HL7 RCRIM Regulated Product Submissions

Transcription

1 HL7 RCRIM Regulated Product Submissions Dr. Georg Heidenreich For internal use only / Copyright Siemens AG All rights reserved.

2 Contents Regulated Product Submission Health Level 7 (HL7) Development Harmonization Activities

3

4 Regulated Product Submission (RPS) Goal Create one standard (exchange message) that can be used for the submission of any regulated product Release 1 Provide a flexible framework that will allow sponsors to send regulatory information using predefined parameters to identify and catalog their content Enables Reviewers to consistently locate discipline specific information & data Allows for the cross-reference of previously submitted material Release 2 Standardize Submission Response (i.e.; two-way communication) Facilitate the processing of submissions and correspondence

5 Goal: Semantic Interoperability Identify products, substances, organisations, documents Use controlled vocabulary to describe values, status, results, metrics Establish relations between them... Semantic Interoperability is based on a common model with an interpretation... so new systems can be connected in a defined way... so new interfacing / programming tech can be derived

6 RPS Release 2 Goals two-way - regulatory authority (e.g. FDA) sends ) to submitter in relation to a regulatory submission request for additional information / meeting minutes / application approval Exchange contact information Associate to the submission/submission unit Multiple contacts (e.g. Technical, CMC) Category of submission - from Sponsor/Applicant (e.g. Meeting Request, New Protocol, Response to Hold) Category of submission response - from Regulator (e.g. Information Request, Response to Meeting Request, Approval) Handle Multi-regulator submissions & Capture basic product information

7 FDA s Strategic IT Goals improve performance re-use data and services be independent of IT platforms and products interoperability among different applications reduce cost of development, operation and maintenance systematic reuse and portability through catalog of components better assessment of cost/value of IT initiatives

8 Reference Information Model (RIM) One basic data model dedicated to health care HL7 messages derived from RIM Supports model driven development Entity Role Participation Act Who......in which role......is doing what......in which Action? Event, Notification, Order, Response, Result, Submission, Approval

9 RIM Organization System to system communication Informs systems of an entity (e.g. person) who appears in a role (e.g. surgeon) who does something (e.g. perform) in an action (e.g. surgery) Action Participation Role Entity performer Surgery subject event-specific aspects of actor performer Surgery subject Surgeon Patient appearance / admissions #srg #pat Dr. Smith Actor M. Jones Actor entity #45509 #16458

10 Two-way communication Regulator send RPS to Sponsor Can update submission hierarchy Can update status Can provide content e.g. letters, questions New: title to submission unit

11 Status of Regulatory Activity Status code attribute Withdrawn Complete (approved) Held (clinical hold) etc.

12 Context of Use Pointer to a file (FileReference) e.g.; like a hyperlink to a file Link to table of contents (code) Create versions of a document (setid) Many in a submission unit

13 Other content If it walks and talks like a context of use. Many in a submission Has a title Has a type Points to a file New: Can be linked

14 New: Category Submission unit code If initial, amendment, etc Category event Type of content in a submission From Sponsor: type of Submission From Regulator: indication, e.g. Acknowledgement/Grant 30-Day Waiver

15 New: Contact Information Submission and Submission Unit Role Different Types of Contents (code) Contacts change over time (statuscode)

16 Person or Organization Contact Role plays Person or Organization Contact entity can be reused (Id) Complex attributes (e.g.; telcom is fax, work phone, etc.) A person is an Agent

17 New: Product Information Submission is a Regulatory Activity Submission is for one or more products HL7 has a common product model Participants from SPL, ICSR and pharmacy

18 Common Product Model

19 RPS Model Regulated Product Submission

20 Harmonization Activities other ISO Technical Committee 215 WG-6 IDMP Projects; Units of Measurement finalized CD ballot document HITSP Harmonization Subcommittee: Gender, Marital Status, Route of Administration, Body Site Joint Initiative Council (ISO, CEN, HL7, CDISC and now IHTSDO- SNOMED CT) FDA Projects (ICSR, RPS)

21

22 References Axendia The Future of the FDA (White Paper) 2008 FDA - Guidance for Industry Providing Regulatory Submissions in Electronic Format - Content of Labeling HL7 January 12th, 2009 HL7 WGM, Jason Rock

23 Glossary Application - Collection of related Regulatory Activities (RPS1 Submissions) for the regulated Products. A more general term for this would be a Dossier, as some of the Regulatory Activities are not applications for an action, just a filing of information. Submission - One Regulatory Activity, consisting of a collection of Packages (RPS1 Submission Units) (which may be grouped into Reviewable Units), to support one regulatory purpose. The purpose could be a notification of a change, or a request to approve a new product or change. Note that not all submissions require approval. Submission Unit - The collection of Documents provided by the Sponsor to the Regulatory Authority at one time. Reviewable Unit - Collection of one or more Submission Units grouped together (usually by subject) that collectively become part of a Submission for purpose of review.