CESIF
Online Master's Degree in Pharmacovigilance and Regulatory Affairs

Madrid, Spain

DURATION

12 up to

14 months

LANGUAGES

Spanish

PACE

Full time

APPLICATION DEADLINE

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EARLIEST START DATE

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TUITION FEES

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STUDY FORMAT

Distance Learning

Key Summary

About : The Online Master's Degree in Pharmacovigilance and Regulatory Affairs provides students with the knowledge and skills to manage drug safety and compliance with regulations. The program focuses on practical applications and theories related to pharmacovigilance and regulatory affairs, equipping graduates to handle health product safety. This course typically spans one to two years, allowing flexibility for busy professionals.

Career Outcomes : Graduates have the potential to pursue careers in various fields, including pharmacovigilance, regulatory affairs, and drug safety. Opportunities may exist in pharmaceutical companies, health authorities, and research organizations, enabling graduates to contribute to ensuring patient safety and compliance with industry standards.

Introduction

The pharmaceutical sector is a sector that is heavily regulated by the Health Authorities in order to protect the health of patients as much as possible and no medicine can be marketed without prior authorization.

The Regulatory Affairs and Pharmacovigilance departments are the main interlocutors of pharmaceutical companies with health authorities both at national and international level.

The online Master's Degree in Pharmacovigilance and Regulatory Affairs is designed to train highly qualified professionals in the field of pharmaceutical regulation, in relations with health authorities in the field of medicines and other legal bases such as medical devices, cosmetics and food supplements.

In addition, it provides in-depth knowledge in the field of pharmacovigilance and safety of clinical trials in order to meet the challenges of the sector with a rigorous and up-to-date approach.

The student will develop a solid specialization and advance his or her professional career in this highly relevant field of public health.

Main Objectives of the Master:

Provide a comprehensive view of regulatory processes with Health Authorities.
Manage adverse reactions in pharmacovigilance and ensure the safety of medicines in clinical trials.
Thoroughly understand international regulations and procedures for marketing pharmaceutical products.
Monitor medicines, ensuring their safe and rational use through continuous risk assessment.
Evaluate the risk/benefit ratio throughout the life cycle of a medicine.
Detect unidentified adverse reactions prior to marketing authorization.

Technical Sheet

General information

Duration: 12 months + 1 month (Professional Development Module) + 1 extra month for TFM preparation.
Equivalence: 60 ECTS
Methodology: 100% online
Continuous assessment of knowledge

100% 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.

Teaching resources: all materials are of high academic quality and are structured for direct application in the professional environment. They are multi-format resources, which adapt to different learning styles for a more dynamic training process.

Connection with the reality of the sector: both the role of the master's director, who has designed and directs its delivery, and the teaching staff, are made up of active professionals, who guarantee the connection of all students with the working reality and the direct application of the knowledge they acquire during the course to their workplace.

Personalized monitoring: you will have a group of tutors at your disposal who will personally monitor your progress, to guide you at each stage and resolve any difficulties you may face during the course.

Participatory training and networking: with spaces for constant exchange and collaboration for students.

Admissions

Curriculum

The online Master's program in Pharmacovigilance and Regulatory Affairs is structured into the following content blocks.

Module 1. Overview of the pharmaceutical industry

Medium and long-term future of the pharmaceutical sector.
Organization and structure of a pharmaceutical company.
Pharmacovigilance and its position in the pharmaceutical industry.
Drug advertising.

Module 2. Introduction to pharmacovigilance of medicines and other pharmaceutical products

Duties of the person responsible for Pharmacovigilance (QPPV), Deputy and relations with other departments of the company.
Good Pharmacovigilance Practices (GVPs). Part I.
Good Pharmacovigilance Practices (GVPs). Part II.
Pharmacovigilance System Master File (PSMF).
Pharmacovigilance agreements with distributors and third-party service companies.
Market surveillance of medical devices. Cosmetovigilance.

Module 3. Management and handling of suspected adverse reactions

Sources of information on pharmacovigilance.
Electronic reporting of suspected adverse reactions.
Bibliographic searches in pharmacovigilance.
MedDRA
Other Pharmacovigilance databases.

Module 4. Clinical research with drugs

Methodology of pharmacoepidemiological research I.
Research methodology Pharmacoepidemiology II.
Observational studies with drugs.
Clinical trials.
Meta-analysis. Other sources of pharmacovigilance data and EOM regulations.
Safety notifications and documentation relevant to the conduct of clinical trials.

Module 5. Aggregate Security and Signal Detection Reports

Periodic Security Reports (PSUR) and their submission to the authorities.
Risk Management Plans (RMP).
Addendum to Clinical Overview (ACO).
Sources, workflow and responsibilities in signal detection.
Qualitative and quantitative procedures for signal detection.
Signal analysis and evaluation.

Module 6. Quality in pharmacovigilance

Pharmacovigilance indicators and KPIs.
Management of the Corrective and Preventive Action Plan (CAPAs).
Standard operating procedures for pharmacovigilance.
Pharmacovigilance inspections.
Internal and external audits.
Risk management in pharmacovigilance.

Module 7. Structure of health authorities involved in drug registration

Regulatory Affairs Department.
Health Authorities: AEMPS and EMA.
Ministry of Health.
Foreign trade. Export and import.
Types of registration procedures I.
Types of registration procedures II.

Module 8. Registration dossier.

Computer tools applied to drug registration I.
Computer tools applied in drug registration II.
Common Technical Document (eCTD). Module I and II.
Common Technical Document (eCTD). Module III.
Common Technical Document (eCTD). Module IV.
Common Technical Document (eCTD). Module V.

Module 9. Post-authorization regulatory procedures

Labelling of medicines and telematic management of technical sheets and leaflets.
Processing of procedures for financing and setting drug prices.
Record modifications. Type of variations.
Five-year revalidations.
Cancellation of a marketing authorisation. Temporary suspension. Request for free samples. Notifications on the marketing of medicines for human use. Application for a pharmaceutical product certificate.
Other post-authorization procedures.

Module 10. Cosmetic products and personal care products

Cosmetic products and facilities. Authorities involved.
ISO Certifications and Regulations in cosmetic products.
Cosmetic product notification portal.
Cosmetic product information file.
Safety assessment of cosmetic products and labelling of cosmetic products.
Risk analysis in cosmetic products. Toxicological profile.

Module 11. Medical devices

Classification of medical devices.
CE marking and Notified Bodies.
Technical file for medical devices.
Labeling and instructions for use.
Post-marketing surveillance.
Eudamed and UDI.