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Accenture Regulatory Services

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Accenture Regulatory Services

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Accenture is leading the next evolution of Regulatory by applying leading edge solutions across the drug and device lifecycle that unify innovative technologies with compliance-focused processes. Visit https://accntu.re/2YqL18r to learn more.

Accenture is leading the next evolution of Regulatory by applying leading edge solutions across the drug and device lifecycle that unify innovative technologies with compliance-focused processes. Visit https://accntu.re/2YqL18r to learn more.

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Accenture Regulatory Services

  1. 1. ACCENTURE REGULATORY SERVICES
  2. 2. REGULATORYPRACTICE SERVICEOFFERINGS Providing Solutions for 20 years 200 skilled Regulatory Professionals Experience in major Technologies – Veeva RIM Partner Active Professional Membership Participation Global Delivery Centers Experience in 90 countries Technology/Digital • Technology strategy road mapping • IT Transformation / Veeva RIM Implementation • Regulatory automation engineering • Labelling automation solution • Authoring templates (StartingPoint) Operations • Regulatory strategy & advisory projects • CMC & Labelling management (incl. authoring, change coordination) • Major & LCM submission management and production − Planning & compilation − Formatting & publishing − Dispatch, archiving & tracking Consulting/Strategy • Business / Process transformation • Program management • Regulatory compliance assessment and remediation programs (CMC, Labelling) • Change management • Training strategy & execution Copyright © 2019 Accenture All rights reserved. 2
  3. 3. 3 HOW ACCENTUREIS REDEFINING REGULATORY Copyright © 2019 Accenture All rights reserved.
  4. 4. END-TO-ENDOPERATIONS SUBMISSIONSERVICES Lifecycle Submission Strategy & Content Plan Author Technical Documents Compile & Format Dossier Publish & Dispatch Submit & Manage HA Interactions Archiving & Submission Tracking SUBMIT PROJECT MANAGEMENT CREATE TRACKPLAN • Starting point LCM templates • Mod 1, labelling & CMC authoring • Change assessment • Submission planning Investiga- tional • Starting point templates • Mod 1, labelling & CMC authoring • Mod 1, designation requests • Submission planning Investigational Application Management Compilation, formatting & publishing, dispatch, archiving & tracking Marketing • Starting point templates • Mod 1, labelling & CMC authoring • Submission planning • Gap analysis • Meeting support Marketing Application Management Compilation, formatting & publishing; dispatch, archiving & tracking Lifecycle Submission Management Compilation, formatting & publishing; dispatch, archiving & tracking HA Questions Coordination Copyright © 2019 Accenture All rights reserved. 4
  5. 5. Supporting our clients by addressing the ongoing lifecycle management requirements that apply to eCTD submissions LIFECYCLESUBMISSIONMANAGEMENT SUBMISSIONTIMELINES 01. Client engages Accenture 02. Submission Publishing (Document and eCTD) 03. QC, validate submission, receive client approval 04. Submission dispatch Submission Requests Copyright © 2019 Accenture All rights reserved. 5
  6. 6. STARTINGPOINT OVERVIEW Content Features Over 450 CTD content templates, each relating to a particular CTD section • Preset heading styles with appropriate CTD numbering – “boilerplate” text • Instructional text – from ICH & regional Guidelines • Sample text from our Regulatory Affairs group based on our 15+ year history as a regulatory operators Functionality Features • A tool to facilitate efficient document authoring through automation in Microsoft Word. Uses custom styles and macros designed to assist in the authoring process and to ensure consistent use of styles and standards • Custom toolbar integrated into the MS Word ribbon as an independent tab to make commonly-used MS Word functions more accessible • Offers predefined heading styles, fonts, margins and table formats to ensure a consistent look and feel across all submission documents • Advanced authoring tools such as document validation, PLR, Replace Styles Accenture’s industry-leading submission authoring solution… Copyright © 2019 Accenture All rights reserved. 6
  7. 7. Regulatory Innovation Services CHALLENGING ORTHODOXIES AND SHAPING THE FUTURE • Breakthrough design thinking workshops • Ideation workshops • Prototyping workshops • MVP and prototype development • Ecosystem & start-up partnerships REGULATORYINNOVATION SERVICES&AUTOMATION Regulatory Automation TRANSFORMING REGULATORY THROUGH AUTOMATION • Robotics capability assessment • Process automation assessment • Robotics operating model design • Online labelling • Patient information leaflets Copyright © 2019 Accenture All rights reserved. 7
  8. 8. 04. Assisted Labeling Authoring &Tracking In an automated world, AI tools can take the complexity out of mapping global to local terms and provide end-to-end traceability. 03. Health Authority Correspondence Processing In an automated world, AI tools can digitize content and automatically enter information in systems for stakeholders to act upon. 02. Regulatory Requirements & Content Plans In an automated world, submission contents are suggested using AI based on past activity. 01. Creating RIM Submission Events In an automated world, this can be done simply with Robotic Process Automation. INTELLIGENTAUTOMATION REGULATORYUSECASES RPA <10% of the manual task duration 0.5 FTE resource saving per 10,000 submissions Increased compliance and data accuracy Reduced time and effort with submission preparation Increased consistency of fillings Improved right first time filing accuracy and fewer HA questions Same day entry of submission approvals and HA question tasks $500,000 headcount saving per 10,000 letters Increased compliance and regained system confidence Reduced effort with reviews and hand offs to multiple affiliates Increased speed in getting updated information to patients Improved compliance with a single source of registered information Copyright © 2019 Accenture All rights reserved. 8
  9. 9. LABELLINGCOMPLIANCEPROJECTS THEBASICS Non-compliance is not an option • The label (prescribing information/SmPC, patient leaflet and packaging) incorporates all that is important about the product and is the point of reference for the patient/HCP • Mistakes in product labelling can lead to disastrous consequences – including product recalls • Confirming labelling compliance is a multidisciplinary process involving multiple stakeholders Project approach to confirm compliance Accenture’s three phased approach: LABELING COMPLIANCE Global Regulatory Local Affiliate MedicalManufact- uring Pharmaco- vigilance 01. Data Collection 02. Gap Analysis & Impact Assessment 03. Remediation & Maintenance Copyright © 2019 Accenture All rights reserved. 9
  10. 10. Learnmore: Accenture.com/Regulatory Copyright © 2019 Accenture All rights reserved. 10

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