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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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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, […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]