Drug Research and Development in Nursing

Specialize in the field of Drug Development and work to improve treatments for diseases for which there is no cure"

With the development of this Postgraduate Certificate in Drug Research and Development in Nursing, students will delve into the study of preclinical drug 
research, that is, from the time a molecule with therapeutic activity is discovered until it is marketed. 

Within the field of research, professionals must also have statistical notions that allow them to carry out the Clinical Trials as accurately as possible. The use of statistics in Clinical Trials allows the researcher to reach reasonable and accurate conclusions from the data collected, and to sound out decisions when certainties are scarce. 

In addition, a very important part of the Drug Research and Development process is to know how to communicate the new discoveries, which will allow further research in this field and promote its use in a generalized way, achieving the consequent benefit in patients.

Another point in favor of this program is that it is offered totally online, free of rigid schedules and the need to attend a physical center. In this way, it will be the students themselves who decide from where to study and at what time, eliminating any physical barrier. In this way, the students only need to have a computer or mobile device with an internet connection to access all the material available on the virtual campus.

Prepare with us in Research and Development of Medicines and specialize until you achieve excellence in this field"

This Postgraduate Certificate in Drug Research and Development in Nursing contains the most complete and up-to-date scientific program on the market. The most important features include:

• Practical cases presented by experts in Drug Research and Development
• The graphic, schematic, and practical contents with which they are created, provide scientific and practical information on the disciplines that are essential for professional practice
• News on Drug Research and Development
• Practical exercises where the self-assessment process can be carried out to improve learning
• Its special emphasis on innovative methodologies in Drug Research and Development
• Theoretical lessons, questions to the expert, debate forums on controversial topics, and individual reflection work
• Content that is accessible from any fixed or portable device with an internet connection

This Postgraduate Certificate is the best investment you can make in the selection of a refresher program for two reasons: in addition to updating your knowledge in Drug Research and Development, you will obtain a degree endorsed by TECH"

The teaching staff includes professionals from the health sector, who bring their experience to this educational program, as well as renowned specialists from leading societies and prestigious universities.

Theultimerdia content, developed with the latest educational technology, will provide the professional with situated and contextual learning, i.e., a simulated environment that will provide immersive education programmed to learn in real situations.

This program is designed around Problem-Based Learning, whereby the professional must try to solve the different professional practice situations that arise throughout the program. For this purpose, the professional will be assisted by an innovative interactive video system developed by renowned and experienced experts in the field of Drug Research and Development. 

Do not hesitate to take this educational program with us. You will find the best teaching material with virtual lessons"

This 100% online Postgraduate Certificate will allow you to balance your studies with your professional work while increasing your knowledge in this field"

The structure of the contents has been designed by the best professionals in research and health, with an extensive background and recognized prestige in the profession, backed by the volume of cases reviewed, studied and diagnosed, and with extensive mastery of new technologies.   

This Postgraduate Certificate contains the most complete and up-to-date scientific program on the market” 

Module 1. Research and Development of Medicines

1.1. Development of New Drugs

1.1.1. Introduction
1.1.2. Development Phases of New Drugs
1.1.3. Discovery Phase
1.1.4. Preclinical Phase
1.1.5. Clinical Phase
1.1.6. Approval and Registration

1.2. Discovery of an Active Substance

1.2.1. Pharmacology
1.2.2. Seeding Trials
1.2.3. Pharmacological Intervention

1.3. Pharmacokinetics

1.3.1. Methods of Analysis
1.3.2. Absorption
1.3.3. Distribution
1.3.4. Metabolism
1.3.5. Excretion

1.4. Toxicology

1.4.1. Single Dose Toxicity
1.4.2. Repeated Dose Toxicity
1.4.3. Toxicokinetics
1.4.4. Carcinogenicity
1.4.5. Genotoxicity
1.4.6. Reproductive Toxicity
1.4.7. Tolerance
1.4.8. Dependency

1.5. Regulation of Drugs for Human Use

1.5.1. Introduction
1.5.2. Authorization Procedures
1.5.3. How a Drug is Evaluated: Authorization Dossier
1.5.4. Technical Data Sheet, Package Leaflet and EPAR
1.5.5. Conclusions

1.6. Pharmacovigilance

1.6.1. Pharmacovigilance in Development
1.6.2. Pharmacovigilance in Marketing Authorization
1.6.3. Post-Authorization Pharmacovigilance

1.7. Uses in Special Situations

1.7.1. Introduction
1.7.2. Regulations BORRAR
1.7.3. Examples:

1.8. From Authorization to Commercialization

1.8.1. Introduction
1.8.2. Drug Financing
1.8.3. Therapeutic Positioning Reports

1.9. Special Forms of Regulation

1.9.1. Advanced Therapies
1.9.2. Accelerated Approval
1.9.3. Biosimilars
1.9.4. Conditional Approval
1.9.5. Orphan Drugs

1.10. Dissemination of Research

1.10.1. Scientific Article
1.10.2. Types of Scientific Articles
1.10.3. Quality of Research Checklist
1.10.4. Drug Incapacitation Sources

Module 2. Biostatistics

2.1. Study Design

2.1.1. Research Question
2.1.2. Population to Analyze
2.1.3. Classification

2.1.3.1. Comparison between Groups
2.1.3.2. Maintenance of the Described Conditions
2.1.3.3. Assignment to Treatment Group
2.1.3.4. Degree of Masking
2.1.3.5. Modality of Intervention
2.1.3.6. Centers Involved

2.2. Types of Randomized Clinical Trials: Validity and Biases

2.2.1. Types of Clinical Trials

2.2.1.1. Superiority Study
2.2.1.2. Equivalence or Bioequivalence Study
2.2.1.3. Non-Inferiority Study

2.2.2. Analysis and Validity of Results

2.2.2.1. Internal Validity
2.2.2.2. External Validity

2.2.3. Biases

2.2.3.1. Selection
2.2.3.2. Measurement
2.2.3.3. Confusion

2.3. Sample Size Protocol Deviations

2.3.1. Parameters Used
2.3.2. Protocol Justification
2.3.3. Protocol Deviations

2.4. Methodology

2.4.1. Missing Data Handling
2.4.2. Statistical Methods

2.4.2.1. Description of Data
2.4.2.2. Survival
2.4.2.3. Logistic Regression
2.4.2.4. Mixed Models
2.4.2.5. Sensitivity Analysis
2.4.2.6. Multiplicity Analysis

2.5. When Does the Statistician Become Part of the Project

2.5.1. Statistician Role
2.5.2. Points of the Protocol to be Reviewed and Described by the Statistician

2.5.2.1. Study Design
2.5.2.2. The Primary and Secondary Objectives of the Study
2.5.2.3. Sample Size Calculation
2.5.2.4. Variables
2.5.2.5. Statistical Justification
2.5.2.6. Material and Methods used to Study the Objectives of the Study

2.6. CRD Design

2.6.1. Incapacitation Collection: Dictionary of Variables 
2.6.2. Variables and Data Entry
2.6.3. Database Security, Testing and Debugging

2.7. Statistical Analysis Plan

2.7.1. What is a Statistical Analysis Plan?
2.7.2. When to Perform a Statistical Analysis Plan
2.7.3. Statistical Analysis Plan Parts

2.8. Intermediate Analysis

2.8.1. Reasons for an Early Stopping of a Clinical Trial
2.8.2. Implications of Early Termination of a Clinical Trial
2.8.3. Statistical Designs

2.9. Final Analysis

2.9.1. Final Report Criteria
2.9.2. Plan Deviations
2.9.3. Guidelines for the Elaboration of the Final Report of a Clinical Trial

2.10. Statistical Review of a Protocol

2.10.1. Checklist
2.10.2. Frequent Errors in the Review of a Protocol

This will provide key knowledge to advance your career"