A seat on the IDMP SPOR Task Force. An interview with Karen Harry, Director Regulatory Information Management at Parexel Informatics

As the industry-nominated representative for the IDMP Task Force Substance & Product subgroup back in 2015, I continue to be invested in the success of the Task Force and the potential impact it could have to drive change within the industry. As Karen Harry has recently taken a seat on it I decided to catch-up with her and hear what drives her.

Tell me a little bit about your background?

I spent over 25 years working in a Reg Ops team at one of the top 10 Pharma Companies. I was part of the team managing the RIM database and in 2008 we migrated our in-house database to InSight for Registrations. In this role I covered a host of responsibilities including definition of processes, user guidance and training and importantly user engagement and processes for managing changes in system scope as well as system upgrades and UAT. It was hugely revealing to understand the different user needs; across both central Regulatory and the local affiliates.

What was it that made you move from Industry to Parexel?

I had the opportunity to work with the Liquent team during the implementation;

“ their passion for the system, their subject matter expertise, and their customer focus meant that we were working together closely ”

They were invested in ensuring best practices were adopted throughout and they were a fantastic team to work with.  In early 2015 I was able to secure a Regulatory Consultant position in Jo English’s team at Parexel; this gave me the opportunity to use my InSight knowledge and experience to work with many clients and support them in their own InSight journey.

You recently took over the role leading the Parexel Business Consulting team, tell me about that team and what their role is?

The Business Consulting team is made up of a fantastic set of Regulatory SMEs who support clients by providing best practice recommendations. They are instrumental in successful client implementations to help clients understand the impacts of the changes for their business processes, configuration and user documentation. They also provide guidance in the use of new and existing functionality and analysis for any data remediation or migration efforts. We have SMEs across InSight Publisher and InSight for Registrations; most have previously worked in industry and all understand the scope of the deliverables, priorities and tight timelines that client project teams face during the implementation of a new system and with maintaining that user buy-in going forward. 

“ The team is customer focused and passionate about InSight and it's future capabilities to support ever increasingly complex regulations such as IDMP, EU MDR and EU CTR.”

With Sue Metz’s retirement I understand that you are now replacing her on the IDMP SPOR Task Force, can you tell me a bit about what that entails as a vendor?

Being a member of the SPOR Task Force provides the opportunity to work with IDMP SMEs across the Industry and to provide feedback to the EMA. There are regular meetings and we review the draft EU implementation guides and provide feedback and comments for consideration by the EMA. Being part of the Task Force also includes representation on other industry and vendor related forums (including the Inter-association Working Group & PMS Subgroup). I’m still finding my feet but because I work closely with a number of our clients for their IDMP needs, my position within the task force will reflect the discussions and needs that they have for a technology solution.

What impact do you think IDMP will have on the industry?

“ IDMP, along with several other initiatives such as UNICOM, will transform the way data is managed in the pharmaceutical industry ”

With the EU taking the lead and other countries following in their path, XEVMPD has paved the way for the Industry; establishing processes and resources to maintain the data set. There will be challenges not least of which will be the parallel submissions for XEVMPD and IDMP, as well as managing the data enrichment and understanding concepts such as Pharmaceutical Product, Manufactured Item and Packaged Medicinal Product. Ultimately, however, standardizing product data will result in positive outcomes; aligning IDMP submissions with the submission of the dossier, supporting cross boarder e-prescriptions and significant efficiencies in support of pharmacovigilance activities.

I know we can expect to see a lot from Liquent InSight over the coming months for IDMP, do you have any last remarks you would like to make?

You are right, we have been making great progress defining business & system requirements for IDMP iteration 1. Working with Product Management our IDMP SMEs have been scrutinizing the EU implementation guides to create in-depth requirements to update the data model to support new concepts and attributes that are introduced. This review also informs our business process best practices. Our business consulting team are leading workshops to support IDMP Education, Data Readiness, Remediation and Migration.

 Many thanks Karen, really looking forward to hearing more over the coming months!

Amy Williams, RIM Product Marketing Director