Master's Degree in Supervision and Management of Clinical Trials - Barcelona
CESIF FORMACION S.L.Máster presencial
Barcelona
Precio a consultar
Duración : 6 Meses
Pharmaceutical laboratories need to hire professionals capable of applying their functional knowledge responsibly in the areas of clinical R&D, pharmacoeconomics, pharmacovigilance and more.
The desired professional profile must combine adequate training and knowledge related to clinical development functions (technical, scientific and regulatory) and a certified background in the specific professional skills required for these roles (planning, project management, teamwork, communication and interpersonal skills), in addition to an appropriate level of English and experience performing these tasks.
This Master’s Degree in Supervision and Management of Clinical Trials is designed to meet the needs of industry in every regard.
The student is provided with practical and professional experience in pharmaceutical laboratories and CROs. This programme incorporates an internship process within international companies in the sector’s leading firms so that participants can attain a high level of professional specialisation.
Finally, CESIF supports the employment and professional journey of each student in the field of clinical research through its lifetime employment service.
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Objetivos
The curriculum covers in depth all the subjects related to the design, implementation and supervision of all types of clinical trials, as well as the different actions carried out 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.
A quién va dirigido
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.
Temario completo de este curso
- 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.
- Ethical and legal aspects of Clinical Trials: Declaration of
- 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.
- Sponsor: structure, organization and management
- 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).
- Site initiation visits (preparation, visit and follow-up).
- 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
- Introduction to Medical Devices: definitions, types,
- 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.
10.700 €