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Best  Practices  for  Automating  Submission  Processes  &  Reporting

Janine  SegichDirector,  Regulatory  Operations

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Disclaimer

The views and opinions expressed in this presentation are solely those of theauthor and do not reflect the official policy or position of InterceptPharmaceuticals, Inc.

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About Intercept

§ Focused  on  the  development  of  therapies  to  treat  chronic  liver  and  intestinal  diseases

§ Rapidly  growing  – Grew  from  <50  to  >400  in  two  years– Currently  have  >  200  full  users  in  Vault  Submissions– Three  offices  (San  Diego,  New  York  &  UK)

§ Utilizing  Veeva  across  a  number  of  areas– Submissions,  QualityDocs,  PromoMats,  MedComms,  CRM

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Agenda

1. Moving  from  manual  to  automated2. Importance  of  measurement3. Connecting  systems

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Typical Manual Folder Structure

ORIGINALS

IN  REVIEW

IN  FORMATTING

APPROVED

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Recommendation: Institute Processes Within Workflows

Each  process  gets  a  dedicated  workflow  and  lifecycle:

§ Editing

§ Quality  review

§ Formatting  

§ Approval

Usage  is  Mandatory

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Sample Lifecycle

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Lifecycle States

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Reflecting the Business: QC Workflow

§ QA/QC  workflow  separate  from  editing  or  review  workflows– Identify  specialized  QA/QC  group

– QA/QC  review  focus

• Editorial

• Internal  consistency  (Content/Data)

• External  consistency  (Content/Data)

• Data/Numbers  Only

– QA/QC  review  types

• Abbreviated  (portion  of  the  document)

• Full  (all  of  the  document)

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Reflecting the Business: Formatting Workflow

§ Formatting  workflow  separate  from  editing  or  review  workflows– Identify  a  specialized  formatting  group  

– Authors  can  initiate  formatting  workflows

– Document  the  appropriate  completion    • Formatting  complete  (document  is  locked  and  ready  for  approval)

• Formatting  partially  complete  (document  stays  at  draft)

• Formatting  not  complete  

§ Regulatory  Ops  has  “super  user”  permissions  to  help  assist  authors

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Classifications for Correspondence

§ Region-­specific   correspondence  classifications  enable  downstream  searching  and  reporting

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Once in System – Must Get People Using It

SOP TrainingAn ongoing

process

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Importance  of  Measurement

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Reporting Examples

§ Reporting  for  initial  IND  or  NDA/MAA– Creating  a  report  for  each  module– Reports  should  be  easily  configurable– Export  to  Excel  with  hyperlinks

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Reporting for Different Needs

§ Module  reports  for  sub  teams§ Reports  for  inspections  or  due  diligence§ Reports  for  submissions

– Submission  log  by  application– Based  on  the  metadata

§ Reports  for  correspondences– Correspondence  log  by  application– Based  on  application  +  classification

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Dashboards for Management and Company Meetings

Module  1 Module  2 Module  3

Module  4 Module  5

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Dashboard Options for Different Uses

Note:  If  document  needs  to  go  back  to  draft  –it  MUST  be  re-­worked  within  the  system.  

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Connecting  Your  Systems(Key  to  Automation)

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eDMS to PleaseReview for Collaborative Authoring

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eDMSPleaseReview

Real-­time  co-­authoring

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eDMS to eCTD Publishing system

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DraftApprovedPublished

eDMS