Pharmacovigilance inspections is one of the activities that has growing more in last years, due to new legal requirements and drug’s safety issues that have been followed by the mass media and general public.
Innovations on technology and use of artificial intelligence and big data for decision making process and broadly use of algorithms have changed the current and prospective panorama.
Inspectors are dealing with complex computerized systems, bioengineering developments and also virtual situations that certainly have an impact on the inspection plan. However, there are still common findings based on “ground reality” that must be solved before going virtual, thus we as inspectors have to deal with digital and non-digital era at the same time.
Ernesto is graduated with a degree of Physician and Surgeon and Master in Public Health and Health System management from Autonomous University of Madrid. He obtained also a degree PhD in Pharmacology and Therapeutics from the University of Valladolid.
Initially worked as a Primary Care physician in the Spanish Public Health System and after finalised the specialisation in Anaesthesiology as anaesthesiologist.
He worked in the Pharmacovigilance Unit for the Spanish Medicines and Health Devices Agency, as a Safety Technician on safety reporting process, evaluation of PSURs, safety database, assessment of safety variations, and in other projects including the safety studies post authorisation database.
After that he moved to Hospital Gregorio Marañón in Madrid, as Medical Director of clinical trials and Ethics Committee secretary for this hospital, the largest hospital in Spain.
In 2007, moved back to the Spanish Medicines and Health Devices Agency as a Good Clinical Practice and Pharmacovigilance inspector. Currently as Head of GCP and PhV inspectorate at the Agency he is in charge of inspections planning, control and execution amongst other and managing a team of 10 inspectors in both fields. Ernesto is still conducting inspections and since 2007 up to now the total of them are c.280 inspections.