Pharmacovigilance & Drug Safety

Biography

Parminder Kaur is a regulatory affairs and PV expert with 19 years of recognized global expertise in a broad range of therapy areas. She has played a major role in setting the in-house RA and PV systems in compliance with the European regulations at various companies. She has provided strategic input for regulatory matters regarding product development aimed for EU launch, ranging from innovative product development incl. gene therapies, biologicals and biosimilars, vaccine and generic product approval as well as orphan designations and early access to unapproved medicines. She has also been highly involved in the pharmacovigilance set-up at various companies. She has played a major role in setting the QA systems in compliance with the European legislation at various companies; assisted various companies during inspections and audits conducted by EU Regulatory Authorities. She is acting as EU-QPPV and deputy QPPV for some companies. Currently, she is running her own consulting firm - RegPak BioPharma Consulting, Netherlands.

Abstract

Abstract : Good pharmacovigilance practice