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

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

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