Online Master in Medical Science Liaison (MSL)
Madrid, Spain
Master degree
DURATION
12 months
LANGUAGES
Spanish
PACE
Full time
APPLICATION DEADLINE
EARLIEST START DATE
TUITION FEES
STUDY FORMAT
Distance Learning
Key Summary
The aim of the Online Master in Medical Science Liaison (MSL) is to enable students to acquire practical training to meet the strategic needs of the medical department vis-à-vis its internal and external stakeholders, including health authorities.
This Master's degree provides students with the necessary knowledge to develop their professional activity in MSL and Medical Advisor positions, expanding their employment opportunities as a medical-scientific expert in their therapeutic area. The MSL position is the most in-demand position within the medical departments of pharmaceutical and biotechnology companies.
Specialize in the most in-demand position within the medical departments of pharmaceutical and biotechnology companies.
- Practical and applied ONLINE methodology: The development of knowledge through active methodologies applied to online training models allows students to combine their studies with the rest of their professional and personal life obligations.
- Personalized monitoring: In addition to the teaching staff, students will have a group of tutors at their disposal who will personally monitor their progress, to guide the student at each stage and resolve any difficulties they may face during the course.
- Connection with the reality of the sector: Both the role of the Program Manager of the course, who has designed and directs its delivery, and the teaching faculty are made up of active professionals, guaranteeing the connection with the working reality of all students and the direct application of the knowledge they acquire during the course to their workplace.
Technical Sheet
General information
- Duration: 12 months
- Equivalence: 60 ECTS
- Methodology: 100% online
- Continuous assessment of knowledge
Calls
Students have the opportunity to plan their training schedule together with their tutors. In this way, each future student can establish the time when the rest of their responsibilities will allow them to achieve the best academic performance and the time to apply the knowledge acquired during the course in their professional field.
Methodology
This Online Master's program is developed over 1 academic year.
During this period, 2 virtual classes will be activated per week and each student will have the possibility of requesting from their personal tutor the virtual tutorials they deem necessary to resolve any difficulty they may encounter during the study of content.
- 24/7 virtual campus: students can access it 24 hours a day, 7 days a week from any device with an Internet connection.
- Compatible with work and family life: each student decides where, when and how they want/can access the course content, taking into account the rest of the professional and family responsibilities that occupy their daily lives.
- Personalized advice: from the first moment to the end of the training process, students will be accompanied by qualified professionals who they can turn to to resolve any difficulties they may encounter.
- Constantly updated content: To ensure the highest quality of our training, our content is subject to continuous review and updating by our teaching staff, ensuring the direct application of the knowledge acquired during the course in the professional field.
The online Master's Program in Medical Science Liaison (MSL) is structured into the following content blocks:
The National Health System. Medicines. Marketing Authorization. Public Financing. Drug Registries.
- Structure and organization of the Health Authorities: Spanish Agency for Medicines and Health Products (AEMPS), European Medicines Agency (EMA) and Food Drug Administration (FDA).
- Marketing authorization for medicines.
- Drug prices and financing.
- Phases of drug registration.
Scientific Basis: Pharmacology and Toxicology
- Introduction to pharmaceutical clinical development.
- Pharmacokinetics.
- Pharmacodynamics.
- Toxicology.
Design and Phases of Clinical Trials
- Types of studies according to their methodology I.
- Types of studies according to their methodology II: Scientific evidence. Meta-analysis.
- Origin of clinical trials. Regulation.
- The biology of medicine. Pharmacogenetics, pharmacogenomics and genetic profiles. Immunotherapy.
- Fundamentals of clinical development. Phase 0 clinical trials.
- Phase I clinical trials.
- Phase II clinical trials.
- Phase III clinical trials.
- Post-authorization studies.
- New clinical trial designs and new regulatory pathways.
- Regulation of clinical trials: Legal aspects and approval processes. EMEA and AEMPS. Ethical and legal aspects, both at European and international level (Helsinki Agreement). Protection of trial subjects and assurance.
Stages of Clinical Trials and Monitoring Methodology
- Feasibility of clinical trials.
- Identification of centers and researchers.
- Protocol in clinical trials.
- Essential documents in a clinical trial.
- Monitoring: purpose and responsibilities.
- Home visit.
- Monitoring visit.
- Closing visit.
Pharmacovigilance
- Pharmacovigilance in clinical trials, legal framework, definitions and management of adverse events (European legislation, FDA and in Spain, definitions of adverse events and others, safety management plan, SMP).
- Adverse event reporting, EudraVigilance (SUSARs reporting, reporting times and procedures, CIOMS report types, MedWatch report, EudraVigilance and safety databases).
- Pharmacovigilance in other clinical trials: post-authorization studies, clinical trials with medical devices and clinical trials with vaccines and advanced therapies.
- Audits and inspections. Signal detection.
Biometrics and Data Analysis
- Classification of statistical studies. Classification axes.
- Types of variables. Measurements.
- Hypothesis testing. Confidence intervals.
- Risks. Relationship between variables.
- Population and Sample.
- Queries, statistical design.
- Statistical analysis plan and statistical report.
- Functions and tasks. Statistics unit.
Pharmaceutical industry
- Pharmaceutical industry environment.
- Structure of a pharmaceutical laboratory.
Medical Department
- General Concepts Medical Affairs.
- MSL interactions with other departments.
- Most relevant roles in Medical Affairs.
- Annual medical plan.
Advertising and Promotion
- Regulation of advertising and promotion. Code of ethics.
Professional development
- Professional career. Importance, career path and professional development after completing the master's degree.
- Career options and structure of the local and international labour market.
- Effectiveness and tools in the job search.
- Job interview: Essential elements for success in the selection process.
Master Thesis project
The Online Master in Medical Science Liaison (MSL) is designed to develop the student's professional skills and abilities to the maximum in the medical and scientific activities of medical departments of pharmaceutical and biotechnology companies, Medical Devices and CROs.