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Trends in Regulatory Compliance

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Trends in Regulatory Compliance November 8, 2000 Today s agenda Overview of ESPS The state of electronic submissions ESPS solutions: people, process, and technology ... – PowerPoint PPT presentation

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Title: Trends in Regulatory Compliance


1
Trends in Regulatory Compliance
  • November 8, 2000

2
Todays agenda
  • Overview of ESPS
  • The state of electronic submissions
  • ESPS solutions people, process, and technology
  • Question Answer session

3
ESPS company overview
  • 191 employees worldwide. Corporate Headquarters
    in Fort Washington, PA. Other locations include
  • La Jolla, CA Raleigh, NC
  • Boston, MA London, UK
  • Public company since 6/17/99 (Nasdaq ESPS)
  • Signed Xerox re-seller technology agreement in
    March 2000

4
ESPS Highlights
  • Leader in Regulatory Publishing Space (70)
  • Leader in the emerging multi-billion dollar
    knowledge publishing space.
  • First mover advantage with knowledge publishing
    suite of products and services with Expanded
    Knowledge Publishing Suite
  • Average revenue growth of 55 (last 3 years)
  • Strong Financial Position
  • Cash positive, virtually debt free,
  • Strong balance sheet, Strong Cash position

5
55 average three year growth
Revenue Growth
Millions
Fiscal years ended March 31
6
ESPS mission statement
  • ESPS, Inc., is the premier provider of knowledge
    publishing solutions that accelerate the
    assembly, management, and exchange of diverse,
    business-critical information for the eWorld.

7
Knowledge Publishing
  • The process of consolidating multiple documents
    to communicate a concept effectively.
  • Convey information through publication
    organization, layout and cross-references.
  • My
  • Report
  • SOPs
  • Proposals

8
Knowledge Publishing Cycle
9
ESPS Content Management
  • ESPS Technology
  • Output-centric
  • Design Assemble Publication(s)
  • Multiple input/output
  • PDF Renditioning
  • Cross-References
  • Finishing Options
  • Hot TOCs
  • Header, Footer, Watermark
  • Special Sheets
  • Pagination
  • Publish
  • Paper, PDF, HTML, XML
  • DMS Technology
  • Input-centric
  • Store Documents
  • Manage Versions
  • Checkin/Checkout
  • Route Documents
  • PDF Renditioning
  • Archive Documents
  • Secure Documents

10
ESPS Life Sciences customers
3M (E) Abbott (E) Agouron (E) Alcon
Laboratories (MD) Allergan, Inc. (MD) Alliance
Pharm (E) Alza (B) American Home Products
-Wyeth Ayerst (E) -Whitehall Robbins
(OTC) Amgen (B) AstraZeneca (E) AstraZeneca
(Ag) Aventis (E) BASF (Ag) Baxter Healthcare
(MD) Bayer (Ag) Biogen (B)
  • NPS Pharm (E)
  • Novartis Pharm (E)
  • Novartis Animal Health (VM)
  • NV Organon (E)
  • Otsuka (E)
  • PRA (CRO)
  • Parke-Davis (E)
  • Pfizer (E)
  • Pharmacia (E)
  • PharmaNet (CRO)
  • Proctor and Gamble (E)
  • Purdue Pharm (E)
  • Quintiles (CRO)
  • Sankyo USA (E)
  • Santen Pharm (E)
  • Schering-Plough (E)
  • Solvay Pharmaceuticals (E)
  • TAP Holdings (E)

Centocor (E) Chiron (B) Chugai (E) Coulter
Pharm (E) Covance (CRO) DuPont Pharm. (E) DuPont
(Ag) Dura Pharm (E) Elan (E) Genentech (B) Glaxo
-SKB (E) Hoffmann LaRoche (E) Immunex (E) Isis
Pharm (E) Johnson Johnson( E) Ligand
(B) Molecular Biosystems (B) Mylan
Pharmaceuticals (G)
11
Highly-Regulated Global IndustriesExternal
Requirements
  • Vertical Industries Regulatory Agencies
  • Pharmaceutical FDA, EMEA, OSHA...
  • Biotech FDA, EMEA, SEC, HPB...
  • CROs FDA, EMEA, HPB...
  • Chemical EPA, OSHA, PMRA, EEA...
  • Utilities NRC, DOE, FERC, PUC, EPA...
  • Telecom FCC, PUC, SEC, EPA, OSHA...

12
Highly-Regulated Global Industries
  • Plus internal compliance
  • SOPs
  • GMPs
  • Risk Management Plans
  • Process Safety Management
  • ISO 9000
  • ISO 14000 standards
  • And other critical information

13
The Burden of CompliancePharmaceutical
  • There are 4,000 global pharmaceutical/ medical
    products companies
  • In the US, companies spent over 22.7 million
    hours
  • Servicing 111 separate reporting/record-keeping
    programs
  • Resulting in 13.7 million annual responses

14
The Burden of Compliance Chemical
  • Environmental Protection Agency has
  • 324 separate information collection programs
  • Resulting in over 84.3 million annual responses
  • And over 119 million burden hours per year

15
Global Paperwork Compliance Costs
Compliance Costs (millions)
175
150
144 billion
147 billion
141 billion
139 billion
138 billion
135 billion
125
94
98
100
93
96
90
92
75
50
47
49
46
48
45
46
25
1997
1998
1999
2000
2001
2002
Non-U.S.
Source Thomas D. Hopkins, Regulatory Costs in
Profile, August 1996, 1997 OECD Data and IDC
1998
U.S.
16
The Truckload of Paper Dilemma
  • Traditional Regulatory Submissions
  • Publish 3 copies each 500,000 pages
  • Final submission fills a tractor trailer truck
  • Two year development publishing timeframe
  • Project staff of 30 - 40 people
  • Lengthy regulatory agency review cycle impeded
    by millions of pages of paper
  • Enter the CoreDossier solution...

CoreDossier
Internet
17
The Truckload of Paper Solution
  • Electronic Regulatory Submissions
  • Dramatically changes the internal review cycle
  • Develop, review, approve and publish concurrently
  • Publish electronically to Internet, corporate
    intranet, using HTML, XML, PDF, TIFF and publish
    direct to paper.
  • Reduce cycle time and cuts required staff
  • May shorten regulatory agency review cycle

18
The State of Electronic Submissions
19
From FDA CDER
  • Since November 1997
  • 45 of all applications had some electronic
    component
  • 80 have electronic CRTs and/or CRFs
  • 15 are complete submissions

20
Current regulatory trends
  • One FDA reviewer states I ? electronic
    submissions
  • Your competition is doing more in less time
  • Producing higher quality deliverables
  • Achieving simultaneous registration
  • Providing increased navigability
  • FDA views the program a great success
  • More guidances are coming

21
What is on the horizon?
CTD and e-CTD November 2000 May 2001
CDER CBER - joint guidance on advertising and promotional labeling November 2000
CDER CBER - joint guidance on eINDs December 2000
CBER- electronic PMA/510K October 2001
CDER- DMFs and annual reports September 2002
22
What is on the horizon?
  • EMEA
  • Product information management
  • EFPIA guidance on electronic submission of MAAs
  • CDER
  • Guidance on electronic submission of investigator
    information

23
Why electronic submissions?
  • Better quality than paper
  • Better organized information
  • Easier to process and to find documents
  • Same technology used for all reviews
  • Improved reviewer efficiency
  • Electronic submissions will be required

24
Starting with the end in mind
We are taking millions of dollars of
information and turning it into a common document
its no easy task. - Chris Tanner
GlaxoWellcome
25
Submission challenges
  • Comply with latest electronic guidances
  • Produce identical paper electronic output
  • Meet submission deadlines
  • Increase efficiency

26
Submission challenges
NDA
70 Customers70 Methods1 NDA
27
Overall benefits
  • Fewer resources needed
  • Quality improvements
  • Cost savings
  • Increased publishing capacity for simultaneous
    agency submissions
  • Compliant with FDA requirements for electronic
    submissions

28
Sample CoreDossier case studies
  • Immunex
  • 12/98 - Installed CoreDossier
  • 3/99 - Shipped BLA to CBER e-Sub shipped prior
    to paper
  • ESPS has been great. Oh, and your software is
    pretty darn awesome!

29
Sample CoreDossier case studies
  • ISIS
  • 3/98 - Used CoreDossier to electronically
    assemble 10-volume CMC section.
  • 4/98 - Submitted the full 366-volume NDA to the
    FDA, then prepared an 80-volume MAA to EMEA.
  • CoreDossier streamlined the internal review time
    by approximately four weeks. CoreDossier was one
    of the reasons that we were able to meet our
    partner deadlines, achieve our milestones, and
    receive progress payouts

30
Case Study Pfizer
One recent NDA filing by Pfizer using CoreDossier
yielded 600,000 in specific cost reduction.
31
ESPS Product Suite
32
kPublisher and CoreDossier
  • CoreDossier
  • Typical User is Regulatory Operations/Regulatory
    Affairs
  • Large, multi-volume, highly structured, often
    government defined, relatively infrequent
  • Supports regulatory and pre-market approval
    publishing and complex functional requirements
  • (CDER, CBER, DAMOS, CADDY, etc.)
  • kPublisher
  • Occasional/casual publisher
  • Smaller, single volume, more frequent
  • Simple user interface, low training requirement
  • Designed for larger user community within the
    enterprise

33
  • Provide enterprise-wide web based access to
    publications
  • Web-based review and approval of publications
  • No client side technology ( no plug-ins or
    Acrobat )
  • Annotation and status based review model
  • Full Text and meta data searching
  • Ability to organize and manage large collections
    of publications
  • Customizable interface by user and role
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