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Regulated Product Submissions

Regulated Product Submissions. Update September 19, 2007 Jason Rock Jason.Rock@GlobalSubmit.com 856.854.4455. Goal. Create one model that can be used for the submission of any regulated product

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Regulated Product Submissions

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  1. Regulated Product Submissions UpdateSeptember 19, 2007 Jason RockJason.Rock@GlobalSubmit.com 856.854.4455

  2. Goal • Create one model that can be used for the submission of any regulated product • Create a framework that will allow sponsors to send regulatory information using predefined parameters to identify and catalog their content • Reviewers will be able to consistently locate discipline specific information

  3. Out of Scope • Document content will not change • Documentation submitted today will be the same documentation submitted tomorrow • Must work within existing business processes • We hope since Applicants and Regulatory Authorities from varied product types are talking we can learn from each other and enhance our process as it suits our needs

  4. Use • Animal and Human products • Including but not limited to food additives, human therapeutics, veterinary products, and medical devices • Worldwide use • Same model for all product types to all regulatory authorities

  5. Keys to success • Keep it simple • Flexible model that handles all regulated products • Incorporate lessons learned from past electronic submission experience • Multi-national Industry and Government involvement • Promote project to raise visibility

  6. Work to date • RPS Project initiated June 22nd 2005 • Leveraged existing Human Pharmaceuticals experience (ICH/eCTD) • Draft Standard for Trial Use (DSTU) • Ballot Passed May 1st 2006 • 23 Storyboards (requirements for specific regulatory functions) • Defined 6 entities and numerous properties • Message model (13 Acts) • Documented RMIM (introduction and walkthrough) • Distributed sample message • Testing kick-off June 18th 2006 • First test submission submitted to FDA Sept. 2006 • Harmonized with BRIDG March 2007 • Normative May 2007 • 21 Storyboards (requirements for specific regulatory functions) • Message model (11 Acts)

  7. Review of BRIDG/RPS

  8. Working On • Implementation Guide • Release 1 implementation • Release 2 not being worked on right now

  9. Release 2 Possibilities • Two-way communication • Minutes and general correspondence (related to two-way communication) including pre-submission information • Referencing • in backbone (Master Files, Other submission/application, Presubmission) • Hyperlink content to other content • Provide information about the submission (e.g. information currently collected on application forms) • information about the product • Contact Information • Facility relationship (submission for a facility instead of a product) • Work with electronic signatures

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