Surveillance

ProduCT

Medical Device Surveillance aims to monitor incidents resulting from the use of medical devices and the dissemination of related safety information. It includes the following activities:

  • Notification of adverse effects to the competent authorities;
  • Notification to the manufacturer;
  • Support in defining actions to be taken and implementing corrective actions.

Pharmacovigilance aims to monitor the safety of medicines with marketing authorization, through the collection and evaluation of adverse drug reactions (ADR), identification of risks associated with the use of medicines, their evaluation, the implementation of measures to minimize risks and communicate these to health professionals, patients, consumers and citizens in general. It includes the following activities:

  • Development and maintenance of the Pharmacovigilance System (Pharmacovigilance System Master File);
  • Development, implementation and maintenance of pharmacovigilance quality systems;
  • Support in the implementation of a Risk Management System and Good Pharmacovigilance Practices;
  • Preparation of Pharmacovigilance Procedures;
  • Preparation of Risk Management Plans (Risk Management Plan);
  • Preparation of Periodic Safety Reports (PSUR);
  • Notification of adverse reactions (CIOMs) to the competent authorities and monitoring;
  • Registration of ICSRs (Individual Case Safety Reports) with EudraVigilance (EVWEB);
  • Management and implementation of Urgent Security Measures;
  • Weekly search for adverse drug reactions (ADRs) in national and international literature;
  • Periodic review of national and international medical literature;
  • Educational materials and Communications addressed to Health Professionals.

Cosmetovigilance, with the objective of monitoring the undesirable effects associated with the use of cosmetic products and the dissemination of safety information related to cosmetics. It includes the following activities:

  • Evaluation and monitoring of complaints related to commercialized cosmetic products;
  • Notification of undesirable effects or issues related to the safety of cosmetic products to the competent authorities;
  • Evaluation of undesirable effects;
  • Safety assessments, including cosmetic product safety reports (CPSRs) for EU compliance.

Nutrivigilance, with the objective of monitoring the undesirable effects associated with the use of food supplements and the dissemination of safety information regarding food supplements. It includes the following activities:

  • Adverse events management;
  • Notification of adverse events to the competent authorities;
  • Preparation of summary reports;
  • Preparation and review of nutrivigilance SOPs.