Steps to RPS Adoption

Transcription

1 Steps to RPS Adoption Joel Finkle Advisor, Emerging Practices CSC Life Sciences BPS Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners DIA, Inc. All rights reserved. 1

2 What are the Steps? Understand how we got here Issue Implementation Guides Build Compliant Tools Build 2-Way Communication Infrastructure Benefit from the improvements ectd 4 History You may ask yourself, Well, how did I get here? 2

3 History RPS Release 1 Approved, Ignored RPS Release 2 Iterations Slowly closed on the requirements RPS Release 2 Normative Fall 2014 Approval at HL7 HL7 Remaining Tasks File Normative ballot resolutions with ANSI Start ISO process months Originally required for EU and Japan to participate Decision at ICH to proceed without ISO Will happen eventually Implementation Guide Doesn t say how to make a submission Only how to make implementation guides that say how to make a submission 3

4 ICH Remaining Tasks Implementation Guide Currently in Step 2 Draft Master Set of Context of Use Codes Internationally-Controlled Vocabularies Regional Tasks Restrictions/Additions to ICH lists Vocabularies for Application Types Submission (Regulatory Activity) Types Submission Unit (Sequence) Types Other Region-Specific Codes Set up 2-Way Communications Technology Business Processes 4

5 Current Status Consultation Phase for Draft Guidance ICH US, EU, Japan Some problems in guides Leftovers from earlier editions of RPS (EU) Possible misinterpretation of how to assign content to specific countries/agencies (EU) Can t change content and metadata at once? (ICH) Not enough detail on 2-way communications (US, EU) English translation of Japanese guide just arrived (JP) Where to find drafts? ICH: EU: US: FormsSubmissionRequirements/ElectronicSubmissions/ ucm htm JP: int-harmony/ich/0004.html Consultation periods end May 22 5

6 Who else can play? Other Countries for Drug Submissions ICH Observers just need an implementation guide Other formats (ASEAN, etc.) can be adopted from RPS but would benefit from ectd 4 s work Non-drug submissions can have different rules IMDRF for devices No sequence numbers Allows multiple Submission Units per message Tobacco Veterinary Implementation Guides You are the reason I've been waiting so long Somebody holds the key 6

7 Implementation Guide Tasks For HL7 How to create specific implementations For ICH How to reproduce the CTD in RPS For Authorities How to deliver each submission type For Sponsors and their Vendors Figure out what it all means! The Vocabulary Stack Sponsor/MAH: Document & CoU IDs, Study IDs and Names, Product, Substance, Excipients Sponsor/MAH: Document & CoU IDs, Study IDs and Names, Product, Substance, Excipients US CDER: More CoU, Keywords, Application Types, Statuses EMA : Similar to US, plus Review Procedurerelated, Mode, Territories CDRH similar to CDER ICH: Context of Use, Keywords, Species, RoA, Duration, Submission Type, Submission Unit Type IMDRF, etc. ISO/HL7: Countries, Languages, Status Codes 7

8 Context of Use Codes ICH Layer Covers CTD Modules 2-5 Should there be suggested universal Module 1 items? Regional Layer Covers CTD Module 1 Additional M2-5 items? Removal of certain M2-5 items? Submission-specific Layer? Additional restrictions on the region s set Example: No Summary of Efficacy on an IND or CTA Example: Only cover letter, label on labeling submissions Standards-Based Controlled Vocabularies HL7 standards determine basic wiring Status Codes Actions such as New, Delete, Replace, Update Types of things such as telecommunications, organizations Confidentiality codes Rules: How to create an RPS message ISO codes for a few things Languages Countries 8

9 ICH Vocabularies Context of Use The Table of Contents Does not include Module 1 Keyword Definition Types Public lists: Species, Route of Administration, Duration, Type of Control Sponsor lists: Indication, Manufacturer, Study ID Document Type: Like STF file-tag, but many more Submission Type Submission Unit Type Other product types will need their own lists ICH Rules Implementation guide specifies which Contexts get which Keywords Some items in RPS Standard not to be used Example: Document Keywords How to instructions Example: changing metadata Transition Sequence More on this later 9

10 Local Controlled Vocabularies & Rules Each region specifies Unique application, submission, submission unit types Additional Context of Use (Module 1) Additional Document Type Keywords (labeling, ad/promo) EU uses Review Procedure, Procedure Role, Countries, Authorities to support CP, MRP, DCP Submission Mode (Grouped, Workshare) US uses Submission unit Categories Form Type Submitter and Contact categories Review Time Building ectd 4 Tools I make all the money, hauling coal by the ton But when Saturday goes around I'm too tired for havin' fun 10

11 Tools: Updated Submission Compiler User Experience Mostly Unchanged Transition Sequence to move old applications Output in New Format New Life Cycle Options Grouped Submissions/Workshare Support More Metadata User Experience Mostly Unchanged Deep down, it s still just a CTD Same set of documents Same PDF requirements 11

12 Transition Sequence How to continue an application from ectd 3 Roll up all existing ectd sequences Issue new Context of Use IDs Reference leaf IDs in Document objects using special ID Don t re-send content Just instructions how to find it and how it will be referred to Vendor community not happy with this idea Essentially another submission format to support Consensus is that the sequence is not needed New ectd 4 sequences can just refer to leafs in the Document object Only advantage of Transition is for Agency migration New Output Format 12

13 Not that complicated Five Easy Pieces 1. Message wrapper and Submission Unit 2. Context of Use 3. Submission (Regulatory Activity) and Application Details including Review and Product 4. Documents 5. Keyword Definitions New Life Cycle Documents are Forever, Context Changes No more Append It s new content But related to old content Granularity Changes One document replaces many Many documents replace one Metadata changes Update keywords (e.g. manufacturer name) Previously must delete and re-add 13

14 Grouping and Sharing Current tools already have to deal with US Bundled Supplements (as of M1 v2.3) EU Grouped Variations and Worksharing ectd 4 / RPS makes it more consistent Specify multiple Regulatory Activities (each with its own Sequence within the Application) Exclude some content from particular Activities Later sequences do not have to be grouped More Metadata Module 1 or Application Forms data Countries Contacts Procedures Categorization of Application Regulatory Activity Sequence Review Information Received from Regulatory Authority Product, Ingredients, Status 14

15 Tools: ID Maintenance Most IDs will be sponsor-specified maintained by the Submission Compiler Application / Submission / Submission Unit Context of Use Review IDs come from agency Documents Maintain IDs in Submission Compiler? Maintain IDs in Repository? Contacts and Organizations Get to know your DUNS Numbers Challenge: Interpreting RPS No Hierarchical Structure Must be poured through a CTD-shaped sieve Grouped submissions challenging to display and navigate Can t depend on item order for viewing Don t expect a simple Web Style Sheet But then, style sheet viewing is only good for single sequences anyway Order isn t obvious: For M3.2.S, typical display groups by Substance, then by items within 3.2.S For 5.3 Clinical Study Reports, no subsidiary Contexts, but group by indications, then study IDs 15

16 Solution: Machine-Readable Implementation Guides Specifies which code sets Example: US NDA = ICH + US M1 IND-specific Hierarchy Order of Context of Use (parent/child) Specifies Keyword (metadata) usage Specifies valid range of values for each type of submission Application type limits Submission Type, etc. Validation Rules Which application/submission/submission unit codes are appropriate for which submission types Cardinality: Only one cover letter Metadata: Clinical Study Report must have Indication and Study ID Alternative: ectd-only Tool Hard-code structure Probably easier for tools vendors to upgrade, since the ectd structure already exists Just translate published items to ectd 4 and interpret receipts back into the ectd viewer But this means vendors must make new software for every region, submission type, industry, etc. 16

17 2-Way Communications I want to tell you something you've known all along Don't leave me hanging on the telephone 2-Way Communication: Infrastructure Current Web Interfaces Not set up for returned content Not set up for notifications Will agencies spruce up web interface? Need to support pickup slips Need to support service providers Sponsor-run servers Automatic receipt and routing Automatic processing into Submission Management Automatic generation of press release! 17

18 2-Way Communication: Tools Current interfaces based on AS2 Agency web servers Some publishing tools support it directly XEVMPD uses AS2 for two-way communication Probably biggest upgrade for ectd 4 tools Benefits of ectd 4 Realized So, you can go out on the street and take your chances But if you do, you better do it right Or you won't feel the benefit 18

19 Return on Investment Category Sponsor Vendor Regulator Tool Flexibility Tool Longevity Ability to Make Corrections to Metadata Improved Communications Tool Flexibility Origin of RPS was for a common tool at FDA Support more than just drugs No need for unique software for review at any division Common file format A data-driven publishing tool Could support devices, veterinary, etc. Could support changes to submissions with just a configuration file Lower costs for support, licensing, etc. if only one tool has to be implemented Justify development costs across multiple industries 19

20 Tool Longevity If submissions can be updated with a configuration file Fewer software implementations (benefits sponsor) Fewer software patches (benefits vendor) More effort can be spent on business process, integrations than just keeping up with the Regulatory Authorities Metadata Corrections Current ectd 3.2 does not permit changes If you ve mis-typed a Manufacturer name a. Leave it as-is and mention the error in a cover letter b. Delete everything in 3.2.S (for example) and re-submit ectd 4 just requires an update to each Context of Use entry using that Keyword Specify existing ID Specify keyword value with an Update code Also applies to contacts, submission metadata 20

21 Communications Speed of response Direct results versus having to wait for letter, fax, etc. Improved Correspondence Connection of Questions to Answers is possible But not yet part of the implementation Record of regulatory action helps integrate Submission Publishing Submission Tracking Correspondence Management Implementation Guides need more detail Life Cycle: Received, Validated, Accepted, Approved No How-To yet And if we don t change? ectd 3.x is likely to still be accepted for years to come However Will competitors beat you to market? better communications better business processes Would you have more upgrades on ectd 3 software? Try to see it my way Only time will tell if I am right or I am wrong While you see it your way There's a chance that we may fall apart before too long 21

22 Thank you Joel Finkle Advisor, Emerging Practices CSC Life Sciences BPS Ask 22