PIPELINE_82

Issue 82

The Journal of the Pharmaceutical Information & Pharmacovigilance Association

August 2025

µPIPELINE

The Busy Professional’s Guide to Stressing Less Vigilance within Third-Party Management A Summary of the PIPA Regulatory Intelligence Webinar

£12.00

or Free for Members

CONTENTS 03 04 06 08 11

Welcome

The Busy Professional’s Guide to Stressing Less Five Key Approaches to Managing Workplace Stress

By Brenda Pollock Vigilance within Third-Party Management

By Helen Lowe

A Summary of the PIPA Regulatory Intelligence Webinar

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.

PIPELINE Editor: Dora Amene

Welcome to another edition of μPIPELINE The PIPA conference is just around the corner, and we are looking forward to seeing many of you there. We have some fantastic, topical sessions lined up and we also look forward to welcoming our exhibitors and networking with all our attendees at the evening meal and quiz night.

PIPELINE EDITORIAL TEAM

Em Norman

This month we have fascinating articles for you to read; including how to be vigilant with your vendor management programmes, how to manage workplace stress and a recap on the May PIPA regulatory intelligence webinar as well as our usual regulatory intelligence updates.

If you want to contribute to μPIPELINE, please do let us know at journaleditor@pipelineonline.org.

See many of you at conference!

Dora Amene

Anne Turnbull

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The Busy Professional’s Guide to Stressing Less Five Key Approaches to Managing Workplace Stress We all experience stress at times. As someone who became physically ill from stress and learned the hard way, in this article I will share 5 proven techniques to help you thrive. Effective stress management combines practical mindfulness tools with deeper mindset work that will help you deal well with what life and work throws at you. A twopronged approach is suggested: the first is building self-awareness and the second is learning how to use tools to develop resilience to maintain high performance and personal well-being.

This is what you do:

Stress can feel like an inevitable part of working life; you’ve got tight deadlines, high expectations, and pressure to deliver quality work. Yet chronic stress doesn’t just affect your wellbeing - it can compromise your performance, decision-making, and overall job satisfaction.

I don’t know about you, but I find that due to being able to connect to devices and work at any time it’s hard to set boundaries. This is particularly true for people that have a strong work ethic.

Stop what you’re doing Take a breath Observe your thoughts and feelings without judgement Proceed with awareness Creating a space between the event and your response, allows you to make choices rather than being reactive.

Taking small steps to change how we deal with things people say or events that happen will start to change your life. I can honestly say that the work I’ve done has completely transformed how I deal with many situations. Although I do still struggle to use the process with certain family members!

3. Build Boundaries That Work For You

Being tempted to check emails when you aren’t supposed to be at work, working beyond your hours or “going above and beyond” are all ok strategies if they only happen occasionally. But when this behaviour becomes the norm that isn’t good for your health.

The first step towards managing stress effectively is self-awareness.

Below are five strategies that any busy professional can implement.

Establish clear communication protocols with your team. Consider setting specific times for checking emails rather than living in a constant state of inbox anxiety.

1. Practice Regular Stress Check-Ins Start by noting how you feel on a scale of 1 - 10 where 10 is mega stressed and 1 is extremely calm. I find it helpful to draw a line in a notebook and mark a cross on the line. Use this as your guide for measuring progress. You can do that check in as you start your working day, and as you clock out. Try doing it for a week or two and see if the act of tracking your stress levels helps remind you to be proactive about managing it.

And saying no is an art. Often you may not be in control of the amount of work that is on your desk. But feeding back to your boss in a considered way is important so that they are aware if your workload is unmanageable. A good manager doesn’t want someone to pretend they are coping then have to take a long period of sick leave due to burnout.

The act of pausing to assess your internal state often provides relief in itself, creating a moment of mindful awareness in your day.

4. Learn the Power of Micro Recovery Breaks You might not have time for hour-long yoga sessions, but I’m sure you can make time for micro-recovery moments. These have been shown to significantly decrease stress levels.

2. Mindset work I found that stepping back and working with someone to see my own behaviours and thinking with perspective was massively helpful. Coaching turned my life around.

One of the most powerful approaches to stress management is learning how to notice your reactions to events and taking a pause before deciding what action you wish to take.

Try the “transition ritual” between meetings or major tasks. This could be as simple as three deep breaths, a brief walk to the kitchen, or spending 30 seconds looking out of a window. These micro-breaks help reset your nervous system and prevent stress from accumulating throughout the day.

The STOP Technique is useful during particularly stressful moments. It helps you think about whether you want to reframe your reaction to something that is happening. It’s a tool I have found helpful at work and at home.

The “physiological sigh” is a double inhale followed by a long exhale and is a scientifically proven technique that activates your parasympathetic nervous system within seconds. This is the part of your body that helps you stay calm and not in “fight or flight” mode.

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This breath tool is discreet enough to use during conference calls and effective enough to measurably reduce stress hormones.

5. Harness the Restorative Power of Nature Research consistently shows that even brief exposure to nature can significantly reduce cortisol levels, lower blood pressure, and improve mood and cognitive function.

The Japanese practice of “forest bathing” (shinrin-yoku) has been scientifically proven to boost immune function and reduce stress hormones. But you don’t need a forest to benefit. Here are a few ideas: • Glance out of your window and look at trees if you have some outside • Eat lunch in a park or green space instead of at your desk • Take walking meetings outside when possible • Step outside for five minutes between tasks • Walk through green spaces on the way to meetings or your office.

Brief spells outside such as walking through a tree-lined street can help you arrive at work or home feeling calm.

For busy professionals, the key is to think of nature time as essential maintenance rather than a luxury. Just as you wouldn’t skip brushing your teeth, don’t skip your regular dose of natural environments. Your stress levels and your performance will benefit significantly.

ABOUT THE AUTHOR Brenda Pollack, The Stress Less Coach, is a qualified trainer and coach. She became very interested in dealing with stress and menopause at work through her own experiences. She is passionate about enabling organisations and individuals to prioritise mental health. Her mission is to educate and empower people to be proactive in looking after their own wellbeing to achieve the life they want She provides 1-1 coaching, workshops and talks.

You can book a free taster coaching session or message her to discuss your personal or organisational needs.

Browse Brenda’s blogs for more tips on personal growth and living with less stress and anxiety. You can also sign up to receive her monthly short emails to nudge you to do something good for your mental wellbeing. You can subscribe from her website in 5 seconds. You’ll get a short breathwork video as a thank you.

Making It Sustainable We are all unique, so I suggest practicing some of these techniques and seeing which work for you. The more you practice the better you are able to manage your stress levels when situations arise that feel particularly hard.

If you want to prevent stress from becoming chronic and overwhelming start with good habits now. You won’t regret it.

Brenda Pollack

Founder, The Stress Less Coach

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VIGILANCE

WITHIN THIRD-PARTY MANAGEMENT Being pro-active within your vendor management programme ensures compliance of your third parties and, ultimately, your own compliance as a Marketing Authorisation Holder (MAH).

to involve PV/MI due to misperceptions over the requirements to determine PV/MI impact.

• Upon review of data received from within your company and/ or the draft contract, you must determine the impact and the need for a pharmacovigilance agreement (PVA) or Safety Data Exchange Agreement (SDEA) or the need for a PV clause within the business agreement. All third parties should be considered for PV/MI impact.

• All PV/MI vendors should have followed a robust selection process (Please refer to µPIPELINE Issue 78 for guidance on selection).

• A procedure should be in place to create a PVA/SDEA for all third parties.

In the previous vendor article published in µPIPELINE edition 78, you will have read about the selection and onboarding process of vendors in relation to Pharmacovigilance (PV) and Medical Information (MI). This article is set to guide you through ideas for the ongoing management required to maintain robust and compliant PV and MI systems when choosing to outsource individual activities. This article is written from the author’s experiences only and the description of best practices seen during those experiences.

Due Diligence The process for due diligence of third parties should have started during the selection process and it is advisable that a risk score is given. A tracker of due diligence with respect to ongoing requirements for each third party can be maintained. It is advisable to create an individual folder for each third party to maintain all due diligence information for easy access during audits and inspections.

Third Parties Versus Vendors

The types of due diligence collected depends on the risk involved; some examples are presented below:

In the world of PV and MI, you will hear many terms in relation to third party companies such as business partner, vendor, distributor, manufacturer or service provider. The most important thing to remember when reading this article is that the type of third party does not matter; any third party supplying a service via contractual obligations, which may have the potential to impact PV and/ or MI, needs to be considered within the realms of third-party management. It is the impact/risk that then determines the level of management required.

• Risk Assessment questionnaires can be used to form part of your ongoing due diligence (they do not replace audits). Ensure that if you perform these, they are reviewed and the impact on your risk score is adequately evaluated and action taken as required (e.g. a call for clarification purposes or ultimately audit should potential risks be identified).

• If the third party offers ‘out of hours’ services (e.g. Local MI or EU QPPV or Local Qualified Person) then tests of these out of hours phone numbers should be conducted and documented.

Maintaining Your List of Third Parties

• Re-request of certification provided upon initial due diligence when expired (e.g. ISO 9001 certification).

To maintain a list of third parties who have an impact on your PV/ MI system, you must first be aware of all upcoming changes and negotiations within your organisation.

Changes and Monitoring Potential Risks

Consider:

Do not assume compliance and wait for the next audit. Potential risks can come through changes, and consideration as to how you will monitor the third party needs to be based on the risks that they may pose. Every company is different, and the scope of your vendor management monitoring programme needs to be based on the complexity of your business.

• Getting buy-in from your larger business: include business development, legal and marketing team(s).

• Educating your company on third party suppliers and the types of impact that may arise, such as marketing/social media programmes that may collect PV data.

• Ensuring that when a new contract is being signed, the PV impact has been considered by a suitably trained employee.

This step can be via a business development/marketing procedure where draft new contracts are sent to PV/MI for review. Again, education is key to ensure there is no reluctancy

Some more complex companies may determine that certain categories of third parties require questionnaires to check for any changes that may have potential impact. Considerations of what changes may impact PV/MI systems are listed below and should be considered for all third parties: 6

• Major re-organisation or other re-structuring e.g. mergers, acquisitions.

• Change in key managerial/appointed function(s) or designated staff.

• Risk to availability of adequately trained and experienced staff e.g. due to significant turn-over of staff, deficiencies in training processes, re-organisation, increase in volumes of work.

• Significant changes to the system since the time of a previous audit, e.g. introduction of a new database(s) for pharmacovigilance activities or a significant upgrade to the existing database(s), changes to processes and activities to address new or amended regulatory requirements.

• First medicinal product on the market (for a marketing authorisation holder).

• Medicinal product(s) on the market with specific risk minimisation measures or other specific safety conditions such as requirements for additional monitoring.

• Outcome of previous audits e.g. has the area/process ever been audited (if not, then this may need to be prioritised depending on criticality); if the area/process has previously been audited, the audit findings are a factor to consider when deciding when to re-audit the area/process, including the implementation of agreed actions.

• Identified procedural gaps relating to specific areas/processes; other information relating to compliance with legislation and guidance taken from metrics or external non-compliances.

• Complaints from external sources, e.g. audits/assessments of the competent authority conducted by external bodies or notification from the commercial development manager.

• Other organisational changes that could negatively impact the area/process, e.g. if a change occurs to a support function (such as information technology support) this could negatively impact pharmacovigilance or medical information activities.

Some of these changes could be identified through amendments within your contract, such as contact persons or addresses etc. Therefore, it is important that the individual dealing with contracts understands which companies have PVAs/SDEAs and reports all changes to the PV/MI teams.

External Non-Compliances If a significant (Critical or Major) non-compliance occurs within your third party, it is important that the PVA/SDEA states that these will be reported. Any report of a significant non-compliance requires the review of the PV/MI service(s) and would be considered a potential risk. It is important to control that risk by requesting CAPA (Corrective and Preventative actions), including due dates, and chase for evidence of the closure of the CAPA. Your company will need to assess the impact of the non-compliance on your own PV/MI systems. Tracking this as a potential third-party risk is a useful step and then filing evidence is recommended. If the third party does not wish, and is not contractually obliged, to share the evidence, then a risk-based audit may be considered to review the potential risk.

taking any unnecessary measures that may otherwise be avoided.

Tracking potential risks and performing due diligence is a good way of demonstrating a robust vendor management system to any auditor or inspector.

Scheduled Periodic Audits and CAPA Management Scheduled audit programmes are required for all PV/MI impacted third parties. The due diligence conducted can help to inform the periodicity of those audits as well as document the ongoing review of potential risks; however, these should never replace the independent audit program.

Upon completion of an audit, the confirmed risk-based score can be evaluated and amended accordingly. This should be repeated on provision and evidence of CAPA closure, during which time the CAPA should be reviewed. If the CAPA or CAPA evidence is not deemed sufficient for a significant finding, then consider changing the confirmed risk.

Escalation Processes If the confirmed risk changes as an outcome of a potential due diligence risk, or a scheduled audit risk or insufficient CAPA evidence of a significant finding, then this should be escalated appropriately within your organisation.

Due to the potential for risk-based audits that may occur as an outcome of your potential risks, risk-based audits can be used as a measure for confirmed risk. However, the impacting non-compliance should always be escalated with the organisation; as other measures may also be considered as well as audit at this point.

Escalation routes and the potential ability to end a contractual obligation based on non-compliance should always be feasible and the legal team should be aware of the processes required to make these steps happen. It is important that in the event of this situation your PV/MI teams know what to do, who to go to and how to document these significant changes within the organisation.

Summary To understand your third parties’ impact on PV/MI you will need buy-in from the larger organisation. The more complex the organisation in regard to sub-contracting and partner relationships, the more need there is for a more formal vendor management program. Your third-party management programme supports your quality management system and is integral to compliance of your PV/MI systems.

Potential Risks v Confirmed Risks The author has found the use of the terms ‘potential’ and ‘confirmed’ risk beneficial when it comes to third party management. An overall third-party risk score should not change until the risk is evidentially confirmed, and this should then be clearly defined within your procedures. This way of working means that you can use for cause audits or evidence review instead of 7

Helen Lowe

QA Compliance Ltd

A Summary of the PIPA Regulatory Intelligence Webinar 12th May 2025 Regulatory intelligence is a critical component in navigating the complex landscape of pharmacovigilance. It involves gathering, analysing, and interpreting regulatory information to ensure internal procedures and systems remain compliant with national and international laws and regulations.

The webinar provided a platform for sharing experiences and challenges in navigating the complex landscape of regulatory legislation. The panellists provided insights into the strategies employed by their organisations to stay compliant and competitive in an ever-evolving regulatory environment through the following questions: What does regulatory intelligence mean to me?

Meera: Glenmark are mainly a generics company, and we therefore have many products and territories to cover for regulatory intelligence. For me, regulatory intelligence is not just the monitoring of information but it’s how the changes are implemented as well. Regulatory intelligence is a vital process that is the core of having a compliant and robust pharmacovigilance (PV) system.

On 12th May 2025, PIPA hosted an insightful webinar that brought together the following three panellists from different backgrounds to discuss their regulatory intelligence process:

Dora: Regulatory intelligence is a key aspect of our dayto-day activities within this ever-evolving industry where we face at least one change in legislation each year. As a UK Qualified Person for Pharmacovigilance (QPPV), National Contact Person (NCP) and project lead for multiple clients, staying on top of pharmacovigilance regulatory requirements/ changes, trends and industry standards ensures that I can provide a compliant service in supporting client projects. It starts with having a robust and systematic method of acquiring the intel from (but not limited to) regulatory authorities and trade association bodies/industry groups, and applying the knowledge gained in day-to-day PV operations.

• Meera Doshi, Local Responsible Person for PV at Glenmark Pharmaceuticals, a mid-sized global generics company.

• Dora Amene, Pharmacovigilance Associate Director for PharmaLex, a Cencora company specialised in end-to-end service provision across the entire pharmaceutical spectrum.

• Chris Isaacs, Regional Patient Safety Manager covering 34 countries across Southeastern Europe, Russia and Central Europe for Novartis, a large global innovative pharmaceuticals organisation.

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Chris: I am a regulatory intelligence subject matter expert for the European region within Novartis and so this topic is something I am involved with on a daily basis. Regulatory intelligence is about the awareness of the changes to the PV landscape within your country and ensuring that both the local and global system is always maintained to a compliant state. It involves a carefully planned and considered process.

What is your reg intel process?

Meera: Updates received from the MHRA are the main source of regulatory intelligence in the UK. Trade associations and industry associations are also a source of regulatory intelligence updates. I am registered to receive alerts from the MHRA when updates have been made on their website, and I review these alerts for any updates relevant to PV. If any such updates are identified, they are sent to our Global PV Compliance team and triaged to the relevant PV functions that are impacted. The relevant functions conduct an impact assessment and, if required, put an action plan in place for the updates to be implemented. The actions are then tracked by the Global PV Compliance team until closure.

The Global regulatory intelligence process is outsourced. The vendor provides a monthly output of regulatory intelligence updates received for all territories where there is an MA. An electronic tool is used for this; however, manual input is also required.

Dora: Cencora PharmaLex follows a global process in providing both global and local PV intelligence services to clients during pre-and post-authorisation phases. Clients may request a global or a local PV intelligence service. The company’s PV Intelligence International Service Line Lead(s) ensures the following main requirements are in place: • A dedicated PV Intelligence SharePoint accessible to all PV staff within the organisation.

A folder is created for each country within the SharePoint, and access to all PV staff is managed by the service line lead. This enables all stakeholders within each country (i.e. QPPVs, NCPs, project leads/team members) access to the PV Intelligence updates for one or more countries so that they can maintain awareness and provide the right level of PV intelligence service (local or global) for their projects.

• A PV Intelligence Master Data tracker, PV Intelligence Newsletter and a Process Impact Assessment (PIA) Report template used by all countries.

Prior to commencing the PV intelligence service in a country, the master data is populated with all the current PV requirements applicable for that country. The newsletter is used in documenting all the results from the monthly screening and a PIA is triggered if, upon initial evaluation, the results are classified as high or medium.

• A PV Intelligence Lead and a Peer Reviewer in each country.

The lead ensures awareness of relevant competent authority and industry group changes related to all PV services by screening the sources every month and documenting the results on the newsletter, performing an initial evaluation and impact assessment (classified as low, medium or high). The lead reviews and updates the Master

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Data tracker if the results from the screening have any impact or changes in the PV requirements for that country.

The lead also ensures that the updated newsletter is communicated to all PV staff within the country (following review by the Peer Reviewer) and uploaded to the country-specific folder within the company’s dedicated PV Intelligence SharePoint. Occasionally intel received from regulatory intelligence solutions (such as Safety Observer) which may require an immediate impact assessment (e.g., due to short due date for implementation) may be screened, reviewed and distributed for implementation outside the monthly screening period.

Prior to distribution of the country’s PV newsletter, the Peer Reviewer reviews the newsletter prepared by the PV Intelligence Lead and the information on the Master Data tracker. The reviewer prepares the PIA (this can also be prepared by the PV Intelligence Lead) and defines the action plan.

The International Service Line Lead (or delegate) reviews and confirms the classification of the initial evaluation and approves the PIA and action plan prior to it being distributed to project leads and process owners for implementation.

The newsletter(s) is communicated to all PV staff no later than calendar day 15.

Chris: Novartis regulatory intelligence is in-house for the majority of countries where Novartis has a presence. The process of identifying new and updated legislation varies across the different countries due to the setup of their local health authority. However, in general, the local PV team signs up to health authority websites but may also proactively review health authority and trade association websites on a frequent basis. If a formal gap assessment is required, a form is used to guide local and global functions on the systems or procedures impacted by the change in legislation and all changes are documented in a change control within the quality management system. For countries where there is no Novartis presence, a vendor will be used who will gather legislative changes at agreed intervals and an agreed frequency and will forward these to the responsible team where their internal process is then followed. In both scenarios, the process is documented within company Standard Operating Procedures (SOPs).

What are the challenges?

Meera: When working in a company that has a global presence, local expertise is imperative to ensure that compliance with local regulations is being met. With the everevolving regulations that are now becoming more complex, it can be a challenge to ensure compliance with regulations, especially now that local regulations seem to be diverging rather than harmonising. Local expertise is key and in some companies the lack of resource / expertise could be a challenge.

Dora: Some of the sources screened and the updates identified in the PV Intelligence screening process overlaps with regulatory affairs, and it can sometimes be tricky when determining who “owns” any internal actions required.

Chris: I think Novartis has a good process in terms of what to do when there are local vs global actions and it has taken a few years of evolution to get there. However, SOPs will only get you so far due to interpretation of process. One of the challenges I see from a regional level is alignment across different countries in adhering to the SOP.

SUMMARY To summarise, regulatory intelligence involves not only staying informed about legislation but also ensuring timely information gathering through a documented, frequent, and proactive approach. As health authority requirements diverge it is essential to maintain expertise on local legislation, especially when part of a global PV system, and having a ‘one-stop shop’ for this information would be beneficial.

In addition, there are approximately 17 countries I oversee where we cover regulatory intelligence but do not have Novartis presence. Therefore, we rely on vendors or internal personnel such as regulatory associates within country. This can have its own challenges because it introduces other aspects of PV such as contracts, audits, qualification, vendor management etc.

At a local level, I see audit findings when we rely on the health authorities providing us the information as opposed to proactively finding the update ourselves. I advocate for the latter.

What changes would you make?

Meera: Ideally there would be a centralised resource or tool that would be available with real-time updates across all regions, which would also include the history of changes.

Major changes in regulations would be communicated with clear implementation guidelines and transition expectations.

When there are complex changes made to regulations, it would be beneficial for more collaboration with interpreting guidance e.g. through webinars and Q&As. Dora: A dedicated page on all competent authority websites listing all the changes made to the various guidance and pages on their site (with a link to the URL for easy access), similar to the MHRA Yellow Card Latest News page.

Chris: Similarly, I agree that having one dedicated area of the health authority website where you can access PV-relevant information across different areas such as QPPV, CTs, Devices etc would be ideal. Something similar to legislation.gov.uk but for PV guidance would be useful. In addition, clarity on exactly what has changed (even a tracked changes version) would be beneficial. On that note, it is always worth saving a copy of each legislative update to allow for an easy comparison against the previous version.

Meera Doshi

Dora Amene

Chris Isaacs

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REGULATORY UPDATES In our regular feature, we highlight some of the most recent regulatory intelligence updates affecting medical information and pharmacovigilance.

• On 09-Jun-2025, the MHRA updated the guidance for healthcare professionals on risk minimisation options for medicines Risk minimisation measures for medicines GOV.UK.

• On 24-Jul-2025, the European Medicines Agency (EMA) released an Addendum to GVP Module VI on ICSR Management, detailing instructions for masking personal data in Individual Case Safety Reports (ICSRs) submitted to EudraVigilance. This guidance took effect on 25-Jul-2025 GVP Module VI Addendum II – Masking of personal data in ICSRs for EudraVigilance. The GVP Introductory Cover Note was also updated to reflect these changes GVP Introductory Cover Note.

• On 10-Jun-2025, the MHRA published: Guidance on the Decentralised Manufacture (DM) designation step Decentralised Manufacture: The designation step - GOV.UK. The designation step is MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise DM. . This step will provide regulatory clarity and the assurance to innovator organisations to progress the next steps in establishing a DM system.

• On 25-Jul-2025, further to the publication of the IR 2025/1466, the EMA updated its Signal Management page on monitoring of EudraVigilance Signal management | European Medicines Agency (EMA) and included a new Q&A document which provides clarifications for MAHs on the termination of the Signal Detection Pilot Questions and answers on termination of MAH EV pilot

An overview of the Human medicines Modular Manufacture and Point of Care regulations 2025 Human medicines Modular Manufacture and Point of Care regulations 2025: Overview - GOV.UK. The information in the guidance is to help organisations understand and prepare for the main regulatory changes that The Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025 will introduce for the manufacture of medicines at - or close to - the point of patient care.

• On 30-Jul-2025, ICH published the updated ICH E2B(R3) Q&As, the Implementation Guide, and Appendix I (G) for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) have reached Step 4 of the ICH Process ICH Official web site : ICH. • On 31-Jul-2025, the EudraVigilance: electronic reporting sections ‘Who needs to report what?’, ‘Masking of personal data in ICSRs/SUSARs submitted to EudraVigilance’, ‘What to do in case of system failure’ was updated EudraVigilance: electronic reporting | European Medicines Agency (EMA).

• On 25-Jun-2025, the MHRA published draft guidance on the collection, verification and reporting of safety events in clinical trials of an investigational medicinal product Clinical trials for medicines: collection, verification, & reporting of safety events - GOV.UK to support amendments that come into force on 28 April 2026. This guidance has since been updated on the MHRA clinical trials collection hub.

• CIOMS has announced the publication of a revised version (Version 2.3) of its Cumulative Glossary with a focus on Pharmacovigilance, which can be downloaded for free from the CIOMS website CIOMS Cumulative Glossary, with a focus on Pharmacovigilance (Version 2.3) - CIOMS.

• On 23-Jul-2025, the EU issued final revisions to the Commission Implementing Regulation (IR) 520/2012. The new IR 2025/1466 of 22 July 2025 provides details of amendments to IR 520/2012 on the performance of PV activities.

Please note that this list has been compiled by the PIPA Committe and should not be relied upon as a definitive list of all industry-relevant regulatory intelligence updates.

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