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 Plan ahead for IDMP compliance - Are you ready for July 2016?

Pharmaceutical companies must start preparing for Identification of Medicinal Products (IDMP) compliance before the European Medicines Agency (EMA) finalises the guidance documents by the end of 2015.

 

"There is increased awareness around the topic of IDMP in preparation for compliance by July 2016. The challenge is, how can companies begin to prepare when the guidance documents will not be available until the end of 2015?" asks Lior Keet, Vice President, Life Sciences R&D Practice, Highpoint Solutions.

 

"The ISO standards on IDMP are finalised, although which components and attributes will be mandatory vs. optional for each regional regulatory body are not. At this stage, companies can perform data gap analysis, take existing product data information and start to map it to the ISO standard and implement appropriate infrastructure to manage the data. If they can expend significant effort upfront, they will not have to rush the process later on," he explained.

 

Highpoint Solutions is a Gold Sponsor with Informatica at the marcus evans IDMP Compliance Challenge and Regulatory Information Management Conference taking place 11-13 February 2015.

 

Asked why pharma should approach IDMP from a Master Data Management (MDM) perspective, Keet says that most companies have product data residing in different formats and systems across the enterprise, which should all be integrated.  

 

"MDM is the most appropriate tool to use in order to aggregate that data, augment and add data to the existing data structures, to centralise the information, as well as provide a means for the IDMP submission management tool to pull the data from the MDM hub for reporting purposes. The hub in essence will be the repository of all product related information that is already aligned to the IDMP ISO standard," he detailed.  

 

In the 18-month window that pharma companies have, a very practical approach towards IDMP compliance is a must. "Focus your efforts on one segment of the enterprise at a time," Keet advised. "Focus on R&D first, where the level of IDMP awareness is more mature. Then progress data analysis to the other groups. Domain expertise is needed to operationalise the ISO standard for business purposes. Establish a governance committee with a focus on implementing or initiating the IDMP initiative - a cross-functional team of people who will monitor and evaluate the efforts towards compliance. Extend the knowledge beyond the core group because IDMP is definitely going to be a long-term journey that changes over time. IDMP should become part of the DNA of your organisation."

 

Highpoint Solutions and Informatica are Gold Sponsors at the marcus evans IDMP Compliance Challenge and Regulatory Information Management Conference. For more information on the event, visit the following website

 

 







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