The traditional quality culture in the pharmaceutical industry is driven by the regulatory process of marketing authorisation and manufacturing authorisation. These components of the South African regulatory control system are exclusively technically-orientated, with no managerial focus. This study identifies several quality management principles which could find general application in the pharmaceutical industry. The research compares the current regulatory control system with the total quality concept, and highlights the positive contribution which the total quality approach is able to make in terms of its field of reference; the strategic business value of quality; quality policy formulation; the quality organisational structure; enhanced operations management; and management's control over quality costs, in particular / Economic & Management Sciences / M.Com. (Business Economics)

The traditional quality culture in the pharmaceutical industry is driven by the regulatory process of marketing authorisation and manufacturing authorisation. These components of the South African regulatory control system are exclusively technically-orientated, with no managerial focus. This study identifies several quality management principles which could find general application in the pharmaceutical industry. The research compares the current regulatory control system with the total quality concept, and highlights the positive contribution which the total quality approach is able to make in terms of its field of reference; the strategic business value of quality; quality policy formulation; the quality organisational structure; enhanced operations management; and management's control over quality costs, in particular / Economic and Management Sciences / M.Com. (Business Economics)

by Cheung Chi-kong, Chu Hok-keung, Ting Wai-tong. / Thesis (M.B.A.)--Chinese University of Hong Kong, 1990. / Bibliography: leaf 83. / Chapter I. --- BACKGROUND --- p.1 / Introduction --- p.1 / The Origin of Chinese Medicine --- p.2 / A Definition of Chinese Medicine --- p.5 / A Survey --- p.6 / Chapter II. --- LITERATURE REVIEW --- p.7 / Chapter III. --- METHODOLOGY --- p.14 / Data Sources --- p.14 / Sample Design --- p.15 / Data Processing --- p.16 / Chapter IV. --- FINDINGS FROM THE STUDY --- p.17 / Chinese Herbal Drugs --- p.17 / Chinese Health Foods --- p.23 / Further Analysis --- p.29 / Chapter V. --- SUMMARY AND RECOMMENDATIONS --- p.37 / Summary --- p.37 / Chinese Herbal Drugs : Recommendations --- p.39 / Chinese Health Foods : Recommendations --- p.52 / APPENDIX --- p.65 / Profiles of Respondents --- p.65 / Questionnaire (English/Chinese Version) --- p.68 / BIBLIOGRAPHY --- p.83

Submitted by Vanessa Barreto Costa (vanessabarreto@hotmail.com) on 2017-04-13T01:33:36Z No. of bitstreams: 1 Dissertação 2017 - Vanessa Barreto Costa - APA.pdf: 1531182 bytes, checksum: b13035225ca5431228ad38395aef2d85 (MD5) / Approved for entry into archive by Pamela Beltran Tonsa (pamela.tonsa@fgv.br) on 2017-04-17T12:17:03Z (GMT) No. of bitstreams: 1 Dissertação 2017 - Vanessa Barreto Costa - APA.pdf: 1531182 bytes, checksum: b13035225ca5431228ad38395aef2d85 (MD5) / Made available in DSpace on 2017-04-17T12:28:17Z (GMT). No. of bitstreams: 1 Dissertação 2017 - Vanessa Barreto Costa - APA.pdf: 1531182 bytes, checksum: b13035225ca5431228ad38395aef2d85 (MD5) Previous issue date: 2017-03-05 / O objetivo dessa dissertação é investigar como as políticas regulatórias podem impactar a resiliência da cadeia de suprimentos através da avaliação de seu impacto nas capabilities formadoras de resiliência. Foram feitas 14 entrevistas semiestruturadas com gerentes de quatro empresas da área médica e farmacêutica e 1 associação de classe no Brasil. A seleção de tais indústrias é relevante, primeiramente devido ao alto nível de regulamentação ao longo destas cadeias de suprimentos e também devido sua criticidade já que, rupturas nessas cadeias de suprimentos podem colocar em risco vidas que dependem destes produtos. Os resultados indicam que a complexidade, tempo e precauções adicionais resultantes da regulamentação, associados a problemas burocráticos e processuais do órgão regulador no Brasil reduzem as capabilities de flexibilidade/redundância, velocidade e visibilidade. Os resultados também enfatizam a importância da indústria médica e farmacêutica construir resiliência na cadeia de suprimentos durante fase de preparação. Como contribuição gerencial esta pesquisa fornece um maior entendimento sobre os desafios para se construir cadeias de suprimentos resilientes nestas industrias no Brasil. Esta pesquisa contribui para a literatura investigando fatores externos na resiliência das cadeias de suprimentos, ao mesmo tempo que expande a pesquisa sobre fatores redutores de resiliência. / The purpose of this dissertation is to investigate how regulatory policies may impact supply chain resilience, through the evaluation of their impacts on the formative resilience capabilities. 14 semi-structured interviews were conducted with managers of four medical and pharmaceutical companies and 1 industry association in Brazil. The selection of such industries is relevant, firstly due to the high level of government regulation along their supply chains. Secondly, due to their criticality, as supply chain disruptions may put lives that depend on medical and pharmaceutical products in danger. The results indicate that the complexity, time and additional precautions resulting from the regulation, associated with the bureaucratic and processual issues of the regulatory body in Brazil reduce the capabilities of flexibility/redundancy, velocity and visibility. In addition, the results emphasize the importance that the medical and pharmaceutical industry builds supply chain resilience in the preparedness phase. As a managerial contribution, this research provides a greater understanding about the challenges around building resilient supply chains in these industries in Brazil. This research contributes to the literature by investigating environmental factors in supply chain resilience. It also expands the research about supply chain resilience reducers.

Pharmaceutical advertising involves the advertising of medicines, medical devices, and healthcare services. A review of available international literature indicates the belief that pharmaceutical advertisements negatively affect healthcare decisions made by consumers. Very little research has been conducted to determine how consumers in South Africa (SA) are affected by pharmaceutical advertisements. This study aimed to determine how consumers in the Nelson Mandela Metropole (NMM) perceive pharmaceutical advertisements. More specific objectives included the investigation of legislation in SA employed in pharmaceutical advertisements, the interpretation and misinterpretation of the advertisements, and the identification of problematic areas in this form of advertising. South African legislation applied to pharmaceutical advertisements was investigated by means of a literature review. A qualitative research design was also used to achieve the aim and objectives. This included a focus group consisting of six randomly selected participants in the NMM. A consumer survey, consisting of a 100 consumers obtained from 10 randomly selected community pharmacies within the NMM, supported the findings of the qualitative techniques. The themes identified in the focus group were incorporated into a questionnaire used in the consumer survey. Three randomly selected pharmaceutical advertisements were also decoded to interpret the components employed in each. The results determined that pharmaceutical advertising is a marketing tool that incorporates various emotional and psychological techniques to persuade consumers. It was also evident that consumers can misinterpret pharmaceutical advertisements. Various legal and ethical problems were identified in pharmaceutical advertisements. These results showed that pharmaceutical advertisements have the possibility of negatively affecting consumers’ healthcare decisions and warrants further investigation.

It is frequently argued that the high costs of clinical trials prior to the admission of new pharmaceuticals are stifling innovation. At the same time, regulation of the access to markets is often justified on the basis of consumers` inability to detect the true quality of a product. We examine these arguments from an information economic perspective by setting a framework where the incentives to invest in R&D are influenced by the information structure prevailing when the product is launched in the market at a later stage. In this setting, by changing the information structure, regulation (or the lack of) can thus indirectly affect R&D efforts. More formally, we construct a moral hazard - cum - adverse selection model in which a pharmaceutical firm exerts an unobservable effort towards developing an innovative (high quality) drug (moral hazard) and then announces the (unobservable) quality outcome to an uninformed regulator and/or consumers (adverse selection). We compare the outcomes in regard to innovation effort and expected welfare under two regimes: (i) regulation, where products undergo a clinical trial designed to ascertain product quality at the point of market access; and (ii) laissez-faire with free entry, where the revelation of quality is left to the market process. Results show that whether or not innovation is greater in the presence of entry regulation crucially depends on the efficacy of the trial in identifying (poor) quality, on the probability that unknown qualities are revealed in the market process, and on the preference and cost structure. The welfare ranking of the two regimes depends on the differential effort incentive and on the net welfare gain from implementing full information instantaneously. For example, in settings of vertical monopoly, vertical differentiation and horizontal differentiation with no variable cost of quality, entry regulation tends to be the preferred regime if the effort incentive under pooling is relatively low and profits do not count too much towards welfare. A complementary numerical Analysis shows how the outcomes vary with the market and cost structure. (authors' abstract) / Series: Department of Economics Working Paper Series

Thesis (MComm)--Stellenbosch University, 2001. / ENGLISH ABSTRACT: New products are indispensable to the growth of the modem business enterprise. Increased global and local competition, better informed consumers, rapidly changing technology and the short life span of products are typical of the reasons why it is necessary to develop new products. Traditionally new product development took place in accordance with a rigid new product development process where a next phase was dependent on the completion of preceding phases. The increased pressure to produce new products in shorter time spans has led to the development and application of less streamlined and rigid processes for the development of new products. The pharmaceutical industry has certain unique characteristics important for new product development. It spends more than five times than the average of all industries on research and development. New product development in the pharmaceutical industry largely depends on the discovery of new clinical entities and the development process is furthermore also highly regulated by governments. The focus of product evaluation in the pharmaceutical industry has also undergone a major shift. Traditionally the industry dealt with diseases which were defined broadly and as such the focus was on diseases and not individuals. The result was that consumer acceptance was virtually never evaluated. The shift is now to consumer acceptance because consumers become increasingly better informed and take part in decisions regarding their health and medical care. A further reason for the consumer focus lies in the genetic understanding of patients and this enable pharmaceutical companies to segment patients on the basis of pharmaco-genomic descriptions. The objectives of the study are twofold. In the first instance, the study assesses whether marketing practitioners in the South African pharmaceutical industry agree with the fundamental principles of new product development which are identified in academic literature. The responses from marketing personnel were obtained and analysed to establish their beliefs regarding new product development. The fundamental principles of new product development which form the focus of this study, were those that Calantone, Di Benedetto and Haggblom (1995) used in their research. The second objective of the study is to compare the findings in respect of the South African pharmaceutical industry with those of the study undertaken by Calantone, Di Benedetto and Haggblom in 1995. The purpose of the study is to establish whether the new product development principles taught in marketing management courses are relevant for the pharmaceutical industry. The method of investigation was divided into two sections, i.e. a literature overview and an empirical study. The literature study commenced with research on new product development in the South African Pharmaceutical Industry and other parts of the world. The Calantone, Di Benedetto and Haggblom (1995) questionnaire was also used in this study for data collection. The 91 pharmaceutical companies listed in Volume 34 of the 1999 MIMS Desk formed the population of the study. After contacting these companies a more accurate list was set up. After taking into account all the mergers that took place, 65 companies eventually constituted the population. Twenty nine of the questionnaires sent were returned and could be used. This represents a response rate of 44.6%. The organisations involved were responsible for 69.4% of the annual turnover of the total pharmaceutical industry in 1998 and their responses could therefore be regarded as representative of the pharmaceutical industry of South Africa. The questionnaire attended to the following principles of new product development: • Product innovation • New product development and launch tasks • Product diffusion • Interface between marketing, research and development • Organisational issues The information collected in respect of each pharmaceutical company was the following: • Annual turnover • Number of products manufactured and marketed • Number of employees • Number of new products launched during the past five years The findings of this study indicate that marketing staff in the South African pharmaceutical industry strongly agreed with those fundamental principles of new product development which were identified in academic literature. There was also a significant correlation between this study and the study undertaken by Calantone, Di Benedetto and Haggblom with respect to the percentage agreement on the various statements. It may thus be concluded that new product development principles taught in marketing managing courses are relevant for and are applied by marketing staff in the pharmaceutical industry in South Africa. / AFRIKAANSE OPSOMMING: Nuwe produkte is onontbeerlik vir die groei van die moderne sake-onderneming. 'n Toename in globale en lokale mededinging, beter ingeligte verbruikers, snel veranderende tegnologie en die kort lewensduur van produkte is tipies van die redes waarom dit belangrik is om nuwe produkte te ontwikkel. Tradisioneel het nuwe produk ontwikkeling volgens 'n rigiede nuwe produk ontwikkelingsproses plaasgevind waar 'n volgende fase afhanklik was van die voltooiing van voorafgaande fases. Die verhoogde druk om nuwe produkte in korter tye te vervaardig het tot die ontwikkeling en toepassing van minder stroombelynde en rigiede prosesse vir die ontwikkeling van nuwe produkte gelei. Die farmaseutiese bedryf het sekere unieke eienskappe wat belangrik is vir nuwe produk ontwikkeling. Die farmaseutiese bedryf bestee meer as vyfkeer die gemiddelde van alle bedrywe op navorsing en ontwikkeling. Nuwe produk ontwikkeling in die farmaseutiese bedryf is grootliks afhanklik van die ontdekking van nuwe kliniese entiteite en die ontwikkelingsproses word verder ook intensief gereguleer deur regerings. Die fokus van produkbeoordeling in die farmaseutiese bedryf het ook 'n verskuiwing ondergaan. Tradisioneel het die bedryf gehandel met siektes wat breed omskryf is en die fokus as sulks was op siektes en nie op individue nie. Die gevolg was dat verbruikersaanvaarding feitlik nooit beoordeel was nie. Die verskuiwing is nou na verbruikersaanvaarding omdat verbruikers toenemend beter ingelig word en deelneem aan besluite wat hulle gesondheid en mediese sorg raak. 'n Verdere rede vir die verbruikerfokus is daarin geleë dat pasiënte nou geneties verstaan kan word en dit maak vir farmaseutiese maatskappye moontlik om pasiënte op 'n farmakologies-genomiese basis te segmenteer. Die doelstellings van die studie is tweeledig. In die eerste instansie beoordeel die studie of bemarkingspersoneel werksaam in die die Suid-Afrikaanse farmaseutiese bedryf, saamstem met die fundamentele beginsels ten opsigte van nuwe produk ontwikkeling wat in die akademiese literatuur geïdentifiseer is. Die response van bemarkingpersoneel is verkry en ontleed om hulle oortuigings ten opsigte van nuwe produk ontwikkeling vas te stel. Die fundamentele beginsels van nuwe produk ontwikkeling wat die fokus van hierdie studie vorm, is dié wat Calantone, Di Benedetto en Haggblom (1995) in hulle navorsing gebruik het. Die tweede doelstelling van die studie is om die bevindings ten opsigte van die Suid-Afrikaanse farmaseutiese bedryf te vergelyk met dié van die studie onderneem deur Calantone, Di Benedetto en Haggblom in 1995. Die doel van die studie is om vas te stel of die nuwe produk ontwikkeling beginsels wat in bemarkingsbestuurkursusse onderrig word, relevant is vir die farmaseutiese bedryf. Die metode van ondersoek is onderverdeel in twee gedeeltes, naamlik 'n literatuuroorsig en 'n empiriese studie. Die literatuurstudie het begin met navorsing oor nuwe produk ontwikkeling in die Suid-Afrikaanse farmaseutiese bedryf en ander wêrelddele. Die Calantone, Di Benedetto en Haggblom (1995) vraelys is ook in hierdie studie vir die insameling van data gebruik. Die 91 farmaseutiese firmas wat in Volume 34 van die 1999 MIMS Desk gelys is, het die populasie van die studie gevorm. Na gesprekke met hierdie firmas en nadat alle samesmeltings in ag geneem is, is 'n meer akkurate lys opgestel en het die populasie uiteindelik uit 65 firmas bestaan. Nege en twintig van die vraelyste wat terugontvang is kon gebruik word. Hierdie verteenwoordig 'n responskoers van 44.6%. Die organisasies wat gereageer het was verantwoordelik vir 69.4% van die jaarlikse omset van die totale farmaseutiese bedryf in 1968 en die responses sou dus as verteenwoordigend van die farmaseutiese bedryf in Suid-Afrika beskou kon word. Die vraelys het aandag aan die volgende beginsels van nuweprodukontwikkeling gegee: • Nuweproduk ontwikkeling en loodstake • Produkdiffusie • Koppelvlakke tussen bemarking, navorsing en ontwikkeling • Organisatoriese kwessies Die inligting wat ten opsigte van elke farmaseutiese firma ingesamel is, is die volgende: • Jaarlikse omset • Aantal produkte vervaardig en bemark • Aantal werknemers • Aantal nuwe produkte wat gedurende die afgelope vyf jaar geloods is. Die bevindings van hierdie studie toon aan dat die bemarkingspersoneel in die Suid-Afrikaanse farmaseutiese bedryf sterk saamstem ten opsigte van die beginsels van nuwe produk ontwikkeling wat in die akademiese literatuur geïdentifiseer is. Daar bestaan ook 'n betekenisvolle korrelasie tussen hierdie studie en die Calantone, Di Benedetto en Haggblom studie ten opsigte van die persentasie wat saamgestem word oor die verskillende stellings. Die gevolgtrekking kan dus gemaak word dat die nuwe produk beginsels wat in bemarkingskursusse aangebied word, relevant is vir en toegepas word deur bemarkingspersoneel in die farmaseutiese bedryf in Suid- Afrika.

Thesis (MBA)--Stellenbosch University, 2012. / Analgesics are the medication most-generally used by modern society. The pain management market has therefore experienced substantial growth over the last few years. This research report aims to provide a critical review of pain management in the pharmaceutical market in South Africa, in order to establish and evaluate the most significant growth factors. This research report provides an overview of the history of pain, the basic physiology of pain and pain classification systems. There are three categories of analgesics - opioid analgesics, non-opioid analgesics and adjuvant analgesics. These categories of analgesics have been analysed according to the most generally-used MIMS pharmacological classification system referring to the analgesic therapeutic classes. These are narcotic analgesics, analgesics and antipyretics, combination analgesics, others such as tramadol and musculo-skeletal agents which consist of NSAIDs and COX inhibitors. Growth over the last four years (from August 2009 to July 2012) will be determined by analysing data per molecule, per product and per manufacturer. Splits between branded and generic drugs will also be analysed. Top prescribers by healthcare professionals will be examined, analysing scripting data from ImpactRx, which covers 85% of the private market data nationally. There are currently approximately 41 analgesic molecules in the assessed pain market which has produced 738 analgesic products. The analgesic market (worldwide and in South Africa) has seen the launch of only a few new drugs. New molecules of the same drug class or family have been launched, but in effect they can be viewed as mere line extensions with claimed reduction in side effects, advanced delivery times or improved efficacy. Two new molecules have been launched in the South African market in the narcotic analgesic class, (oxycodone and hydromorphone), however these molecules have been available internationally for years. Accelerated growth of the pain management market has mainly been met by combination analgesics, which in essence are not new, but rather a combination of different active ingredients or new drug delivery systems. The impact of product withdrawals on market share is also evaluated. The development and acceptance of generics are highlighted as key contributing factors in the growth of the analgesic market. Important to note is that generics often compete in their own generic market share. This may be the reason why the generic market does not show a significant increase over branded products. Another significant trend evident in the increased acceptance of generics, is that manufacturers, in order to keep market share, may choose to produce their own generic medication after their branded products patent has expired. Pain is one of the main reasons why patients seek medical attention and it is the physician’s ethical responsibility to treat patients and provide them with effective pain relief medication. The WHO analgesic ladder as a guideline for treating pain has proven to be effective after 25 years in practice. It is forecasted that an increase in the narcotic analgesic class will be noted. Pain is heavily undertreated worldwide and in South Africa, Increased awareness, education, new advanced research and knowledge may help to address this dilemma.

published_or_final_version / Business Administration / Master / Master of Business Administration

Thesis titled Commercial communications in czech pharmaceutical industry is about how to use marketing communication tools (advertising, public relations, sales promotion, personal selling, etc.) in the pharmaceutical industry. A specific feature of pharmaceutical marketing is separate communication to public (patients) and to professionals (doctors) which requires using different communication messages and also different channels to each target group. Pharmaceutical marketing is regulated by advertising law, by the Council for Radio and TV Broadcasting and by the provisions of the State Institute for Drug Control which control the ways how two target groups are addressed. Possible marketing tools are described from both theoretical (legal) and also practical (marketing communication of specific pharmaceutical company) terms.