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 […]
Read moreUpdated eSubmission Roadmap
Published onThe 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 […]
Read moreRSIDM in North Bethesda, February 11-13
Published onFrits 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 […]
Read moreIDMP as enabler for standardization, automation and interoperability
Published onImplementing 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 […]
Read more4 steps towards ERP-RIMS interoperability
Published onIs 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 […]
Read moreWebinar Materials – Integrated information management
Published onIn 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 […]
Read moreWebinar Series – Practical solutions for information management
Published onIn 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 […]
Read moreOMS / RMS UAT has been finalized!
Published on
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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