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International Clinical Trials

Quality Upkeep

To ensure a smooth transition from the pre-authorisation to the post-authorisation phase of the lifecycle of a medicinal product, the marketing authorisation (MA) applicant is responsible for ensuring a robust pharmacovigilance (PV) system is in place to monitor patient safety once the product is on the market. During clinical trials, patient exposure is limited and closely monitored, and very specific criteria must be met for patients who are eligible to take part in the study. However, once the product is on the market and more widely available, patient exposure will be much more widespread and patients may experience adverse reactions (ARs) that have not been observed previously in a clinical trial setting.

To maintain compliance with EU post-marketing regulatory requirements, the MA holder (MAH) must ensure that the following are in place:

• PV systems (including appropriate technology, quality management system, and PV processes)
• Qualified Person for PV (QPPV) and deputy and local safety-responsible representatives (where required under national legislation)
• PV system master file (PSMF)
• Risk management and minimisation systems
• Signal management • Global literature search strategy
• EudraVigilance (EV) maintenance, including Article 57 database

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David Hukin is the Head of Pharmacovigilance and the PV team at Quanticate. David has a PhD in cell physiology and biophysics and 15 years’ experience in the pharmaceutical industry, with more than 14 years working in the PV sector. He has worked across speciality pharma/biotechnology companies and has gained preand post-marketing experience in a range of therapeutic areas, including gastroenterology, hepatology, neurology, oncology, psychiatric conditions, ATMPs, and orphan drug indication products for rare diseases. Since 2015, David has worked in the specialist PV service provider sector, leading multiple large teams responsible for clinical and post-marketing for customers ranging from small pharma/ biotech to large speciality and generic companies, before joining Quanticate in 2018.
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David Hukin
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