Chapter 1.
The Healthcare Environment addresses the dynamic nature of healthcare systems around the world,
their components, and the relationships among the components. It also discusses major differences between
healthcare systems in other countries and the healthcare reform phenomenon that is currently engulfing the globe.
Furthermore, it provides an overview of the worldwide need for healthcare regulation, and presents the major
processes regulated internationally It also focuses ns two of the most important regulatory submissions, namely,
minions, namely, the In the Investigational New Doug (IND) and the New Drug Application (NDA) processes
and their requirements.
-Healthcare Environment- operational stage of p industry. -Health- complete state of well-being
-Illness- judgement of health by med HC -Healthcare- any helpful activity to maintain and improve
health.
-Services: Preventive, acute, chronic, restorative palliative -HC system- quality products, affordable cost
Or Setting of healthcare provisions
System Components
1. Primary providers are those facilities and individuals directly involved in treating people in need, that
is, 3 MAJOR INTERNATIONAL REGULATORY BODIES
hospitals, other healthcare facilities, and physicians. 1. Food and Drug Administration (FDA),
2. Secondary providers are organizations or individuals providing resources needed for integrated health care. 2. European Agency for the Evaluation of Medicinal Products (EMEA),
3. Japanese Ministry of Health and Welfare or Kosheisho.
Resources: (1) Financial, (2) Human, (3) infrastructure, (4) technological
FDA RESPONSIBILITIES (Regulations): (1) applications, (2) standards, (3) pharmacovigilance,
(4) compliance, (5) supporting departments
Investigational New Drug (IND) application
The contents of the application are (1) sponsor and trial monitor names; (2) commitment
for not starting the trial before the application is approved; (3) commitment that the institutional review
3 guiding Principles of ideal system: (1) Accessibility, (2) high quality, (3) affordability board (IRB) and the sponsor will com- ply with all relevant FDA guidelines; (4) investigational plan; (5)
investigator's brochure; (6) trial protocol; (7) chemical, manufacturing, and quality assurance data; (8)
pharmacological and toxicological data; and (9) marketing experience data.
2 Types Product License:
1. Shonin- product approval for efficacy and safety
2. Kyoka- license to handle the shonin- approve product based on personnel and facilities qualifications
Chapter 2, The Pharmaceutical Industry Economy looks at a major industrial sec nor in search of higher
productivity and long-term viability under constantly evolving regulatory and competitive environments. The
chapter provides an overview of the pharmaceutical industry, its associated industries, and common
organizational structures, while presenting a variety of industry statistics and insights on competitive forces. It
explains the nature and importance of the multiple stakeholders associated with the industry, who are
categorized in five main groups-prescribers, influencers, regulators, financers, and consumers. Furthermore, the
interrelationships and potential conflicts between the different stakeholders are presented and analyzed.
Chapter 3, The Pharmaceutical Marketing Environment discusses how products satisfy customer needs and
wants and the importance of customer satisfaction. In addition, it addresses the role of marketing in society, and
analyzes the marketing management function in today's business world. It also deals with the four Ps of
marketing, namely, product, price, place, and promotion, and their role in the marketing management process
and environment. Chapter 3 further confronts the ethical dilemmas often faced by pharmaceutical marketers
around the world, and discusses the pharmaceutical product marketing mix, as well as the marketing
environment. In addition, it focuses on two major professional avenues available to industry marketers, namely,
product management and medical marketing.
Part 2, Marketing Strategy is the core section of this pharmaceutical marketing guide. It consists of eight
chapters, which discuss strategy components ranging from the need for a global strategy cascade, the elements
of marketing research, market segmentation, and the importance of competitor and situational analyses, to the
concepts of positioning, targeting, profiling, product life cycle, new product development, and portfolio
management methods. Furthermore, it discusses common competitive strategies, as well as the intensifying
competition between ethical and generic drug manufacturers.
Chapter 4, What Is Marketing Strategy A marketing strategy is a long-term plan that outlines how an
organization intends to reach its target audience, build brand awareness, and drive sales. It involves setting
specific goals and objectives, identifying the target audience, and developing a range of tactics to achieve those
goals..
Chapter 6, Market Segmentation gives the definition of a market and explains the need for distinct market
segment identification and detailed analysis. Several segment strategies are discussed.
