an important role in ensuring the efficacy, safety, and especially the economic aspect of drug use. A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product manufactured without a licence from the innovator company and marketed after the expiry date of the patent or other exclusive rights. At present, unlikely FDA’s regulations, Vietnam’s law does not require all generic drugs launching in the market to prove the bioequivalence, the same efficient and safe as innovator drugs. Because of the rapid growth of the domestic pharmaceutical market, the standard and quality of generic drugs compared with innovator drugs have to be consolidated and proved through trials of bioequivalence, then building the faith of professionals and patients in using generic drugs. Thus the expansion of number and improving quality of the bioequivalence assessment centers become an important task of Vietnam pharmaceutical industry in the context of integration with the global pharmaceutical industry. Key words: generic drugs, innovator drugs, patent, bioequivalence, treatment.

New pharmaceutical product development: Barriers to overcome and opportunities to exploit

2008 ◽  
Vol 14 (3) ◽  
Author(s):  
Nic S Terblanche
Keyword(s):  
Pharmaceutical Industry ◽  
Biotechnology Industry ◽  
Pharmaceutical Product ◽  
New Drugs ◽  
New Approach ◽  
Pharmaceutical Product Development ◽  
Sales And Marketing ◽  
Rate Of Increase ◽  
State Of Affairs ◽  
The Cost

The pharmaceutical industry experienced an unprecedented rate of increase in the cost of developing new drugs while the number of new drugs that were approved and accepted in the marketplace has reached a very low level. Various factors are responsible for this state of affairs. One of the major opportunities available to the pharmaceutical industry to improve this situation is to collaborate with the biotechnology industry. The future solutions to a host of current diseases as well new strains of existing ones lie in the cooperation between these two industries. The pharmaceutical industry will, however, have to carefully manage challenges such as increased governmental control and the damaged image of the industry. There are many opportunities offered by offshoring, advanced application of information technology, climate change and a new approach to sales and marketing, all of which the pharmaceutical industry can exploit. Should the pharmaceutical industry manage to address the issues responsible for the high costs prevalent in the industry, its role as partner with the biotechnology industry could prove to be very beneficial for both these industries.

scholarly journals Methodical Services of the Central Libraries of the Regions: Questions of Organizational and Staffing Maintenance

2018 ◽  
Vol 67 (1) ◽  
pp. 103-109 ◽  
Author(s):  
Irina P. Tikunova
Keyword(s):  
Best Practices ◽  
Professional Growth ◽  
Professional Training ◽  
Staffing Levels ◽  
Russian State ◽  
The Russian Federation ◽  
Workforce Capacity ◽  
The Government ◽  
State Library ◽  
Goals And Objectives

The activity of methodical services is prerequisite for sustainable development of libraries and effective innovation. The article presents the results of the first survey over the last 30 years, conducted by the Center for study of problems of the development of libraries in the information society of the Russian state library in April — October 2017, aimed to analyse the organization of methodical services in the Central libraries of subjects of the Russian Federation, to assess their workforce capacity and to offer solutions to the revealed problems. The results of the data analysis (representativeness is 94%) demonstrates that in most of the Central libraries the methodical activity is the priority (core) trend, and methodical services continue to evolve. In their organization there is a great diversity, which manifests in setting the activity goals and objectives, in choosing the approaches to determining staffing levels, building a structure. The capacity of human resource in most of the libraries can be considered quite high: experts belong to the potentially productive age group, have sufficient experience, and regularly update their knowledge. Among the acute problems is lack of the approved methods for calculation of the normative standards for staffing levels of these units, as well as the requirements for professional growth training for methodologists. There is made the conclusion on the need to work out recommendations for the formation of staff size of methodological services, to identify and spread the best practices for the development of the government order for performance of works (services) on the methodological support of librarianship. For the organization of advanced professional training of methodologists, it is needed to combine the efforts of Federal libraries and actively introduce distance learning.

scholarly journals Modern Trends and Specifics of Additional Professional Education of University Teachers

wisdom ◽  
2021 ◽  
Vol 19 (3) ◽  
pp. 55-67
Author(s):  
Irina ARYABKINA ◽  
Olga DONINA ◽  
Natalya IVANUSHKINA ◽  
Anatoliy CHERNYKH ◽  
Nadezhda GAJBUROVA ◽  
...  
Keyword(s):  
Professional Education ◽  
Professional Growth ◽  
University Teachers ◽  
Economic Transformations ◽  
The Subject ◽  
Characteristic Features ◽  
Training Professional ◽  
Further Development ◽  
Goals And Objectives ◽  
Methods Of Control

The subject of consideration in this article is additional professional education as a pedagogical system, an integrated set of methods, for,ms and means of obtaining, expandi,ng and deepening the competencies, which have already been formed earli andas acquiring new ones. Nowadays, the development and further improvement of additional professional education have become actual in recent decades. In Russia, this is carried out in the context of a profound restructuring of society. Therefore it has its own characteristic features due to socio-economic transformations and corresponding changes in the labour market. It is stated that additional professional education of teachers acquires a special social status and is distinguished by its motives and values, goals and objectives, forms of organization and content, teaching technologies and methods of control and assessment. The goals and objectives of additional professional education of teachers have been represented, including the formation of their motivation for professional growth, advanced training, professional retraining, as well as the prevention of professional and the strain of personality, overcoming professional and personal crises. The result of studying this issue was the identification of modern trends and directions for the further development of the system of additional professional education for teachers.

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