TECH offers this program for nurses who wish to specialize in the field of Drug Research and Development”

This Postgraduate diploma in Drug Research and Development is designed to specialize nurses with a vocation in pharmacological research, a fundamental facet in finding new treatments for the fight against diseases for which a cure has not yet been found.

Thanks to this Postgraduate diploma, students will delve into the study of preclinical drug research, as well as statistics, which is essential to reach reasonable and accurate conclusions. However, in any research, it is also essential to have a broad knowledge of the legislation in force in order to avoid regulatory or ethical errors.

In short, after completing this Postgraduate diploma, the student will be able to comply with ethical standards in Clinical Trials, not only compliance with legislation to ensure the protection and enforcement of the rights of participants, but also in areas such as methodology, to ensure compliance with the standards of validity and reliability for the data obtained and the correct design of Clinical Trials.

In addition, this program has the advantage of being offered in a 100% online format, so the students will not have any schedule obligations or need to move to a physical space, being able to organize by themselves where and when to study. A self-management of your time that will allow you to combine your studies with the rest of your daily obligations. 

Broaden your knowledge through this Postgraduate diploma in Drug Research and Development that will enable you to achieve excellence in this field"

This Postgraduate diploma 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 assignments
• Content that is accessible from any fixed or portable device with an internet connection

This Postgraduate diploma 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 qualification endorsed by the largest Digital University in the world: TECH”

The teaching staff includes professionals from the engineering sector, who bring their experience to this specialization 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 learning programmed to study 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. To do so, the nurse will be assisted by a novel interactive video system developed by renowned and experienced experts in the field of Drug Research and Development. 

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

This 100% online Postgraduate diploma will allow you to combine your studies with your professional work while expanding 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 diploma contains the most complete and up-to-date scientific program on the market" 

Module 1. Drug Research and Development in Nursing

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 Interventions

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 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. 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. 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

Module 3. Bioethics and Regulations

3.1. Basic Ethical Principles and Most Relevant Ethical Norms

3.1.1. Aims of Biomedical Science
3.1.2. Rights and Freedoms of Researchers
3.1.3. Limits to the Right of Research
3.1.4. Ethical Principles of Clinical Research
3.1.5. Conclusions

3.2. Ethical Evaluation of Clinical Research on Drugs and Medical Devices

3.2.1. Introduction
3.2.2. Areas of Bioethics

3.2.1.1. General Aspects
3.2.1.2. Research Ethics

3.2.3. Justification of Bioethics

3.2.3.1. Clinical Indeterminacy
3.2.3.2. Relevance of Scientific Objectives
3.2.3.3. Preclinical Data

3.2.4. Ethical Conditions of Clinical Trial Designs
3.2.5. Drug Research Ethics Committees

3.2.5.1. Definition
3.2.5.2. Functions
3.2.5.3. Composition
3.2.5.4. Conclusions

3.3. Subject Selection in Clinical Trials

3.3.1. Criteria
3.3.2. Special Patients and Vulnerability
3.3.3. Vulnerability Assessment

3.3.3.1. Age
3.3.3.2. Severity of Disease
3.3.3.3. Other Types of Vulnerability
3.3.3.4. Vulnerability Protection

3.3.4. Conclusions

3.4. Risk-Benefit Balance in Clinical Trials

3.4.1. Potential Benefits
3.4.2. Potential Risks
3.4.3. Minimizing Risks
3.4.4. Risk Level Assessment
3.4.5. Final Assessment of the Risk-Benefit Balance
3.4.6. Conclusions

3.5. Protection, Informed Consent and Participant Information Form

3.5.1. Participant Information Form (PIF)

3.5.1.1. Type of Information Provided
3.5.1.2. Information Processing

3.5.2. Informed Consent

3.5.2.1. Concepts
3.5.2.2. Obtaining Procedure
3.5.2.3. Clinical Trials with Minors
3.5.2.4. Clinical Trials with Patients with Modified Capacity to Give Consent
3.5.2.5. Clinical Trials in Emergency Situations
3.5.2.6. Clinical Trials in Pregnant or Breastfeeding Women
3.5.2.7. Clinical Trials with Disabled
3.5.2.8. Informed Consent for Genetic Studies

3.5.3. Insurance and Financial Compensation

3.5.3.1. Safety
3.5.3.2. Indemnification
3.5.3.3. Compensation

3.5.4. Confidentiality
3.5.5. Violations
3.5.6. Continuation of Treatment After the Trial
3.5.7. Conclusions

3.6. Good Clinical Practices in Clinical Trials

3.6.1. History
3.6.2. Legal and Ethical Framework
3.6.3. Guideline for Good Clinical Practice (GCP)

3.6.3.1. Basic Principles
3.6.3.2. Drug Research Ethics Committee (CEIM)
3.6.3.3. Researcher
3.6.3.4. Promoter
3.6.3.5. Protocol
3.6.3.6. Investigators Brochure (IB)
3.6.3.7. Promoters Manual
3.6.3.8. Essential Documents

3.6.4. Conclusions

3.7. Legislation on Clinical Trials with Drugs and Medical Devices

3.7.1. Introduction
3.7.2. EXCLUSIVO DE ESPAÑA

3.7.2.1. Law26/2006
3.7.2.2. RD1090/2015
3.7.2.3. Law 41/2002

3.7.3. Drugs Used in Clinical Trials

3.7.3.1. Manufacturing and Importation
3.7.3.2. Labelling
3.7.3.3. Acquisition
3.7.3.4. Unused Drug

3.7.4. European Legislation
3.7.5. FDA, EMA and AEMPS
3.7.6. Communication
3.7.7. Conclusions

3.8. Legislation on Clinical Trials with Healthcare Products

3.8.1. Introduction
3.8.2. EXCLUSIVO DE ESPAÑA
3.8.3. Clinical Research with Medical Devices
3.8.4. European Legislation
3.8.5. Conclusions

3.9. Authorization and Registration Procedures for Drugs and Medical Devices

3.9.1. Introduction
3.9.2. Definitions
3.9.3. Drugs Authorization
3.9.4. Drugs Dispensing
3.9.5. Public Funding
3.9.6. Conclusions

3.10. Legislation on Post-Authorization Studies

3.10.1. What are Post-Authorization Trials?
3.10.2. Studies Justification
3.10.3. Classification

3.10.3.1. Security
3.10.3.2. Drug Utilization Studies (DUS)
3.10.3.3. Pharmacoeconomic Studies

3.10.4. Guidelines
3.10.5. Administrative Procedures
3.10.6. Conclusions

A unique, key and decisive training experience to boost your professional development"