The goal of healthcare is to achieve a cure for diseases and a better quality of life for patients. Investing in research is important, but so is having specialized professionals"

Increased investment in research in the healthcare field to improve the quality of life of patients means that more and more professionals specialized in this field are needed. Hence the importance of expanding information in all areas of research. 

This Postgraduate certificate in Drug Research and Development is designed to specialize professionals from different health branches in pharmacological research, a fundamental facet to find new treatments that allow the improvement of patients.  

In this way, students will delve into the study of preclinical drug research, i.e., from the discovery of a molecule with therapeutic activity until it is marketed. Another very important part of this process is to know how to communicate new discoveries, which will allow further research in this field and promote its use.  

Within the field of research, the professionals must also be equipped with statistical notions that will enable them to conduct clinical trials as accurately as possible. Statistics play a fundamental role in any clinical trial, from the design, conduct, analysis and reporting, in terms of controlling and minimizing bias and confounding factors, as well as measuring random errors.  

The use of statistics in clinical trials allows the clinical investigator to reach reasonable and accurate conclusions from the information collected, and to probe decisions when certainties are scarce. Statistics are key to preventing errors and biases in medical research. Therefore, the inclusion of this module in this program is noteworthy.

Expand your knowledge through this Postgraduate certificate in Drug Research and Development that will allow you to specialize until you achieve excellence in this field”

The Postgraduate certificate in Drug Research and Development contains the most complete and up-to-date educational program on the market. The most important features include:

• The development of 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 development
• New developments in drug research and development
• Practical exercises where self-assessment can be used to improve learning
• Special emphasis on innovative methodologies in drug research and development
• Theoretical lessons, questions to the expert, debate forums on controversial topics, and individual reflection assignments
• Content that is accessible from any fixed or portable device with an internet connection

This Postgraduate certificate is the best investment you can make when selecting a refresher program, for two reasons: in addition to updating your knowledge in Drug Research and Development, you will obtain a qualification endorsed by TECH Global University”

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

The multimedia 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 training programmed to train 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 professor will be assisted by an innovative interactive video system created by renowned and experienced experts in the field of Drug Research and Development.

Do not hesitate to take this training 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 content has been designed by leading professionals in the Drug Research and Development, with extensive experience and recognized prestige in the profession, backed by the volume of cases reviewed, studied, and diagnosed, and with extensive knowledge of new technologies applied to Drug Research and Development.

The Postgraduate certificate in Drug Research and Development contains the most complete and up-to-date scientific program on the market” 

Module 1. Drug research and development

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 Interactions

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
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 Information Sources

Module 2. Biostatistics

2.1.Study Design

2.1.1.Research Question
2.1.2.Population to be Analyzed
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. Blinding Degree
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 to be 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.Design of the CRF (Case Report Form)

2.6.1.Information Gathering Variables Dictionary
2.6.2.Variables and Data Entry
2.6.3.Database Security, Testing and Debugging

2.7.Statistical Analysis Plan

2.7.1.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 be a key learning experience to advance your career”