Drugs from Use to Abuse. Pharmacovigilance and Regulation

Facultatea

Descriere

Studies level: Master’s degree (level 7 EQF/CEC and CNC)

Broad field: Biological and biomedical sciences

Study field: Pharmacy

Study program: Drugs from use to abuse. Pharmacovigilance and regulation

Qualification: Pharmacovigilance Research Assistant

The objective of the Drugs from use to abuse. Pharmacovigilance and regulation Master’s degree program is the training of specialists in the field of pharmacovigilance and clinical trials involving drugs, specialists who will improve the medical system through active involvement in monitoring the efficacy and safety of pharmacotherapy, critical assessment of drug intoxications, identification and reporting of adverse reactions, development of substance misuse reduction plans and optimization of therapy on pharmacokinetic, clinical and paraclinical criteria. Professional training will be provided by specialists in the fields of pharmacology, toxicology, laboratory analysis and related areas of applicable legislation (law).

Starting with the academic year 2023-2024, the master’s students, supported by Astra Zeneca, will have the opportunity to carry out a practical training at the Pharmacovigilance Centre of Excellence in Târgu Mureș.

Who is it for?

  • Graduates of the Faculty of Medicine
  • Graduates of the Faculty of Pharmacy
  • Specialists coming from a socio-economic background (pharmaceutical industry, regulatory and control authorities for medicinal products and food supplements) who can justify basic knowledge in the specialties covered by the Master’s degree.

Detalii suplimentare

Professional competencies

  • The identification and prevention of adverse effects which may occur as a result of the use of medicinal products in the indications set out in the summary of product characteristics (SPC),
  • The identification and prevention of adverse effects which may arise from the use of medicinal products for non-therapeutic purposes (off-label use, doping, homicide, suicide),
  • The provision of consultancy and expertise on the safe and effective use of medicines in patients of all ages (children, adults, elderly),
  • The provision of consultancy and expertise on the safe and effective use of medicines during pregnancy and breastfeeding,
  • The provision of consultancy and expertise in cases of misuse of medicines and management of drug intoxication and drug misappropriation (doping, trafficking, criminal use).
  • The collection and analysis of biological samples.

 

Transversal competencies

  • The identification of the objectives to be achieved, of the resources available, of the conditions for their completion, of the phasing and timing of the work, of the respective deadlines and of the associated risks;
  • The application of techniques and interpersonal skills for effective teamwork;
  • The effective use of information sources and communication and assisted training resources.

 

Occupational prospects

  1. Pharmaceutical Industry
  • Pharmacovigilance Specialist
    • Monitors and evaluates adverse drug reactions, reporting them to regulatory authorities;
    • Ensures compliance with regulatory requirements and manages drug-related risks;
    • Contributes to the development and implementation of risk minimization strategies.
  • Pharmacovigilance Data Analyst
    • Works with databases to identify safety signals and trends.
  1. Regulatory and Public Health Institutions
  • Analyzes drug safety data and ensures regulatory compliance for medicinal products.

  1. Research and Development
  • Pharmacoepidemiology Researcher
    • studies the use and effects of medications in large populations.
  • Pharmacovigilance Consultant
    • advises pharmaceutical companies and institutions on drug safety strategies.

Documente

Planuri de învățământ

Facultatea

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