Handling sensitive patient data in the US – Guide to HIPAA Compliance

In the following post Pharma IT will describe the content of the HIPAA legislation and give some points to what is important in respect to implementation of HIPAA compliance. Should you need assistance to establish HIPAA compliance in your organisation, please contact us HIPAA – the Health Insurance Portability and Accountability Act sets the standard …

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Are we all done with Serialization after the EU implementation?

FMD Implementation Most companies in the pharmaceutical sector have their eyes on EU and have full speed on their FMD implementation. Every week, good news and progress are announced from different partners in the Supply Chain, and more and more countries are getting their national systems connected to the central database EMVO. This is all …

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Pharmacovigilance – Guidance on EU Risk Management Plans

In the EU, a Risk Management Plan (RMP) should be submitted as part of a Marketing Authorisation Application by the Marketing Authorisation Applicant (MAA). It should also be submitted for marketed products by the Marketing Authorisation Holder (MAH) in case of major updates affecting the benefit-risk balance or by request from EMA or a national …

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Why should small and medium size Pharmaceutical and Biotech Companies outsource their Data Protection Officer?

The EU General Data Protection Regulation will become effective on the 25th of May 2018. As outlined below the Data Protection Officer (DPO) position will most likely be a part time position in small and medium size Pharmaceutical and Biotech Companies. The DPO position will not be in line with the company’s core capabilities and it could be difficult …

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Pharma IT hires new Quality and Compliance Consultant

Pharma IT is happy to announce that Stine Kristensen from  2016 will join Pharma IT as a Senior Pharma Consultant. Stine has more than 10 years of experience within the Pharmacutical Industry and is specialised within Quality and Compliance consulting. Stine has already been assigned to a Compliance Consulting task for one of the large Pharmaceutical Companies in the Copenhagen area. …

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How to setup your own GInAS installation for IDMP

With EMA’s publication (slide 25) of their current plan to facilitate the implementation of the International Organization for Standardization (ISO) identification of medicinal products (IDMP) standards as with Article 57(2) of Regulation (EU) 726/2004 and considering that EMA has communicated that the first iteration implementation of the Product Management System (PMS) will mainly include xEVMPD data – the …

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Pharma IT Services

PharmaIT focus on delivering services and consultancy related to business processes and IT within the Pharmaceutical Industry. We focus on Quality and set High Standards for our self. Our identity is to be small, agile and competitive, We only engage with the best – our consultants are Experienced and Professional, having many years of experience within Pharma …

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