About: Dr. Andrew Marr - Managing Director
ISO IDMP is the next wave in the pharmacovigilance legislation after xEVMPD. But with a global scope and requiring data integration from the entire company it is a much bigger wave. In 2012, the five ISO standards referred to as “ISO IDMP” were approved. Their purpose is to standardise the identification of medicinal products, ultimately leading to improved pharmacovigilance across products, companies and jurisdictions. It has a global scope and in Europe for instance it will take effect by 2016.
1. What implications does ISO IDMP standard have for the pharmaceutical industry?
The main issue here is that the amount of information which is going to be required by the regulators to be provided that describes an authorised medicinal product is going to increase significantly. At the moment in Europe we have the xEVMPD standard and the IDMP will replace that in July 2016 and will be significantly larger. From the FDA perspective in the US, they will evolve the current version of the structured product labeling to include more information. That, however, will not be driven at the same speed as it is for Europe. So the main implication is about the increased provision of data. The issue, therefore, is where is that data in the company? Is it something that is immediately accessible?
2. What are the main practical challenges of IDMP compliance preparations?
There are two aspects with regards to this. The first aspect is the data itself; locating the data and making sure it is high quality. The second is the systems that might be needed either enhancing the ability to draw together the information internally within the company but also to deliver it to the regulators. For most companies, the technical challenges are relatively smaller compared to the data challenges; locating the data and assessing the quality format and then making it available as correct data types and of adequate quality.
3. How can an effective Master Data Management project be a critical input for IDMP compliance preparations?
I am not saying that Master Data Management is a critical input, however, it is certainly an advantageous thing to do. One of the issues that we have had throughout the previous cycles of provision of data is that companies generally have silos of information that are withheld in a business unit. It might be copied or modified to other locations. What Master Data Management does, is to provide the opportunity to identify or create an authoritative source of information that can be used throughout the company. In doing so though, it needs to be aligned with what the regulators want. And this gives the IDMP project the opportunity for a Master Data Management activity to run in parallel and gain some synergies. If the IDMP project goes on totally independent to the Master Data Management project then you could end up with conflicts. The IDMP project brings a large of data model, standard definitions and vocabularies that could be of great use to the pharmaceutical company in establishing standards for Master Data Management rather than reinventing the wheel. There is information in the standards and implementation guides that could really be of value and benefit to the company.
4. What would you like to achieve by attending the IDMP Compliance Challenge and Regulatory Information Management conference?
As a Speaker, Chair and Workshop Leader, what I am looking for is an audience that will engage in this, to question, to learn and share experiences. Mostly I think that for someone to attend the conference, they would have already recognised the necessity for and some of
the value of IDMP. What I think they can learn from this is how they can best explain to their organisations why things are important and share some of the best ways of approaching it. On a personal level, I am sure I will catch up with a lot of colleagues and people that I have worked with in the past and meet some new people as well.
Andrew P Marr, PhD, is Managing Director of Marr Consultancy Ltd, a consultancy firm established in 2011, that provides services to the pharmaceutical industry, software vendors and service providers to the industry, specialising in the Extended Eudravigilance Medicinal Product Dictionary (XEVMPD) and ISO Identification of Medicinal Products (IDMP). Previously Dr. Marr has worked for 27 years in Regulatory Affairs at GlaxoSmithKline and heritage companies, latterly in the role of Director of e-Regulatory Development. He has been involved heavily in numerous agency-industry initiatives on information exchange. He is currently a member of ISO Technical Committee 215, WG6 working on the development of the implementation guides for IDMP.
The IDMP Compliance Challenge and Regulatory Information Management conference will take place on the 11-13 February 2015 in Berlin.