Amer Alghabban is currently the Managing Director of GxP Compliance and Training Partners (GCTP) helping pharmaceutical companies to achieve compliance with GCP, GVP, GCLP and GLP.
Amer has over 27 years experience in the pharmaceutical industry.
He has been an invited speaker at over 110 international congresses. Mr. Alghabban has published reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance and other publications. He was Assistant Editor for 11 medical journals and an invited Course Director for Pharmacovigilance Auditing at the UK RQA. As part of his current role as QA Expert, he is serving as GxP QA adviser for Allecra Therapeutics SAS and has served as VP of GxP Quality Assurance, Compliance at Karyopharm Therapeutics Inc. and similarly as the Senior QA representatives of Biotech companies in Switzerland and the U.K. Prior to GCTP, he was Global Director, Head of Quality Assurance & Audit Management at Merck Serono, Geneva, Switzerland.
His other previous positions included Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Basel, Switzerland and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK.
Good Clinical Practice (GCP) inspection by the US Food and Drug Administration (FDA) can lead to the detection of problems with the conduct of your clinical trial. FDA requirements regarding GCP and related inspections have been around for decades.