Managing the process into submission by Pharma Student

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About Octagon

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Octagon Research Solutions, Inc. is a development partnering organization that offers regulatory, clinical, process and IT solutions to the life sciences industry

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The Octagon Advantage: •

Deep Domain Knowledge

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Cross-functional eSub Expertise

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A Holistic Process Approach

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Creative Use of Technology

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Your Speaker

Michelle Mc Guinness Director, Solution Business Development mmcguinness@octagonresearch.com 610-535-8300 X 577

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Submission Process Management: Managing the Process into Submission

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Learning Objectives

• Four key components of the submission management process • Importance of submission process metrics and process visibility • Understand the critical questions that competitive organizations can answer about the submission process

What is submission management?

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Art or a Science?

What is submission management?

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Art or a Science?

How do you manage your submissions?

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• Tools – – – –

MS Office Applications Email Voicemail Post-it notes

• Communication – Project Team meetings – Status Reports

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The Process

Submission Process: A collection of people, actions, events and deliverables that are geared toward the development of of a regulatory submission – Four key components of successful submission process management • • • •

Content Tasks Resources Issues

– Each component has specific information associated with it – submission process metrics

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Managing Content

Requires planning and tracking throughout development – Author, review and approval processes – QA and QC processes

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Dependencies may impact (delay) completion of other components (reports, summaries)

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Someone in process must be accountable for delivery

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Content standards in place (templates)

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Must be provided in a specific format “submission ready” (**Best Practice**)

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Managing Tasks

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Standard procedures detailing the necessary activities

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Different deliverables require different tasks to be completed

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Time and resources are associated with each task

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If one task isn’t completed or takes longer than expected, other pending tasks may be affected

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Tasks should be aligned with submission goals

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Managing Resources

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Defined by availability and skill level

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Competencies are impacted by experience – Skills may increase over time – Familiarity with outdated requirements may be irrelevant

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Require significant and specific training investment – – – –

New technology solutions (PDF, XML backbone) New deliverables based on industry standards (eCTD, CDISC) New corporate standards (templates) New processes may be required (new roles)

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Managing Issues

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“Unplanned events” crop up throughout the process

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Most common scenarios – Inaccurate project plans – Out of date processes require rework • Hand-offs between functional areas • Content owner doesn’t understand deliverable requirements

– QA/QC processes are not optimized • Issues are identified late in process (cost increases)

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Identification and resolution require time and resources – Diversion of skilled resources during peak business cycles

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Recurring issues (trends) allude to process problems

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Accurate

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Relevant (actionable)

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Recent (real time)

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Presented in the context of the larger process

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Span functional areas

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Address all aspects of the process (content, resources, tasks & issues)

Good submission process metrics are…

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360° Views

Submission process metrics provide perspective – Past – benchmarking • Build on previous experiences and reflect organizational competencies • Use historical data to support present activities

– Present – analysis • Real-time, actionable information • Minimize rework and bottlenecks

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Critical Questions

Strategic – Cross-project level Do I have the resources to manage all planned projects over the next 1-3 years? Does my group/organization have the band width to handle a unplanned project? Do I see any potential “bottlenecks” over the next 1-2 years? Do I see consistent trends across projects which should be addressed?

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Critical Questions

Strategic – Project level How long will it take to produce our submission? Will we meet our deadline? How do we get back on track? Can I affect change in real-time to eliminate delays and rework? What impact will other projects have on my ability to have the resources I need?

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Critical Questions Operational – What are my key issues? –How are issues impacting timelines? –Are issues being resolved? –Is there a trend in the project issues? –How do I prevent this from occurring next time?

– Are resources with the appropriate capabilities and proficiency levels available for the tasks assignments? – How long should a task take? – How will an unplanned change to the content plan impact my submission? Copyright 2005 Octagon Research Solutions, Inc. All rights reserved

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Critical Questions Tactical – How long should a task take? –How long have I spent working on this task? –When is my task due?

– What tasks are assigned to me? –What tasks should I be working on now?

– How has this issue been resolved in the past? – How can I resolve multiple issues of a similar type at one time?

Benefits of Managing the Submission as a Process

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Provide predictive data to support proactive plan shifts

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Assist in identification/resolution of systemic problems – An issue or inefficiency may exist “between” departments – Metrics provide feedback associated with level of quality – Training is often the answer

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Provide options during the process

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Provide justification for resourcing strategy or project direction

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Provide confirmation that resources are aligned with corporate goals (an approved submission)

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Provides confidence in your process!

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ViewPoint

What is ViewPointTM : ViewPointTM was created to unify process, content, and connectivity. It creates a centralized system that enables real-time visibility into an organizationâ&#x20AC;&#x2122;s critical path processes, planning, resources and metrics.

Key Components: Content --- Tasks --- Resources --- Issues

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The ViewPoint Solution

“Submission Process Optimization”

Project & Cross-Project Visibility

Deliverables

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Four key components of the submission process – – – –

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Learning Objectives

Content Tasks Resources Issues

Importance of submission process metrics and process visibility – On time, according to plan – On budget

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Understand the critical questions that competitive organizations can answer about the submission process – Eliminate rework – Optimize resources

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Conclusion

If you can't describe what you are doing as a process, you don't know what you're doing. -Deming (1900-1993)

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Join Us for Our Next Webinar!

Regulatory Submissions and Advisory Committee Meetings: Preparing Your Organization for Success

Part 3: Bringing it all Together April 19, 2005 11:00 a.m. EST www.octagonresearch.com For additional information about ViewPoint or Octagon Research Solutions, please contact us: Info@octagonresearch.com 610-535-6500 Copyright 2005 Octagon Research Solutions, Inc. All rights reserved