Become an expert in the field of Design, Methodology and Legislation in Veterinary Clinical Trials in a few months” 

Design, Methodology and Legislation are essential aspects to guarantee the validity of the results, which will be used as scientific evidence to support therapeutic decision-making in practice and to endorse the registration of a drug for marketing. This is why professionals with specific and advanced knowledge in these areas are increasingly in demand in the labor market. 

For this reason, TECH has designed a Postgraduate diploma in Design, Methodology and Legislation, so that students can acquire the necessary skills and competencies to be able to work in this area of veterinary medicine, with maximum efficiency in their work. And this, through the exploration of topics such as Laboratory Certification, Quality in Research, Identification of Information Sources, Technical Documentation or the Legislation and Regulations Applicable in Veterinary Clinical Trials, among many other relevant aspects. 

All this, in a comfortable 100% online mode that gives total freedom to the student to organize their studies and schedules, without the need to travel, or seeing altered their daily work. In addition, the most updated multimedia contents, the most complete information and the latest teaching tools are available. 

Reach your maximum potential in just a few months and stand out in one of the most promising areas of the veterinary labor market”   

This Postgraduate diploma in Design, Methodology and Legislation contains the most complete and up-to-date scientific program on the market. The most important features include:   

• The development of practical cases presented by experts in Design, Methodology and Legislation
• The graphic, schematic and eminently practical contents with which it is conceived gather scientific and practical information on those disciplines that are indispensable for professional practice 
• Practical exercises where self-assessment can be used to improve learning. 
• Its special emphasis on innovative methodologies  
• 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 

Access all the content available in the Virtual Campus on Management, Start-up and Implementation of Clinical Trials” 

The program’s teaching staff includes professionals from the sector who contribute their work experience to this specializing 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 education programmed to learn in real situations.  

The design of this program focuses on Problem-Based Learning, by means of which the professional must try to solve the different professional practice situations that are presented throughout the academic course. For this purpose, students will be assisted by an innovative, interactive video system created by renowned and experienced experts. 

Access the most exhaustive information on Legislation and European regulations"

Improve your skills in Methodological Procedures and Veterinary Clinical Trial Design"

The content and structure of this program have been designed by the outstanding professionals that make up TECH's team of experts, who have poured their experience and their best skills into all the material. All this, based on the most efficient pedagogical methodology, Relearning, which guarantees an optimal assimilation of the contents by the students, in a natural, precise and dynamic way. 

Thanks to the pedagogical methodology of TECH Relearning, you will be able to acquire new knowledge without the need to spend too much time studying”

Module 1.  Legislation Applicable to Veterinary Clinical Trials  

1.1. European Medicines Agency (EMA)    
1.2. European Legislation and Regulations Applicable to Medicinal Products and Veterinary Clinical Trials I 

1.2.1. Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on Veterinary Drugs 

1.3. European Legislation and Regulations Applicable to Veterinary Drugs and Clinical Trials II 

1.3.1. Maximum Residue Limits 

1.4. International Conference on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products. VICH Program 
1.5. Veterinary Drug Registration Procedures 

1.5.1. Centralized, Mutual Recognition and Decentralized Procedure 

Module 2.  Veterinary Clinical Trials I. Design and Methodology 

2.1. Veterinary Clinical Trials  

2.1.1. Veterinary Clinical Trial Research  
2.1.2. Conditions for Conducting a Veterinary Clinical Trial Investigation 
2.1.3. Types of Veterinary Clinical Trials   

2.1.3.1. Types of Trials According to the Study Design  
2.1.3.2. Parallelisms  
2.1.3.3. Cross-Over Transplantation  
2.1.3.4. In Pairs  
2.1.3.5. Sequentials  

2.2. Identifying Sources of Information for a Veterinary Clinical Trial  

2.2.1. How To Find Information We Are Interested In  

2.2.1.1. Choice of Source  
2.2.1.2. Resources and Access Modes   
2.2.1.3. How to Search for the Best Evidence on a Topic  

2.3. Elaboration of a Protocol for the Conduct of a Clinical Trial with Veterinary Medication 

2.3.1. General Information 
2.3.2. Justification and Objectives 
2.3.3. Test Outline 

2.4. Design of the Veterinary Clinical Trials   

2.4.1. Selection of Individuals  
2.4.2. Inclusion/Exclusion Criteria 
2.4.3. Treatment 
2.4.4. Destination of Study Animals, Products Derived from Study Animals and Products under Clinical Investigation and Control Products.  
2.4.5. Adverse Events (AEs)  

2.5. Methodology in Veterinary Clinical Trial Research   

2.5.1. Hypotheses  
2.5.2. Randomization  
2.5.3. City  
2.5.4. Sampling  
2.5.5. Uncontrolled Trials   
2.5.6. Controlled Trials  

2.5.6.1. Open  
2.5.6.2. Blind
2.5.6.3. Double-Blind  
2.5.6.4. Triple-Blind  
2.5.6.5. Pilot  

2.6. Methodological Procedures in a Veterinary Clinical Trial (VCT)  

2.6.1. Discrimination Between CD in Humans and Animals  
2.6.2. Differences  
2.6.3. Implementation  
2.6.4. External and Internal Validity   
2.6.5. Variables  
2.6.6. Consent  
2.6.7. Reproducibility  
2.6.8. Risk  

2.7. Evaluation of the Efficiency of the Veterinary Clinical Trial  

2.7.1. Statistics 
2.7.2. Records Management 
2.7.3. Annexes Attached to Protocol  
2.7.4. Changes in Protocol  
2.7.5. References 

2.8. Research Quality in a Veterinary Clinical Trial  

2.8.1. Legal Aspects    
2.8.2. Scientific Aspects      
2.8.3. Risk-Benefit Assessment  

2.9. Ethical Principles in a Veterinary Clinical Trial  

2.9.1. Historical Background  
2.9.2. Ethical Codes  
2.9.3. Application of Ethical Principles 

Module 3.  Veterinary Clinical Trials II. Management, Initiation and Implementation  

3.1. Clinical Trial Management Preclinical Development  

3.1.1. Preclinical Development 

3.1.1.1. Animal Experimentation Committees  

3.1.2. Exploratory Clinical Trial  
3.1.3.  Regulatory Clinical Trial  

3.2. Clinical Trial Authorization Process  

3.2.1. Application for a Veterinary Research Product  
3.2.2. Request for a Veterinary Clinical Trial  

3.3. Documents at the Beginning of the Clinical Trial  

3.3.1. Contract Management  
3.3.2.  Clinical Trial Protocol  

3.4. Clinical Trial Initiation and Implementation  

3.4.1. Initial Visit and Center Opening  
3.4.2. Data Collection Notebooks (DCNs)  
3.4.3. Electronic Data Capture (EDC)  

3.5. Clinical Trial Documentation Archive  

3.5.1. Medication Shipment and Management  
3.5.2. Documentation Custody  

3.6. Final Report   

3.6.1. Center Closures  
3.6.2. Clinical Trial Documentation Audit  
3.6.3. Audit of Data Management Activities

3.7. Laboratory Certification  

3.7.1. Laboratory Certification: GMP 
3.7.2. Laboratory Certification: GLP 
3.7.3. Laboratory Certification: ISO 

3.8. Regulatory Dossier Structure  

3.8.1. Document Management           
3.8.2. Validation of the Internal Structure  
3.8.3. Electronic Communication with Regulatory Agencies  

3.9. Writing Results  

3.9.1. Publication of Clinical Trials in Scientific Journals  

3.10. CONSORT Recommendations 

Opt for a program that will allow you to get up to date on the latest trends in Design, Methodology and Legislation in Veterinary Clinical Trials”