The ultimate scope of IDMP is as big as ever and companies do need to plan for how to deal with IDMP in the longer-term
The session, Assessing Authorities’ & Companies’ Progress Towards the IDMP, hosted by ProductLife Group & featuring expert commentators, set out a new plan of action for the life sciences industry for adopting the new global ISO standard
Paris, France - July 7th, 2015 – A webinar hosted last week by life sciences outsourcing and consulting services specialist ProductLife Group as part of its Evolve thought leadership programme, has set out a new, updated roadmap for pharma organisations preparing for IDMP compliance.
The webinar, featuring the latest advice from three expert commentators on regulatory and data standards requirements, discussed the revised timelines being agreed for the transition to the new global ISO standard, Identification of Medicinal Products (IDMP). This had been due to replace the current eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) by July 2016.
Although no new official deadline has been formally announced, the July 2016 target is now seen as unrealistic. This is due to a number of practical hurdles including the delayed availability of ISO Implementation Guides which are still being revised and updated. It is likely to be January 2016 at the earliest before agreed ISO guidelines start to become available and as late as August 2016 before the final version of the ISO guideline on substances is complete. European guidance for the first stage of implementation for medicinal products will be available in the first quarter of 2016 and for substances in the second quarter of 2016.
The next step is for the European Commission to respond to the new proposals for a phased implementation, which will go before the Heads of Medicines Agencies on July 7.
Discussing the evolving timeframe, speakers Romuald Braun, Vice President of Strategy for Life Sciences at INFOTEHNA Group; Andrew Marr, Managing Director of Marr Consultancy; and Erick Gaussens, Chief Scientific Officer at ProductLife Group agreed that a revised roadmap would be beneficial for companies. It will give organisations more time to adapt the requirements for their own strategic benefit, and favours a phased approach which will be more realistic and manageable to achieve, they said.
Each speaker warned against seeing this as an opportunity to put IDMP preparation efforts on hold.
“The EMA and NCAs are confident that the European Commission will accept the new proposals when they are agreed by the Heads of Medicines Agencies,” said Andrew Marr. He is coordinating vendor and expert input to the EU ISO IDMP Task Force, which provides recommendations to the European Medicines Agency and national competent agencies (NCAs) – ie those making the decisions on the implementation of the new standards.
“In the meantime there is only one real plan being developed, which is to push forward with phased but dependent implementations for products, substances, organisations and referentials [vocabularies],” he noted.
The benefit of the new phased approach and revised timelines, he said, will be “more effective change management; better adoption of the new operating model; the chance to achieve a sustained higher quality of data; and the chance to forecast the necessary resources appropriately.”
Instead of one huge, overwhelming programme of work, organisations can now think in terms of 4-5 distinct projects with more realistic timelines and more easily defined scope – “creating the basis for real projects and planning, especially for those companies which have not yet started their IDMP journey.” For those with plans already underway, the revised implementation plan offers an opportunity to review whether they are doing things in the right order, he added.
Commenting for ProductLife Group, Erick Gaussens said, “Everyone will benefit from extra time to think, prepare and budget for IDMP. There is now plenty of opportunity for all parties to consider their roles and responsibilities.”
Romuald Braun of INFOTEHNA Group advised organisations to start now to ensure they are “on target without any of the hassle,” adding that it will be essential for companies to design and test business processes with real users, real data and real IDMP solutions. “By September 2015 you could have a first pilot underway with one product, and have begun expanding that and developing the integration by February 2016, so that by April you have something that’s thoroughly tested and even ready to use,” he said.
Having additional time to get the basics right means organisations also have an opportunity to explore scope for additional internal efficiency wins for their businesses, through greater automation and streamlining of information management processes.
The new IDMP standards were originally intended to aid identification of substances and medicines for pharmacovigilance purposes; the scope has grown however and there is now growing interest in using IDMP data for broader healthcare purposes. “The ultimate scope of IDMP is as big as ever and companies do need to plan for how to deal with IDMP in the longer-term,” Marr noted.
About ProductLife Group
ProductLife Group is the leading, proven and trusted pan-European specialist outsourcing services provider for the Regulatory, Safety and Quality functions of the Life Sciences and Cosmetics industries. Through the optimum deployment of people and intellectual assets we enable our clients to achieve greater R&D effectiveness; significant cost reduction in capital and revenue terms; and improved operational speed and efficiency at the highest quality. These performance-enhancing improvements are delivered through a blend of the highest quality people and services comprising In-sourcing, Functional outsourcing, Strategic Business Process Outsourcing and Consultancy based on deep domain expertise and thought leadership. More at ProductLife Group or follow us on Twitter at @ProductLife_EU
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