Managerial Roles (Pharmaceutical Management), Slides of Marketing Management

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Managerial Roles Ramisa Anjum Lecturer University of Asia Pacific Department of Pharmacy Learning Objectives ➢ Definition of Manager ➢ Five Functions of Fayol’s Management ✔Planning, Organizing, Commanding, Coordinating, Controlling ➢ Characteristics of an Effective Manager ➢ Who is a Pharmacist? ➢ Managerial Roles of Pharmacists ➢ Roles of Industrial Pharmacists ✔Production, Product Promotion, Inventory Management, Regulatory Affairs, Research and Development ➢ Role of Hospital Pharmacists ➢ Role of Clinical Pharmacists ➢ Role of Community Pharmacists Definition of Manager01 Roles of Industrial Pharmacists 06 Five Functions of Fayol’s Management02 Characteristics of an Effective Manager Roles of Hospital Pharmacists 07 Topics Who is a Pharmacist?04 Managerial Roles of Pharmacists Roles of Clinical Pharmacists 08 Roles of Community Pharmacists 03 05 09 Definition of Manager 01 1. Planning Planning is the first function of management. Planning is an attempt to predict the future of the organization and to determine the measures needed to transition to this new state. At the heart of the planning process is the development of a formal action plan. This plan should be based on the resources available to the organization and on possible trends that may occur in the future. The ideal plan should combine: ▪ Purposefulness: The general plan to be supported by the separate plans of the smaller structures and units in the organization. ▪ Continuity: The planned actions to be considered as elements of a continuous process of development. ▪ Flexibility: The plan to take into account the possibility of unexpected circumstances. ▪ Accuracy: The plan should be as accurate as possible. 2. Organizing The organization is the second function of management. Organizing is the activity by which the company receives everything it needs for its operation - raw materials, tools, capital, and personnel. The organization depends mainly on the number of staff. As the number of people increases, so do the various functions that are performed in the organization, respectively the need for control over the work of people increases. All this leads to a well-known model of organizational pyramid or hierarchy. 3. Commanding The commanding aims to achieve the optimal effect of the efforts of workers, in the interest of the whole organization. The leader can stimulate the initiative of his subordinates by delegating rights to them, thus providing them with opportunities to fully realize their potential and skills. This can happen at the cost of making individual mistakes, the severity of which is significantly limited with proper control. The manager can quickly turn a person with unspeakable abilities into a first-class specialist, not doing all the work for him, but helping him through the method of prompting. 4. Coordinating Coordination aims to ensure optimal harmony between the various activities of the organization. Good coordination facilitates the work and makes the functioning of the organization more successful. This function is designed to balance the different aspects of the work, for example, to observe proportional spending in terms of available financial resources, production needs, stocks, and market demand. 5. Controlling Control is designed to ensure compliance with everything that happens in the organization with pre-defined plans, principles, and standards of work. In such a context, control aims to detect errors and weaknesses in the work to neutralize them and prevent them from recurring in the future. Characteristics of an Effective Manager 03 Lead Experience Knowledge Effective Communication Time Management Conceptual Skill Confident Delegate Work ➢ In order to be an effective manager, a manager needs to be able to lead the employees in an efficient manner ➢ A manager must gather professional experience of working in a professional environment and leading a team ➢ Experience as a manager is a must but so is knowledge. This is the key to greater innovation for the betterment of the organization ➢ Effective communication is a staple that all the best managers have, it means listening to your team and working with them to produce results within their position ➢ Conceptual skills, ability to think critically and analytically, solve problems. Most important in upper management level ➢ Another key factor in being a successful manager is time management that makes sure you have time to communicate with employees and accomplishing goals throughout the week. ➢ To be an effective manager, you need to be confident in your abilities, experience, and decision-making skills. ➢ Knowing when and how to delegate makes you a better manager. You might delegate work to distribute responsibility more evenly, or because the task or initiative is more relevant to another team member's priorities, skills, or interests. Roles of Industrial Pharmacists 06 ❏ Industrial pharmacists conduct research, testing and analysis in the development of medicines and production of pharmaceuticals and related supplies. Industrial pharmacists use the latest methods, technologies and processes to develop new medications, and may be involved in clinical drug trials. ❏ Formulation medicines following Good Manufacturing Practice (GMP), a system for ensuring that products are consistently produced and controlled according to quality standards. ❏ GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. ❏ Ensure the quality of the products by regulating quality control and quality assurance by maintain proper documentation ❏ Preparation of regulatory guideline & maintain safe work environment. Roles of industrial pharmacists Production Management The Production Process: Converting input to output INPUT ● Resources ● Raw Materials CONVERSION PROCESS ● Add value OUTPUT ● Goods ● Services ❏ Production: Application of resources such as people and machinery to convert materials into finished goods and services. ❏ Production and Operations Management: Managing people and machinery in converting materials and resources into finished goods and services. Responsibility of Production Manager Planning and production process Selecting the most appropriate layout Controlling the production process Implementing the production plan Production managers ensure that manufacturing processes run reliably and efficiently. Responsibilities of the job include: ❏Planning and organizing production schedules and overseeing production processes ❏Assessing project and resource requirements, which includes selecting, ordering and purchasing of raw materials, also equipment and machineries when required ❏Estimating, negotiating and agreeing budgets and timescales with clients and managers ❏Determining quality control standards and ensuring that health and safety regulations are met according to defined guidelines ❏Re-negotiating timescales or schedules as necessary to meet the target production ❏Organizing the repair and routine maintenance of production equipment ❏Communicating with buyers and marketing and sales staff ❏Supervising and managing the work of junior staff and Organizing relevant training sessions. Promotion • Promotion is the function of informing, persuading and influencing a purchase decision. • Integrated marketing communications (IMC) is the coordination of all promotional activities—media advertising, direct mail, personal selling, sales promotion, and public relations—to produce a unified customer-focused message. Regulatory Affairs ❏ A regulatory affair is a profession which acts as the interface between pharmaceutical industry and drug regulatory authorities across the world. ❏ It is mainly involved in the registration of drug products in respective countries prior to their marketing. ❏ The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. Regulatory Affairs Regulatory professionals are responsible for: 1. Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned ❏ Manufacturing license approval and renewal ❏ New product registration ❏ Price approval and revisions ❏ Product renewal ❏ Approval of changes in existing products ❏ Promotional materials approval ❏ International Marketing Certificates/Approvals ❏ Manufacturing agreement issues with others 2. Collecting, collating and evaluating scientific data 3. Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its product. 4. Advising on legal and scientific restraints and requirements 5. Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole 6. Helping the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. Additionally, the regulatory affairs department will often take part in the development of product marketing concepts and is commonly required to approve packaging and advertising before it is used commercially. Functions Related to Regulatory Affairs in New Product Launching ❏ Research & Development ❏ Clinical trial ❏ Investigational new drug application (INDA) An INDA is a submission to the FDA requesting permission to initiate a clinical study of a new drug product. ❏ New Drug Application (NDA) The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States. ❏ Abbreviated New Drug Application (ANDA) An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use. ❏ Pharmacovigilance (ADR Reporting system) Research & Development ❏ Pharmaceutical R&D refers to the pharmaceutical research and development of new medicines. The process begins with understanding the disease and selecting a target (usually a receptor site on a cell) that can potentially be affected by a drug molecule (Institute of Medicine 2007; PhRMA 2009). ❏ Most commonly, researchers use high-speed screening of huge libraries of molecules to identify a few hundred leading compounds, though sometimes they create a molecule or genetically engineer one. In the lab, the leading candidates are tested to see if they absorb, metabolize, and excrete properly, without being too toxic, and to see if they are distributed to the proper site of action. ❏ Adjustments are made to improve performance, and candidates are tested both in the lab and in animals before clinical trials begin with humans. Drug Creation and Research Activities ❏ Clinical pharmacy is the branch of pharmacy in which clinical pharmacists provide direct patient care that optimizes the use of medication and promotes health, wellness, and disease prevention. ❏ Clinical pharmacists work directly with physicians, other health professionals, and patients to ensure that the medications prescribed for patients contribute to the best possible health outcomes. A clinical pharmacist aim to develop and promote the rational and appropriate use of medicinal products and devices. ❏ A clinical pharmacist is patient oriented ❏ Major job responsibilities of a clinical pharmacist includes: ➢ Evaluating the untreated health issues of patients ➢ Performing medical tests on patients ➢ Monitor real time health condition of patients ➢ Analyse and co-relate the clinical data ➢ Ensuring patients receive the correct medications at right time ➢ Advising patient about health-related matters and tracking the health progress of patients ➢ ADR reporting and drug interaction monitoring ❏ To promote the correct and appropriate use of medicinal products and devices. Clinical pharmacy activities aim at: ❏ Maximising the clinical effect of medicines, minimising the risk of treatment-induced adverse effects and minimising the expenditures for treatments. Responsibilities of Clinical Pharmacists Roles of Clinical Pharmacists I. Medication Review Review medication chart, review medication history II. Drug information Seeking information, organising information services for both the health care practitioners and the patients. III. Attending Rounds To observe the patients under medication I. Pharmacokinetics/ therapeutic drug monitoring Studying the kinetics of drugs and optimising the dosage. II. Clinical Trials Planning, evaluating and participating in clinical trials III. Pharmaco-economy. Using the results of clinical trials and outcome studies to determine cost- effectiveness evaluations. IV. Teaching & Training Pre- and post-graduate teaching and activities to provide training and education programmes for pharmacists. V. Drug use studies and research Drug use studies/ outcome research/ pharmacovigilance; collecting data on drug therapies, their costs and patient outcome through structured and scientific methods. 09 Roles of Community Pharmacists Community Pharmacy ❏ A community pharmacy is a community based pharmacy. ❏ It is an important branch of the pharmacy profession and involves a qualified pharmacist. ❏ A community pharmacy is a healthcare facility that provides pharmaceutical services to a specific community. ❏ Clinical pharmacists can work together with pharmacists in other parts of the healthcare system such as the hospital or community pharmacy. A clinical pharmacist does not give you your medicines. You have to collect your medicines from a community pharmacy in the usual way. ❏ Communicating with patients ❏ Ensuring patient privacy ❏ Offering patient counseling ❏ Receiving prescriptions and registering patients ❏ Entering prescriptions in computer ❏ Handling restricted-use medications ❏ Filling & labeling pharmaceutical products ❏ Compounding prescriptions ❏ Supervise the work of technical staff ❏ Oversee the ordering of all equipment and supplies needed ❏ Ensure the maintenance of records and good working environment Responsibilities of a Community Pharmacist