IDMP Ontology Training Recordings 2025

Available on demand from February 21, 2025, this training composed of 5 pre-recorded webinars, will enable you to effectively utilize IDMP-O and ensure regulatory compliance.

The IDMP-O training is designed to equip you with a comprehensive understanding of how the IDMP Ontology addresses complex challenges inherent in the IDMP domain. Delivered by the creators of the IDMP Ontology, this training will provide you with expert insights into the ontology’s structure, usage, and benefits, enabling you to effectively utilize it to streamline processes, enhance data interoperability, and ensure regulatory compliance within the pharmaceutical industry. Upon completing the course, participants can apply to join a one-year partnership program that includes accreditation to provide IDMP-O training consultancy.

Speakers

• Raphael Sergent, Head of QA & Pharma, Solutions Lead, Accurids
• Sheila Elz, Master Data Manager, Bayer
• Fabian Muttach, Regulatory Information Manager – Global Regulatory Affairs, Boehringer Ingelheim
• Joerg Stueben, Head of Regulatory Information, Management and Senior Expert, Boehringer Ingelheim International GmbH
• Max Fink, Associate Data Engineer, Boehringer-Ingelheim
• Prity Kumari, Business Consultant Quality, Data Engineer, Boehringer-Ingelheim
• Ulrich Kies, Senior 3rd Party Manager, Boehringer-Ingelheim
• Jeanneke Spruit, Junior Manager Regulatory Information Management, Deloitte
• Remco Munnik, Director – Deloitte Life Science & Healthcare, Deloitte
• Elisa Kendall, Lead Ontologist, EDM Council
• Norman Schmuff, Associate Director in FDA
• Aditya Tyagi, Project Manager, Pistoia Alliance
• Asiyah (Yu) Lin, Senior Data Scientist, Pistoia Alliance

Module 1: Introduction to IDMP (85 mins)

1. IDMP: Identification of medicinal products.
2. Impact of IDMP on patients, industry, and regulators.
3. IDMP in Europe: SPOR.
4. IDMP in Europe: EMA’s agile implementation.
5. From regulatory documents to data.
6. ROG: The Regulatory Optimization Group.
7. How to incorporate IDMP in your business.
8. IDMP ontology and implementation challenges.

Module 2: IDMP-O Overview and Benefits (81 mins)

1. IDMP and regulatory compliance.
2. Benefits of IDMP implementation using IDMP-O.
3. IDMP data elements and standards addressed with IDMP-O.

Module 3: Getting Started with IDMP-O (91 mins)

1. Introduction to the IDMP-O project.
2. IDMP ontology development (methodology).
3. How to implement IDMP-O in your company.
4. End-to-end data mapping.
5. Solving pain points.

Module 4: Use Cases (77 mins)

1. Overview of methodology to build and implement based on pain points and use cases.
2. Implemented case studies: EMA PoC – shortages.
3. Supply chain use case.
4. Structured CMC and PQ/CMC.

Module 5: IDMP-O Dependencies and Implementation Guide (67 mins)

1. Pharma implementation guide.
2. IDMP-O dependencies – Pistoia Alliance network of ontologies.
3. Expanding global usage of IDMP standards for patient safety, including IDMP-O in PRISM, RWE, and AI.
4. Use cases.

Prices

• Members: $250
• Non Members: $500

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