In Episode 2 of What's Next in PV, Tereza Korecka sits down with Vojtech Kvita and Josue Vazquez from NextPV Services to break down exactly what audit readiness looks like in 2026 - under the expanded requirements of EU Regulation 2025/1466 and heightened regulatory expectations worldwide. It's a practitioner-to-practitioner conversation on what actually works, what adds real value, and what you can accomplish even when timelines are tight. Whether you're building your first audit program, preparing for an imminent inspection, or trying to demonstrate the strategic value of auditing to leadership, this episode delivers the clarity and action steps you need. (0:05) - Episode opening and introductions (0:28) - What is a PV audit? Differentiating between audits and inspections (0:38) - Vojtech begins explaining the fundamental differences between audits and inspections (2:32) - Discussion on regulatory authority inspections (EMA, FDA) (5:12) - Josue adds perspective on audits being about effectiveness, not just compliance (6:06) - Tereza transitions to EU Regulation 2025/1466 and its impact on auditing (6:41) - Vojtech explains how the regulation formalizes existing audit practices (10:14) - Josue confirms regulation doesn't fundamentally change how audits are performed (11:47) - Vojtech discusses practical contract implications under the new regulation (14:43) - Tereza summarizes: audits are meant to make life easier, not harder (14:52) - Vojtech's perspective from both sides of the audit table (16:30) - Shifting mindset: audits as opportunities, not threats (16:36) - Josue addresses the fear of findings and why audits shouldn't be feared (17:11) - Vojtech compares inspections to "the boogeyman" in PV (17:24) - The healthy nervousness analogy: inspections like university exams (18:23) - The six types of PV audits: Tereza asks about different audit types and when to use them (18:50) - Vojtech explains the audit universe: system audits, process audits, and organizational structure (22:39) - Josue discusses when to conduct different audit types based on MAH lifecycle (27:20) - For-cause audits explained: triggered by findings or deviations (30:29) - Gap analysis vs audit: what's the difference and how to use each? (30:50) - Vojtech defines gap analysis as a flexible, less formal assessment tool (33:35) - Vojtech continues: gap analysis enables more open conversations than formal audits (36:00) - Josue emphasizes both processes are for improvement, with different approaches (39:07) - Practical scenario: 6 months to first PV inspection with no audit prep - are they in trouble? (39:30) - Vojtech's reality check: you're not in trouble, but prioritization is key (43:48) - Vojtech on reinspection preparation: checking CAPA status from previous inspections (44:08) - Josue introduces mock inspections as a critical preparation tool (46:48) - Vojtech's final advice: don't fear audits, maintain your system, expect findings (49:58) - Discussion on not forcing findings when companies are compliant (50:52) - Josue's auditing philosophy: human approach, open communication, respectful evaluation (53:44) - Vojtech shares an inspection anecdote about inspector credentials and unnecessary gotcha moments (55:10) - Josue's example about language-based findings that don't serve improvement purposes (57:26) - Tereza's closing remarks and thank you Hosted by Tereza Korecka | Co-hosts: Vojtech Kvita and Josue Vazquez, NextPV Services Keywords: pharmacovigilance, PV audit, audit readiness, EU Regulation 2025/1466, gap analysis, inspection preparation, QPPV, MAH compliance, vendor oversight, PV quality management, GVP, drug safety, pharmaceutical auditing, system audit, process audit, third-party oversight
