Covering Human Medicines, Phytovigilance and Cosmetovigilance, our pharmacovigilance activities secure the risk reduction process, facilitating the monitoring of the safety of medicines that have been placed on the pharmaceutical market.
Human Medicines
- Provision of QPPV and 24/7 Safety Contact Person Services
- Follow up, validation & assessments of ICSRs
- Preparation and submission of AEs and APRs in the appropriate format to the regulatory bodies, in compliance with the statutory timelines
- Registration of Sponsor, ΜΑΗ, AMP and Trial IMPs in Eudravigilance
- Development of CT-specific Supportive Documentation Related to Safety Reporting
- Performing literature search and obtaining literature articles and reviews, to guarantee up to date information
- Pharmacovigilance SOP writing and maintenance
- Establishing and maintaining PSMF
- Preparation of periodic safety update reports (PSURs)
- PhV Inspections by the local Pharmacovigilance Center including development and maintenance of documents, follow-up of corrective and preventative actions
- Risk Management Plan preparation
- Insertion and update of medicinal products in the European databases Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
- Audits and preparation for inspections by regulatory authorities
- Pharmacovigilance Training for pharmaceutical sales representatives and / or company personnel
- Preparation, maintenance and updating the Pharmacovigilance System Master File (PSMF)
- Drafting, reviewing and updating the Safety Data Exchange Agreements (SDEA)
- Data Entry
Phytovigilance
- Collection of spontaneous reports of adverse reactions
- Post marketing survey
- Regulatory updates
- Toxicological evaluation
Cosmetovigilance
- Adverse reactions gathering and archiving
- Evaluation and follow up of the cause
- Management the communication of serious undesirable effect to the Authorities
- Updating the Product Information File
- Regulatory updates in the case of new restrictions or prohibitions in the use of cosmetic ingredients
