Within the services offered by Experior to its clients, there is a Department of Pharmacovigilance, which has a highly qualified professional team with a great deal of experience in all the areas of medication safety, both during the process prior to product marketing (Pharmacovigilance during clinical research) and after the medication has been marketed (Post-marketing pharmacovigilance).

Pharmacovigilance Services during the clinical research phase

• Serious adverse event management (management, evaluation and electronic reporting of SAEs). Pharmacovigilance database consultancy
• Coding with MedDRA
• Expedited reporting of Unexpected Serious Adverse Reactions in clinical trials to the relevant authorities
• Preparation, notification and distribution of annual reports and periodic safety reports to the relevant authorities (AEMPS, autonomous regions y Ethics Committees) and investigators
• Contact point/reporting of safety issues to the regulatory authorities
• Pharmacovigilance training for investigators and staff involved in the clinical trials
• Safety data evaluation

All clinical trials must have a pharmacovigilance system in order to ensure that all serious adverse events or other safety-related information are collected and notified to the relevant persons within the notification periods.

Post-marketing Pharmacovigilance

• Serious adverse event management (management, evaluation and electronic reporting of SAEs). Pharmacovigilance database consultancy
• Coding with MedDRA
• Expedited reporting of individual cases of Serious Adverse Reactions
• Preparation, notification and distribution of annual reports of periodic safety update reports (PSUR) to the Health Authorities
• Regular systematic bibliographic search that allow to identify those individual cases to be notified
• Pharmacovigilance training for company staff (medical department, sales network, marketing ...)
• Be the person responsible for pharmacovigilance with the relevant authorities

Experior offers a range of pharmacovigilance services for marketed medications. Our fully meet the requirements of Spanish law and European Guidelines, Volume 9 A.