Transcript None - SAPRAA

DEPARTMENT OF HEALTH
Medicines Regulatory Affairs
(Pharmaceutical & Related Product
Regulation & Management)
EDMS Workflow Specification and Software
Configuration Project Update
E Taute
SAPRAA 21 Nov 2008
1
Project Management
2
Scoping Workshop
3
Software Licenses
4
Workflow Specifications
and Configutarion
5
Internal Testing
Formal
Windchill
Training
(1-8)
Document
Storage
(Paper)
(1-5)
Document
Scanning
& Printing
(1-3)
6
Informal
Windchill
Training
(1-8)
Pilot Testing
Server
Network
(electronic
storage)
(1-5)
Data
Integration &
Maintenance
(1-8)
Recruit & Train
Dataprocessors
(1-8)
7
Deployment
Recruit
Technical
Experts
(1-8)
Help Desk & Stabilisation Support
8
Slide 2
EDMS Workflow & Configuration Project
EDMS Workflow Specification and Software Configuration Timeline
Project Phases (Deliverable)
Date
Phase 1 – Assessment
May 2008
Phase 2 – Design To-Be Environment
July 2008
Phase 3 – Configuration
Phase 4 – Testing
Phase 5 – Implement/Operate
November 2008
February 2009
May 2009
Slide 3
EDMS Workflow & Configuration Project
It is expected that the EDMS Project will provide the following within the
scope of the configuration contract :
•
Conformance to local regulatory requirements
•
Ability to perform search and retrieval operations on the information stored in
the system
•
Ability to perform workflow management in-house
•
Provide web-enabled centralised control
•
Conform to international regulatory standards
•
Conform to Government IT standards
•
Provide necessary tools to perform publication of updated information on
website
•
Provide ability to maintain security/control via digital signatures
•
Ability to deliver version and iteration control
•
Provide a clear archiving strategy; and
•
Accommodate paper-based submissions
Slide 4
EDMS Workflow & Configuration Project
Current and Future Commitments
• Workflow Configuration
• Document Configuration
• Scanning Capacity
• Training
• Information Management
• Data Management
• Change Management
• Human Resource Capacity Building
Slide 5
EDMS Workflow & Configuration Project
Major Indicators
• International agency implementation & harmonization
• Local Industry acceptance with provisos
- security, compatibility, capacity
• Electronic process will satisfy environmental & archiving
concerns
• Data integration
• Business Process Management (Standardisation and time-line
control)
• Knowledge Management (Management reporting, supervision
and efficiency)
• Format cross indexing (MBR1  MRF1  eCTD)
• Capacity building
Slide 6
MRA Network Topology
Video Conferencing
192Kb Diginet Line
3 x ISDN
Laboratory
Bloemfontein
& ISDN Backup
PV
Medunsa
Software
Vendors
2nd Fl (1)
I & LE
13th Fl (8)
CT & E
External
NRA Agencies
12th Fl (8)
MER
Secure Information
Adapters
Pharmacists
Internet
Internet
WWW
WWW
Security Control & Encryption
11th Fl (6)
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EDMS
Information
Database
& Licensing
Cam
Evaluators (150)
Zizo
Enquiries
CISCO network & Cabling
Other Healthcare
Providers
General Public
Scanning
Laboratory
Potchefstroom
ADR
Cape Town
Medical
Doctors
PV
Bloemfontein
2nd Fl (1)
Ops &
Admin
2nd Fl (7)
Cluster
Mgmt
2nd Fl (5)
Registry
Gr Fl (3)
Siamed
MCC Board
Manufacturers (300)
Clinical Trials &
PV
12th Fl (1)
High Security & Climate Control
MCC Chairpersons (24)
& backup power
Slide 8
EDMS Workflow & Configuration Project
Delays and Problems
• EU Funding
• Delay in award of contract and eventual sign-off
• Software funded by DoH
• Specialists for testing (implementation support) – Appointment not approved
• Data capturers not yet optimally utilised
• Server security
• Amendment Bill
Successes and Milestones
• Windchill in Licensing up and running
• Hardware Audit Completed
• As-Is Process Maps completed
• To-be Process Maps completed
• Commenced with configuration
Slide 9
EDMS Workflow & Configuration Project
CTD / eCTD
Why?
Harmonisation
To provide for a common format/template for the submission of information
to the regulatory authorities in the 3 ICH regions + South Africa
• “Common Technical Document” signed-off by ICH in November 2000
Advantages / Objectives:
• Resource saving for industry
• Facilitate simultaneous submission in all the regions
• Facilitate exchange of regulatory information
• Harmonised format to be further supported by the eCTD
• More efficient assessment, e.g. use of hyperlinks
• Faster availability of new medicines
EDMS Workflow & Configuration Project
CTD / eCTD
However, CTD is only a FORMAT !
It’s not a “single” dossier, with a “single” content
since
• Legal requirements differ in the regions
• ICH guidelines have not yet harmonised all
requirements
• SA guidelines not all harmonised
• Pharmacopoeiae are not harmonised
EDMS Workflow & Configuration Project
Module 1:
Not Part of the CTD
Content to be determined by
authorities
Module 1
Regional
Information
1.0
CTD Table of Contents
2.1
CTD Introduction
2.2
Non-clinical
Overview
2.4
Module
Module22
Quality
Overall
Summary
2.3
Modules
3-5
Non-clinical
Summaries
2.6
Clinical
Overview
2.5
Clinical
Summary
2.7
Module 3
Module 4
Module 5
Quality
3.0
Non-clinical
Study Reports
4.0
Clinical
Study Reports
5.0
Module 2-5
CTD
12
Heart of Dossier
MRF1
PART 2 Basis for Registration and
Overview of Application
CTD
Module 2
PART 2A Pharmaceutical and
biological availability
PART 2B SBRA
PART 2C Pharmaceutical Expert
Report
Section 2.3 Quality Overall
Summary
PART2D Pre-Clinical Expert Report
Section 2.4 Nonclincial Overview
Section 2.6 Nonclinical Written
and Tabulated Summaries
PART 2E Clinical Expert Report
Section 2.5 Clinical Overview
Section 2.7 Clinical Summary
Technical “part” of Dossier
MRF1
CTD
PART 3 Pharmaceutical & Analytical
PART 3A: Active Pharmaceutical Ingredient (API)
Module 3
3.2.S Drug substance
PART 3B: Formulation
3.2.P Drug Product
3.2.P.1 Description and composition of the drug
PART 3C: Specifications & Control Procedures for
Pharmaceutical Ingredients
3.2.S.4 Control of Drug Substance
3.2.P.4 Control of Excipients
PART 3D: Container & Packaging Materials
3.2.P.7 Container Closure System
PART 3E: Manufacturing Procedure
3.2.P.3 Manufacture
PART 3F: Final product Specifications & Control
3.2.P.5 Control of Drug Product
PART 3G: Stability Data of the Finished
Pharmaceutical Product (FPP)
3.2.P.8 Stability
PART 3H: Pharmaceutical Development
3.2.P.2 Pharmaceutical Development
PART 3I: Expertise and premises used for the
Manufacture of a Biological Medicine
Technical “part” of Dossier
CTD
MRF1
PART 3 Pharmaceutical & Analytical
PART 3A: Active Pharmaceutical Ingredient
(API)
PART 3B: Formulation
PART 3C: Specifications & Control
Procedures for Pharmaceutical
Ingredients
PART 3D: Container & Packaging Materials
Module 3
3.2.S Drug substance
3.2.S.4 Control of Drug Substance
3.2.P Drug Product
3.2.P.1 Description and composition of the drug
3.2.P.2 Pharmaceutical Development
3.2.P.3 Manufacture
PART 3E: Manufacturing Procedure
3.2.P.4 Control of Excipients
PART 3F: Final product Specifications &
Control
3.2.P.5 Control of Drug Product
PART 3G: Stability Data of the Finished
Pharmaceutical Product (FPP)
3.2.P.6 Reference Standards or Materials
PART 3H: Pharmaceutical Development
3.2.P.7 Container Closure System
PART 3I: Expertise and premises used for
the Manufacture of a Biological
Medicine
3.2.P.8 Stability
3.3 References
EDMS Workflow & Configuration Project
CTD/eCTD Challenges
• EU eCTD vs MRF1 vs SA eCTD
• Module 1
PART1
• Screening
• BE data + dissolution data
• Reference products
• Module 3 “Body of Data”
• On-line submission / CD / DVD
• Paper submissions
• Paradigm shift