August 2026
The Value of Central Data Warehouses (CDW) in Medical Affairs: Transforming Metrics into Strategic Insights From Theory to Practice: Reflections on PIPA’s QPPV and PSMF Training Regulatory Updates
Issue 87
The Journal of the Pharmaceutical Information & Pharmacovigilance Association
The New UK Clinical Trials Regulations: What They Mean for the NHS
£12.00
or Free for Members
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CONTENTS 03 04 06 10 14 16
Editor’s Report
New Committee Member
The New UK Clinical Trials Regulations: What They Mean for the NHS By Nabeel Khan, PharmD, MSc., PgD The Value of Central Data Warehouses (CDW) in Medical Affairs: Transforming Metrics into Strategic Insights By Natalia S. Gandarillas and Michael DeLuca From Theory to Practice: Reflections on PIPA’s QPPV and PSMF Training By Keri Wall
Regulatory Updates
As always, feedback from the membership is welcomed and we encourage you to interact with us and the wider PIPA membership via our online platforms below: Official PIPA Website: https://www.pipaonline.org/ LinkedIn: https://www.linkedin.com/company/pipa-pharmaceutical-information-and-pharmacovigilance-association/ We hope to see you online at one of our events in the near future. If there is anything you would like to see PIPA get involved with or do, please do get in touch at pipa@pipaonline.org We encourage our members to contribute to μPIPELINE and make suggestions on topics for articles. Please contact us at journaleditor@pipaonline.org if you would like to contribute or make suggestions for the next edition.
Copyright for any article accepted for publication in PIPELINE is transferred to PIPA once the article is submitted. Copyright covers the exclusive rights to reproduce & distribute the article in any form (such as photocopies or electronic copies) and applies to the complete article and any part within. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form without written permission from PIPA. PIPA will, wherever possible, grant permission to authors to subsequently use their articles, or to others to take limited numbers of copies, provided permission is obtained from the editors in advance. PIPA members are permitted to print a copy of PIPELINE and / or save a single copy of the electronic file for their personal use. While all reasonable efforts are made to ensure the accuracy of the information presented in this journal, the editors do not accept any liability for loss arising from reliance on the information presented. The opinions expressed in the journal are not necessarily those of PIPA, its Committee or companies to which members belong - unless otherwise stated.
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Editor’s Report WELCOME TO THE THIRD ISSUE OF µPIPELINE FOR THE YEAR The 2026 PIPA Conference is fast approaching, and we hope to see as many of you as possible at the Denham Grove Hotel in Uxbridge, London, on 9th and 10th September 2026. It’s not too late to join us; just head over to the website where you can find further information about the programme and how to book: https://pipaonline.org/conference/conference-2026/. If you attended last year’s conference, you can look forward to another strong programme this year as we continue to build on previous events by welcoming new speakers and exploring emerging hot topics. Many of the subjects we include in our conference programmes are of interest to individuals working in functions that work closely with Medical Information and Pharmacovigilance, so please spread the word to your Regulatory Affairs, Medical Affairs, Quality Assurance and Medical Scientific Liaison colleagues, as we have non-member booking options that include the cost of PIPA membership. For further information please contact us via pipa@pipaonline.org
PIPELINE EDITORIAL TEAM
Dora Amene
In this edition of µPIPELINE, we introduce our newest committee member, Anita Lewis, who has joined our Medical Information and Training workstreams. Nabeel Khan has written another insightful article on the new UK Clinical Trials Regulations and what it means for the National Health Service (NHS). Michael DeLuca and Natalia Gandarillas have contributed another interesting piece on the value of Central Data Warehouses (CDW) in Medical Affairs: transforming metrics into strategic insights. PIPA committee member, Keri Wall, has provided her reflections on the recent PIPA trainings on UK Qualified Person for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF) which took place on 09th and 10th June 2026 respectively. We invite you to explore this edition and welcome your feedback. Your perspective is always highly valuable. If you’d like to contribute to µPIPELINE, or suggest articles you’d like us to include, please do reach out via journaleditor@pipaonline.org.
Anne Turnbull
We look forward to connecting with many of you at conference!
Nabeel Khan
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INTRODUCING OUR NEW
Committee Member In this edition of μPIPELINE, we would like to introduce you to our newest committee member: Anita Lewis. Anita Lewis
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One of the things I enjoy most about working in MI is that no two days are the same, you are constantly learning. I also value the opportunity to make a meaningful difference to people’s lives. Early in my career, I spoke directly with patients, helping answer their questions, ease their concerns, and connect them with colleagues who could provide further support. Knowing that even a single conversation could have a positive impact was incredibly rewarding.
How long have you been a PIPA member? I actually became a PIPA member before I secured my first MI role. Once I realised that MI was the career I wanted to pursue, I joined PIPA to learn more about the profession and connect with the wider MI community. Membership gave me valuable insights into the role, helped me prepare for interviews, and undoubtedly played a part in helping me secure my first position. I’ve now been a PIPA member for around 10 years, attending several annual conferences and benefiting from the opportunities to learn, network, and keep up to date with developments in MI.
What advice would you give to someone starting a career in MI? I’ve spoken to many people who see MI as a stepping stone to other roles within the pharmaceutical industry. While it can certainly open the door to a wide range of career opportunities, after spending around 16 years in a variety of MI roles, I can confidently say that it is a rewarding and fulfilling career in its own right. It’s a career that is constantly evolving, from learning about new medicines, to embracing new technology, or changing ways of working, there’s always something new to learn.
How long have you been on the committee and what made you join? I’ve only recently joined the committee, so I’m just getting started! I’m really looking forward to contributing and getting involved. Joining the Training Workstream felt like a natural fit, as developing people and supporting learning has become a real passion of mine over the last few years in my role as a Global MI Leader. I also thought it was a great opportunity to collaborate with others outside my company, especially given the exciting changes in technology that are happening now.
My advice for anyone starting out would be: Listen to your customer. Every customer has different needs. Some are looking for detailed scientific information, while others need a clear, concise answer. Take the time to understand what they’re asking, how much detail they need, and when they need the response by. Tailor your communication style accordingly, whether you’re speaking with a healthcare professional, a patient, or another stakeholder.
Which workstream(s) are you involved in? I’m part of the Training Workstream. In my current role at Roche, I’ve led the development of an interactive training curriculum for MI professionals, covering everything from onboarding new colleagues to advanced development for experienced team members. It’s been rewarding to create training that helps people build confidence and develop in their roles, and I’m excited to bring that experience to PIPA.
Champion the value of MI. MI is about much more than answering enquiries. The insights gathered from healthcare professionals and patients can help shape medical strategy, identify unmet needs, and inform colleagues across Medical, Commercial, Patient Safety, and other functions. Building relationships across the organisation helps you understand the bigger picture and maximise the value MI can bring.
What inspired you to pursue a career in MI, and what has been the most rewarding part of your journey so far? I started my career in academia, where a key part of my role involved communicating scientific research to healthcare professionals and students. I quickly realised that communicating science was what I enjoyed most, so I began exploring opportunities in the pharmaceutical industry. A simple Google search introduced me to MI, and it immediately felt like the right fit. I immersed myself in learning more about the profession, joined PIPA, and soon secured my first MI role.
Embrace innovation. AI is already transforming the way we work and offers exciting opportunities to improve efficiency and support the delivery of high-quality, customer-focused information. Be open to using AI to improve the way you work, while continuing to rely on your scientific knowledge and professional judgement.
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The New UK Clinical Trials Regulations: What They Mean for the NHS On 28 April 2026, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 came fully into force, representing the most significant reform of the UK’s clinical trial legislation in over two decades. The new framework modernises the way clinical trials are designed, reviewed and conducted, with the overarching aim of making the UK a faster, more efficient and globally competitive environment for clinical research while maintaining high standards of participant safety. For NHS Trusts, university Clinical Trials Units (CTUs), research sponsors and Research & Development (R&D) departments, these reforms extend well beyond legislative change. They influence trial setup, governance processes, pharmacovigilance activities, sponsor oversight, and the day-to-day management of both commercial and academically sponsored Clinical Trials of Investigational Medicinal Products (CTIMPs).
This creates several operational challenges, including:
A More Risk-Proportionate and Efficient Regulatory Framework
• Maintaining consistent protocol versions across jurisdictions; • Coordinating regulatory amendments submitted through different systems; • Ensuring harmonised participant documentation; • Defining sponsor responsibilities across multiple regulatory frameworks; and • Preventing document version drift between UK and EU submissions.
A central objective of the new regulations is to streamline trial approvals by adopting a more proportionate, risk-based approach. The legislation introduces a new category of low-risk “notifiable trials”, typically involving authorised medicines used within their licensed indications and presenting minimal additional risk to participants. Where eligibility criteria are met, these studies may receive automatic authorisation if the MHRA raises no objections within 14 days following validation. The regulations also place the Combined Review process on a statutory footing. Rather than operating as an administrative initiative, Combined Review is now embedded within legislation, enabling a single integrated application covering both MHRA regulatory review and Research Ethics Committee (REC) approval.
Rather than treating these as independent processes, NHS sponsors should consider implementing a unified governance framework supported by standard operating procedures (SOPs), integrated document management systems and clearly defined ownership of regulatory activities.
For NHS organisations, these changes are expected to reduce study set-up times, particularly for pragmatic, adaptive and platform trials that are increasingly embedded within routine NHS care. Earlier regulatory decisions may also support faster site activation, improved recruitment timelines and more efficient delivery of nationally prioritised research.
Capacity, Timelines and Operational Planning The UK reforms are intended to accelerate domestic study approvals. However, multinational trials remain constrained by the additional requirements of the EU Clinical Trials Regulation. Early experience following implementation of CTIS has demonstrated that multinational submissions continue to require considerable administrative resource. Published evaluations describe extensive submission dossiers, significant staff training requirements and substantial timelines for major modifications. Consequently, NHS organisations participating in cross-border studies should anticipate increased sponsor-office workload despite improvements to UK approvals.
Implications for NHS Governance and Research Delivery Although the new UK regulations simplify domestic approvals, governance requirements become more complex for multinational studies involving both UK and European Union (EU) sites. EU sites continue to operate under the EU Clinical Trials Regulation (CTR) using the Clinical Trials Information System (CTIS), while UK sites follow the new UK regulatory pathway through Combined Review within IRAS (Integrated Application Research System). Consequently, sponsors conducting UK-EU trials must maintain parallel governance processes.
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For multinational UK-EU studies, safety reporting becomes inherently more complex. UK reporting requirements operate alongside EU pharmacovigilance processes, including EudraVigilance and CTIS, meaning sponsors must establish clear reporting pathways from the outset.
Ethics, Informed Consent, Data Protection and Transparency The new UK regulations place greater emphasis on participantcentred research by encouraging proportionate consent processes and reducing unnecessary administrative burden for lower-risk studies.
Funding, Infrastructure and Workforce Development
Across Europe, the Clinical Trials Regulation has also strengthened transparency through the public CTIS portal, allowing patients and healthcare professionals to identify ongoing clinical trials more easily.
Commercial sponsors may experience fewer operational barriers due to established national model agreements, standardised costing methodologies and NHS England’s National Contract Value Review process.
However, increased transparency does not diminish obligations relating to confidentiality and data protection. Personal information and commercially confidential material remain protected, while the legal basis for processing personal data under data protection legislation remains distinct from informed consent for participation in research.
Academic sponsors, however, remain more vulnerable to the increased complexity associated with multinational regulation. The additional administrative workload associated with CTIS submissions, regulatory amendments and ongoing document maintenance can disproportionately affect publicly funded trials and smaller research-active organisations.
For NHS sponsors, ethics submissions, participant information sheets, privacy notices, data-sharing agreements and publication strategies should therefore be developed together to ensure consistency across regulatory, ethical and data governance requirements.
Investment in regulatory expertise, CTIS and IRAS training, centralised document management and specialist sponsor support will therefore be essential if NHS organisations are to maximise opportunities arising from the new regulatory environment while maintaining research quality.
Safety Reporting and Pharmacovigilance
Key Actions for NHS Organisations
The reforms also have important implications for pharmacovigilance. Within the UK, Serious Unexpected Suspected Adverse Reactions (SUSARs) continue to be reported to the MHRA, while annual Development Safety Update Reports (DSURs) for Combined Review studies are submitted through IRAS without separate Research Ethics Committee notification.
To maximise the benefits of the new regulatory framework, NHS organisations should consider the following priorities: • Designate a senior operational lead for UK-EU multinational trials; • Develop integrated SOPs covering Combined Review, CTIS, pharmacovigilance, privacy requirements and document version control;
A key additional consideration is signal detection, which refers to the ongoing process of identifying new or changing safety information from accumulated adverse event data. Under the new regulatory environment, sponsors are expected to adopt more proactive and systematic approaches to signal detection, using aggregated safety data from clinical trials, real-world evidence, and external pharmacovigilance databases where appropriate. This includes regular review of adverse event trends, statistical signal detection methods, and timely evaluation of emerging safety concerns.
• Strengthen regulatory and sponsor-office capacity to support multinational studies; • Monitor multinational trials separately when evaluating research set-up performance against NHS England targets; and • Routinely assess recruitment equity and participant diversity in line with NHS England guidance to ensure that accelerated research delivery is accompanied by equitable access to clinical research opportunities.
For NHS sponsors, this means ensuring that pharmacovigilance systems are capable not only of reporting individual cases but also of analysing data across studies to identify potential safety signals early. Clear governance arrangements should be in place for signal validation, escalation, and communication to regulators, investigators and ethics committees where necessary. Failure to detect and act on emerging signals in a timely manner could have implications for participant safety and regulatory compliance.
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Conclusion
References:
The 2026 UK Clinical Trials Regulations represent more than a legislative update. They introduce a modernised, proportionate regulatory framework designed to improve the efficiency of clinical research while maintaining robust participant protections. For NHS organisations, successful implementation will depend not only on understanding the new legal requirements but also on adapting governance structures, strengthening sponsor capabilities and investing in operational infrastructure.
• The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 — legislation.gov.uk [accessed at: https://www. legislation.gov.uk/id/uksi/2025/538] • GOV.UK — Clinical trials for medicines: notifiable trials — automatic authorisation/14-day mechanism [accessed at: https:// www.gov.uk/guidance/clinical-trials-for-medicines-notifiable-trials] • HRA — Safety reporting guidance — DSUR/Combined Review/REC notification claim [accessed at: https://www.hra. nhs.uk/approvals-amendments/managing-your-approval/safetyreporting/]
For organisations delivering multinational research, the greatest challenge will be integrating UK and EU regulatory pathways into a coherent governance model. Those able to establish robust, coordinated processes across regulatory approvals, pharmacovigilance and research governance will be well positioned to benefit from faster study delivery, increased research competitiveness and improved opportunities for NHS patients to participate in high-quality clinical research.
• GOV.UK/DHSC — “Government drives forward its 150-day clinical trial target” — corrects the outdated “still pursuing” claim (target already hit: 122 days) [accessed at: https://www.gov. uk/government/news/government-drives-forward-its-150-dayclinical-trial-target] • GOV.UK — Clinical trials regulations: transitional arrangements — governs old-rules vs new-rules trials, pharmacovigilance transition, directly relevant to the NHS operational-planning section [accessed at: https://www.gov.uk/guidance/clinical-trialsregulations-transitional-arrangements]
Nabeel Khan
PharmD, MSc., PhD
Pharmacovigilance Officer, Cambridge Clinical Trials Unit
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The Value of Central Data Warehouses (CDW) in Medical Affairs: Transforming Metrics into Strategic Insights As Medical Affairs organisations increasingly interact with a variety of external stakeholders including key opinion leaders (KOLs), healthcare professionals (HCPs), patients, caregivers, etc. a significant amount of interaction data is captured across Medical Information, Field Medical, Scientific Communications, and Evidence Generation activities. For Medical Affairs to demonstrate value and impact, the ability to connect and analyse data across functions has become a strategic priority. Central data warehouses, or data lakes, are increasingly being implemented to consolidate disparate data sources, improve analytics capabilities - including insight generation to enable more informed strategic decision-making. This article explores the growing role of centralised analytics platforms within Medical Affairs, highlights key findings from a recent industry survey conducted by EVERSANA in partnership with phactMI, and discusses practical considerations for organisations seeking to leverage data more effectively to generate insights, improve operational performance, and support strategic planning.
Why Centralised Data Matters in Medical Affairs
The Evolution from Reporting to Insight Generation
Medical Affairs functions sit at the intersection of scientific exchange, customer engagement, evidence generation, and healthcare insights. Every interaction with KOLs, HCPs, patients, caregivers, patient advocacy organisations, and payers, generates valuable data.
A key finding from the industry survey was that organisations are increasingly moving beyond traditional reporting toward broader insight generation activities. The Medical Affairs functions that mostly commonly generate data that feed into the CDW are:
Historically, much of this information has existed across multiple disconnected systems including Medical Information databases, Field Medical CRM platforms, content management systems, contact centres, independent analytics tools, and business intelligence platforms.
•
Medical Information
•
Medical Science Liaison / Field Medical
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Scientific / Medical Communications
While operational metrics remain essential, respondents reported a growing focus on:
While these systems have supported operational activities effectively, they often create data silos that limit an organisation’s ability to identify trends, connect insights across functions, and translate data into meaningful action. CDW offers a potential solution by creating a unified environment where information can be consolidated, analysed, and visualised across multiple Medical Affairs functions. Much like how customer relationship management systems transformed commercial operations over the last decade, centralised data environments have the potential to transform how Medical Affairs organisations generate and utilise insights.
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Operational Metrics
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Insights Generation
•
Evidence Generation Planning
•
Data Gap identification
•
Key Performance Indicators (KPIs)
•
KOL mapping
•
HCP segmentation and profiling
•
Patient Journey
This reflects a broader shift occurring across Medical Affairs.
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Historically, analytics programmes often focused on answering questions such as:
While these operational metrics remain important, organisations are increasingly seeking to answer more strategic questions:
“How many enquiries were received?”
“What scientific themes are emerging?”
“Did we achieve our service levels?”
“Where are the largest evidence gaps?”
“How many scientific interactions occurred?”
“What information do healthcare professionals need most?” “How should future medical strategies be prioritised?”
The ability to answer these questions requires more than dashboards. It requires connected data.
Central Data Warehouse and Data Lake Considerations Although organisational approaches differ, implementation of centralised analytics platforms typically involves several common components.
Component
Purpose
Examples
Data Sources
Capture information from Medical Affairs activities
MI databases, CRM systems, content management systems, contact centres
Data Integration
Consolidate information from multiple sources
Data warehouse or data lake environment
Analytics Layer
Transform data into usable outputs
Dashboards, analytics tools, reporting platforms
Insights Generation
Identify trends and opportunities
Scientific themes, customer needs, evidence gaps
Decision-Making
Support strategy and planning
Medical plans, content strategy, evidence generation priorities
Table 1. Illustrative framework for centralised Medical Affairs analytics.
Identification of customer insights and data gaps are extremely valuable because they can be shared back within the organisation to help with life cycle management, publication planning, data generation and analysis, educating future clinical trial development, and also to identify possible internal training needs.
Medical Information as a Critical Contributor One of the most notable findings from the survey was the prominent role of Medical Information within centralised analytics programmes. Medical Information was the most frequently reported Medical Affairs function contributing data into these environments, closely followed by Field Medical. Medical Information teams routinely interact with the most diverse customer types and manage large volumes of customer interaction data and capture significant meta data:
Technology Platforms and Artificial Intelligence The survey highlighted considerable diversity in the technologies being used to support centralised analytics initiatives. Organisations reported leveraging a range of platforms including Tableau, Power BI, Databricks, AWS, Microsoft Azure, Snowflake, Spotfire, Qlik, and several specialist healthcare analytics solutions.
- Enquiry category topics, - Customer type / characteristics, - Response utilisation, - Source of enquiry, - Handling, - Standard response vs. custom, - Product-specific trends, - Data gaps, - On-label vs. off-label question / response, etc.
Interestingly, adoption of Artificial Intelligence (AI) and Machine Learning (ML) appears less mature than adoption of centralised data environments themselves. While some organisations reported using AI-enabled analytics capabilities, the majority indicated that such functionality is not yet widely deployed. This finding may reflect a common reality facing many organisations today. AI can only be as effective as the data that supports it.
Medical Information is a critically important customer-facing function that supports the safe and effective use of company products. It is important for medical information teams to demonstrate their value across their organisations and to be seen as an important strategic player. Gaining actional metrics, customer insights, and customer satisfaction are critically important for demonstrating value.
Before organisations fully embrace advanced analytics, predictive modelling, or generative AI solutions, they must first establish robust foundations based on high-quality, accessible, and wellgoverned data. In this respect, the development of centralised data warehouses and data lakes may represent an essential step toward realising the broader potential of AI within Medical Affairs.
However, when data are analysed in isolation, although they provide valuable operational insights, they form only part of the overall Medical Affairs value and impact story. When integrated with Field Medical, Scientific / Medical Communications, and broader Medical Affairs data sources, they have the potential to generate significantly richer organisational insights.
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Governance and Cross-Functional Collaboration
Looking Ahead: Building the Foundation for the Future
Technology alone does not guarantee success.
The survey findings suggest that centralised analytics capabilities are becoming increasingly established across the pharmaceutical industry.
Effective centralised analytics programmes require strong governance frameworks, clear ownership models, and collaboration across multiple functions.
Many organisations have progressed beyond exploratory discussions and are actively implementing, expanding, or optimising their data warehouse and data lake strategies.
Stakeholders commonly involved include: Medical Affairs, Medical Information, Field Medical, Data & Analytics, Information Technology, Compliance, Data Privacy, Quality and Commercial Excellence.
At the same time, the opportunity extends far beyond data centralisation.
Successfully connecting these groups requires alignment on data definitions, access permissions, reporting standards, privacy requirements, and business objectives.
The true value lies in transforming data into actionable insights that support scientific engagement, evidence generation, operational excellence, and strategic decision-making.
Organisations that establish these foundations early are often better positioned to scale analytics initiatives over time.
As Medical Affairs continues to evolve toward a more data-driven operating model, Medical Information is a key contributor to establishing Customer Experience frameworks and generating valuable customer insights. Organisations that successfully connect their data, establish strong governance, and develop effective analytics capabilities may be better positioned to understand stakeholder needs, identify emerging opportunities, and demonstrate the strategic value of Medical Affairs. This is going to be even more critically important as customers shift to utilising more self-service and AI driven solutions, and there are less human-to-human interactions.
For further information, please contact:
Natalia S.Gandarillas
Michael DeLuca
natalia.gandarillas@eversana.com
michael.deluca@eversana.com
MPharm, MSc
PharmD, MBA, MSRA
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From Theory to Practice: Reflections on PIPA’s QPPV and PSMF Training Attending PIPA’s recent face-to-face training sessions on the UK Qualified Person for Pharmacovigilance (QPPV) role and the Pharmacovigilance System Master File (PSMF) on 09th and 10th June 2026 respectively, provided a valuable opportunity not only to revisit core regulatory expectations but, more importantly, to reflect on how these concepts are actually applied in real-world pharmacovigilance (PV) systems. While both courses were rich in technical content, one of the most valuable aspects for me was the opportunity to connect with colleagues from across the industry. Through open discussion, we were able to share practical examples from our own organisations; what works well, what challenges we face, and how we interpret and implement regulatory expectations in practice. For me, these conversations really brought the training to life and helped bridge the gap between theory and day-to-day reality. Revisiting the QPPV Role: Accountability and Oversight
The PSMF: From Requirement to Oversight Tool
The QPPV training was a strong reminder of the level of accountability associated with the role. The QPPV is ultimately responsible for the PV system, ensuring that it is compliant, effective, and focused on protecting patient safety.
The PSMF training sessions provided a helpful refresher on Good Pharmacovigilance Practices (GVP) Module II requirements but also shifted how I think about the document. Rather than viewing the PSMF purely as a regulatory requirement, the training emphasised its role as a central tool for understanding and managing the pharmacovigilance system. When it’s used properly, it gives a really clear overview of how the system operates - from organisational structure and responsibilities through to processes, data sources, and systems.
A key theme throughout the training was that oversight - not execution - is central to the role. While many operational activities may be delegated internally or outsourced, accountability still sits with the QPPV. This includes responsibility for system performance, compliance with regulatory obligations, and ensuring that risks are identified and managed appropriately.
It also became clear how important the PSMF is from an inspection perspective. It is often the first document inspectors review, and it plays a big role in shaping the direction of the inspection. That in itself reinforces how important it is that the PSMF is not only complete, but also accurate, up to date, and genuinely reflective of how the system works in practice.
What really stood out to me during the discussions was how challenging effective oversight can be in practice - something I recognised from my own experience as well. Many attendees shared examples of increasing system complexity, evolving organisational structures, and reliance on third-party vendors. All of these factors can make it harder to maintain clear visibility across the system. It really reinforced how important strong governance structures, clear escalation pathways, and meaningful performance metrics are in making oversight workable.
Inspection Reality: Learning from Common Findings The session on PSMF inspection findings was one of the most useful parts of the training, as it really showed how expectations are applied in practice.
Another important takeaway for me was the need to ensure that oversight is not only happening but can actually be demonstrated. It’s not enough to feel confident that you understand how the system is performing - there needs to be clear evidence of this through activities such as key performance indicator (KPI) review, participation in governance forums, and awareness of deviations and corrective and preventive actions (CAPAs). These are often the areas that inspectors focus on.
A consistent theme was that many findings are not necessarily due to a lack of understanding, but more often due to gaps in execution or maintenance. Examples included outdated or incomplete PSMFs, inconsistencies between documented processes and what actually happens, and limited visibility of outsourced activities. One example that particularly stood out was where there was no clear evidence of meaningful QPPV review of the PSMF. Although the document had technically been signed off, there was nothing to demonstrate that a proper review had taken place. It’s a good reminder that compliance isn’t just about having documentation it’s about showing that it is accurate, current, and actively used. Another key takeaway was the importance of alignment. The PSMF is used as a central reference point during inspections, so any disconnect between the document and reality can quickly become an issue.
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Finally, communication came through as a recurring theme. Many of the inspection findings discussed were ultimately linked to gaps in communication, whether across functions, with affiliates, or with external partners.
The Value of Sharing Experiences Whilst the technical content was extremely useful, the most impactful aspect of both training sessions for me was the opportunity to learn from others. Hearing how colleagues from different organisations approach key aspects of PV, such as governance structures, vendor oversight, KPI monitoring and inspection readiness, provided a level of practical insight that you simply don’t get from guidance documents alone.
Conclusion Overall, the sessions reminded me that PV isn’t just about meeting regulatory requirements - it’s about ensuring patient safety through effective systems, strong oversight, and continuous improvement.
It was also interesting to see how different organisations have adapted their approaches depending on their size, structure, and portfolio. Although the regulatory framework is the same, the way it is implemented can look quite different in practice. These discussions gave me a few new ideas, but also some reassurance that many of the challenges we face are shared across the industry.
For me, the biggest value came from being able to connect these concepts to real-world practice through discussion with peers. Hearing how others approach similar challenges gave me a more practical perspective and a few ideas to take away.
They also highlighted the importance of working closely across functions. PV doesn’t operate in isolation, and many of the challenges discussed - particularly around processes, systems, and data - require strong collaboration with Regulatory, Quality, Medical, and even IT teams.
As PV systems continue to grow in complexity, opportunities like this to share experiences and learn from each other are very important. They not only support our own development but ultimately help strengthen the systems we work within and improve outcomes for patients.
Key Reflections Reflecting on both training sessions, a few themes really stood out to me. Firstly, oversight needs to be visible and evidenced. It’s not enough to have oversight in principle; it needs to be demonstrated in a way that inspectors can clearly see. Secondly, the PSMF should be treated as a living document, not just something that is updated periodically for compliance purposes. It can be a really useful tool for understanding and managing the system more effectively. It also reinforced how important meaningful metrics are. Without them, it becomes very difficult to understand how the system is performing or where the risks are.
Keri Wall
PV Manager and PIPA Committee Member
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REGULATORY UPDATES • On 06-May-2026, the U.S. Food and Drug Administration (FDA) announced that it is piloting one-day inspectional assessments intended to make its inspectional resources more targeted and efficient. As part of the pilot, the agency is conducting shorter, focussed screening assessments to complement the standard FDA inspections as the information collected is used to better target other oversight activities. The pilot started in April 2026 and will continue through fiscal year 2026 across multiple FDA inspectorates. Link: FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight | FDA.
• On 19-May-2026, there was an update made to the MHRA Directory of current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines page where a link to ‘Q13 – Continuous Manufacturing of Drug Substances and Drug Products’ was added International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines - GOV.UK. There was also an update made to the guidance on ‘Clinical investigations for medical devices. How to notify the MHRA of your intention to carry out a clinical investigation for medical devices on 19-May-2026’ where notes were added to the section: ‘Fee waiver programme details’. Link: Clinical investigations for medical devices - GOV.UK.
• On 08-May-2026, the FDA published the final guidance entitled ‘Post-approval Pregnancy Safety Studies’, with recommendations on different methodologies that can be used in the post-approval setting to study the safety of drugs and biological products when used during pregnancy. In addition to the use of Case Reports and Case Series, the guidance includes sections on Pregnancy Registries and Complementary Studies. This finalises the corresponding draft guidance issued in May 2019. A summary of the changes made to the May 2019 draft version is provided in the Federal Register Notice.
• On 22-May-2026, the European Medicines Agency (EMA) published revised versions of two documents (Explanatory Note and Q&A guidance) relating to GVP Module VII on PSURs. Both guidance documents have been developed to clarify certain aspects of the single assessment specific to Nationally Authorised Products (NAPs). The changes bring alignment with the EU Commission Implementing Regulation (IR) No 2025/1466 published on 12-Aug-2025 which describes amendments to IR No 520/2012 on the performance of pharmacovigilance activities. Both documents are to be considered as interim guidance until the GVP VII module is revised. Links:
o FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics | FDA o Federal Register :: Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability
o Periodic safety update reports (PSURs) | European Medicines Agency (EMA)
o Postapproval Pregnancy Safety Studies | FDA
o Explanatory Note to GVP - update Apr 2021
• On 11-May-2026, the Medicines and Healthcare products Regulatory Agency (MHRA) published a news story inviting views on proposed changes to medical device regulation. The news story mentioned that new pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the Great Britain (GB) market have been published by the MHRA on the World Trade Organisation (WTO) notification portal on Friday 8th May 2026. The notification provided an opportunity for WTO members to comment on the draft pre-market regulatory requirements, titled the draft Medical Devices (Amendment) Regulations 2026. Link: MHRA invites views on proposed changes to medical device regulation - GOV.UK.
o Periodic safety update reports (PSURs) | European Medicines Agency (EMA) o Q&A on PSUSA Guidance Document for Assessors - update Oct 2017 • ICH has published the final version (adopted on 03-Jun-2026) of Annex 2 of the ICH GCP E6(R3) on Good Clinical Practice, to cover additional considerations for Interventional Clinical Trials that incorporate decentralised elements and/or realworld data. ICH subsequently announced (on 10-Jul-2026) the availability of the consolidated GCP Guideline, which combines Principles, Annex 1 and Annex 2 in a single document. Links: o ICH Official web site : ICH
• On 13-May-2026, the latest conformity assessment routes flow chart was added to the guidance: ‘Medical devices: conformity assessment and the UK Conformity Assessed (UKCA) mark How to conform with the legal requirements for placing medical devices on the market’. Link: Medical devices: conformity assessment and the UKCA mark - GOV.UK.
o https://www.ich.org/news/ich-e6r3-good-clinical-practice- annex-2-adopted-and-published
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• On 04-Jun-2026, the FDA published a new final guidance titled ‘Certain Postapproval Requirements and Resources for Abbreviated New Drug Applications (ANDAs)’ relevant to generic drugs. The document is to assist holders of ANDAs (US) by highlighting post-approval requirements for the generic drugs, and by referring to related guidance and other resources available. Link: Certain Postapproval Requirements and Resources for ANDAs | FDA.
deadline had been extended to 31 July 2026. Link: https:// www.gov.uk/guidance/register-medical-devices-to-place-onthe-market. The MHRA guidance on ‘Borderline products: medical devices and other products: How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.’ was also updated as follows: the line ‘Alcohol-only pre-injection swabs and wipes are considered to be medical devices as are those containing anti-microbial substances such as chlorhexidine, cetrimide or iodine’ has been changed to ‘Alcohol-only pre-injection swabs and wipes are considered to be medical devices’. Link: https://www.gov.uk/government/ publications/borderlines-with-medical-devices.
• On 11-Jun-2026, the MHRA updated the guidance document on ‘Medical devices: ask for a regulatory advice meeting from the MHRA: How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.’ by adding additional information on ‘How to request a regulatory advice meeting’, fees timing update, and updated point of contact. Link: https://www.gov.uk/guidance/medical-devices-ask-for-aregulatory-advice-meeting-from-the-mhra.
• On 29-Jun-2026, the MHRA Inspectorate published a new blog post warning against the unsupervised use of Artificial Intelligence (AI) to draft inspection responses. This relates to the warning letter published by the FDA in April 2026 listing deficiencies over ‘Inappropriate Use of Artificial Intelligence’. The MHRA reports that it experienced situations where inspection responses contained inaccurate or misleading information, including references to guidance that does not exist. The Agency highlights that false statements to inspectors represent a regulatory offence, hence the importance of human oversight. Link: Use of AI for GXP inspection responses: setting standards without stifling innovation – MHRA Inspectorate
• On 11-Jun-2026, the MHRA updated the guidance on ‘Regulation of medical devices in Northern Ireland: Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.’ by adding an updated point of contact email. Link: https://www.gov.uk/guidance/medical-devices-eu-regulationsfor-mdr-and-ivdr. • On 29-Jun-2026, MHRA guidance document on ‘Register medical devices to place on the market: How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.’ was updated. The ‘Fees’ section of the guidance was updated to explain that the Annual Fee payment
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