Clinical Research Master 8th Edition

 Investigacion clinica 2

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Introduction

The Clinical Research Master has been designed by Medical Practice Group to form experts in clinical research and in all its dimensions. Even though the program enables all students to participate actively in any of the clinical research’s strands- researcher, data manager, nurse investigator, member of committee of clinical trials, instructor of clinical trials and medical instructor – in a practical way, it also pretends to occupy an existing gap in the academic education.

In this sense, it covers not only basic knowledge, but also a demanding program that approaches extensively and deeply the related fields for this activity.

Our postgraduate program also offers the possibility for students to realize internships in the Investigation and Development Departments in well-known institutions in this area.

 

Certification: The student will be able to choose, once enrolled in the master, between the following certifications:

  • Proper Certificate of Medical Practice Group.
  • Proper Certificate of "Universidad Camilo José Cela".

Students that want to obtain the Master certificate issued by “Universidad Camilo José Cela” aren’t able to access the Health Professions Continuous Formation Commission’s credits from the Community of Madrid, which are granted according to certain contents. Refer to Technical Secretariat.

 

Aimed  to university graduates, undergraduates and licensed in the Health Sciences field.
Modality
  • Quasi-Presence
Date 26th October 2015
Hours 600 teaching hours
Price

Quasi-Presence: 4.700 €

Online by streaming: 4.250 €

(Scholarship programs, group discounts and former students.)

Associates logo camilo jose cela
Internships

Internships in the Contract Research Organization (CRO), well known international prestige:

logo adknoma

Objectives

  • Equip graduates in in Biomedical Science the knowledge and required abilities for the design, start up and coordination of clinical research projects according to the actual laws.
  • Train the student for the development of specific skills in research and other clinical aspects. The program covers from methodological basis of the biomedical investigation to concepts related to clinical trials (legal and ethical requirements, monitoring, analysis and scientific diffusion).
  • Prepare the student to become a competitive professional in the clinical research area.

Program

 SECTION I. CLINICAL RESEARCH BASIS

  • Unit 1. Introduction to the course. Why is information needed to investigate?
  • Unit 2. Generality.
  • Unit 3. General concepts in animal research.
  • Unit 4. General concepts in clinical research.
  • Unit 5. The scientific information.
  • Unit 6. Statistics.
  • Unit 7. Epidemiology.

SECTION II. BASIC SCIENCES AND ITS APPLICATION IN CLINICAL RESEARCH

  • Unit 1. General laboratory techniques.
  • Unit 2. Legal regulations for animal testing.
  • Unit 3. Genomics and transcriptomics.
  • Unit 4. Proteomics and  metabolomics.
  • Unit 5. Biology systems.
  • Unit 6. Translational research.
  • Unit 7. Farmacology.
  • Unit 8. Farmacogenetics.
  • Unit 9. Testings phase 0.
  • Unit 10. Biotecnology.
  • Unit 11. International conference on armonisation.

SECTION III: THEORETICAL BASIS IN CLINICAL TRIALS

  • Unit 1. Basic laboratory techniques.
  • Unit 2. Principles of the clinical trial.
  • Unit 3. Context of clinical trial.
  • Unit 4. Qualitative research studies.
  • Unit 5. Protection y diffusion of results.

SECTION IV: DEVELOPMENT OF CLINICAL TRIALS AND CLINICAL TRIALS FOR SPECIALITIES

  • Unit 1. Prior to the research activities.
  • Unit 2. Research activities.
  • Unit 3. Post-research activities.
  • Unit 4. Particular trials for specialities.
  • Unit 5. Trials including surgery.

SECTION V: REGULATORY, LEGAL AND ETHICAL ENVIRONMENT IN BIOMEDICAL RESEARCH

  • Unit 1. Legal environment for the development of research.
  • Unit 2. Special situations.
  • Unit 3. Process of medication marketing.
  • Unit 4. Regulation for the approval of devices and tests.
  • Unit 5. Pharmacovigilance.

SECTION VI: POFESSIONAL DEVELOPMENT IN THE CLINICAL RESEARCH AREA

  • Unit 1. Ethics in clinical investigation.
  • Unit 2. CEIC definition, composition and functions.
  • Unit 3. Financiation in Spain and Europe.

Methodology

Total hours

  • 600 teaching hours: 480 online hours, 65 on-site assistance and 55 to work to master.

On-site assistance

  • The sessions will take place in the Training Center of Medical Practice Group (MPG). They will combine conferences as expositions, theory classes, debates, seminars and round tables, where student participation will be required to encourage the exchange of ideas between participants. Workshops and discussion forums will be developed as well. There will be tutoring to guide the process of learning of the student, attend their doubts and analyze self-assessment results.

Online Personal Work

  • The individual activities and the group will have continuity due to the creation of a virtual environment of learning and exchange (Virtual Classroom – Web Meeting), accessible via the MPG website.

The virtual classroom will offer all students necessary resources for the correct development of learning, including communication tools, formative contents and links for support and work of reference.

At the beginning of the formative activity, the student will receive the access codes for the e-learning platform of MPG and will be registered in the Virtual Classroom. The Virtual Classroom includes specified objectives of the training, a summary of the contents, and a guide of the activities for the online follow-up, as well as self-assessment exercises, discussing themes in forums, solution of practical cases, search of data sources, bibliography and documentation.

A group of tutors will guide through the process of learning, to ease the continuing of the master, and to stimulate and enliven participation. The tutors will also supervise compliance of activities envisaged in the program.

Work to Master

  • Each student will have to realize a final work to master essential to obtain the certification.

Internship

  • Medical Practice Group offers to all students the possibility to participate in an optional internship program that will allow them to take a closer look at the implementation of the acquired knowledge. These practice programs will take place in prestigious centers in Spain, which are integrated in the National Health System.

Acquisition of the certification

  • In order to obtain the certification, it’s essential to have a minimum of 90% on-site assistance, realize the activities and the evaluation test during the indicated period, reaching a minimum of 70% as final grade. The final work to master must also be approved within the indicated period.

Teaching Staff

ACADEMICAL COORDINATION:

no perfil D. Jesús López-Torres

  • Family doctor at Centro de Salud Universitario Zona IV de Albacete.
  • Associate teacher of  Preventive Medicine and Public Health at Universidad de Castilla-La Mancha.
  • Doctor in Medicine. Expert in Family and Community Medicine.

TEACHERS:

no perfil D. Ángel Castaño

  • Pathologist in the Community of Madrid.

Javier Arias D. Javier Arias Díaz

  • General Subdirector. Instituto de Salud Carlos III.
no perfil D. Fernando Fuentes
  • .

no perfil Dña. Marta Gil Jiménez

  • .

Jaime del Barrio D. Jaime del Barrio Seoane

  • Senior Advisor. Healthcare & Life Sciences Ernst & Young.
  • General Director at Instituto Roche until 2014.

Hector Cebolla D. Héctor Cebolla

      • Doctor in the UNED Social Structure Department.

no perfil D. César de la Fuente

      • University graduate in Nursery. Expert in anesthesia.

no perfil Dña. Itziar de Pablo

      • Clinical Pharmacologist.
      • Clinical Research and Clinical Trials Unit at Hospital Universitario Ramón y Cajal.

no perfil Dña. Isabel Fernández-Arias

      • Medical Advisor at Unidad de Atención Especializada de Pfizer.

no perfil Dña. Inés Galende

      • Head of Área, SERMAS. Comunidad de Madrid.

Cristina Gmez Piqueras Dña. Cristina Gómez Piqueras

      • Head of General Subdirection Service of Data Research.

Javier Gomez Garcia D. Javier Gómez

    • Biostatistics Manager and data management in PharmaMar.

Juan Medino D. Juan Medino

      • Documentalist, Biblioteca Hospital de Fuenlabrada.

no perfil D. Antonio Nieto

      • Head of Biostatistics in PharmaMar.

no perfil Dña. Isabel Pardos

      • Manager of clinical operations in PharmaMar.

no perfil D. Óscar Salamanca

      • Managing Director in APICES.

no perfil Dña. Arantxa Sancho

      • Centralized Unit at AEMPS.
      • Alternate Member of Comité de Medicamentos de Uso Humano (CHMP) de la EMA.
      • Clinical Pharmacology Service at Hospital Universitario Puerta del Hierro. Majadahonda, Madrid.

no perfil Dña. Marisa Serrano

      • Pharmacist.
      • Independent Clinical Trial Monitor at Hospital Ramón y Cajal.

no perfil Dña. Jessica Sardá Fargas

  • .

Antonio Gomez Outes D. Antonio Gómez Outes

  • Clinical Advisor at División de Farmacología y Evaluación Clínica de la AEMPS.

no perfil D. Ernesto Vera

  • Head of Service of Área de Inspección de Buena Práctica Clínica y de Farmacovigilancia, Departamento de Inspección y Control de Medicamentos de la AEMPS.

no perfil Dña. Sol Ruiz Antunes

  • Head of División de Biotecnología y Terapias Avanzadas, División de Productos Biológicos de la AEMPS.

no perfil D. Miguel Ángel Macía Martínez

    • Head of service of de Evaluación de Riesgos, División de Farmacoepidemiología y Farmacovigilancia de la AEMPS.

Payment Plan

MPG offers three modes of payment:

 

1) Three terms of payment: 4.700 €Interest free!

  • 1st term.Payment of registration that will be confirmed on receipt of booking deposit of 700 €.
  • 2nd term. Before starting, the master must be credited up to 60% of the total amount.
  • 3rd term: The remaining amount must be credited one month after the starting date of the master.

 Quasi-Presence CR Master

Enrollment
Before starting the master
One month after the starting sate of the master
 700 € 2.120 € 1.880 €

 

2) Prompt Payment: 4.500 € Prompt payment discount!

The amount will be credited in a single payment before starting the master.

 Quasi-Presence CR Master

Single Payment
4.500 €

3) Installment Payment:

Registration before starting the master, and 9 monthly pays of 495€. The first monthly payment will be credited in the month of the starting date. The rest of the monthly pays will be credited along the consecutive months.

 Quasi-Presence CR Master

Enrollment
Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9
700 € 495 € 495 € 495 € 495 € 495 € 495 € 495 € 495 € 495 €

The students that select this mode of payment will credit their registration by bank transfer or TPV, and the remaining payments by direct debit.

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