To streamline their operations and meet IDMP regulatory requirements, organizations need to invest wisely.
In my previous post, I discussed the challenges to European pharmaceutical companies preparing to comply with the Identification of Medicinal Products (IDMP) standards mandated by the European Medicines Agency (EMA). A company’s exact roadmap to compliance will vary depending on its unique circumstances and priorities, but to prepare for the July 1, 2016 deadline, all companies will need to proceed through a distinct series of steps:
1.Structure your project
The first thing companies must do is formalize the language and architecture of the project. With so many teams within an organization involved, it’s important that there’s a way to express, interpret and communicate the project requirements between stakeholders, and then orchestrate the solution development and subsequent execution logically and efficiently. Using unified modeling language (UML) to visualize the system and its attributes, and an accompanying enterprise architecture (EA) framework can help teams coordinate and structure the overall effort.
2. Engage your team
Organizations also need to ensure awareness and engagement at all levels of affected departments. This might mean conducting one-to-one interviews or workshops with executive and operational staff, conducting training or developing self-training materials
3. Evaluate the environment
A third step for companies is to define the as-is and to-be organization, processes and systems that govern and hold IDMP data. The sorts of questions that must be asked include:
Which of our existing downstream systems is it feasible to preserve?
Where in the solution will data be created, how will it be stored, how will it be published and at what point will IDMP-compliance be ascertained?
How do we provide secure, robust access to third-party providers?
To what extent is the solution expandable and future-proof?
4. Evaluate the data
Companies must also assess their submission readiness—format, location completeness and compliance—of the data pertaining to existing products. Two factors need to be considered:
Collation. This process includes gathering the required source-data together, merging fields and domains from different sources, reviewing software and hardware compatibility and transcribing paper records.
Compliance. The accumulated data must be evaluated for compliance with the five ISO standards, to determine what changes must be made before the data is submission-ready.
5. Define your solution
Finally, companies must establish the overall requirements and specifications of their solution and define a plan that will take them there. Although software applications to actually interact with an EMA portal and make submissions cannot be finalized or tested until the agency's specifications have been released, the short timeframe makes it essential that companies detail as much of their proposed solution as possible up front.
While steps 1 and 5 must come first and last, respectively, the remaining three steps do not need be completed in sequential order. Companies can tackle them in parallel throughout the assessment project, based on their inter-dependency and scale.
To implement the systems and processes required for IDMP, organizations will have to make substantial investments, up to tens of millions of dollars for some larger pharmaceutical companies. However, provided companies address each of the five steps described here, they will be more than justified in their investment—by meeting IDMP regulatory compliance, streamlining operations and gaining the ability to expedite adoption of subsequent standards