This is a personal blog from Marijke Blaauwhof, Healthcare and Life Sciences Consultant at Deloitte.
“For the last 5 years, I have been interested in the life-sciences industry with a strong focus on supporting large transformations within the pharmaceutical organizations through-out the value chain. Having worked in the pharmaceutical industry prior to joining Deloitte, I had a clear drive to continue supporting clients in this area. When I read that Deloitte had acquired Iperion last year I was immediately intrigued.
Passion and drive
This was due to the fact that they not only serve clients in the pharmaceutical regulatory domain, an area I have never worked in before, but that they also have a great cliental network, top of the range experts and a team that has a true a passion and drive for what they do. Soon after I was lucky enough to get the opportunity to work with Iperion on some of their IDMP related projects. For the last couple of months, I have been supporting two different clients on the subject of IDMP implementation with the Iperion / Deloitte team where I mainly support in the project management and data governance work packages.
Not a one size fits all
Having no prior background or experience in regulatory affairs, and submission compliance projects within the Pharmaceutical industry, I knew there will be a lot of new things to learn especially on the subject of IDMP and data management, but also in general how the submission process works in collaboration with the regulatory bodies. When it comes to IDMP I quickly realized they are definitely a front runner in advising clients in implementation and IDMP requirements. I was amazed at how many different aspects there are to consider and elements that need to be in place when going through a submission process with the new IDMP standards. These IDMP projects can vary greater per organization and they have sometimes very different needs. Thus, making the solution not a one size fits all.
Typical elements within scope of the projects I support include, among others, advising on the technology architecture of the organization, investigating the organization’s IDMP data quality and approach to remediate as well as provide recommendations on typical processes and IDMP requirements needed to be fulfilled by a regulatory information management system. It was evident from the start of the projects how Iperion goes above and beyond to challenge and but also ensure they stand 100% behind what they advise. They ensure they are up to date on the latest development and foster collaboration not along across industry but also with regulatory bodies.
Exciting and evolving projects
What I really enjoy most about these projects, is the opportunity to be creative not only in how you implement IDMP and achieve compliance, but also strategizing with the client on how IDMP can bring further drive data standardization initiatives and benefits across the whole pharmaceutical continuum. Furthermore, there is always a need to bring different stakeholders along the journey of IDMP implementation to ensure IDMP is well understood and adopted within the organization. This mix makes these types of projects always exciting and evolving.
The Iperion / Deloitte team itself has made me feel incredibly welcome and it is evident how over the years this team has grown both in size and expertise into a great impactful team, with a fun working culture and great support system. As a tight-knot consultant team they always make sure there is ample time to knowledge share and learn from some of the top leaders in certain subject matters within regulatory.
I am looking forward to see Iperion / Deloitte continue to be a leader in IDMP, reach new heights in all their projects and continue to drive the data standardization agendas.”
Healthcare and Life Sciences Consultant – Organization Transformation at Deloitte
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