The program brings together a diversity of key concepts so that the business professional has a broad knowledge in important clinical areas. In this way, the operation and responsibilities of the Medical Department in the pharmaceutical industry will be comprehensively addressed. Likewise, the importance of this area in the organizational environment will be stand out, highlighting its informative work on treatment advances and the need for scientific and communicative skills. 

With TECH, you will immerse yourself in the world of clinical trial monitoring and master the most advanced monitoring and control techniques" 

Syllabus

Following this approach, TECH has designed the Postgraduate certificate in Medical Department in Pharma Biotech. The student will delve into clinical trials, standing out their importance, the phases that conform them, the legislation that regulates them and the objectives they pursue. In addition, clinical trial methodologies will be discussed, including the necessary documentation and strategies for dealing with the challenges inherent in this process. 

It will also focus on clinical trial monitoring and follow-up, highlighting the relevance of efficient project management. In the same sense, participants will be able to explore clinical practice studies based on real data, as well as the importance of collaboration with healthcare professionals. 

Consistent with the above, a quality educational experience will be offered, which will provide students with a wide range of teaching materials, available in an exclusive virtual library. All this added to the implementation of the Relearning method, which will ensure the professional an enriching and effective learning experience. Moreover, the fact that this program will be offered with a virtual methodology will allow participants to adjust their time in a more flexible way. In view of the fact that they will be able to access the content at any time and from anywhere, since they will only need a device with an Internet connection, which will allow them to adapt easily without fixed schedules.  

This Postgraduate certificate takes place over 6 weeks and consists of 1 module: 

Module 1. The Medical Department

Where, When and How is it Taught?

TECH offers the possibility of developing this Postgraduate certificate in Medical Department in Pharma Biotech completely online. During the 6 weeks of the specialization, the student will be able to access all the contents of this program at any time, which will allow them to self-manage their study time. 

Module 1. The Medical Department 

1.1. The Medical Department 

1.1.1. General Structure of the Medical Department in Different Companies 
1.1.2. Purpose and Functions of the Department 
1.1.3. Roles in the Medical Department 
1.1.4. How They Relate to Other Departments: Marketing, Access, Sales, etc. 
1.1.5. Career Opportunities for the Medical Department in the Pharmaceutical Industry 

1.2. Monitoring 

1.2.1. Fundamentals of Clinical Development 
1.2.2. Legislation in Clinical Trials 
1.2.3. Types of Clinical Trials 
1.2.4. Clinical Trials Phases 

1.2.4.1. Phase I Clinical Studies 
1.2.4.2. Phase II Clinical Studies  
1.2.4.3. Phase III Clinical Studies 
1.2.4.4. Phase IV Clinical Studies

1.3. Clinical Trials Methodology 

1.3.1. Clinical Trial Design 
1.3.2. Stages in the Development of Clinical Trials 
1.3.3. Clinical Trials Viability 
1.3.4. Identification and Selection of Researcher Centers 
1.3.5. Recruitment Materials and Strategies 
1.3.6. Contracts with Research Centers 
1.3.7. Protocol 
1.3.8. Patient Information Sheet and Informed Consent 

1.4. Trial Monitoring: Monitoring and Control 

1.4.1. Monitoring Visit 

1.4.1.1. Pre-Study Visit 
1.4.1.2. Initiation Visit 
1.4.1.3. Monitoring Visit 
1.4.1.4. Closing Visit 

1.4.2. Remote Monitoring 
1.4.3. Monitoring Visit Reports 
1.4.4. Data Management Obtaining Results

1.5. Real Clinical Practice Studies RWE 

1.5.1. RWE Studies: Design, Analysis, Minimization of Bias. 
1.5.2. Types of RWE Study 
1.5.3. Integration in the Medical Plan 
1.5.4. Inquiry and Communication of Results 
1.5.5. Current Challenges in the Use of Evidence and Knowledge of RWE 
1.5.6. How RWE Can Support Decision Making Throughout the Product Life Cycle 
1.5.7. Initiated Studies/Trials and Research Collaborations Investigator 

1.6. The Medical Affairs Department

1.6.1. What is the Medical Affairs Department? 

1.6.1.1. Purpose and Functions of the Department
1.6.1.2. General Structure of the Department in Different Companies  
1.6.1.3. Interactions Between Medical Affairs and Other Departments (Clinical Operations & Commercial Departments) 
1.6.1.4. The Relationship of Medical Issues in Terms of Product Life Cycle 

1.6.2. Creation of State-of-the-Art Data Generation Programs 
1.6.3. Medical's Co-Leadership Role  
1.6.4. Affairs in cross-functional pharmaceutical organizations

1.7. Roles in The Medical Affairs Department 

1.7.1. Role of the Medical Advisor 
1.7.2. Functions of the Medical Advisor 
1.7.3. Participation Tactics with HCP 

1.7.3.1. Advisory Board and promotion programs 
1.7.3.2. Scientific Publications 
1.7.3.3. Planning of Scientific Congresses 

1.7.4. Elaboration of a Medical Communication Plan 
1.7.5. Design of Medical Product Strategy 
1.7.6. Management of Medical Projects and Studies Based on Real Clinical Practice Data (RWE). 
1.7.7. Role of the Medical Science Liaison 

1.7.7.1. MSL Functions: Medical Communication and Interlocutors 
1.7.7.2. Implementation of Medical Projects and Territorial Management 
1.7.7.3. Investigator Initiated Studies/Trials and Research Collaborations 
1.7.7.4. Scientific Communication and Insights Gathering 

1.8. Compliance In the Medical Affairs Department

1.8.1. Concept of Compliance in the Medical Department 

1.8.1.1. Promotion of Prescription Drugs 
1.8.1.2. Interrelation with Health Professionals and Organizations 
1.8.1.3. Interrelation with Patient Organizations 

1.8.2. Definition of On Label/Off Label 
1.8.3. Differences Between Commercial Department and Medical Affairs 
1.8.4. Code of Good Clinical Practice in Medical Promotion and Information 

1.9. Medical Reports 

1.9.1. Comprehensive Communication Plan 
1.9.2. Media and Omnichannel Plan 
1.9.3. Integration of the Communication Plan in the Medical Plan 
1.9.4. Information Resources in Biomedicine 

1.9.4.1. International Sources: Pubmed, Embase, WOS, etc 
1.9.4.2. Sources in Latin America: CSIC, Ibecs, LILACS, Indexes etc. 
1.9.4.3. Sources for Locating Clinical Trials: WHO, ClinicalTrials, Cochrane CENTRAL, etc. 
1.9.4.4. Drug Information Sources: Bot Plus Web, FDA, etc 
1.9.4.5. Other Resources: Official Bodies, Web Pages, Scientific Societies, Associations, Evaluation Agencies, etc.   

1.10. Pharmacovigilance 

1.10.1. Pharmacovigilance in Clinical Trials 

1.10.1.1. Adverse Event Management  

1.10.2. Notification of Adverse Events, Eudravigilance.  
1.10.3. Periodic Security Reports  
1.10.4. Pharmacovigilance in Other Clinical Trials: Post-Authorization Studies

You will learn how to collect and communicate results to improve medical care in the Biotech field" 

The main objective of this program is to provide the business professional with the knowledge and tools necessary to work in clinical areas. This will enable you to use your business skills to contribute to the company's success in the medical and pharmaceutical field. In this way, you can ensure regulatory compliance, efficient project management, marketing strategy development and effective communication with healthcare professionals. 

You will become an expert in clinical trials, their fundamentals, phases and the legislation that surrounds them, through this 100% virtual program"  

TECH makes the goals of their students their own goals too
Working together to achieve them

The Postgraduate certificate in Medical Department in Pharma Biotech enables the student to:

1. Acquire knowledge about the history of strategic Management 
2. Categorize the different definitions over time 
3. Evaluate financial efficiency  
4. Optimize working capital management 
5. Understand the different types of healthcare systems, such as public, private/private insurance, and managed health care 
6. Assess unmet patient needs and chronicity management
7. Understand what Market Access is and how the need for this function arises in the pharmaceutical industry 
8. Know about the structure, organization and functions of the National Health System
9. Delve into the steps to be followed to plan the market access of a new drug
10. Review the points to be analyzed in a phase prior to the development of the access plan to know about the environment and competitors
11. Know about the capabilities and ethics of the Coach 
12. Understand the essence of Coaching and its approach to learning 
13. Acquire basic knowledge about the fundamental concepts of leadership and its application in the pharmaceutical industry
14. Understand and categorize leadership theories, exploring the leadership process and the different existing styles and models
15. Obtain an effective tool to achieve results
16. Define unique and differentiated value propositions