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RPS Industry Perspective
Hans Beinke
DITTA Board member, DITTA RPS WG Vice-Chair, Siemens Healthcare
(with technical assistance from Karin Sailor, Medtronic & Linda Tremblay, Johnson & Johnson)
DITTA IMDRF RPS & SaMD Workshop
Tokyo, 23 Mar. 2015
OUTLINE
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Potential TOC Benefits
TOC Implementation Suggestions
TOC Concerns
Potential RPS Benefits
RPS Concerns and Requirements
Importance of the Business Case
Future of RPS
My Current View/Level of Comfort
‒ Note: Varied uses of RPS
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POTENTIAL TOC BENEFITS
• A consistent harmonized TOC structure aids in
submission planning and compilation when a product
is being submitted to multiple markets.
‒ TOC guidance provides easy to access information
about content requirements in each region.
‒ Numbering and section titles provide a common
terminology across regions.
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TOC IMPLEMENTATION
SUGGESTIONS
• Full Global Adoption:
‒ The TOC must be broadly adopted / accepted by many
countries.
‒ Adoption by IMDRF regulators is a good start.
‒ It would be helpful if IMDRF can partner with other
regulators to help drive broader adoption.
• Ongoing Governance:
‒ The TOC cannot be viewed as a static document.
‒ A process is needed to discuss proposed changes and
continually work towards convergence of required content.
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TOC CONCERNS – FOLDERS &
NOMENCLATURE
• Folder structure and nomenclature in current
Health Canada pilot pose challenges:
‒ Total file path names near maximum accepted
by MS Windows.
‒ Sponsor can only store the structured copy at
root directory level and without context.
‒ ICH compliant publishing tools used by
sponsors can’t support current nomenclature
(e.g. caps, special characters “.” “&” “,”
“spaces”) and length of individual folder
names. Precludes carry through of TOC and
inter-document linking.
• RECOMMENDATION: Industry and regulators
should collaborate to find an alternative
structure that can meet everyone’s needs.
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TOC CONCERNS – DOCUMENT
GRANULARITY
• The TOC requires that documents be authored at a much greater level of
granularity:
‒ Additional work for many companies.
‒ Difficult to justify without demonstrable benefits.
2.4-Device Description
Main Submission
App A: Test
Report
2.4.1- Comprehensive Device
Description & Principles of Operation
2.4.2- Description of Device
Packaging
App B: IFU
2.4.3- History of Development
App C:
Clinical
Report
2.4.4- Reference& Comparison to
Similar &or previous generations of
the device
POTENTIAL RPS BENEFITS
• A common electronic file format is valuable to industry:
‒ Common electronic file format across IMDRF regulators
choosing to adopt RPS.
‒ May enable common electronic file format usage between
pharmaceuticals and devices (i.e. sponsors supporting both
drugs & devices, or combination products).
• RPS offers additional e-file functionality :
‒ Enables lifecycle view of files under an Application (i.e.
original filing, responses to additional information,
amendments, etc.).
‒ 2-Way communication would allow consistent and potentially
real time tracking of submission status.
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RPS CONCERNS &
REQUIREMENTS
• The standard is technically complex:
‒ Significant resources to implement and maintain; for both
industry and regulators.
• Before implementing RPS, an analysis of available electronic
submission formats vs business objectives should be performed:
‒ Is RPS really the best solution?
• If a decision is made to move forward with RPS the cost and
technological barrier for stakeholders that do not support drugs
product e-CTDs would require resolution (i.e. simple & nominal
cost RPS publishing software).
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IMPORTANCE OF THE BUSINESS
CASE
• Objective evaluation of criteria/objectives versus various
technical options:
‒ Regulators Perspective
‒ Industry Perspective
• As important to Regulators as Industry.
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IMPORTANCE OF THE BUSINESS
CASE
• Points to Consider:
‒ The medical device and drug worlds are very different:
o Vast range of medical device technology and OEMs
o Size of submission
o Jurisdictional variance in device risk classification for the same
product
o Field updates and product enhancement
o Pace of change and scope of product lines impacted
‒ One solution (especially if complex/costly) will not work for all
regulators or companies.
‒ Multiple solutions will likely result in selection of the least most
simple/least costly option regardless of company or regulator size.
‒ Multiple solutions might undermine the objectives of RPS.
‒ Cost and Complexity could hinder adoption beyond the current IMDRF
members.
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IMPORTANCE OF THE BUSINESS
CASE
• Defining Technical Options:
‒ Small subgroup of Regulators & Industry
o Current view of RPS (HL7/XML)
o Variations of the current RPS view
o “Smart Forms”
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FUTURE OF RPS?
• Structure for Convergence?
‒ Submission Structure
‒ Submission Content
‒ Regulation?
• Think 10-20 years ahead
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MY CURRENT VIEW/COMFORT
LEVEL
• Business case approach is very positive
• Devil is in the details
• Current Comfort with TOC – 75%
• Current Comfort with RPS – 25%
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QUESTIONS AND DISCUSSION
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THANK YOU
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