University certificate
The world's largest faculty of medicine”
Introduction to the Program
Una titulación universitaria 100% online que te llevará a actualizar en tan solo seis meses tus conocimientos sobre Medical Affairs”
La industria farmacéutica está en continua evolución, transformando en la actualidad su papel en el campo de la investigación con medicamentos de uso humano. Asimismo, la incorporación de nuevas tecnologías y la necesidad de contar con profesionales cada vez más cualificados y con amplias capacidades, ha hecho que el departamento de Asuntos Médicos crezca considerablemente en las compañías más relevantes del sector.
En este escenario, los Medical Affairs deben hoy en día dominar los conceptos claves sobre los ensayos clínicos, las metodologías de diseño, planificación, etapas, gestión de los datos y monitorización en el sector farmacéutico. Así, ante la creciente necesidad por parte de las empresas de contar con especialistas con conocimientos actualizados, TECH ha diseñado esta titulación universitaria en formato académico 100% online.
Un programa que sin duda destaca por la dirección y equipo docente que lo integran y cuyo saber sobre la figura de los Medical Affairs queda reflejado en el temario que ha sido elaborado ad hoc para esta Postgraduate diploma. Así, el especialista dispondrá de videorresúmenes de cada tema, videos en detalle, esquemas, lecturas esenciales, que aportarán un enfoque teórico innovador. Además, los casos de estudio aportados por el profesorado aproximarán al egresado a situaciones reales, cuyos métodos y estrategias podrá aplicar en su praxis diaria.
Esta titulación universitaria supone para el profesional de la medicina una excelente oportunidad para poder estar al día de los últimos progresos en dicho departamento a través de una enseñanza que podrá cursar cómodamente, cuando y donde desee. Tan solo requiere de un dispositivo electrónico con conexión a internet para poder acceder al contenido alojado en el campus virtual. Una libertad y flexibilidad, que facilitan además la compatibilización de las responsabilidades más exigentes con una opción académica de calidad.
Por otro lado, un prestigioso Director Invitado Internacional impartirá unas minuciosas Masterclasses.
Un reputado Director Invitado Internacional ofrecerá unas exclusivas Masterclasses que ten aportará las claves más efectivas para desempeñar en la actualidad las funciones de Medical Affaires”
Esta Postgraduate diploma en Medical Affairs contiene el programa científico más completo y actualizado del mercado. Sus características más destacadas son:
- El desarrollo de casos prácticos presentados por expertos en medicina y en la industria farmacéutica
- Los contenidos gráficos, esquemáticos y eminentemente prácticos con los que está concebido recogen una información científica y práctica sobre aquellas disciplinas indispensables para el ejercicio profesional
- Los ejercicios prácticos donde realizar el proceso de autoevaluación para mejorar el aprendizaje
- Su especial hincapié en metodologías innovadoras
- Las lecciones teóricas, preguntas al experto, foros de discusión de temas controvertidos y trabajos de reflexión individual
La disponibilidad de acceso a los contenidos desde cualquier dispositivo fijo o portátil con conexión a internet
Dispones una biblioteca de recursos multimedia las 24 horas del día. Accede a ella a través de cualquier dispositivo electrónico con conexión a internet”
El programa incluye en su cuadro docente a profesionales del sector que vierten en esta capacitación la experiencia de su trabajo, además de reconocidos especialistas de sociedades de referencia y universidades de prestigio.
Su contenido multimedia, elaborado con la última tecnología educativa, permitirá al profesional un aprendizaje situado y contextual, es decir, un entorno simulado que le proporcionará una capacitación inmersiva programada para entrenarse ante situaciones reales.
El diseño de este programa se centra en el Aprendizaje Basado en Problemas, mediante el cual el profesional deberá tratar de resolver las distintas situaciones de práctica profesional que se le planteen a lo largo del curso académico. Para ello, contará con la ayuda de un novedoso sistema de video interactivo realizado por reconocidos expertos.
Esta titulación te acercará a las últimas novedades en la investigación de medicamentos de uso humano, sus tipos, sus fundamentos éticos"
Ahonda cuando lo desees en el diseño de estrategia médica de producto y la investigación con medicamentos"
Syllabus
The syllabus of this Postgraduate diploma has been elaborated by a team of professionals that has extensive experience the Pharmaceutical Sector. This is evident in a content that offers a theoretical-practical vision of Medical Affairs departments, clinical trial planning, future expectations of Medical Affairs departments and the professional competencies currently demanded by companies in the industry. All this will also be possible thanks to the multimedia material (video summaries, detailed videos), essential readings and case studies that make up the library of didactic resources of this program.
With this Postgraduate diploma you will obtain a theoretical and practical vision of the current functioning of the Medical Affairs departments of large pharmaceutical companies”
Module 1. The medical affairs department
1.1. What is the medical affairs department?
1.1.1. History of the Medical Affairs y department and its evolution in pharmaceutical companies
1.1.2. Objective and functions of the department
1.1.3. General department structure in different companies
1.2. Medical affairs department in pharmaceutical and Biotechs companies
1.2.1. Relationship of medical affairs with commercial departments
1.2.2. Relationship of medical issues with the Market AccessDepartment
1.2.3. Relationship of medical issues with the Regulatory Department
1.2.4. Relationship of medical issues with the Research and Clinical Trials department
1.2.5. The relationship of medical issues in terms of product life cycle
1.3. Medical issues based on product life cycle
1.3.1. The medical strategy based on the product life cycle
1.3.2. Launching strategies
1.4. Medical plan and product plan
1.4.1. Definition of medical and product plan
1.4.2. Product plan structure: strategic and action plan
1.4.3. Medical Affairs and Medical Societies: support for health care professionals through the companies
1.5. Roles in the Medical Affairs Department: the Medical Advisor
1.5.1. Medical Advisor functions: design of medical product strategy
1.5.2. Management of medical projects and Phase IV studies
1.5.3. Medical project finance
1.6. Roles in the medical affairs department: the MSL
1.6.1. MSL functions: medical communication and interlocutors
1.6.2. Implementation of medical projects and territorial management
1.6.3. MSL Skills
1.6.4. Time organization and prioritization
1.7. Medical communication and Insights gathering
1.7.1. High-impact F2F communication
1.7.2. Tailoring communication to profile and Insights based communication
1.7.3. Management of medical requests and negotiation
1.8. Integral communication plan
1.8.1. Media and omni-channel plan
1.8.2. Communication at congresses
1.8.3. Integration of the communication plan in the medical plan
1.9. RWE and Phase IV studies
1.9.1. RWE and Phase IV study design
1.9.2. Medical plan integration
1.9.3. Investigator Initiated Studies/Trials and Research Collaborations
1.9.4. Collection and Measuring of Results
1.10. Compliance in the medical affairs department
1.10.1. Promotion definition
1.10.2. On Label/Off Label Definition
1.10.3. Differences between commercial department and medical affairs
1.10.4. Integrity at Work
Module 2. What is the reason for a Medical Affairs department? Its reason for being
2.1. Medical Affairs: the new role of the pharmaceutical industry
2.1.1. From how it was to how it is now
2.1.2. From Industries to Science
2.1.3. Beyond clinical trials: generating evidence
2.2. Expectations for the future of Medical Affairs departments
2.2.1. Relationship with public institutions, physicians and patients
2.2.2. “Win-Win” or "all as one" as the future
2.2.3. Coordination of Clinical Trials
2.2.4. Research Project Design
2.2.5. Patient as a source of success
2.3. Commitment of the pharmaceutical industry
2.3.1. In promoting the welfare of patients with ethical criteria of professionalism
2.3.2. In generating and maintaining confidence in the prescribing of medicines
2.3.3. Objective: to contribute to the quality of care in a sustainable manner
2.4. Ability to measure the impact of what we do
2.4.1. Training and information
2.4.2. Correct analysis of scientific and non-scientific information
2.4.3. Evaluating whether or not a treatment works for our patients
2.4.4. Know whether the strategic decisions we have made are having the desired impact the desired impact
2.4.5. Genuine concern for patients
2.5. Development of a health sciences professional in the pharmaceutical industry
2.5.1. Design of a Training Plan what to study?
2.5.2. Self-training
2.5.3. Team profile: innovation, leadership, etc
2.5.4. Development plans within the role
2.5.5. Career Plans
2.6. Research with drugs for human use
2.6.1. Definition, justification and objectives of research with medicinal products for human use for human use
2.6.2. Types of drug research studies
2.6.3. Ethical Foundations Standards of Good Clinical Practice
2.6.4. Agents involved in clinical research: promoter, investigator, monitor, the patient
2.7. Clinical Trials Phases I
2.7.1. Phase 0 Clinical Studies
2.7.2. Phase I Clinical Studies: Is the treatment safe?
2.8. Clinical Trials Phases II
2.8.1. Phase II Clinical Studies: Is the treatment effective?
2.8.2. Clinical Trials Phases III Is the new treatment under study better than the conventional treatment?
2.8.3. Phase IV Clinical Studies: What else do I need to know?
2.9. Clinical Trials Methodology
2.9.1. Clinical Trial Design
2.9.2. Clinical Trial Planning
2.9.3. Stages in the Development of Clinical Trials
2.9.4. Monitoring: follow-up and control. The Importance of Quality
2.9.5. Data Management Obtaining results
2.9.6. Risk-based monitoring
2.9.7. Decentralized studies
2.10. The future of clinical trial research
2.10.1. Clinical Trials Evolution
2.10.2. From clinical evidence to regulatory need
2.10.3. From clinical trial data to price approval: what more data needed?
2.10.4. Patient Monitoring
2.10.5. The cooperative environment for evidence generation
Module 3. Professional competencies to work in Medical Affairs
3.1. Effective public speaking
3.1.1. Ensuring the success of your presentation: overcoming stage fright. Rely on oneself to occupy all the space. Harmonize (voice, gestures, posture, gaze)
3.1.2. Clearly present your ideas: organize your thinking. Define your objectives to maintain a direction. Structure your message
3.1.3. Establishing an authentic dialog: understanding the keys to communication. Use and take advantage of the group's resources. Encourage and control public participation. How to get ideas across?
3.1.4. Make the public your ally: keep them interested with or without media. Learn how to react during exchanges with improvisation. Know how to close
3.2. Manage emotions in conflict situations
3.2.1. Understanding emotions: the role of the brain. Identifying Emotions
3.2.2. Develop emotional balance: manage incoherent emotional reactions. Develop Self-confidence
3.2.3. Using emotions to build trust
3.2.4. Resolve conflict situations
3.2.5. Develop Control skills
3.3. Leadership
3.3.1. Strategic planning: tools to build the vision focused on achieving the objectives. Planning as a Success Warranties
3.3.2. Decision-making: decision-making process with a clear methodology to avoid unnecessary subjectivity. Balance between reason and emotion
3.3.3. Achievement orientation: work by objectives. Tools for defining objectives and their follow-up. Introduction to OKRs
3.3.4. Continuous improvement: continuous learning. The Deming Cycle
3.4. Influence and negotiation
3.4.1. Basic principles of negotiation: I actively promote collaboration to provide the best solution for my clients and colleagues
3.4.2. The Negotiation Process Objectives. Sides of the War of Negotiation
3.4.3. Negotiation Strategies How to approach the negotiation?
3.4.4. Communication and influence: convincing and making winning proposals
3.5. Personal Brand
3.5.1. Understanding what personal branding is: Why is it important and what does it bring us?
3.5.2. Building and managing your personal brand: five universal goals for building your personal brand. How to establish a network of contacts?
3.5.3. Social networks: choose your social networks (Linkedin, Twitter, Facebook, Instagram)
3.5.4. Launching your personal brand: personal branding campaigns and how to measure success
3.6. Adaptation to Change
3.6.1. Accepting change: this is the phase of understanding the need for change, when people are stabilized and accept the new situation
3.6.2. Resistance to change: knowing how to identify the barriers and difficulties that position people against change is a way to find solutions that help to incorporate new ways of doing things
3.6.3. Process of Change. The hero's journey: understanding the process of change from denial to transformation of individuals
3.6.4. Change management in organizations: understanding Kotter-like models of change management in organizations
3.7. Problem Solving
3.7.1. Understanding the problem: understanding the problem, identifying its causes and the challenges it presents
3.7.2. Idea generation: processes of ideation and creativity to develop different solutions different solutions
3.7.3. Analysis: idea analysis models
3.7.4. Decision-making: tools for decision making
3.8. Team Management
3.8.1. Functional teams: achievement-oriented teams. Lencioni Pyramid
3.8.2. Team management tools: effective meetings, delegation, etc
3.8.3. Motivation techniques: models for motivating the people who make up the teams. Intrinsic and Motivation Extrinsic Motivation
3.8.4. Feedback: reinforce the employees' sense of responsibility in the development of the company's work
3.9. Professional efficiency. Time Management
3.9.1. The time paradigm: understanding the relative importance of time
3.9.2. Personal efficiency: be a strategist of your time and focus on what is really important to improve your productivity
3.9.3. Time management tools and techniques: stress management, time management tools and methods
3.10. Job Placement
3.10.1. Setting your career goal: tools to define your career goal
3.10.2. CV preparation: identification of professional skills and competencies for CV preparation
3.10.3. Job search: job search techniques. Networking, social networks, search engines and headhunter management
3.10.4. The Interview How to face a job interview?
A 100% online academic option designed for professionals who wish to study a Postgraduate diploma compatible with their personal responsibilities”
Postgraduate Diploma in Medical Affairs
If you are interested in the world of healthcare and would like to work in a dynamic, exciting and ever-changing field, our Postgraduate Diploma in Medical Affairsprogram is perfect for you. With online classes and flexible training, you will be able to acquire the knowledge and skills necessary to excel in this sector. At TECH Global University, we believe in the importance of staying up to date on the latest trends and advances in the healthcare field, especially as it relates to the pharmaceutical and medical device industry. That's why our Medical Affairs program is designed to cover all aspects of medical and regulatory management, from research and development to commercialization and post-approval follow-up.
Stand out in the healthcare industry with our Medical Affairs program.
Our expert faculty members are highly experienced and will provide you with the tools and techniques necessary to conduct clinical research, as well as the ability to interact with the scientific community and regulators. You will learn how to manage communications and strategies with the various stakeholders involved in the commercialization of pharmaceuticals and medical devices. With online classes and online education, our program gives you the flexibility to study when and where you want. You can attend live classes or, if you prefer, watch the recordings at a time that is convenient for you. Our collaborative learning model allows you to connect and share experiences with other students and professionals from around the world. Don't miss out on the opportunity to excel in the healthcare and pharmaceutical industry with our Postgraduate Diploma in Medical Affairs program. enroll now at TECH Global University of Technology and excel in your career!