E4: Medical Writing in Pharmacovigilance: DSUR, PSUR, RMP, and Benefit-Risk Documents

E5: Computerized Systems in Pharmacovigilance: How to Choose, Validate, and Operate the Right Tools

Choosing a PV tool is no longer just a safety database decision. Computerized systems now sit across pharmacovigilance operations: safety databases, PSMF tools, QMS platforms, reporting layers, integrations, dashboards, automation, and AI-enabled capabilities. In Episode 5 of What's Next in PV, Tereza Korecka speaks with Jan Kolouch and Vojtech Kvita from NextPV Services about how PV teams should approach computerized systems as strategic infrastructure, not just software. The conversation covers: * What makes a tool relevant for pharmacovigilance and GxP work * Why companies should start with process, data flow, and intended use before vendor demos * Strategic routes: current vendor modules, new vendors, integrations, APIs, and internal builds * How scorecards, sandbox testing, and business requirements help decision makers * Why cost should be assessed beyond licence price * What validation means for configurable and cloud-based tools * Where AI fits, and why automation and audit trails still matter * How the approach differs for small biotechs and large pharma companies This is a practical episode for PV, QA, IT, regulatory, and biotech leaders reviewing their technology stack or preparing for a regulated tool selection project. Hosted by Tereza Korecka | Guests: Jan Kolouch and Vojtech Kvita, NextPV Services Keywords: pharmacovigilance, computerized systems, computerized tools, PV systems, GxP validation, safety database, PV technology, AI in pharmacovigilance, automation, audit trail, data integrity, PSMF, QMS, vendor selection, biotech PV (00:53) - Opening and guest greetings(01:01) - Episode topic: computerized tools in pharmacovigilance(01:20) - Computerized systems are broader than safety databases(02:55) - How to decide whether a tool is used for PV activities(04:07) - Why PV system decisions are becoming more complex(04:29) - Digitalization, AI momentum, and cross-functional decision-making(07:17) - Main strategic options for better PV tools(07:41) - Current vendor modules, new vendors, integrations, APIs, and internal builds(11:04) - Why teams should invest time in tool selection and interoperability(12:30) - What to assess before looking at vendor options(13:16) - Demos, system inventory, data flow, and validation considerations(16:03) - Scorecards, business requirements, and system requirements(17:02) - How to compare functionality without ignoring cost(17:39) - Shortlisting vendors, sandbox testing, and pricing models(20:06) - Building a viable business case and assessing benefit-risk(21:38) - What validation means for GxP tools(22:18) - Configuration, implementation, cloud setup, and validation packages(26:04) - Why validation can range from simple testing to a full project(27:11) - AI trends without turning the episode into an AI validation deep dive(28:05) - Enterprise LLMs, local models, system-of-record data, and human oversight(33:06) - Automation before AI and why audit trails matter(35:32) - Practical decision process: from use case to governance(36:13) - Define use case, regulatory impact, data access, cost, validation, and ownership(39:54) - Small biotech vs large pharma: what changes and what stays the same(40:21) - Lean compliant stacks, fragmentation, vendor lock-in, and governance(43:53) - Final takeaway question: choosing PV tools in May 2026(44:37) - Computerized systems as strategic PV infrastructure(47:07) - Do not be afraid to move toward computerized systems and supervised AI(48:44) - Closing remarks

E4: Medical Writing in Pharmacovigilance: DSUR, PSUR, RMP, and Benefit-Risk Documents

Medical writing in pharmacovigilance is not just writing. It is the point where safety data, process outputs, cross-functional input, and benefit-risk judgement come together into a document regulators can evaluate. In Episode 4 of What's Next in PV, Tereza Korecka speaks with Katarina Cechlovska and Hana Sourkova from NextPV Services about what strong PV medical writing actually requires, including: * What medical writing covers in pharmacovigilance, from case narratives to aggregate reports and risk management documents * Why aggregate reports depend on signal detection, risk minimisation, case collection, exposure data, regulatory input, and source-data quality * Where DSURs, RMPs, PSURs/PBRERs, and addenda to clinical overviews appear across the product lifecycle * Why teams underestimate timelines, review cycles, and cross-functional coordination * Common quality issues such as inconsistent data, outdated content, and late submissions * What works, and what breaks, when medical writing is outsourced * How a small biotech should start planning its first major PV document This is a practical conversation for PV teams, regulatory teams, and biotech leaders who want documents that are not only submission-ready, but defensible. Hosted by Tereza Korecka | Guests: Katarina Cechlovska and Hana Sourkova, NextPV Services (00:12) - Recorded intro and episode overview(00:53) - Opening and guest introductions(00:58) - Defining medical writing in pharmacovigilance(01:10) - Safety documents across the product lifecycle(01:59) - Fixed structures, regulatory expectations, and strict timelines(02:40) - Why medical writing is more than "just writing"(02:56) - Aggregate reports, data interpretation, and the benefit-risk story(04:52) - Weak writing as a symptom of weak upstream process(05:44) - When these documents appear across the product lifecycle(06:00) - DSURs, RMPs, PSURs/PBRERs, and ACOs(07:12) - Documents as the evolving picture of benefit-risk over time(07:34) - Why teams underestimate the effort and timelines(07:58) - Medical writing timelines, review cycles, and data readiness(09:32) - Last-minute data chasing, review chaos, and lower document quality(10:59) - "Garbage in, garbage out" applied to medical writing(11:17) - Inputs and contributors needed for aggregate reports(13:01) - Authorship, reviewers, contributors, and deadlines(13:43) - Quality and compliance failure question(13:56) - Common quality failures: inconsistent data, outdated content, late submission(14:57) - Process failures behind aggregate report issues(16:06) - Outsourcing medical writing when internal capacity is limited(16:31) - Outsourcing while retaining MAH accountability(18:49) - Why outsourcing works best as a connected partnership(19:52) - Small biotech scenario: preparing a first major PV document(20:24) - Start with planning, document calendar, owner, and source-data checklist(21:12) - Reusing existing materials and identifying high-risk gaps(23:05) - Final advice question: reducing submission stress and findings(23:29) - Final advice: start long before the deadline(24:29) - Good documents reflect data quality and clear ownership(24:53) - Closing remarks Keywords:pharmacovigilance, medical writing, PV medical writing, DSUR, PSUR, PBRER, RMP, benefit-risk evaluation, aggregate reports, drug safety, regulatory documents, biotech PV, submission readiness

E3: EU MAA Pharmacovigilance Readiness: Operating Model, QPPV, and Submission Preparation

If your biotech is planning EU market entry, MAA readiness in pharmacovigilance means more than assembling a document package. In Episode 3 of What's Next in PV, Tereza Korecka speaks with Jan Kolouch and Vojtech Kvita from NextPV Services about what needs to be in place before MAA submission, including: * Why MAA readiness should be treated as a functioning, auditable PV system * When to start building readiness and why 12-18 months is the preferred window * How to think about operating model, vendor setup, and safety database decisions * What an effective QPPV setup looks like before submission * What inputs are needed to build a usable PSMF * How to approach RMP readiness, including the value of a development RMP * What to prioritize next week if your timeline is already tight This is a practical conversation for biotech teams moving from clinical development toward EU commercialization and trying to build a submission-ready PV system without unnecessary chaos. Keywords: pharmacovigilance, MAA readiness, EU market entry, biotech, QPPV, PSMF, RMP, safety database, vendor oversight, PV system, marketing authorization application, EU submission (00:00) Intro and episode overview(00:58) What MA readiness means for biotech companies entering the EU(06:35) Is BLA timing enough, or should teams start earlier?(12:53) Practical MAA prep timeline and the 12-18 month window(15:48) First decisions: operating model, vendors, and safety database ownership(21:20) What an effective QPPV setup looks like before MAA(26:47) Building and maintaining the PSMF(32:01) How to prepare a strong RMP and why a development RMP helps(37:38) What to do next week if you are already behind on MAA readiness(42:51) Wrap-up and closing

E2: PV Audit Readiness 2026 - Types of Audits, Gap Analysis, and Your Inspection Survival Guide

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) - Opening and introductions (0:28) - What is a PV audit? Audit vs inspection (2:15) - Inspections by authorities (EMA/FDA/national authorities) (5:12) - Compliance vs effectiveness perspective (6:23) - EU Regulation 2025/1466: why it matters (6:41) - Regulation formalizes and emphasizes existing expectations (7:16) - Stronger risk-based approach and subcontractor oversight emphasis (10:14) - Regulation does not fundamentally change audit execution (11:47) - Practical contract/right-to-audit implications (16:30) - Mindset shift: audits as improvement, not punishment (17:11) - Inspection as "the boogeyman" + exam analogy (18:23) - Different audit types discussion begins (22:39) - When to use different audits by MAH lifecycle context (26:35) - Triggered/ad hoc (for-cause style) audits discussed (30:29) - Gap analysis vs audit: practical differences (35:37) - Formal audit, findings, and CAPA expectations (39:07) - Scenario: 6 months to first inspection, no formal prep yet (41:49) - Preparation priorities: team, agenda, docs, communication (43:48) - Reinspection prep: CAPA status and evidence of improvement (44:08) - Mock inspection as warm-up exercise (46:21) - Summary: warm-up mindset and healthy nervousness (46:48) - Final advice: don't fear audits/inspections (49:51) - Do not force findings when things are working well (50:52) - Josue's human approach to auditing (53:49) - Inspector badge anecdote ("gotcha" moment) (55:14) - Language-focused findings vs meaningful system improvement (57:26) - Closing remarks 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

E1: PV Regulation 2025-2026: What Changed, What's Coming, and What You Must Do Now

In this episode of What's Next in PV, co-founders Jan and Vojtech sit downto break down exactly what EU Regulation 2025/1466 means for marketingauthorization holders, biotech companies, and PV professionals navigating the2025-2026 regulatory wave. Key topics covered: - Signal management overhaul: Why standalone signal notifications have been eliminated, and what "EudraVigilance monitoring in parallel" actually requires - EVDAS mandate: The end of the pilot program, how to decide at which stage of your signal management processto use EVDAS, and why the reference period timing matters - Third-party auditing requirements: New subcontracting rules, contract clauses that now need updating, and how audit scope has expanded - GVP module revision wave: Which modules are being updated in Q1-Q4 2026 - Inspection readiness: Practical steps to take now, whether your organization is small and agile or large and complex   TIMESTAMPS: (00:00) - Intro and episode overview (00:46) - Why 2025-2026 is a pivotal moment for PV regulation (context setting) (01:13) - EU Regulation 2025/1466: The first major overhaul since 2012 (02:25) - Topic 1: Signal management - what has changed and why it matters (03:22) - History of EudraVigilance and the EVDAS pilot program (2017-2025) (05:22) - End of the EVDAS pilot: what mandatory "monitoring in parallel" actually means (06:09) - How MAHs can decide at which stage of signal management to use EVDAS (07:30) - Risk assessment before deciding your EVDAS strategy (08:03) - Why standalone signal notifications were eliminated (09:07) - Practical implications: how signals are now communicated to authorities (11:13) - PSUR vs. non-PSUR holders: who is affected and how (12:53) - Monitoring PRAC and meeting minutes as part of your signal management (14:08) - Why MAH and regulator EVDAS views differ - and what this means in practice (15:36) - EVDAS deep dive: ERMR, line listings, and the three core functionalities (17:26) - Reference periods explained: 15-day, 1-month, 3-month, 6-month, 1-year (19:07) - The fixed period trap: why you cannot run EVDAS retrospectively (21:08) - How to determine the right monitoring frequency for your portfolio (22:11) - Topic 2: Third-party and auditing - new requirements under Regulation2025/1466 (22:36) - Subcontracting rules: MAH consent now required for further delegation (23:45) - Practical contract guidance: MSA vs. SOW - where to include new clauses (24:55) - All subcontracted PV activities must now be included in audits (25:21) - A candid conversation: are audits always adding value? (27:09) - How to run audits that find real risk, not just checkbox findings (28:14) - What good audit strategy actually looks like (30:40) - Topic 3: GVP module updates coming in 2026 - the full picture (31:18) - GVP Module 9 (Signal Management): what to expect and when (32:06) - GVP Modules 5, 6, and addendums: scope of changes (33:22) - How organizations of different sizes should manage the update wave (35:17) - Should companies wait for Module 9 before updating SOPs? (36:01) - Deviation-based approach vs. full SOP update - which is right for your org? (38:14) - Practical implementation: memos to file, signal detection plans, and interim steps (39:12) - The "no less frequent than 6 months" clause being removed from Module 9 (40:03) - Topic 4: What companies should do to be inspection-ready right now (40:18) - The two implementation deadlines: August 12, 2025 and February 12, 2026 (41:40) - PSMF updates: deviations, wording changes, and what to check in your templates (42:11) - A message for overwhelmed teams: how to start when everything feels urgent (43:42) - Closing thoughts from Jan: planning for the wave of changes ahead(44:44) - Note on non-EU organizations: why context matters when communicating changes internally (45:14) - Closing thoughts from Vojtech: SOP interdependency and getting it right the first time (47:07) - Sign-off and next episode preview