Master's Degree in Supervision and Management of Clinical Trials - Madrid

Master

En Madrid

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Descripción

  • Tipología

    Master

  • Lugar

    Madrid

  • Duración

    6 Meses

Pharmaceutical laboratories require professionals capable of applying their functional skills in different areas, such as clinical R&D, pharmacoeconomics, pharmacovigilance and more.

The ideal professional profile should combine adequate training and knowledge in clinical development functions (technical, scientific and regulatory) with a background experience in the professional skills required for these roles (planning, project management, teamwork, communication and interpersonal skills). Likewise, the ideal professional should have an appropriate level of English.

This Master’s Degree in Supervision and Management of Clinical Trials aims to meet the needs of the industry in every aspect.

The student is provided with practical and professional experience in pharmaceutical laboratories and CROs. This programme includes an internship process within international corporations in the sector’s leading firms so that participants can attain a high level of professional specialisation.

Finally, CESIF supports and boosts the employment and professional journey of each student through its lifetime employment service.

Instalaciones y fechas

Ubicación

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Madrid
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C/ Arapiles, 11, 28015

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The curriculum explores all the subjects related to the design, implementation and supervision of all types of clinical trials, as well as the different actions performed by the medical and scientific departments of the industry to ensure proper market access for new medicines. To achieve it, you will learn about:
- Environment and structure of the pharmaceutical industry and CROs.
- Functions of the medical and scientific departments.
- Design, implementation and supervision of clinical trials.
- Pharmacovigilance.
- Data management.
- Registration and market access for medicines.
- Other scientific studies.

This professional specialisation programme is for persons with higher degrees, preferably in health sciences (biology, pharmacy, medicine, chemistry, etc.) who wish to move quickly into managerial roles related to clinical development and medical and scientific departments, both in pharmaceutical laboratories and in the professional structures of any local or international contract
research organisation (CRO) with a presence in our market.

Students who successfully complete the Master’s Degree (resolution and delivery of all the practical cases proposed and completion of the Final Master’s Degree Project with pass mark) will receive the corresponding diploma of the Master’s Degree in Supervision and Management of Clinical Trials of CESIF.

- Practical “Learning by doing” methodology: Through case studies (design and implementation of clinical trials, follow-up and supervision of studies, financing and closure of trials, scientific communication, data management, etc.) and lectures by relevant speakers in the field, students engage with the industry’s dynamics and are able to apply the knowledge gained to the reality of the pharmaceutical sector.
- Tutorials and personalised guidance: Throughout the course, students will have the support of the teaching staff, made up of active professionals with extensive practical experience, and academic coordinators.

Students who so wish may pursue an internship in international companies from related sectors, in accordance
with the guidelines of the current regulations and in areas directly applicable to the contents of the master’s
programme.
The Career Services department manages the internship programme through direct relationships with the
business world.
Each student is offered personalised guidance and treatment so that they can choose the opportunity that best suits their profile.
Any financial remuneration of the internship will depend on each company’s standards.

Within the pharmaceutical sector there is a wide variety of professional roles related to clinical research and
medical and scientific activities. This affords students specialising in these areas access to a wide range of
options for their future professional development.

This master’s programme gives access to these professional domains and responsibilities:

- Clinical operations department (Clinical trial supervision, Clinical trial assistance, Project/Coordination managers, Biometrics)
- Scientific department (Pharmacovigilance, Pharmacoeconomics)
- Other related roles (Registries, Quality assurance, Institutional relations)

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Opiniones

Materias

  • Clinical Trials
  • Pharmaceutical industry
  • Ethical and legal aspects
  • Pharmacovigilance
  • Quality assurance
  • Pharmacoecopidemiology
  • Pharmacoeconomics
  • Medical Devices
  • Project management

Temario

  • Introduction to the pharmaceutical industry and scientific
    basis for clinical research
    • The Drug. Life Cycle of Medicines.
    • The national and global pharmaceutical industry.
    • Basic concepts on pharmacokinetics and
      pharmacodynamics.
    • Toxicology, toxicity assessment. Clinical trial design.
    • Investigational producto.
  • Clinical Trial, definition and types
    • The Clinical Trial: definition and classification.
    • Adaptive Clinical Trials. Translational research.
    • Clinical Research in the biotechnology industry.
    • Clinical Research in pediatrics and rare diseases.
    • CNS Clinical Research.
    • Clinical Research in oncology.
    • Clinical Research in advanced therapies. Phase I units.
    • Clinical Research in primary carec.
  • Regulatory environment of the Clinical Trial
    • Ethical and legal aspects of Clinical Trials: Declaration of
      Helsinki and Good Clinical Practice standards.
    • Legal aspects of Clinical Trials (National and European
      Regulations).
    • Personal data protection.
      *Workshop FDA Regulatory Seminar and ClinicalTrials. Gov
    • Clinical trial essential documents and essential
      sponsor documents: Protocol, Investigator’s
      Brochure.
  • Structure and planning of Clinical Trials
    • Sponsor: structure, organization and management
      plan for clinical trials. Study SOPs. Strategic alliances
      between companies.
    • Pharmaceutical company versus CRO. Bid Defence.
    • Study management plans. Monitoring plan, data
      management plan, security plan, communication plan. Metrics in Clinical Research.
    • The clinical trial subject. Subject information sheet and
      informed consent. Subject recruitment and retention
      strategies. Other materials used for subject recruitment.
    • Feasibility study. Site selection and investigators
      participating in the clinical trials (pre-study visits).
    • Outsourcing of services. Identification and
      management of third parties.
    • Internal training of the monitoring and the
      investigator teams (investigator meetings).
    • Administrative Management CEICs and AEMPS -
      initiation of a clinical trial. * Workshop Administrative Management CEICs and
      AEMPS - practical session on trial start-up.
    • The Clinical Trial contract. Legal and economic
      aspects.
  • Start-up, monitoring and completion of clinical trials
    • Site initiation visits (preparation, visit and follow-up).
      Sites activation.
    • Administrative Management CEICs and AEMPS during
      the development of the clinical trial and at the end of the
      study.
    • Monitoring visits (preparation, visit and follow-up).
      * Workshop Site initiation visits and Monitoring Visits
      (preparation, visit and follow-up).
    • Risk-Based Monitoring.
    • Collection and management of clinical data.
    • Clinical Trial drug management.
    • Payment management during the study.
    • Close-out visits (preparation, visit and follow-up).
    • Trial documentation and archiving.
    • Management of the Clinical Trial from the hospital (clinical study coordinator and data entry).
  • Pharmacovigilance and quality assurance
    • Prevention of fraud and/or scientific misconduct.
    • Audits and inspections on clinical trials.
    • Pre-authorization drug safety (I): legislative basis,
      adverse events, DSUR.
    • Pre-authorization drug safety (II): management of safety
      information in clinical trials, protocol, contracts, practical
      information.
    • Post-authorization pharmacovigilance (I): legislative
      basis generalities, practical information.
    • Post-authorization pharmacovigilance (II): adverse
      reaction suspicions, risk management plans, PSUR,
      signal management. *Workshop Analysis of 2 cases of suspected adversevevents pre- and post-authorization.
  • Data management and analysis. Interpretation of results
    • Data Base Lock (Data Management)
    • Basic Concepts of Biostatistics
    • Statistical analysis plan and interim and final study
      reports
  • Pharmaecopidemiology, pharmacoeconomics and market access
    • Epidemiological studies, regulations and guidelines.
    • Descriptive and analytical epidemiology.
    • Analysis of Biases and interpretation of diagnostic tests.
    • Introduction to the economic evaluation of health
      care interventions. Types of analysis of the economic
      evaluation of interventions.
    • Existing methodologies for conducting an economic
      evaluation: modeling and clinical trials/observational
      designs.
    • Spanish health care organization (public health care,
      private health care and agents).
    • The role of institutional relations in the pharmaceutical industry.
    • Evolution of registration and market access
      strategies. Drug pricing and financing (therapeutic
      positioning reports). *Workshop Market Access.
  • Medical Devices
    • Introduction to Medical Devices: definitions, types,
      notified organizations.
    • Legislative framework for Medical Devices.
    • Development and documentation of a Medical Device:
      clinical investigation plan, investigator’s manual. Monitoring of clinical trials with medical devices:
      differences vs. drugs .
    • Medical device management: receipt, custody,
      storage, accounting, recall. Safety: ADCs, device
      deficiencies, protocol deviations, MDCG regulations.
      *Workshop Medical Devices
  • Project Management
    • The concept of planning.
    • Project Management in clinical trials.
    • Project Management skills and effective project
      management tools.
    • Peculiarities of project management depending on the
      company.
    • High impact presentations.
  • Personal development
    • Careers (LinkedIn, personal branding).
    • Effective presentations, communication.
    • Teamwork, cooperation, time management.
  • Conferences
    • Bid defense meetings.
    • Conference opening session.
    • Digital health.
    • Clinical research and cooperative groups.
    • Real world data and real world evidence.
    • Digital transformation and big data.

Más información

¿Necesitas un coach de formación?

Te ayudará a comparar y elegir el mejor curso para ti y a financiar tu matrícula en cómodos plazos.

900 49 49 40

Llamada gratuita. Lunes a Viernes de 9h a 20h.

Master's Degree in Supervision and Management of Clinical Trials - Madrid

Precio a consultar