The FDA is moving forward with digitalisation in all areas and the CDER NextGen Portal is a good example. What is the CDER NextGen portal? CDER’s NextGen Portal is a cloud based system for users to report information to the FDA. From Drug Development Tools (DDTs) to amendment submissions, stakeholders can utilise the NextGen Portal. …
Author Archives: Olaf Schoepke
eSTAR – FDA’s next move to go digital
On 10th January 2023 the FDA announced a joint eSTAR, the electronic Submission Template And Resource pilot together with Health Canada. This is another approach in digitalisation via harmonising submission formats, allowing originators to reuse data and documents in different regions. The pilot will test the use of a single eSTAR submitted to both the …
Article 57 xEVMPD to IDMP/SPOR – Automated Consistency Check
As stated in our previous blog, EMA’s webinar “DADI-PMS Webinar Agenda – ‘Variations Form for Human Medicinal Products – What will happen at Go-Live’” made it clear that data quality [in PMS] is dependent on xEVMPD. PMS, the Product Management Service out of the EMA SPOR project builds on the data foundations of the Referential …
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Article 57 xEVMPD to IDMP/SPOR: PMS Data Migration
EMA’s webinar “DADI-PMS Webinar Agenda – ‘Variations Form for Human Medicinal Products – What will happen at Go-Live’” made it more than clear: data quality [in PMS] is dependent on xEVMPD. In our previous blog on PMS Data Migration we highlighted some of the challenges faced by Marketing Authorisation Holders (MAHs) already and these challenges …
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Article 57 xEVMPD to IDMP/SPOR PMS Data Migration: are you ready?
The situation All Marketing Authorisation Holders (MAHs) in the European Union (EU) and the European Economic Area are required to submit information on their authorised medicinal products to the Article 57 database of the European Medicine Agency (EMA) in accordance with Article 57(2) of Regulation (EC) No. 726/2004. It is a legally binding requirement from …
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A first glimpse of the UPD Public Portal
Although still under development, the UPD Public Portal offers a first glimpse of what will come: better access to medicinal product information for the public. Let’s have a look at what is on offer. The homepage mainly gives access to the substance and medicine index as well as the search functionality. As expected, under the …
Medicinal Product Line Outsourcing
Change creates opportunity, they say. Here’s one change that might benefit – if handled right – the medicine originator, the service provider, and foremost the patient by just moving the responsibilities of an entire medicinal product line into different hands. Part I – The Opportunity What opportunity am I talking about, as outsourcing itself is …
Are you listening to your animal patients?
We at Instem pride ourselves with mastering the technology to support the pharmaceutical, medical device and veterinary profession, bringing their life enhancing products to market faster. But that is not all. We also pride ourselves with being able to understand our clients’ patients, and this includes animals. The need for getting a better understanding of …
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Union Product Database – EMA’s Agile Approach?
With the pressure mounting to implement the New Veterinary Regulations (NVR) which came into force 28th January 2022, releases of the Union Product Database (UPD) to be implemented under the NVR are getting more frequent. In true software development fashion, is the EMA using the Agile approach to get solutions out more frequently and much …
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New Veterinary Regulations – Volume of Sales
Only days to go – The New Veterinary Regulation is coming into force on 28th January 2022. Time is running out for Marketing Authorisation Holders (MAHs), regulators and solution providers. The New Veterinary Regulation (NVR) is coming into force on 28/January/2022. Part of the NVR is the requirement for MAHs to provide information about the …
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Pharma Whisper 