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Leverage Submission Standards and Data Standards to Drive Operational Improvements

November 13-14, 2017
  • Alexandria, VA

CBI’s Global Regulatory Summit provides a forum for industry stakeholders to discuss key challenges related to the electronic submission of regulated product information. At a strategic level, the conference is focused on the global management of electronic data and connecting standards to actual use cases and content. At a tactical level, our aim is to provide an opportunity for a deeper discussion on how to implement regulatory standards.

EXPERT COMMENTARY PROVIDED
ON KEY ISSUES INCLUDING:

  • Submitting INDs in eCTD Format
  • Building a Regulatory Operations
    Roadmap for New Submissions
  • Creating Multi-Stakeholder Teams to
    Support Product Submissions Globally
  • Controlling and Managing Data to Ensure
    it is Used Accurately and Appropriately
  • Filing Promotional Material and
    Labeling Electronically
  • Capturing the Value of IDMP and
    SPOR Beyond Regulatory Adherence

* Global Regulatory Submissions has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Previous Attendee Acclaim:

The presenters at the IDMP Update Forum have a finger on the pulse of IDMP and its impact on the Pharma Industry.

Regulatory & Safety Director, AbbVie

The program was very good — The respected industry names were there. It was extremely well formatted and
CBI was very professional.

Associate Director, Enterprise Data Management, Bristol-Myers Squibb

Global Regulatory Summit

Leverage Submission Standards and Data Standards to Drive Operational Improvements

CBI’s Global Regulatory Summit provides a forum for industry stakeholders to discuss key challenges related to the electronic submission of regulated product information. At a strategic level, the conference is focused on the global management of electronic data and connecting standards to actual use cases and content. At a tactical level, our aim is to provide an opportunity for a deeper discussion on how to implement regulatory standards.

EXPERT COMMENTARY PROVIDED
ON KEY ISSUES INCLUDING:

  • Submitting INDs in eCTD Format
  • Building a Regulatory Operations
    Roadmap for New Submissions
  • Creating Multi-Stakeholder Teams to
    Support Product Submissions Globally
  • Controlling and Managing Data to Ensure
    it is Used Accurately and Appropriately
  • Filing Promotional Material and
    Labeling Electronically
  • Capturing the Value of IDMP and
    SPOR Beyond Regulatory Adherence

* Global Regulatory Submissions has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Previous Attendee Acclaim:

The presenters at the IDMP Update Forum have a finger on the pulse of IDMP and its impact on the Pharma Industry.

Regulatory & Safety Director, AbbVie

The program was very good — The respected industry names were there. It was extremely well formatted and
CBI was very professional.

Associate Director, Enterprise Data Management, Bristol-Myers Squibb