ectd Next Major Version / Regulated Product Submission

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1 ectd Next Major Version / Regulated Product Submission Trusted ectd Solutions At GlobalSubmit, we re not only thought leaders, we re trusted advisors to the FDA, to our clients and to agencies worldwide. Jason Rock, Chief Technical Officer GlobalSubmit, Inc. Jason.Rock@GlobalSubmit.com October 4, 2012

2 Introduction Jason Rock CTO of GlobalSubmit Blog: theectdsummit.com/summit/ Website: Pg 2

3 Today s Topics Background FDA, EU, HC Drivers & Timelines New FDA Module 1 and RPS RPS & ectd Differences Major Changes to Systems Pg 3

4 BACKGROUND Pg 4

5 RPS - Facts RPS Regulated Product Submissions Developed Under Health Level Seven Similar To ectd System To System Communication Next Version Of ectd Will Be RPS Content Does Not Change Minor Infrastructure Change Pg 5

6 Goal Create One Model Handle Any Table Of Contents Easily Locate Information Pg 6

7 Out Of Scope Document Content Will Not Change Existing Business Processes Might Change Pg 7

8 Benefits of RPS All Regulated Products Attributes Can Be Corrected Single XML File Better Re-use Of Documents Better Integration With DMS Pg 8

9 International Harmonization RPS will go through ISO International Conference on Harmonisation Drugs ectd 4 is RPS will participate through ISO Global Harmonization Task Force Devices Proposed to GHTF as ested Pg 9

10 Timeline HL7 Draft Standard ballot Sept 11 HL7 Normative Standard ballot Jan 13 ANSI Standard June 13 ISO standard Jan Dates have already slipped Pg 10

11 Jason s Timeline HL7 Draft Standard ballot Sept 11 HL7 Normative Standard ballot Jan 14 ANSI Standard June 14 ISO standard Jan 15 Pg 11

12 FDA, EU, HC DRIVERS &TIMELINES Pg 12

13 Europe Wanted organized approach Allows regional input TIGes RPS Subgroup formed 2009 composed of FR, NL, DE, AT, UK, IRL, GR, EMA, EFPIA, EGA, EuropaBio and AESGP. Pg 13

14 Europe TIGes Objectives Set up the structure for work Organise EU requirements Learn SDO process Exchange information Set up educational material Pg 14

15 Health Canada Implement 6 months behind FDA Implement for Devices, Vet Med and Human Pharmaceutics Pg 15

16 FDA s Goals For RPS Goals: All Centers Using The Same Systems (Major Cost Savings) Provide Electronic Review To All Centers Improve Reviews RPS Is A Significant Element Of The PDUFA 5 Year Plan Pg 16

17 FDA Implementation CDER/CBER For human pharmaceuticals Mid-2013 Why wait? Alignment with ICH Pg 17

18 FDA s New Module 1 Based on experience since 2003 Updated Table of Contents Mini-step to RPS Bundled submissions One submission to be submitted to multiple applications A.K.A Global Supplements CDER OPDP CBER APLB Pg 18

19 FDA New Module 1 Added Id (Company id) DUNS number Submission description Contact information (e.g., regulatory, technical) Submission type display values Submission sub-type Supplement effective date Cross reference application number Removed Date of submission Pg 19

20 RPS & ectd Pg 20

21 RPS Vs. ectd (1 Of 4) RPS Organize Applications and regulatory activities Single XML File Folder Structure Undefined ectd Flat structure Multiple XML Files Folder Hierarchy And Names Defined By Guidance Pg 21

22 RPS Vs. ectd (2 Of 4) RPS Attributes Globally Defined And Assigned At The File Level Attributes can be corrected ectd Attributes Assigned at Folder Level Some At File Level Attributes cannot be corrected Pg 22

23 RPS Vs. ectd (3 Of 4) RPS Virtual TOC: Documents Appear In A Browse-able Structure Based Purely On Their Metadata Structure Created Externally By A Viewing Tool Otherwise Only A Flat File List Would Be Seen Allows For Regional Or Product Differences In Organizing Documents Into A TOC ectd Electronic TOC: Documents Appear In A Browse-able Structure Based Largely On How Their Leaf Nodes Are Linked Into An Overall Hierarchy Of Leaves Structure Inherently Part Of The XML And Appears Within Any Web Browser Cannot Easily Add New Content For Regional Differences Or Other Regulated Products Pg 23

24 RPS Vs. ectd (4 Of 4) RPS Re-use documents Across Applications Formalized ectd Re-use documents Across Applications Not Formally Described And Subject To Specific Regulators Rules Pg 24

25 RPS New Contact Information Application References Organization of Product FDA will not accept product Two way communication Pg 25

26 Sample Instance Controlled Vocabulary Pg 26

27 RPS Highlights One sequence to many product E.g. Manufacturing change Reuse of attributes E.g. fix typos Same standard beyond drugs E.g. DDMAC Two way communication E.g. receive letters from regulators Pg 27

28 RPS Highlights Reuse content E.g Study submitted in Investigation can be reused in marketing Provide contact information Fully support all new EU requirements E.g Variation legislation Pg 28

29 Transition to RPS FDA usually 2 year overlap Health Canada usually 1 year overlap EU varies Pg 29

30 RPS Model Release 2 Pg 30

31 Major Changes to Systems Data format is completely different Ensure identifiers are unique All sequences in all applications Bundled submissions One sequence for many products Re-use of content Documents and a set of document Document hyperlinks will be challenging Pg 31

32 Conclusions SDO allow everyone to participate RPS Is Coming Get Involved Standards Are Only As Good As The People That Help Create Them Submit ectd As Soon As You Can RPS Is An Evolutionary Upgrade From ectd Pg 32

Steps to RPS Adoption

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