Helen Lowe has over 16 years’ experience within the pharmaceutical and biological sector, with in‐depth knowledge and extensive global PV QA auditing experience involving local operating companies, affiliates, co‐developments, marketing/license partnerships, distribution, and regulatory due diligence. She has conducted numerous GCP clinical investigator site audits, medical information audits, and regulatory audits, and has assisted with computer system validation audits. She has also participated in or managed several health authority inspections (including FDA, BfArM, MHRA, AEMPS).
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