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Regulatory Information Management: It's time to harness the true value of your data

Complete your journey from paper to data with expert advice from Regulatory Authorities, IDMP and SPOR Taskforce members, and industry leaders

The Key to your digital data being IDMP Ready

SPOR and IDMP updates: Meet the deadlines
  • Get insights on the implementation guidelines: Scope, requirements and advice for the industry
  • Substance Management: Hear the latest experience and views from the Medicines Evaluation Board to ensure you're up to date
  • Understand the future of data: IDMP for business management, not just compliance
  • OMS systems: Secure best practices for implementation and understand how it links to other regulatory processes
Learn, streamline, improve: Build a complete RIM database
  • Obtain the tools you need to deliver a new RIM platform with leading case studies from Merck and Roche 
  • Examine the key concepts of structured authoring with case study examples of the benefits it brings to a regulatory organisation
  • Understand how a Target Operating Model (TOM) can enable higher quality data and consistency with feedback from the Stakeholder Implementation Group
  • Discover new opportunities for regulatory automation by effectively leveraging AI with Boehringer, Cunesoft and Gilead Sciences 
Get your RIM system ready for horizontal regulations
  • Get the latest updates, guidelines and feedback on HL7 FHIR with Bayer
  • Is your system all set for the Clinical Trial Portal? Assess the connection between serialisation activities and RIM with Grünenthal GmbH
  • Breaking down silos: Join the panel discussion to find out how industry can make the shift to an integrated way of working

  • Hear the latest updates on CESSP and the impact on IDMP

Regulatory Information Management: What's on?

SPOR | An update on the implementation guides: Scope, requirements and advice for industry
  • Walking through the implementation guides step by step
  • Assessing how the implementation guides are being interpreted
  • Industry feedback on the draft implementation guides
  • An update from the task force on expected time-lines Lack of available guidance for iteration one

Patrick Middag, Associate Director, Regulatory IT, Bristol-Myers Squibb, Belgium

PANEL DISCUSSION | Target Operating Model (TOM): Assessing the benefits of the TOM for the industry
  • Understanding the extent to which TOM will enable higher quality data with a higher level of consistency
  • Understanding how the data is going to be submitted and when it is going to be assessed
  • Feedback from the stakeholder implementation group

Patrick Middag, Associate Director, Regulatory IT, Bristol-Myers Squibb

Laurent Lefebvre, Regulatory CMC Associate Director - RA, Novartis Pharma AG

ISO IDMP related implementation at and by the regulator - MEB experience and views on substance management
  • Progress on the implementation of IDMP substance management through EU-SRS
  • Views of a National Competent Authority on the role of data in regulatory exchange
  • Relation of standards to the telematics plan of the MEB
  • Discussing the status of SMS implementation in the EU

Joris Jampmeiher, CIO, Medicines Evaluation Board

PANEL DISCUSSION | Redesigning the regulatory landscape: Assessing the paradigm shift from today´s standard way of working towards a data-driven future
  • Examining the move in industry from a document to data driven approach
  • Assessing the best approach for structured content authoring from a business point of view
  • Understanding how to get insight out of your data towards a more flexible data model
  • How can industry shift from a siloed to an integrated way of thinking and working?

Vada A Perkins, Global Regulatory Policy & Intelligence, Bayer

Rodrigo Palacios, PTR Global Head for Business Systems, Roche

Conference Workshop: Filing Variations

Join our full day Filing Variations workshop on 23rd of April, with Sumaiya Patel, a director of a regulatory consultancy with over 11 years’ experience in both pre and post approvals for generic, CRO and big pharma organisations.

Run by Pharmaceutical Training International, our official training partner, this workshop will provide you with the knowledge necessary to ensure speedy regulatory approval and filing variation procedures that are cost-effective.