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Author Archive for: SamarindRMS

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Samarind is now part of the Instem group

instemInstem, a leading provider of IT solutions to the global early development healthcare market, announced that it has acquired the UK-headquartered Samarind organization to help bring scalability and next generation capabilities to the increasingly complex global regulatory environment.

Samarind provides Regulatory Information Management (RIM) solutions to the life sciences sector that significantly improve the quality of regulatory information and help achieve and maintain compliance for pharmaceutical, biotech and medical device products.

 

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Latest Webinars

Please see below for our most recent webinars – click on the webinar image to play.

How Samarind RMS will be implementing the pending ISO IDMP guidelines.  Topics covered include: 1) IDMP – what is it and what information is required?  2) Samarind’s consultative approach to your IDMP requirements, 3) The latest IDMP news and a demo of our system.  Broadcast date: 1st July 2015

Why IDMP should be served from a ‘Single Point of Truth’®.  Topics covered include: 1) Why a RIM solution is ideal to manage the pending ISO IDMP standards, 2) What makes Samarind’s ‘Single Point of Truth’® unique?  3) A live demonstration focusing on the ‘Single Point of Truth’® and how this will benefit you when implementing the pending ISO IDMP standards.  Broadcast date: 15th July 2015

IDMP: A consultant’s view.  Frits Stulp, a consultant and subject matter expert in IDMP talks around the current IDMP status and what we should be doing now.  Broadcast date: 29th July 2015

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Good Data Discipline: Responding to new XEVMPD Maintenance Guidelines

Read our article in DIA’s Global Forum

At the end of January 2014, formal guidelines were issued concerning the way updates must be made to European pharmacovigilance data. Miranda Pothiawala, director at Samarind, discusses the implications now that tight timeframes have been set for getting submitted product data in order.

As of two years ago, any life sciences company distributing products in Europe has been subject to a mandate to submit comprehensive product information and documentation to a central electronic database – the EudraVigilance Medicinal Product Dictionary (EVMPD) – in the interests of improving patient safety.

To read the full article, please visit the DIA website: http://www.diahome.org/en-US/News-and-Publications/Newsroom/~/media/PDFs/News-and-Publications/GF/GF-Good_Data_Discipline.ashx

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Is it time to turn your reporting structure ‘upside down’?

How familiar are you with the current issues around eCTD, that is Electronic Common Technical Document?  (If your primary interest is Europe, see here for more information: http://esubmission.ema.europa.eu/ectd/  and if your interest is in the US, see here)

If you are unsure about the term, which I admit isn’t that user-friendly perhaps, then the good news is it’s not that hard to unpack. All eCTD really means is a standards-based way the industry is going in to move from delivering drug marketing applications to regulatory authorities not in paper, but in an electronic format. The main drivers include a push by the ICH (International Conference on Harmonisation) process – which is to say US, Japan and Europe – which wants to use one common format: hence eCTD. (Please note this is for information on human drugs alone, although there is work going ahead in the veterinary field as well as in cosmetics.)

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