IDMP Field Notes: Compliance Trends in Q1 2015
With the European Medicines Agency (EMA) date for compliance to IDMP (Identification of Medicinal Products) looming, Q1 2015 has seen a significant increase in IDMP activity. Both Informatica & HighPoint Solution’s IDMP Round Table in January, and a February Marcus Evans conference in Berlin provided excellent forums for sharing progress, thoughts and strategies. Additional confidential conversations with pharmaceutical companies show an increase in the number of approved and active projects, although some are still seeking full funding. The following paragraphs sum up the activity and trends that I have witnessed in the first three months of the year.
I’ll start with my favourite quote, which is from Dr. Jörg Stüben of Boehringer Ingelheim, who asked:
“Isn’t part of compliance being in control of your data?”
I like it because to me it is just the right balance of stating the obvious, and questioning the way the majority of pharmaceutical companies approach compliance: A report that has to be created and submitted. If a company is in control of their data, regulatory compliance would be easier and come at a lower cost. More importantly, the company itself would benefit from easy access to high quality data.
Dr. Stüben’s question was raised during his excellent presentation at the Marcus Evans conference. Not only did he question the status quo, but proposed an alternate way for IDMP compliance: Let Boehringer benefit from their investment in IDMP compliance. His approach can be summarised as follows:
- Embrace a holistic approach to being in control of data, i.e. adopt data governance practices.
- This is not about just compliance. Include optional attributes that will deliver value to the organisation if correctly managed.
- Get started by creating simple, clear work packages.
Although Dr Stüben did not outline his technical solution, it would include data quality tools and a product data hub.
At the same conference, Stefan Fischer Rivera & Stefan Brügger of Bayer and Guido Claes from Janssen Pharmaceuticals both came out strongly in favour of using a Master Data Management (MDM) approach to achieving compliance. Both companies have MDM technology and processes within their organisations, and realise the value a MDM approach can bring to achieving compliance in terms of data management and governance. Having Mr Claes express how well Informatica’s MDM and Data Quality solutions support his existing substance data management program, made his presentation even more enjoyable to me.
Whilst the exact approaches of Bayer and Janssen differed, there were some common themes:
- Consider both the short term (compliance) and the long term (data governance) in the strategy
- Centralised MDM is ideal, but a federated approach is practical for July 2016
- High quality data should be available to a wide audience outside of IDMP compliance
The first and third bullet points map very closely to Dr. Stüben’s key points, and in fact show a clear trend in 2015:
IDMP Compliance is an opportunity to invest in your data management solutions and processes for the benefit of the entire organisation.
Although the EMA was not represented at the conference, Andrew Marr presented their approach to IDMP, and master data in general. The EMA is undergoing a system re-organisation to focus on managing Substance, Product, Organisation and Reference data centrally, rather than within each regulation or program as it is today. MDM will play a key role in managing this data, setting a high standard of data control and management for regulatory purposes. It appears that the EMA is also using IDMP to introduce better data management practice.
Depending on the size of the company, and the skills & tools available, other non-MDM approaches have been presented or discussed during the first part of 2015. These include using XML and SharePoint to manage product data. However I share a primary concern with others in the industry with this approach: How well can you manage and control change using these tools? Some pharmaceutical companies have openly stated that data contributors often spend more time looking for data than doing their own jobs. A XML/SharePoint approach will do little to ease this burden, but an MDM approach will.
Despite the others approaches and solutions being discovered, there is another clear trend in Q1 2015
MDM is becoming a favoured approach for IDMP compliance due to its strong governance, centralised attribute-level data management and ability to track changes.
Interestingly, the opportunity to invest in data management, and the rise of MDM as a favoured approach has been backed up with research by Gens Associates. Messers Gens and Brolund found a rapid increase in investment during 2014 of what they term Information Architecture, in which MDM plays a key role. IDMP is seen as a major driver for this investment. They go on to state that investment in master data management programs will allow a much easier and cost effective approach to data exchange (internally and externally), resulting in substantial benefits. Unfortunately they do not elaborate on these benefits, but I have placed a summary on benefits of using MDM for IDMP compliance here.
In terms of active projects, the common compliance activities I have seen in the first quarter of 2015 are as follows:
- Most companies are in the discovery phase: identifying the effort for compliance
- Some are starting to make technology choices, and have submitted RFPs/RFQs
- Those furthest along in technology already have MDM programs or initiatives underway
- Despite getting a start, some are still lacking enough funding for achieving compliance
- Output from the discovery phase will in some cases be used to request full funding
- A significant number of projects have a goal to implement better data management practice throughout the company. IDMP will be the as the first release.
A final trend I have noticed in 2015 is regarding the magnitude of the compliance task ahead:
Those who have made the most progress are those who are most concerned about achieving compliance on time.
The implication is that the companies who are starting late do not yet realise the magnitude of the task ahead. It is not yet too late to comply and achieve long term benefits through better data management, despite only 15 months before the initial EMA deadline. Informatica has customers who have implemented MDM within 6 months. 15 months is achievable provided the project (or program) gets the focus and resources required.
IDMP compliance is a common challenge to all those in the pharmaceutical industry. Learning from others will help avoid common mistakes and provide tips on important topics. For example, how to secure funding and support from senior management is a common concern among those tasked with compliance. In order to encourage learning and networking, Informatica and HighPoint Solutions will be hosting our third IDMP roundtable in London on May 13th. Please do join us to share your experiences, and learn from the experiences of others.