You will learn about the structure of the Medical Departments and their functions in different companies, thanks to this Postgraduate certificate only offered by TECH" 

Why Study at TECH?

TECH is the world's largest 100% online business school. It is an elite business school, with a model based on the highest academic standards. A world-class centre for intensive managerial skills training.   

TECH is a university at the forefront of technology, and puts all its resources at the student's disposal to help them achieve entrepreneurial success"

At TECH Global University

Innovation

The university offers an online learning model that combines the latest educational technology with the most rigorous teaching methods. A unique method with the highest international recognition that will provide students with the keys to develop in a rapidly-evolving world, where innovation must be every entrepreneur’s focus.

"Microsoft Europe Success Story", for integrating the innovative, interactive multi-video system.  

The Highest Standards

Admissions criteria at TECH are not economic. Students don't need to make a large investment to study at this university. However, in order to obtain a qualification from TECH, the student's intelligence and ability will be tested to their limits. The institution's academic standards are exceptionally high...  

95% of TECH students successfully complete their studies.

Networking

Professionals from countries all over the world attend TECH, allowing students to establish a large network of contacts that may prove useful to them in the future.  

100,000+ executives trained each year, 200+ different nationalities.

Empowerment

Students will grow hand in hand with the best companies and highly regarded and influential professionals. TECH has developed strategic partnerships and a valuable network of contacts with major economic players in 7 continents.  

500+ collaborative agreements with leading companies.

Talent

This program is a unique initiative to allow students to showcase their talent in the business world. An opportunity that will allow them to voice their concerns and share their business vision. 

After completing this program, TECH helps students show the world their talent. 

Multicultural Context

While studying at TECH, students will enjoy a unique experience. Study in a multicultural context. In a program with a global vision, through which students can learn about the operating methods in different parts of the world, and gather the latest information that best adapts to their business idea. 

TECH students represent more than 200 different nationalities.   

Learn with the best

In the classroom, TECH teaching staff discuss how they have achieved success in their companies, working in a real, lively, and dynamic context. Teachers who are fully committed to offering a quality specialization that will allow students to advance in their career and stand out in the business world. 

Teachers representing 20 different nationalities. 

TECH strives for excellence and, to this end, boasts a series of characteristics that make this university unique:   

Analysis

TECH explores the student’s critical side, their ability to question things, their problem-solving skills, as well as their interpersonal skills.  

Academic Excellence

TECH offers students the best online learning methodology. The university combines the Relearning method (a postgraduate learning methodology with the highest international rating) with the Case Study. A complex balance between tradition and state-of-the-art, within the context of the most demanding academic itinerary.  

TECH is the world’s largest online university. It currently boasts a portfolio of more than 10,000 university postgraduate programs. And in today's new economy, volume + technology = a ground-breaking price. This way, TECH ensures that studying is not as expensive for students as it would be at another university.  

At TECH, you will have access to the most rigorous and up-to-date case studies in the academic community”

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"