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Truliant Hot Takes

Highlights from Conference Attendance

As a company we endeavour to attend all the pivotal conferences so that we may keep abreast of pertinent industry updates, strengthen our network and reacquaint ourselves with colleagues and clients.

Members of the Truliant team were present at the recent Veeva conference which took place in Madrid at the beginning of the month which was a great opportunity to keep up to date with the development of new tools available on the market. 

At the end of May we attended the Why Summits which proved to be another successful and educational event.  One session, of many, which is worthy to share discussed the importance of building a successful Pharmacovigilance System Master File (PSMF).  

The PSMF is a comprehensive document designed to house the details of the marketing authorization holder’s (MAH) pharmacovigilance (PV) system.  It can be a hefty document and needs to be regularly maintained.  It needs to be available for inspectors to review during an inspection.  The session discussed the importance of ensuring that all stakeholders and contributors understand their role within the generation/upkeep of the PSMF and undergo timely training to ensure they are ready to contribute to updates.   The presenter went on to discuss five individual themes to ensure the creation/maintenance of the PSMF is a success, namely:

1.       A well-documented process for production/maintenance of PSMF

2.       Ensuring stakeholders understand the importance of the PSMF and are trained on requirements

3.       The availability of good quality data noting that it may need to be pulled from multiple systems

4.       Appreciation of regulations and requirements which may change depending on region

5.       Quality Management

The MAH’s ability to maintain an accurate PSMF is an indicator of the quality oversight of the company’s entire PV system and is something inspectors will expect to review.  This session was pertinent as there has been recent mentions of the quality, QPPV oversight and availability of the PSMF in recent inspections.  To note, when requested the PSMF should be made available as part of the inspection documentation within seven days.  Though ten years old, the following article provides insight from inspectors during their assessment of the PSMF with an emphasis on areas for improvement.

Medical Writing | Post-Approval Regulatory Writing | Responding to concerns over the PSMF: Inspectors offer key insights (

Producing an updated PSMF within seven days can seem like a daunting task; let’s be honest so some it may appear nigh on impossible.  It would be interesting to know if any companies test whether they have the capabilities to respond to such a request?  From a Truliant perspective, this is something that we always take into consideration when helping our clients with their PSMF and PSMF processes.


Real-world data and real-world evidence in regulatory decision making – Report of the CIOMS Working Group XIII

The importance of collecting real-world data (RWD) and real-world evidence (RWE) in an endeavour to garner more ‘real-life’ information about your product post-license to support efficacy, effectiveness and/or safety claims is well known to all of us in the industry.  The fact that over the years, many medicines regulatory agencies have appeared increasingly willing to consider RWE derived from the analysis of RWD to address regulatory questions culminates in the need to have a consensus report which the CIOMS Working Group XIII have released online this month.

As we know, randomised-controlled trials (RCTs) have been the gold standard for obtaining safety information and establishing the efficacy of new products. But RCTs can come with limitations with respect to selected participating patient populations, limited duration of product exposure due to study duration and limited statistical power to detect rare adverse events etc. RWE can bridge this gap.  By observing what is happening in the real-world, when there is no pre-defined criteria/protocol to follow, RWE can add vital, expanded information to the product label and increase a company’s product knowledge whilst addressing regulatory authority questions.

The fact that medicines regulatory agencies are expressing willingness to consider RWE to support claims of efficacy or effectiveness as well as of safety is changing the way RWE is generated and used within the regulatory environment.  To help those responsible for generating or interpreting RWE the CIOMS has produced this consensus report “Real-world data and real-world evidence in regulatory decision making”.  

The report consists of five chapters as follows:

Chapter 1 – describes RWE for decision making during the product lifecycle

Chapter 2 – describes sources of RWD

Chapter 3 – discusses RWE for regulatory use: key considerations

Chapter 4 – discusses ethics and governance

Chapter 5 – provides conclusions and future directions

You can download a copy, and peruse at your will, here;

 Real-world data and real-world evidence in regulatory decision making - CIOMS

CDER’s (Center for Drug Evaluation and Research) Emerging Drug Safety Technology Meeting (EDSTM) Program

As the pharmaceutical industry looks to expand its use of artificial intelligence (AI) across a products lifecycle, the use of how AI may help within the realms of pharmacovigilance (PV) is not going unnoticed.  The use of AI to process individual case safety reports (ICSRs) is one area currently being explored but a balance is needed between human input and AI (for instance in the case of assessing causality).

The FDA is collaborating with the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIV - Artificial Intelligence in Pharmacovigilance to address some of these challenges.  CDER are also launching the Emerging Drug Safety Technology Meeting (EDSTM) program which will focus on the use of emerging technology in PV, foster discussions with participants on proposed usage of emerging technology in PV and provide a forum to facilitate mutual learning.  The FDA plans to ‘leverage these learnings to inform potential regulatory and policy approaches within PV and consider providing regulatory advice on specific technologies to facilitate their adoption, when appropriate”.

The EDSTM program offers applicants with an approved application and/or other relevant parties who meet the eligibility and selection criteria, with an opportunity to meet with CDER staff to discuss their research, development, and use of AI and other emerging technology in PV.  You can read more about the EDSTM program here; CDER’s Emerging Drug Safety Technology Meeting Program | FDA


FDA Draft Guidance on Risk Evaluation and Mitigation Strategy Logic Model  

The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled “REMS Logic Model: A Framework to Link Program Design with Assessment”.  The guidance describes an FDA recommended framework for developing clear goals, objectives and strategies that align with intended outcomes.  The intention of the guidance is to help applicants of new drug applications, biologics license applications and abbreviated new drug applications ensure that REMS assessment planning is incorporated in the design of a REMS.

The draft guidance is out now and the deadline for comments is 5th August 2024.

You can find more information here: REMS Logic Model: A Framework to Link Program Design With Assessment | FDA


Upcoming Events from Truliant

Webinar News

We are a third of the way through our three-part webinar entitled “FutureVigilance” having heard five industry experts [Richard Wolf, Colleen Walsh, Santosh Cheruvupalli, Nicole Baker and Emma Brookes] guide us through the world of Pharmacovigilance Process and Change Management at the beginning of the month. 

If you missed the first episode you can watch it here: 

Don’t forget you can still catch up on our first webinar which took place on Thursday 29th November 2023 discussing digital transformation and putting the patient first.   This can be viewed on either of these platforms:


Safety Summit

Following the announcement in April of our Safety Summit, we have been keeping you in suspense with who our guest speakers are going to be.  Not any more! We are taking to LinkedIn to announce our speakers and build the excitement and anticipation week on week.  So far, we have been delighted to announce that Minhaj Obeidullah and Tina Veizovic, MSc MBA will be speakers for the Career Development Track and Michael Aronov will join us as a speaker for the Business Track.  More speakers will be announced over the coming weeks so please follow our LinkedIn page to keep abreast of the updates.

Truliant’s Safety Summit will run over five consecutive days from Monday 23rd September through Friday 27th September in that global timeframe of 9.30am-11am EST and 2.30pm-4pm GMT.  It is open to all Pharmacovigilance and Risk Management Professionals.  Each day will focus on a specific track, each composed of interesting discussion, guest appearances and information sharing related to the following topics:

Mon 23rd September

Technology Track - What is the true potential of AI for PV?

Tues 24th September

Career Development Track – What career options are there for people joining PV?

Weds 25th September

Emerging Pharma Track – From clinical trials to product launch: Strong foundations of a PV system

Thurs 26th September

Business Track – Mergers and Acquisitions: Business Transformations

Fri 27th September

Risk Management – Insight into Risk Management


The agenda is jam-packed and hitting all the right notes for cross-collaboration and global learning plus it’s absolutely free!

To register, please use the following link:


Podcast News

We are busy planning Season 3 of our podcasts and we will be shouting from the rafters when we are ready to release the date of the first episode, so don’t worry, you won’t miss it!

If you haven’t had chance to listen to the previous seasons of our “Innovation and the Future of Pharmacovigilance” podcasts they can be accessed from any of these platforms;

🍏 Apple:

🎧 Spotify:

💻 Google Podcasts:

📺 YouTube Podcasts:

📣 TuneIn + Alexa:

🔊 Amazon Music:

🌐 Podcast Index:

💾 Deezer:

🎤 Player FM:

Future Events

Representatives from Truliant will be available to meet at the PIPA Conference from 18-19th September in Heathrow, UK; we’re very much looking forward to attending and participating in the packed agenda. If you’d like to arrange a meeting please don’t hesitate to reach out to us on


Newsletter Content

If you are interested in our view/insight into a topic we will endeavour to do our best to cover it in a future newsletter.  Please reach out to Pam Strowgger ( with the details.


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