Earlier this month OpenText customers from Americas and Europe gathered at the OpenText™ Documentum™ for Life Sciences user group and discussed Identification of Medicinal Products (IDMP) 2.x rollout and how they can get ready. Industry analyst, Kelly Hnat, from K2 Consulting, a member of the Core Research Team for the Gens & Associates World Class RIM survey brought her industry expertise in discussion with Sunetra Ray from OpenText Life Sciences Product Management.
Understanding ISO IDMP and its evolution
IDMP is on the mind of Life Sciences organizations worldwide, especially those operating under the governance of the European Medicines Agency (EMA). ISO IDMP standards establish a consistent way to represent medicinal and pharmaceutical products across geographies. Regional Health Authorities adopting IDMP will have the ability to share data in support of public health to improve pharmacovigilance, regulatory efficiency, and patient access to medicines and information.
A quick poll of the audience revealed that most are at the beginning of their IDMP journey—some have not started, some are in discovery mode, or others have started preparing the data. Kelly provided insights into how EMA’s implementation of IDMP is evolving, and what’s involved in the new structured data submission requirements.
Solving industry compliance challenges
The discussion also included the new web-based form Digital Application Dataset Integration (DADI) and how it is going to impact future submissions. Preparing for this, Life Sciences organizations are looking inwards to their existing infrastructure to support the accurate completion of DADI forms. Some of the customers provided insights into how they are currently managing the master data, and how they plan to change that in the future in the light of IDMP 2.x rollout.
During the user group, Product Manager Sunetra Ray explained the multi-faceted approach for OpenText Documentum for Research and Development taking advantage of IDMP implementation to bring efficiencies and business process simplification. Dictionary updates with controlled vocabularies, auto-cascading of IDMP metadata, efficient IDMP keyword-based searches bring efficiencies and consistency across systems. She also discussed the future vision of the product aligning with the IDMP rollout and industry adoption of the same beyond EMA.
Audience members shared their approach to keep their EDMS metadata consistent with their IDMP data hub, and how they plan to reuse the gathered structured product data bringing new perspectives to the discussion. The user group concluded after some sharing of current experiences.
The Documentum for Life Sciences User Group will reconvene on September 14 to discuss the topic of securing prints from unauthorized access within manufacturing environments. You can subscribe to the user group by registering to the next session.