Celegence/Qdossier participated as exhibitors and speakers during this year’s Regulatory Submissions, Information, and Document Management Forum (RSIDMF) from February 13-15, 2023, in Bethesda, Maryland.

Celegence Presentations, Short Courses & Other Contributions throughout the forum included the following:

• Short Course: On the Road to an EU Filing: Getting Familiar with Critical EMA IT Systems
• Welcoming: Welcoming Remarks and Presentation of the Excellence in Service Award
• Session 7 Track 1: New Developments in RIM Reference Model and IDMP Semantics
• Session 8 Track 1: IDMP Ontology: Semantic Interoperability Throughout the Entire Medicinal Product Lifecycle
• Session 10 Track 2: Along the Path of Drug Approval; A Hodgepodge of Correspondence With the FDA, EMA Support for SMEs and ICH M11 CeSHarP

Qdossier’s Director of Regulatory Information Management and Program Chair for RSIDM’s Regulatory Informatics tracks, Michiel Stam took part in many of the sessions and talks throughout the forum and connected with the speakers, exhibitors, sponsors and delegates.

He also had fruitful discussions with industry’s top regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related systems.

Here are Michiel Stam’s Key Takeaways from the RSIDM Forum 2023:

• Speed & Agility: Speed and agility are critical to save cost and bring benefits to patients faster. Ulo Palmer already kicked off the conference on Monday emphasizing this. This means we must be able to make better informed decisions faster, which are based on high quality data according to F.A.I.R. principles (Findable, Accessible, Interoperable and Reusable).
• IDMP: IDMP is seen as an important catalyst by both Regulators and Sponsors. Many plan to use the IDMP model as the basis for setting up supporting data governance and data management frameworks. The HL7 FHIR messaging format will enable interoperability for IDMP data beyond the own organization, in exchange with Health Authorities. This interoperability can be extended to the Health Care domain, by connecting IDMP data with other data sets sharing the same FHIR resources.
• Global Terminologies: At the same time, various implementation efforts have made us realize that it is not possible to achieve global interoperability using the IDMP standard and the FHIR messaging format alone. Global terminologies do not exist and within the Enterprise there are no common standards across the different data sources; there is a lack of semantic interoperability.
• Reference Data Management: As global standardization is not an option, Reference Data Management using semantic technology can enable us to manage complex terminologies beyond single controlled vocabularies. For this purpose, the Pistoia Alliance is developing the IDMP ontology, which will allow data to meet the F.A.I.R. principle.
• Structured Data: Our hunger for structured data is not satisfied by IDMP data alone, as there is more information in a regulatory dossier than what gets covered by IDMP. There are other initiatives to manage data complementary to IDMP, such as the Digital application dataset (DADI) or PQ CMC.
• Reliance on Documents: Yet, the reality of today is that we are almost solely relying on documents. Structured data only submissions are currently more aspirational. There is still a lot of work to be done before we arrive at a truly data driven approach.
• Barriers to Overcome: There are financial, technological, political and maturity barriers to overcome before we are fully able to upgrade to Regulatory 3.0. Let us make no mistake about what a data driven approach means; it means data first and documents second. Therefore, it is NOT about finding more efficient solutions to take the data from the documents we created in the first place.
• Gradual Transition: We are in a gradual transition from documents to data. At the end of the road, it is still expected that we will have narrative text to make the claims and provide justifications based on structured data that we present.
• Group of Motivated Individuals & Groups: Growing It is very encouraging to see that there is an ever-increasing group of motivated individuals and organizations, such as Accumulus, the Pistoia Alliance and our own DIA community, which also includes sponsors and vendors that are determined to drive this transition.

Celegence provides the pharmaceutical industry with consulting services and technology solutions that are tailored to the evolving operational and strategic needs of manufacturers in areas such as RIMS data management, publishing and medical writing. We can assist you throughout the entire product life cycle to ensure that you and your organization are compliant with all global pharmaceutical regulatory requirements.

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