Our past conferences have been packed full of valuable information and outstanding networking opportunities, and we know this year will continue the tradition. Welcome to our 4th Global IDMP Working Group (GIDWG) Stakeholder Meeting that is now preliminary planned for third week of September 2024 and will be hosted by Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, Anvisa) in Brazil.
End-to-End Demonstration Q4 2023 – Q2 2024
Testing of use cases for PhPID operating model
PURPOSE:
Testing framework, including business rules, best practices, software and operating model, for the global IDMP implementation and maintenance of global identifiers for marketed products.
SCOPE:
•Validate and generate PhPIDs for medicinal products based on GIDWG/EWG Business Rules
•EDQM + non-EDQM countries
•Similar products from different countries
•Larger batches & smaller data sets for regulators
•Testing of Pharmacovigilance, Drug Shortages and Cross-border Healthcare use cases
STATUS: ongoing
Video: PhPID Explained
Produced by Uppsala Monitoring Centre (UMC), this film gives an overview of how Pharmaceutical Product Identifiers (PhPIDs) are created and assigned to medicinal products.
PhPIDs are a key part of the IDMP standards and will have a significant impact on how pharmacovigilance is carried out, and will contribute to the safer use of medicines globally.
19-20 October: CTADHL sixth trans-Atlantic workshop.
Focusing on CTADHL’s objectives, the sixth Trans-Atlantic Workshop will again bring
together experts engaged in the various aspects of IDMP implementation across the globe –
from product development to regulatory processes, dissemination, clinical use, and
utilisation & outcome assessments.
18 October: Global IDMP Working Group (GIDWG) Stakeholders Public Meeting
Welcome to our 3rd Global IDMP Working Group (GIDWG) Stakeholder Meeting.
The GIDWG’s mission is to conduct and report on projects leading to the establishment of a framework for the global implementation of the ISO IDMP standards and maintenance of global identifiers.
The GIDWG will report on 5 pilot projects (1. Substance Identifiers, 2. Dose form Identifiers, 3. Strength Definitions Identifiers, 4. Operational Model, and 5. FHIR for information exchange) for global use cases including Pharmacovigilance, Drug Shortages and Cross Border Healthcare.
Please find presentations from the public meeting below:
IDMP Webinar – Current status and the road to implementation
Uppsala Monitoring Centre (UMC) believes that IDMP represents a game-changing development in the world of pharmacovigilance by establishing a common language and facilitating the effective exchange of vital medicinal product data across the entire drug development and regulatory lifecycle. By enabling harmonized data exchange, IDMP enhances our ability to identify, evaluate, and mitigate risks associated with medicinal products. In an open, 1 hour webinar on 14 June 2023, UMC will welcome interested parties to learn more about the current status of IDMP and how various global stakeholders, including UMC, are collaborating to implement the standards and make them a reality.
UPDATE: Recordings of the webinar are now available – see below
Podcast explains IDMP standards
The Identification of Medicinal Products (IDMP) standards promise to harmonise how pharmaceutical products and substances are described around the world. But how will that benefit patients and who will make sure the standards are properly implemented? Uppsala Monitoring Centre’s Malin Fladvad and Olle Lagerlund join the Drug Safety Matters podcast to discuss the advantages and challenges of this global standardisation effort.
23-25 October: Global Pharmaceutical Regulatory Affairs Summit
From 23-25 October 2023, UNICOM will be presenting all the results of WP2 related to substances. For more details, see the UNICOM website.
US FDA guidelines on IDMP implementation
The US Food and Drug Administration (FDA) has released a guideline on IDMP for industry entitled “Identification of Medicinal Products—Implementation and Use”. This guidance explains FDA’s position and progress on aligning the Agency’s standards to Identification of Medicinal Products (IDMP) standards.
Identification of Medicinal Products—Implementation and Use – March 2023 [PDF]
UNICOM working paper on IDMP in ICSRs
A key UNICOM aim is to improve the processing and analysis of individual case safety reports (ICSR) that describe one or more suspected adverse drug reactions (ADRs) that occur in a single patient. To this end, the organisation has released the working paper “IDMP Coding Principles and Guidance for ICSRs“.
The working paper provides recommendations for practical IDMP implementation aspects (for example, PhPID generation) and for handling drug information in general (such as grouping concepts, use of name parts), aimed at improving ICSR data management and pharmacovigilance analysis.