Manufacturers of digital medical devices, medical devices that incorporate electronic programmable systems (PEMS) and software that are medical devices in itself, will have full responsibility to establish and maintain ‘security by design’ with the introduction of the Medical Device Regulation (MDR). A secure product development life cycle based on state-of-the-art practices and modern tool chains should be implemented. Where digital health technologies are becoming complex, cybersecurity conformity assessments ensure, both for end users and manufacturers, that products meet […]
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Personal blog | My first IDMP implementation projects
This is a personal blog from Marijke Blaauwhof, Healthcare and Life Sciences Consultant at Deloitte. “For the last 5 years, I have been interested in the life-sciences industry with a strong focus on supporting large transformations within the pharmaceutical organizations through-out the value chain. Having worked in the pharmaceutical industry prior to joining Deloitte, I had a clear drive to continue supporting clients in this area. When I read that Deloitte had acquired Iperion last year I was […]
Read morePersonal blog | With time comes a certain perspective
This is a personal note from Camiel Hoogendoorn, one of our senior consultants “It was a cold but sunny day in November in 2015 when I got the email that I was hired by Iperion Life Sciences Consultancy. I was eager to start working at this small company with great ambitions. At that time Iperion was a mostly unknown business both to the industry as a whole and to myself. Little did I know, but all of that […]
Read morePersonal blog | A shared vision to make a change
This is a personal note from Amy Williams, the newest Director of Team Iperion. “Three months in and last week provided the first opportunity to meet colleagues face-to-face. Starting a new role in the midst of a pandemic provides a nuance to onboarding previously unanticipated. This made the meeting face-to-face all the sweeter. The pleasure of meeting someone for the first time in person who you already feel you know; the revelations of height and mannerisms that simply […]
Read moreCTR | Industry CTR Readiness
CTIS Webinar responses: Ready or not Deloitte-Iperion held a webinar on 20 September 2021, exploring some of the challenges Industry will face when preparing for and operating under the new Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS). During the webinar we surveyed the audience to understand where representatives from Industry felt they were on the scale of preparedness and where some of their concerns truly lie. With Industry representing nearly three-fourths of attendees the survey […]
Read morePersonal blog | My first year triggers my enthusiasm even more
A personal story of Vera Ogbeide about her first year as a Data Process Expert at Iperion – a Deloitte business. I have a very broad interest and come from a business related field. I am always eager to explore new subjects, both business/management related as industry specific. Over the years, my interest in analyzing data increased, using my knowledge in econometrics, operation research and data analytics. In my search for further development and my enthusiasm in learning […]
Read moreCTR | Application procedures and Timelines under CTR
The European Commission hopes to create a favorable environment to conduct clinical trials in the EU with the implementation of the Clinical Trial Regulation (CTR), which is expected to go live 31 January 2022. In this article we provide an overview of the key considerations with regards to application procedures and timelines regarding the submissions of clinical trial applications. New considerations with CTIS While the EU CTR harmonizes clinical trial assessment procedures by introducing CTIS, it does […]
Read moreOptimism and hope – 2022 has started
The year 2022 has just began. We have entered it with optimism and hope. Whatever the year brings, we will be ready to empower the life sciences industry and regulators to innovate, improve business processes and optimize regulatory information management in the broadest sense for better patient outcomes. We will work hard, forge new partnerships and share our expertise and innovation for the benefit of everyone in the time of the pandemic. We are absolutely driven to increase […]
Read moreCTR | User management in CTIS
The European Commission hopes to create a favorable environment to conduct clinical trials in the EU with the implementation of the Clinical Trial Regulation (CTR), which will be going live at 31 January 2022. In the weeks before we will publish articles to help you prepare. In this article we provide an overview of the key considerations with regards to user management under CTR. Introduction of the Clinical Trial Information System (CTIS) The Clinical Trial Information System […]
Read moreCTR | Legal representation set out in the EU Clinical Trial Regulation
The European Commission hopes to create a favorable environment to conduct clinical trials in the EU with the implementation of the Clinical Trial Regulation (CTR), which will be going live at 31 January 2022. In the weeks before we will publish articles to help you prepare. In this article we provide an overview of the key considerations with regards to legal representation under CTR. Legal representative requirements under CTR According to Article 74 of the CTR, if a […]
Read moreIperion in the media: 2021 in review
2021 saw Iperion continue to expand its global media reach. Some of the key articles published in 2021 are here: New European medicinal data standards – getting ready for change In January 2021, The European Medicines Agency (EMA) published a guide to implementing IDMP data standards forecast to be ”a game changer” for the life sciences sector. Iperion’s Remco Munnik, who has been working with the EU focus group creating the EU IDMP Implementation Guide version 2, […]
Read moreIperion welcomes Amy Williams to the team
We are very pleased to welcome Amy Williams to our team. She will assume the position of Director within Iperion – a Deloitte business, from December 6th. Amy brings 15 years of experience in life sciences, working in Regulatory Affairs – both within the industry and as a software/service provider (Merck Serono, Parexel/Calyx). Amy is passionate about collaborating between industry, health authorities and vendors to alleviate the challenges and needs of the regulatory industry. Her experience in RIMS […]
Read morePersonal blog | My first projects at Iperion
This is the personal story of Anne Claire Sparla, one of our senior consultants. Last June, I joined Iperion – a Deloitte business as a Senior Consultant. When I was previously working for a company that specializes in Medical Devices, I quickly noticed the impact and importance of regulatory compliance in the life sciences industry. More specifically, I experienced how new regulations cause all kinds of challenges within a company, but have a positive impact in transparency, operational […]
Read morePersonal blog | The evolution of Managed Services – An eyewitness account
This is the personal story of Tommy Twilhaar, Service Operations Lead of our Managed Services department. The evolution of Managed Services – An eyewitness account During my (Medical) Biology study, I was focused on going into research. However with graduation around the corner I started to re-evaluate my course of action. Would an entire day of working in a lab really give me satisfaction? It didn’t take long to come up with an answer and it was loud […]
Read morePersonal blog | My first months at Iperion – a Deloitte business
A personal story of Monica Roelofs about her experiences as a Consultant at Iperion – a Deloitte business. My first months at Iperion – a Deloitte business Only a few months after my graduation, I got into contact with Iperion – a Deloitte business. I have a background in biomedical research and innovation in healthcare and I was eager to start making a difference after these years of studying. Although at first it was not clear to me […]
Read morePersonal blog | As a project lead, you want to succeed
A personal story of Nadia Goutziers about her experiences as a Project Lead at Iperion – a Deloitte business. Being assigned as the project lead, you want the project to succeed – for the client, but also for the internal team. I want to give you an insight in a typical day as a project lead at Iperion – a Deloitte business. After starting up my computer, I notice there is an email from the project sponsor of […]
Read morePersonal blog | My first year at Iperion – a Deloitte business
A personal story of Angela Aleksovska about her experiences working one year at Iperion – a Deloitte business. My first year at Iperion – a Deloitte business Having spent the last few years in research and academia has given me the perks of knowing the beauty of designing new molecules and materials. And as more new life science comes to the fore, there has to be new ways of assessing it. So, as important as it is to […]
Read moreISO IDMP EU Implementation Guide v2.1 – what’s new?
As of Wednesday 30th June, an updated release of the EU’s IDMP Implementation guide v2.1 is now available from the European Medicines Agency (EMA) – the next step towards the implementation of ISO IDMP in Europe and initially for the Centralized Procedure. Although v2.0, published in February, was a solid, stable release – giving software vendors and life sciences organizations something tangible to work with in their next IDMP preparations – there are some subtle changes in v […]
Read moreIperion Life Sciences Consultancy becomes part of Deloitte
As of May 2021 Iperion Life Sciences Consultancy will become a Deloitte business. By combining our specialist industry knowledge and passion for our cause with Deloitte’s network and expertise, we hope to make a greater contribution to the accelerated approval of new or improved medicines as well as the provision of high-quality information to patients and the healthcare sector. Our commitment to promote data standardization for better patient outcomes Six years ago, we started Iperion with ambitions to boost […]
Read morePress release: Iperion Life Sciences Consultancy Becomes Part of Deloitte
Deloitte has announced its acquisition of Iperion Life Sciences Consultancy, a dynamic globally-operating firm dedicated to transforming human medicine safety, outcomes and experiences through the application of high-quality, standardized, regulated product information in digital form. As of May 1, Iperion is operating as Iperion – a Deloitte business. The business will run as part of Deloitte’s Risk Advisory function. Iperion’s co-founder Frits Stulp will serve as a partner within the Deloitte Risk operation, and his counterpart Karel Bastiaanssen […]
Read morePersonal blog | Being a Data Process Expert is anything but boring
A personal story of Natasja Troost-Riksen about her experiences as a Data Process Expert at Iperion Life Sciences Consultancy. At the end of November 2017 I joined Iperion as Data Process Expert. Because Life Sciences was rather new to me, I started it, thinking this was a nice temporarily job. However, already during my first day I was positively surprised by the work and atmosphere and since then I have never thought about leaving the company. First I […]
Read morePersonal blog | My first year as a Data Process Expert
A personal story of Aji Fatou Badjan about her first year as a Data Process Expert at Iperion Life Sciences Consultancy. As a fresh graduate from university, I wasted no time grabbing the opportunity to work at Iperion when it crossed my path. Luckily the language barrier as I speak little to no Dutch was no issue. Looking back one year later, I am happy that I took up this challenge. At first, I was skeptical about […]
Read moreEuropean Medicines Agency Launches IDMP Implementation Guide and Sets Clock Ticking for Life Sciences Companies to Get Their Data in Order
Today the European Medicines Agency (EMA) has published IDMP data standards that will drive change and innovation in the life sciences sector. Remco Munnik, Associate Director at Life Sciences consultancy, Iperion, has been working with the group creating the EU IDMP Implementation Guide version 2.0 (EU IG). Iperion will reveal the implications of the data standards for the life sciences sector in a webinar on March 1st . The EU IG, covering the submission of data on medicinal […]
Read morePersonal Blog | 2 years at Iperion
A personal story of Julle Vos about his 2-year anniversary at Iperion Life Sciences Consultancy. The 1st of February 2021 marks my second year working for Iperion Life Sciences Consultancy. I must say it was a bit of gamble at first. Having an educational background in biomedical science, it was not entirely what I had studied for or anticipated on. After many combined years of internships working in various University laboratories, I was interested in trying something different, […]
Read moreMeet us during DIA’s RSIDM and DIA Europe
With the start of 2021 we are looking forward to yet another year where we strive to keep making the difference in life sciences. Where we previously shared our vision and knowledge during real life conferences where we could meet face to face and could really connect with the industry, we have to stay flexible and meet each other in different ways on other platforms. Two events we are digitally attending are DIA’s Regulatory Submissions, Information and Document Management […]
Read morePersonal Blog | Setting goals for 2021
A personal story of Sara Brink Berdajs about closing off 2020 and setting goals for 2021 It was around end of October, when I realized that we’re approaching the end of the year. Many of you might recognize the trigger: start of discussions around planning for 2021. Getting the strategic intentions and goals defined, and then connect the more tactical and operational aspects, like types of projects we want to do and have lined up, what does that […]
Read morePersonal blog | My first year at Iperion
A personal story of Jeanneke Spruit about her first year as junior consultant at Iperion Life Sciences Consultancy Only one year ago, I started working at Iperion. Fresh out of university, I was nervous to start my ‘adult working life’. I started with a job in the data entry Services department, but was soon convinced by my boss to switch to the consultancy side of Iperion. I was sceptic about consultancy at first: I believed that consultants were […]
Read moreReviewing Iperion in the media in 2020
While 2020 has proven to be something of a challenge as we battle a virulent pandemic, it has also seen Iperion continue to extend its media presence globally. Here, we look back at some of our favorite topics and link to a handful of key articles. IDMP at a crossroads Frits Stulp reflects on recent developments in IDMP and what 2020 has in store, concluding that, if there is one priority that must rise above all others […]
Read moreIperion introduces the IDMP Readiness Questionnaire
In June, EMA released the draft of the 2nd version of the ‘IDMP/SPOR PMS Implementation Guide’ which is now in the consultation phase. This new release contains an updated chapter 2 (Medicinal Product Information) and a first version of chapter 3 for the process on how product data should be submitted as part of the Target Operating Model (TOM). Once the consultation is finished it is expected that the final version of the Implementation Guide will be published […]
Read moreBlog | Harnessing IDMP internally: breaking down departmental silos & improving product insights
The IDMP data standards provide structured medicinal, pharmaceutical product and substance data models, as well as mechanisms to uniquely identify products and their components. As well as facilitating a wide range of exciting regulatory and healthcare use cases, the standards can help organizations overcome traditional information silos and inconsistent data quality across different functional areas, to improve important business insights. This has the potential to transform information flows. The ISO IDMP data models can be used as a […]
Read moreBlog | Exploring IDMP use cases: don’t sell your organization short
The suite of ISO IDMP data standards has the potential to support a broad spectrum of transformational new healthcare and regulatory applications. Yet articulating the benefits of IDMP adoption to a CEO or CIO remains a challenge for project proposers, who must confront the common perception that this is merely another compliance cost. Iperion Life Sciences Consultancy provides a range of IT services to help companies transition towards process transformation and service innovation, underpinned by comprehensive, high-quality, standards-based […]
Read moreWebinar IDMP Implementation Guide with Main 5
Our webinar on EU Implementation Guide on 30 March 2020 was a success. We have noticed there is a clear need for practical information on the Implementation Guide and the necessary next steps. Due to this success we are planning new webinars on the Implementation Guide, together with MAIN5, especially for the DACH-region. EU ISO IDMP Implementation Guide In February 2020, EMA published Iteration 1 of the EU ISO IDMP Implementation Guide. The EU IG provides detailed guidance […]
Read moreWebinar EU Implementation Guide
In February 2020, EMA published Iteration 1 of the EU ISO IDMP Implementation Guide. The EU IG provides detailed guidance on how ISO IDMP data fields should be interpreted, submitted and maintained within the EU regulatory framework supported by SPOR (Substances, Products, Organisations and Referentials Management Services). Webinar In order to assist with the digestion of the published documentation, we are planning a webinar session to address the EU IG and answer your questions. Iperion consultants have been […]
Read moreEU ISO IDMP Implementation Guide is here – what you need to do?
The first version of the much-anticipated European Union International Organization for Standardization Identification of Medicinal Products Implementation Guide (EU ISO IDMP IG, hereafter in short EU IG) has been published. The availability of this guidance document makes now the pressing time for industry to better understand the impact of IDMP and set out activities to prepare for its implementation. In this article, the chapters of EU IG are laid out, providing a high-level summary on what is available […]
Read moreArticle | Capitalizing on Standardized International Product Data
The latest regulations for human and veterinary medicinal products, as well as medical devices, include the mandate to set up databases with detailed information about available products. These databases must be realized and implemented in the near future, and require a concerted effort now if tangible real-world benefits are to follow. An article of Associate Director Remco Munnik is published on the website medtechintelligence.com on 29 January 2020. Capitalizing on Standardized International Product Data Substantial effort and […]
Read morePutting the EMA medicines database to effective use
Goals for IDMP in Europe must not be diluted in 2020, if standardized medicinal product data is to be of tangible real-world benefit, says Iperion’s Remco Munnik in PharmExec.com. An eye-watering level of investment has been ploughed into the preparations for the EU’s implementation of the ISO IDMP (identification of medicinal products) standards over recent years. It is disappointing, then, that we are not further along in harnessing these developments for real-world gain. So in 2020 focus and […]
Read moreArticle | IDMP: Making patients the priority in 2020
IDMP is at a crossroads. In 2020, will veterinary regulations disrupt progress on human medicinal product standards, and in the meantime who’s speaking up for patients? Iperion calls for focus and mutual support during what will be a critical year for the regulatory network’s product transparency initiatives. An article of Managing Director Frits Stulp is published on the website Pharmaceutical Executive on 19 November 2019. IDMP: Making patients the priority in 2020 2019 saw decent progress towards ISO Identification […]
Read morePartnership with Gens & Associates
Iperion Named Strategic IDMP Advisory Partner in New Gens & Associates Program Offering Complete Regulatory Information Management Support to the Life Sciences Industry European life sciences consultancy Iperion is one of just two strategic consulting partners globally to have been invited to join a new premier Regulatory Information Management membership program devised by Gens & Associates. Iperion will bring its unique IDMP data standard expertise, along with other relevant experience to the program, designed to help life sciences […]
Read moreThe Public’s Growing Appetite for Product Data
Whatever international regulators’ demands might be, society’s expectations will ultimately dictate the need to prepare comprehensive, up-to-date product data that patients, clinicians and pharmacists can scrutinize on demand, says Frits Stulp of Iperion Life Sciences Consultancy. This is the beginning of the article published in The Journal for Clinical Studies in October 2019. Read the full article here. In this article Frits Stulp is calling for action It is undoubtedly unfortunate that the timelines around IDMP have been […]
Read moreBlog: A case for continued IDMP collaboration and adoption: It’s about the patients
IDMP supports the core missions of industry and regulators, which is grounded upon the premise that each plays a vital role in promoting and protecting public health. The external relationships and information obtained from healthcare providers and patients help complete the co-dependent ecosystem of life science, which is used to inform and impact clinical research and regulatory decisions throughout the product development life cycle. The success of the ecosystem is dependent upon the availability and exchange of high-quality […]
Read moreIperion welcomes Lise Stevens to our team
We give a very warm welcome to our new colleague Lise Stevens. Lise currently serves as Associate Director for regulatory information management and pharmacovigilance at Iperion. She will be joining our team in the US, where we recently opened an office. This expansion of Iperion is the next step in our mission to enable the life sciences industry and regulators to innovate, to improve business processes and to optimize the supply chain leading to faster and more efficient […]
Read moreIperion in partnership with Main5
Combining the strengths of MAIN5 and Iperion Life Sciences Consultancy for the benefit of the European Pharmaceutical Industry. MAIN5 and Iperion Life Science Consultancy entered into a strategic alliance to better serve customers within the field of implementation of Regulatory Information Systems, data management, project management and change management. “As the pharmaceutical industry faces organizational, technical and coordination challenges in an ever faster changing regulatory environment, the combined expertise of our companies will allow our customers access to […]
Read moreProduct data, not just for regulators
Managing Director and co-owner of Iperion, Frits Stulp, wrote an article that was published by Pharmaceutical Executive. In this article he reminds companies about the importance of ISO IDMP and the ultimate end goal: Patient Safety Product data, not just for regulators International regulators’ hunger for increasingly detailed product information and complete lifecycle traceability might be the primary driver for new systems and process investment. Yet it is ultimately the public’s expectations that should dictate the need to […]
Read moreIperion launches the Advanced Response Team
In her mission to support and improve the Life Sciences industry, Iperion has taken another step in achieving this. Iperion launched the Advanced Response Team, ART. This team helps pharmaceutical companies solve urgent issues quickly and sustainably. ART is a network of highly experienced and independent consultants with a passion for changing the pharmaceutical industry to make medicines available for patients more efficiently. ART broadens the range of fields in which Iperion can support life science customers beyond […]
Read moreMasterControl: New and More Powerful Analytics
The new functionality MasterControl Analytics will be introduced in MasterControl version 11.7 onwards. Reports will look different and you have more possibilities. It also implies fundamental changes to the tool. The tool is available in all MasterControl modules and solutions. The tool’s biggest change lies in its use of JReport, a highly customizable Java reporting and business intelligence solution that allows users to view, filter and interact more with their data. The improved analytics functionality will feature […]
Read moreBlog: eHealth – future of healthcare and life sciences?
Executive Summary Digital health tools are rapidly emerging into the market and we would like to get an understanding of its implication on the healthcare and life sciences industry, and how they can start preparing for the transition towards digitalization. The article looks into 3 examples of eHealth tools, namely: Wearable devices like Apple Watch and Fitbit have changed the way we manage our health. Digital tools like mySugr & Asthma Sense are providing alternative options for patients […]
Read moreUpdated eSubmission Roadmap
The Head of Medicines Agencies (HMA) have updated the eSubmission roadmap The major changes in the new version are: Timelines for eCTD 4.0 have been removed, while the mandatory use of eCTD and VNeeS continue to be valid Timelines for the stepwise delivery towards the mandatory, fully integrated, single submission portal and use of data-set The New Veterinary Regulation (NVR) has been included At Iperion, one of our main drivers is to assist the pharmaceutical industry in […]
Read moreIperion welcomes Remco Munnik
With a clear vision in mind Iperion Life Sciences Consultancy has taken the next step in realizing her mission. As of July 1st Remco Munnik will join Iperion to strengthen the team. Remco will be responsible for sales team leadership, extension of subject matter expertise and service delivery, contributions to telematics topics throughout the international network, as well as giving workshops and training. Remco Munnik brings twenty years of experience in Regulatory Affairs, with a focus on […]
Read moreIperion present at DIA 2019 Global Annual Meeting
Iperion Life Sciences Consultancy will be present at the DIA 2019 Global Annual Meeting in San Diego, held from June 24-26. Visit us at booth #819! After the success of last years visit, we are also present in 2019. The focus on our booth is about making a plan for digitalization and regulatory information management. Visitors will get tested on their plan. Do you want to know more? Check here on how we can help you plan your […]
Read moreMasterControl PDF Publishing Best Practices

From the technical support team we see an increase of support tickets related to publishing issues. With this publication we want to help you to common issues and how to troubleshoot.
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