The current importance of pharmacological research makes this Postgraduate certificate an essential education for pharmacists. Don't think twice and specialize with us”

In the field of drug research, the pharmacist must have a broad knowledge of all aspects related to drug development, but they must also have sufficient knowledge of statistics to be able to conduct clinical trials as accurately as possible. 

The importance of statistical knowledge is due to the fact that it is the most appropriate way to reach reasonable and accurate conclusions from the information collected, and to probe decisions when certainties are scarce. Therefore, education in this field is essential for pharmacists specializing in the research sector.

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 a subsequent benefit for patients. Therefore, this program brings together all these sections, which will allow the professional to obtain a global but accurate vision of the process of Drug Research and Development.

As a perfect complement to this very complete program, TECH offers students a completely new educational methodology in a 100% online format, one of the main advantages of studying at this university. In this way, our students only need to have a computer or mobile device with an internet connection, and can continue their education from anywhere in the world, without limits of borders or schedules, and combining their education with the rest of their daily obligations.

Train with us in Drug Research and Development and specialize until you achieve excellence in this field"

This 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 case studies presented by experts in Clinical Trials  
• 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
• Latest developments in Clinical Trials 
• Practical exercises where the self-assessment process can be carried out to improve learning 
• Special emphasis on innovative methodologies in Clinical Trials 
• 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 connectiont

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 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 prepare for real situations. 

The design of this program focuses on problem-based learning, by means of which the healthcare professional must try to solve the different professional practice situations that arise throughout the academic program. For this purpose, the lecturer will be assisted by an innovative interactive video system created by renowned and experienced experts in the field of Drug Research and Development, and with great experience.

Do not hesitate to take this 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 the Drug Research and Development sector, with extensive experience and recognized prestige in the profession, endorsed by the volume of cases reviewed, studied and diagnosed, and with a broad knowledge of the new technologies applied to the Drug Research and Development.

This 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. Data 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 the 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 program will provide key education to advance your career"