Multiprofessional Care Integration Challenges

Medicines and Medical Devices

Safety and Risk Management in the Real World Clinical Practice

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November 15th 2021 - December 13th 2021
Ana Paula Martins (PhD)
Innovative therapies and medical devices the frontline of health systems’ transformation into a learning system. They are supported in new risk management approaches that should increase efficiently the detection, analysis and management of preventable safety issues and therefore optimizing patients health outcomes. EU Pharmacovigilance and Risk Management Regulations are crucial for compliance requirements.

Optimizing risk management activities, developing approaches to risk mitigation and understanding
the links between safety specifications, pharmacovigilance plans, risk minimization programmes and real-world studies are important topics to be specifically addressed in this 4 module intermediate-advanced course.

There are enormous challenges and tremendous opportunities for practice in this area due to the
foreseen disruptive health technologies like advanced therapies, combined medications and companion diganostics. Big data systems will dramatically change the way how research and regulatory sciences will evolve now and in the years to come.
Healthcare Professionals, Risk Management and Pharmacovigilance managers from Pharmaceutical Industry, Trainees in Pharmacovigilance Units, Master and PhD students.
  1. To understand the European Legislation for Risk Management and Pharmacovigilance and review the regulatory requirements and their inclusion in the European System for Managing and analysing information on suspected Adverse Drug Reactions to Medicines.
  2. To critically appraise within current regulatory framework and guidelines to risk management Plans.
  3. To increase ability to implement the requirements from Good Practice on Medication Errors issued by the European Regulatory Network in 2015.
  4. To provide in depth knowledge of Spontaneous Reporting systems, case management tools and causality assessement in Pharmacovigilance.
  5. To analyse the application of signal detection methodology and to review documents for risk and benefit communication.
  6. To analize the main study designs in pharmacoepidemiology for assessing drug safety issues specifically non-experimental designs as cohort, case-control, case-crossover studies.
  7. To develop a critical understanding of the study designs, assessement and application of post-authorization drug safety data, safety monitoring, and risk management associated with pharmaceuticals and medical devices.
Academic background in Health Sciences ( PhD, Master degrees or Bachelors)