Aarti Bahirat

Aarti holds a Pharmacy and MSc in Pharmacology degree, with a comprehensive understanding of the full lifecycle of drug development. Since starting the quality assurance journey in October 2017, Aarti has gained experience in auditing quality systems and inspection management. Aarti has been involved in planning, conducting, reporting, and developing CAPAs for GCP/GVP audits of Investigator Sites, Internal system/process, local affiliates, licensing partners and Vendors. Additionally, Aarti has acted as a Quality representative for clinical studies, providing guidance and advice on quality issues and compliance requirements. Aarti, has also supported regulatory inspections in GCP/GVP areas. Aarti is a distinguished professional with extensive experience in the pharmaceutical industry, contract research organizations (CRO), and National Health Service (NHS). Having worked within several sectors, Aarti has gained a wealth of knowledge in drug development, clinical research, regulatory affairs, and Pharmacovigilance. This breadth of experience has allowed Aarti to develop a keen understanding of the intricacies involved in the pharmaceutical landscape. She is a core member of Patient Centricity in global safety within GSK and very passionate about patient engagement and involvement in improving patient and public safety. In addition to her professional achievements, Aarti have attended conferences and seminars as a speaker and participated in panel discussion. She is also one of the author of ‘The NIS handbook - Quality Oversight of Non-Interventional Studies (NIS)’, developed in collaboration with expert members from RQA-JSQA organisations. This handbook was developed for Quality Assurance (QA) professionals to support reviewing, advising and overseeing non-interventional studies (NIS) for medicinal products, but can be of use to anyone engaged in NIS for medicinal products.