Spin-off’s or start-up’s – especially with in the medical device industry – can benefit from a standard set of QMS templates, to ensure a solid foundation to base their quality management in the company on. The QMS templates provides the necessary baseline of QMS documents for the busy entrepreneur, to comply with both internal as …
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 …
Read moreHandling sensitive patient data in the US – Guide to HIPAA Compliance
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 …
Read moreAre we all done with Serialization after the EU implementation?
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 …
Read morePharmacovigilance – Guidance on EU Risk Management Plans
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 …
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. …
Read morePharma IT hires new Quality and Compliance Consultant
Happy to publish an overview of Service Offerings that can be provided by Pharma IT, should you need our assistance in any way don’t hesitate to contact us – link
This article is the second in a series that will reflect on the activities that can or should be initiated now or soon in order to be prepared for the first IDMP reporting deadline in 2017. This second article reflects on high level IDMP Program planning. Even though the scope for the first IDMP reporting …
This article is the first in a series that will reflect on the activities that can or should be initiated now or soon in order to be prepared for the first IDMP reporting deadline . This first article reflects on IDMP IT System architectures options. Even though the scope for the first IDMP reporting is …
Read moreReflections on possible IDMP IT System Architecture options
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 …