News

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. To best prepare for […]

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 […]