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Article | IDMP: Making patients the priority in 2020

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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 […]

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Partnership with Gens & Associates

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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 […]

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The Public’s Growing Appetite for Product Data

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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 […]

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Blog: A case for continued IDMP collaboration and adoption:  It’s about the patients

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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 […]

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Iperion welcomes Lise Stevens to our team

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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 […]

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Iperion in partnership with Main5

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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 […]

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Product data, not just for regulators

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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 […]

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Iperion launches the Advanced Response Team

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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 […]

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MasterControl: New and More Powerful Analytics

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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 […]

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Blog: eHealth – future of healthcare and life sciences?

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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 […]

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Updated eSubmission Roadmap

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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 […]

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Iperion welcomes Remco Munnik

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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 […]

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Iperion present at DIA 2019 Global Annual Meeting

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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 […]

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RSIDM in North Bethesda, February 11-13

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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, […]

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IDMP as enabler for standardization, automation and interoperability

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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/

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How OMS RMS can benefit your company

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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 […]

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MasterControl release policy

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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 […]

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Iperion continues its work for ISO

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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 […]

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4 steps towards ERP-RIMS interoperability

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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 […]

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Iperion named a Sample Vendor by Gartner for Compliant GxP Cloud Services in 2018 Hype Cycles

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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]. […]

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Visit Iperion at DIA Boston, June 25-27

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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 […]

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Webinar to prepare you for Medical Device Regulations (MDR) Part II

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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.

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Webinar to prepare you for Medical Device Regulations (MDR)

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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.

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Webinar Materials – Integrated information management

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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 […]

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Iperion Life Sciences Consultancy acquires Regulatory Consultancy Practice of US based Identifica

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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 […]

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Webinar Series – Practical solutions for information management

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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 […]

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20 years later, 21 CFR Part 11 is more relevant than ever

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20 years later, 21 CFR Part 11 is more relevant than ever – by Cindy Fazzi, MasterControl Staff Writer If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about. First off, what’s new with Part 11? Every now […]

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FDA Guidance Answers Questions Regarding Data Integrity

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FDA Guidance Answers Questions Regarding Data Integrity by David Jensen, Marketing Communications Specialist, MasterControl An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “Data Integrity and Compliance with cGMP.” The purpose of the guidance is to address some of the frequently asked questions and to clarify the role of data integrity in drug manufacturing.

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The Dutch Medicines Evaluation Board i-Day

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On 23 February, the Dutch Medicines Evaluation Board organized its i-day. The MEB informed the audience that they had emerged from a period of technological struggles to being able to start implementing their i-vision. I-vision deliberately moves away from the “e-“prefix to the “i-“ prefix to emphasize that their endeavors in the information-area go beyond simply implementing new electronic systems into restructuring the way they process information as one of the major European NCAs.

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Upcoming event: Global regulatory and submissions management in the pharmaceutical industry Vienna

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The Global Regulatory and Submission Management in the Pharmaceutical Industry will start tomorrow in Vienna, Austria. After a previous invitation to be a guest speaker, Frits Stulp will act as chairman during Day 1 of the event. On Day 2, on behalf of Astellas he will present ‘Astellas: A practical IDMP implementation and stepping stone for RA optimization’. Key topics discussed during this event, are: Regulatory intelligence and its practical impact; eCTD and MMA special cases; EU Telematic […]

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IDMP Webinar: Pistoia Alliance, January 19th

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Iperion is looking forward to share practical considerations in bringing IDMP data under control and usable for both submission and business purposes at the PISTOIA webinar coming Thursday, together with Edsel David, Andrew Marr and Martin Romacher! Hope you will join! Title: IDMP: It’s all about the patient: enhancing patient safety through improved R&D information exchange When: Thursday 19th January 2017 @ 11am-midday EDT Who: Frits Stulp, Andrew Marr, Edsel David, Martin Romacker and Sergio Rotstein on what […]

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New timelines have been shared by the EMA

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During the Task Force Meeting on the 13th of December, new SPOR (Substance, Product, Organization and Referential Management Services) timelines have been shared. The timelines include: Organisational and Referential Management Services (OMS and RMS): due to technical challenges and disaster recovery testing, the User Acceptance Testing and implementation have been delayed until April 2017. The systems will Go Live in June 2017. Substance Management Services (SMS): a Go Live is expected at the end of 2017. Implementation guidelines: […]

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Update on the Panel discussion in Philadelphia, US

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Our IDMP Consultant Adnan Jamil attended the 2nd Annual IDMP Update Forum in Philadelphia, together with Christian Buckley (Astellas). They participated in the expert panel discussion and provided attendees with their experiences from the Astellas IDMP program. Several topics were discussed within the panel discussion: Building Cross-Functional Support for IDMP Since IDMP has a broad impact on the business, requiring data to be collected from multiple organizational domains (regulatory affairs, clinical, manufacturing, etc.) The panel members discussed how […]

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MasterControl released version 11.6

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The MasterControl team has released version 11.6 which includes several upgrades designed to enhance the user experience and provide a more streamlined approach to quality management. Many of the new features included in this release are a direct reflection of customer input. In version 11.6 ‘PleaseReview’ has been added which is a real-time collaboration tool that will help users’ organizations save time, eliminate the frustrations and costs inherent in the document review process. Included in this new version […]

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