PIM Status and Future Plans

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PIM Status and Future Plans

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Contents

• PIM Status
• PIM Simulation Objectives and Outcome
• Issues
• Future Planning/Strategy

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PIM Review System Status

• PIM Review System first release v1.0 is now in
  production
• Uses DES v2.0
• Applicants are currently invited to submit
  product information in support of an initial MAA
  for a new active substance or generic medicinal
  product
• The system can be accessed via Eudranet
  (http//pim.eudra.org). Users must be
  authenticated
• Production System will not be used until the
  first submission is received - a training system
  to mirror the production system has been
  established for training and demonstrations
  regulators only so far applicant access?
• Information and draft guidance for applicants can
  be accessed via PIM website is still under
  review

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PIM Review System v2.0

• Version 2.0 of the system to be released in May
  2006. Will comprise
• Significant enhancements to the review interface
  based on user feedback
• Implementation of further functionality to meet
  user requirements
• Simplification of business process implementation
• Functionality to fully support complex
  post-authorisation activity.

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PIM DES and LAT

• DES v2.1 currently in production
• V2.2 to be published for consultation May 2006,
  will
• confirm inclusion of the DES in eCTD EU Module 1
• finalise the standard statements
• refine the capacity of the DES to meet the
  regulatory requirements to generate combined SPC
  and potentially PL at Form level
• fully support variations
• support comments from applicants on
  implementation of changes proposed by regulators
• incorporate other changes as necessary,
  controlled by formal Change Control Procedure
  with QRD
• LAT v2.0 (aligned with DES v2.2) planned for
  production release beginning July 2006 (one month
  delay) to include all core requirements

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PIM Principles

• At this stage, PIM applies to the Centralised
  Procedure only
• PIM is optional for applicants, not mandatory
• If product information is submitted in PIM
  format, there will be no accompanying paper or
  Word files only electronic information
  provided, reviewed and archived Access to the
  information will only be through the PIM review
  system (with back-up procedures if necessary)
• Once PI for an application has been submitted
  using PIM, in all but the most exceptional
  circumstances this approach must be maintained
  for the lifecycle of the product

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Member State NCA Visits

• 20 MSCA visits now made or imminent with regard
  to the implementation of PIM. Specific objectives
  of the visits are
• Demonstration of the PIM review system to users
• Provide explanation as to how the PIM Review
  System should be used in the context of the
  Centralised Procedure for the business process
  for the review of Product Information
• Provision of practical advice on PIM
  implementation, and creation of a forum for
  discussion of implementation issues and
  implications for Competent Authorities.
• NOT intended as substitute for training

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MS Key Issues

• Local Copy and Storage
• Access to system for external experts (EudraNet)
• Version control of additional documents
• User creation and set-up
• Business Process, particularly Day 80 - 120
• Process for receiving notification of the
  availability for review of a PIM submission
• Status reporting and reminder functions
• Extension beyond the Centralised Procedure
• Handling of parallel variations
• All these issues need to be resolved with
  practical experience

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PIM Simulation - Context

• Testing so far on the PIM review system and DES
  has been restricted to
• Formal functionality testing as part of the
  system development
• Ad-hoc testing in day-long workshops, where parts
  of the business process for exchange and review
  were re-created, issues raised
• PIM is a major new approach impacting EMEA,
  Industry and all Member States

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PIM Simulation - Principles

• Prior to the first live submission, and now
  that the system is in production, there was an
  opportunity to simulate the review and exchange
  process in a more thorough and realistic manner.
• Intention was to re-create as accurately as
  possible, using an already-authorised converted
  product and during a condensed 8 week period,
  the review process for a new application
  involving all parties who would normally be
  involved in such a business process (EMEA MSs and
  applicant)

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PIM Simulation Objectives(1)

• Test the functionality of the system in as
  realistic and detailed manner as possible
• Test the interaction of the LAT and other
  authoring tools with the review system, and
  exchange with industry
• Test the system access, business interactions and
  exchanges in a realistic manner
• Uncover any issues which must be resolved prior
  to first live submission in
• Review System
• DES
• Training Material
• Guidance
• Pre-empt any difficulties and address them now
• Establish possible areas of confusion,
  hot-spots
• Provide an opportunity for future users of PIM to
  gain valuable experience with the system and
  process and provide feedback

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PIM Simulation Objectives(2)

• Clear objective was to gain feedback on the
  system
• Simulation activity based on system version in
  production that is, v1.0, and DES v2.0
• Hope was that most/all issues raised with
  specific system functionality will have already
  been raised and taken into account for the next
  system version release v2.0 or future DES/LAT
  versions
• Expectation was that simulation would produce
  valuable feedback on the overall interactions and
  business process that have not yet been tested to
  such a degree

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Simulation Current Status

• Timeline, milestone description and training
  material distributed
• EMEA and 11 Member States involved
• Timeline adhered to in terms of milestones (i.e.
  distribution of comments at key points, receipt
  of responses from applicant)
• Activities in between these milestones listed as
  a guideline, according to current business
  process as it is understood. Participants
  encouraged to work independently, interact in a
  normal manner with colleagues both within
  agency and with EMEA/other agencies, recreate
  usual review activities, only using PIM.
• Activities should be greatly simplified in
  accordance with limited time, but activities
  should be representative of real review work as
  far as possible
• Nearing the end wrap-up workshop tomorrow

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Issues Arising from Simulation - User Management

• User Management a challenge as this is the first
  time we have to consider the concept of
  individual system users in the Centralised review
  procedure
• Resolution
• Simpler user management being implemented in the
  system
• EMEA user creation/management SOP being
  developed, with dedicated administrator resources
  for this task.
• Full MS training to be provided for MS user
  management.

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Issues Arising from Simulation System Performance

• Performance issues resulting from a variety of
  possible sources
• Infrastructure
• Hardware/Software
• Application Code
• Resolution
• Bandwidth increase
• Application code optimisation (review system
  v2.0)
• Extensive further load and performance testing
  being carried out in all environments

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Issues Arising from Simulation Unexpected system
behaviour

• Some minor bugs and unexpected behaviour
  experienced as a result of using the system in a
  business context
• All logged and under resolution - several patches
  released already and all to be tested for review
  system v2.0

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Issues Arising from Simulation System Limitations

• Review procedure made more challenging by a
  combination of users having to familiarise
  themselves use of new system, and the fact that
  the system has some functionality improvements to
  be made to meet complex requirements e.g
• Advanced management of comments
• Improved functionality to be provided by review
  system v2.0 and DES v2.2

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Issues Arising from Simulation Business Process

• Difficulties with business process experienced,
  arising mainly through exposure of review work of
  all parties in one centralised location -
  significant concept change. Also due to system
  complexity (arising from complex requirements)
• Some confusion over concepts of review groups
  and stages
• Some confusion over status of comments and
  actions
• Different requirements and different business
  processes in all MSs - challenging to reconcile
  in one centralised system whilst maintaining
  simplicity/system usability

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Business Process issue Resolution

• PIM review system v2.0 to be simplified
  significantly a more open implementation with
  the potential to be fine-tuned once the system
  and processes are understood and familiar, and
  requirements can be accurately voiced
• More practical approach
• Improvements to training material and guidance

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Issues with LAT

• Several issues experienced with the LAT none
  blocking, all logged and resolved as patches or
  to be resolved in LAT v2.0
• No issues experienced as a result of using a
  different authoring tool with the review system
  tested in a parallel smaller simulation

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Future Planning/Strategy

• First PIM submission expected June 2006
• Still intending to receive and review this
  submission in line with the published policy,
  using review system v2.0
• However, this approach is subject to the
  satisfactory resolution of all issues, and
  successful testing of the new review system
  version and business process via a second
  simulation (to be carried out end May 2006) a
  final decision by EMEA will be made in May
• Possible alternative strategies include the
  transmission of the paper alongside the PIM
  submission in the first instance if policy is
  revised, it will be made immediately publicly
  available
• For questions or to enquire re. involvement in
  PIM, please contact pim_at_emea.eu.int