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 […]
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Personal 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. To best prepare for […]
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.
Read moreMasterControl Conference Barcelona, 15-16 May 2019

With more then 100+ attendees, 20+ presenters and 25+ sessions you will have the opportunity to meet and talk with experts, chat with peers, catch up on the latest MasterControl developments and functionalities. Learn how to get the most out of your QMS efforts and many more! So don’t miss this event. You can still register. We hope to meet you all there!
Read moreRIM webinar: Delivering Better Efficiencies Across Operations
Join Amplexor and Iperion in a webinar February 26th on RIM: Delivering Better Efficiencies Across Operations – Automating Multiple Systems and Streamlining Compliance Reporting.
Read moreRSIDM in North Bethesda, February 11-13
Frits Stulp, Managing Director Iperion Life Sciences Consultancy, will be speaking at the next Regulatory Submissions, Information, and Document Management Forum (RSIDM) in North Bethesda, February 11-13. He is the IDMP topic group lead for the IRISS Forum and heavily involved as EU-SRS project manager for Medicines Evaluation Board / European Medicines Agency. Regarded as an SME on IDMP, will be sharing his views on the role of the IRISS IDMP Topic Group in SPOR and IDMP Developments, […]
Read moreIDMP as enabler for standardization, automation and interoperability
Implementing IDMP can help your organization by gaining efficiency due to standardization, automation and interoperability. We define 5 stages in this process. 1.Consider structured product information as an asset for your organization 2.Make the transition from paper to high quality structured data 3.Enable the exchange between processes, functions and systems 4.Facilitate the exchange of structured data between organizations 5.Achieve global interoperability Want to learn more about our vision on IDMP, watch our webinar Link: https://iperion.com/webinar-materials-idmp/
Read moreHow OMS RMS can benefit your company
The overall concept of these services is to offer high quality, standardized and consolidated data, codes and terminologies for the usage by and exchange of data between systems and stakeholders. These services will facilitate a diverse set of stakeholders, ranging from Marketing Authorization Holders, Health Authorities, Academia, industry liaisons to Healthcare professionals, patients and more. OMS and RMS are a European initiative, but can be used as a driver for global harmonization within your company, as a key […]
Read moreMasterControl release policy

Over the past few years, MasterControl has rolled out countless enhancements and new features, based largely on customer feedback. As part of their mission to help customers make life-changing products available to more people sooner, they continually re-evaluate how their software release policy can deliver more value to customers quicker. In summer 2014, MasterControl version 11.0 was released with more enhancements than any previous MasterControl release. Announced at the same time was the frequent release train, which referred to […]
Read moreIperion continues its work for ISO
Over the last 3 years Iperion was part of the Dutch mirror group of the international ISO/TC 215 Health Informatics/WG 6 ‘Pharmacy and medicines business’. We are honored to have been asked for this task again. This means Iperion will continue to give her support to ISO for the period 2019-2021. The International working group ISO/TC 215/WG 6 considers for its scope all aspects of medical informatics that apply to e-pharmacy and medicines in general. The aim of […]
Read more4 steps towards ERP-RIMS interoperability
Is my new production method approved? What is the first batch implementing my product-update? Most companies still align their regulatory and production operations through phone calls and good old hard work. But bigger operations, increasingly complex supply chains and the ever changing regulatory landscape of 21st century pharma demand 21st century solutions. Connecting your RIMS and your ERP is not easy but it is doable. Iperion proposes four steps to get your RIMS and ERP connected: Bring […]
Read moreIperion named a Sample Vendor by Gartner for Compliant GxP Cloud Services in 2018 Hype Cycles
This year, Iperion launched its new GxP compliant cloud platform, specially designed for Life Sciences enterprises. The combination of a fully automated and compliant private cloud platform and managed services gives these organizations the possibility to increase the pace of their digital transformation. Iperion was recognized by Gartner as a sample vendor for Compliant GxP Cloud Services in two Gartner Hype Cycle reports: Hype Cycle for Life Sciences Research and Development, 2018[1] and Hype Cycle for Life Sciences, 2018[2]. […]
Read moreVisit Iperion at DIA Boston, June 25-27
Visit us at booths #1154 and #1254! Iperion Life Sciences Consultancy and Iperion Life Sciences Cloud will be present at the DIA 2018 Global Annual Meeting in Boston (USA), held from June 24-28. The DIA is held annually to foster the international exchange of actionable insights to improve global healthcare through the advancement of lifesaving medicines and technologies. The annual meeting will host more than 6,000 professionals in the pharmaceutical, biotechnology, and medical device communities from more than […]
Read moreWebinar to prepare you for Medical Device Regulations (MDR) Part II
The new Medical Device Regulations (MDR), which come into force by May 2020, include new features, new requirements and far more details than the old medical device directives. To understand the risks imposed on your business continuation, it is time to know the implications and start preparations on time. Iperion and Amplexor will help you with this, in a two-part webinar series. The second part starts on May 24th.
Read moreWebinar to prepare you for Medical Device Regulations (MDR)
The new Medical Device Regulations (MDR), which come into force by May 2020, include new features, new requirements and far more details than the old medical device directives. To understand the risks imposed on your business continuation, it is time to know the implications and start preparations on time. Iperion and Amplexor will help you with this, in a two-part webinar series, starting on April 25.
Read moreeRegulatory Summit 24-26 April, Lisbon
At the eRegulatory Summit to be held on 24-26 April in Lisbon, Portugal, Frits Stulp and Hans van Leeuwen will introduce the best practice to leverage the Enterprise Resource Planning (ERP) and Regulatory Information Management System (RIMs) linkage for the implementation of the Falsified Medicines Directive (FMD) through a case study at Astellas.
Read moreWebinar Materials – Integrated information management
In this webinar, we have illustrated the role of Identification of Medicinal Products (IDMP), Regulatory Information Management System (RIMs), Structured Content Authoring (SCA) and Enterprise Resource Planning (ERP)-RIMs integrated approach towards global interoperability. Below you will find all the webinar materials, this include the webinar recording, as well as the webinar slides. In addition, we have included a questionnaire that will help you identify your product information maturity on our Regulatory Maturity Matrix. Webinar Recording Webinar Slides […]
Read moreIperion Life Sciences Consultancy acquires Regulatory Consultancy Practice of US based Identifica
Iperion has set out to become one of the global players in regulatory consultancy Iperion Life Sciences Consultancy (Iperion) has acquired US based Identifica’s regulatory consulting practice. The acquisition is a logical step in Iperion’s ambition to become a global specialists in regulatory consultancy. The consultancy and related regulatory services will be available via offices in Netherlands and Boston (USA) in support of European, US and Canadian based life sciences customers. As a result of the acquisition expertise […]
Read moreRSIDM conference Washington
At the RSIDM conference on 5-7 Feb, Michiel Stam, Vada Perkins, Andrew Marr and Frits Stulp will jointly give a short course on the principles and practical benefits of IDMP.
Read moreWebinar Series – Practical solutions for information management
In the dynamic environment of the pharmaceutical industry, companies are imposed with inevitable challenges, dealing with complex systems, processes, technology, and on top that, regulatory requirements. In an effort to cultivate discussions on these underlying issues, Iperion has created a platform to share the lessons learnt, highlighting the best practices we have assimilated to help you mitigate such business challenges. In this web series we will address the following topics: Interesting for… Life science professionals working or […]
Read moreWe C.A.R.E.
Iperion Life Sciences Information Systems understands the importance and value work talent. Providing them with opportunities to learn, grow and contribute to life sciences industry continues to be one of our priorities. Our organization started a special program, C.A.R.E. to optimize recruitment, to empower the employees and to work on binding in the long run. The program is supported by the European Social Fund (ESF).
Read moreArticle 3: Cybersecurity: identifying the weakest link

The majority of organizations implement a cloud strategy in order to be more efficient or save capital investment costs.
Read moreOMS / RMS UAT has been finalized!

The User Acceptance Testing (UAT) of Organization Management Service (OMS) and Referential Manage Service (RMS) has been finalized on the 7th of April. This concludes the first components of the EMA SPOR master data management plan.
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