CARY, N.C., June 9, 2021 /PRNewswire/ -- CATO SMS ,a global provider of specialized clinical research solutions, announced today that it has appointed Dr. Ernesto Vera-Sanchez to vice president of regulatory strategy and head of Good Practices (GxP) consulting services. Dr. Vera-Sanchez, who brings to CATO SMS nearly 20 years of global regulator and inspectorate experience, will spearhead CATO SMS' quality and safety initiatives serving the company's biopharmaceutical clients.
Prior to joining CATO SMS, Dr. Vera-Sanchez achieved an accomplished career at the Ministry of Health, Spanish Agency of Medicines and Medical Devices (AEMPS), where he was promoted to positions of increasing responsibility. He recently served as head of Inspectorate of Good Clinical Practice (GCP) and Pharmacovigilance (PhV) Inspections. During his tenure, he acted as:
- national expert to the European Medicines Agency (EMA);
- designated participant in the Emergency Task Force for COVID-19 products;
- chair of good PhV practices for the Spanish Technical Inspections Committee;
- member of the GCP Inspectors and PhV Inspectors working groups for the EMA;
- representative of AEMPS as a member of the Spanish GCP inspectors group;
- member of the working group of the International Coalition of Medical Regulatory Authorities.
Dr. Vera-Sanchez's involvement in industry initiatives has led to important developments, including implementing critical aspects of inspections and guiding new PhV legislation. He also is an active participant in the FDA-EMA initiative, in which he:
- participated in the FDA's Bioresearch Monitoring training program (BIMO);
- conducted sponsor, clinical site and CRO inspections accompanied by FDA investigators;
- engaged in joint inspections where FDA and EMA practices were harmonized.
"We are pleased to welcome a highly experienced senior regulator to our organization," said Mark A. Goldberg, M.D., executive chairman, CATO SMS. "Ernesto's extensive regulatory, GCP and pharmacovigilance knowledge will help provide our customers with independent and proactive quality assurance support to minimize regulatory risk while protecting the safety and well-being of study participants."
Dr. Vera-Sanchez began his career as a primary care physician and specialist in anesthesiology. He holds a medical degree and dual master's degrees in public health and management of health institutions from the Universidad Autonoma de Madrid. He also earned a philosophus doctor degree in pharmacology and therapeutics from the Universidad de Valladolid.
About CATO SMSCATO SMS is a provider of specialized clinical research solutions that was formed in 2019 when Cato Research merged with SMS-oncology. With more than 30 years of experience focusing on the needs of small and emerging biopharmaceutical companies, CATO SMS effectively designs and executes studies — from strategy to approval — in complex indications and modalities across a variety of therapeutic areas with a proven center of excellence in oncology. CATO SMS' regulatory, therapeutic and operational expertise enables the company to meet goals and exceed expectations. Visit CATO-SMS.com for more information.
SOURCE CATO SMS