Implementing Structured Content – Labeling and Medical Writing
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Implementing Structured Content – Labeling and Medical Writing

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This talk will discuss the different challenges within Labeling and Medical Writing as they have attempted to adopt Structured Content. We will discuss the planning and key considerations ...

This talk will discuss the different challenges within Labeling and Medical Writing as they have attempted to adopt Structured Content. We will discuss the planning and key considerations Organizations conduct prior to implementing Structured Content, and some of the results we’ve seen to date. For labeling, we will trace the lineage from initial SPL requirements through today. We will discuss some of the readiness and implementation challenges groups faced as they try to keep pace with the demands of the Business and their desire for technical solutions. We will discuss techniques for adopting Structured Content within Labeling and Medical Writing, building toward a harmonized technology that is User focused and achievable.
The talk will draw on experiences in deploying Content Management within a Pharmaceutical Company for Labeling, as well as Market research and the recent trend in the potential of the Industry moving to Structured Content.
Key questions we’ll cover:
• How to get started with a SCM project for your Business?
• Key considerations for your Implementation
• What level of granularity in share Content?
• Methods for Change Management
• Methods for Shared Content
• Internal challenges and building a Business Case, e.g. Regulatory requirements and feature requirements
• Potential use of Structured Content beyond re-use, Authoring and Compliance

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  • Now after looking back, I would like to focus on where I’ve seen the industry moving and methods people are taking to get there.
  • One way to begin a Project or Program is to develop a vision, a high-level Business Case that you can begin to socialize internally and get momentum for.
  • In talking with a number a growing companies, they have unique challenges when discussing RIM. As products are getting approved, and with further innovation ever changing, theses companies often are moving a pace that is difficult to manage. As the revenue is increasing, staff is increasing and the knowledge needs to be managed and transferred.In some instances, the smaller/mid-size companies are partnered with Larger companies for certain Products/Programs. These partnerships increase complexity, as the Department is now trying to manage their Internal records, Agency-drive records and also support their Partner company. The challenges for reporting, access and maintenance are ever-growing as the companies success story grows. Outsourcing is often utilized CRO’s, submission publishing and then the hand-over is challenging as they try to manage the interactions with Agencies and bridge the Gap.
  • SCM is appealing, but we need to consider how technically and procedurally it will fit into the overall architecture. Disruption is grounds for fear, uncertainty and doubt. We are proposing to move people out of their comfort zone, so let’s not turn their world upside down.
  • ROI is critical, and has been a roadblock in my experience to adoption of SCM. Companies have invested in Document Management, eCTD and other requirements. Executives are skeptical of spending more Capital.
  • Here are 3 useful methods for evaluating a solution, all of which will give you a chance to Pre-view a solution prior to purchasing and help prove a Business Case.
  • Once the regulatory review process is introduced, Labeling differs from other opportunities and simpler Use Caes for SCM.
  • Europe is a great example of the complexities that the Labeling Use case contains. The various presentations and strengths turns a 60 page document into an 800 page document.Audio: Product Information Management, or PIM, was developed to help ease the burden of translations into over 20 languages in the EU. This is a graphical representation of the Anatomy of Product Information in the EU – (1x) you can see the exponential number of documents and complexity in managing all that information for a single productGraphics Note:Darken the blue box. Programming Notes:At 1x highlight pack size over (not flag)
  • Statistical Analysis Plan is in Green, Protocol and the CSR
  • In my past life we trained
  • As you collect requirements, I want to take some time to review what I see as key roles to any successful project…
  • Oftentimes, these Projects need Sponsorship, e.g. a Senior member of the Department who sees and understands the goal of the Project.Key to Budget discussionsKey for Presenting the Project to Senior ManagementSounding board and potentially decision maker for a Project as it gets started and progresses toward implementation
  • The Business Lead in my view is the Pivotal role in a successful implemnetation –They are the Quarterback – they understand the Business, and know enough about the Solution to translate between IT and the Business UsersThey also work with the Champion – they are the conduit between the Users, IT and Senior Management.Build consensus, make priorities
  • Who ever the IT person is, you need one Depending on the project, this does not have to be a labor intensive effort. We will talk later about deployment approaches, what I would stress for IT, you need someone who understands the current Infrastructure at your company.They can also help manage competing projects and priorities and help keep your project on schedule20% of their time
  • In addition to Resource impacts, one often-overlooked aspect of a Project plan is the needs of the Users.Consider the whole picture when thinking about the Users of the Solution:What Policy are impacted, or do we need new ones?What kind of Training will be needed and when?Identify who will be responsible for the Updating, Accuracy and reporting of the Information in the system.
  • Shifting from the Process and Planning, I will discuss different Technology approaches that are prevalent.There is the classic internal implementation that we are used to, where we deploy IT solutions at our Data Centers, and our IT staff maintain them.More commonly, Pharma companies are looking for hosted solutions. Hosting is a great way to cut down your own IT needs, and have a vendor support the system.For example at Virtify– we work with Sidus as our hosting vendor. The benefits we’ve seen with Sidus is that they are vendor the FDA uses, which give us and our clients the assurance that there is a robust solution in place. Sidus has been a great partner of ours.
  • And finally, start with a High-value target – keep your eye on the Goals and the ROI you’ve developed and do not lose sight of the Users throughout your deployment.I will now hand it back to Satish.

Implementing Structured Content – Labeling and Medical Writing Implementing Structured Content – Labeling and Medical Writing Presentation Transcript

  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 1 Implementing Structured Content – Labeling and Medical Writing Challenges, Recommendations, etc… Bernie Coney, May 8, 2014
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 2 Agenda • Look into a past experience of Structured Content within Industry • Building the business case for Structured Content • Change Management and Lesson Learned • Trends in deployment and critical success factors 2
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 3 Background for Pharma • Pharma Industry tends to be more risk averse and slower to adopt new technology than other industries • Pharma has a complex set of requirements that need to be rooted in compliance and efficiency of operation, and scalable for Pharma. • Regional expansion/Partnerships hot topics • XML is ideal for the exchange of information between systems. We’ve seen this in the implementation of SPL in the US and eCTD. • Agencies have shown interest and adoption of xml, e.g. xEVMPD, SPL, PIM, eCTD, and RPS.
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 4 One Historical Case of Labeling and XML USPI, PPI, Med Guide, Drug Listing, Labeler Codes and Establishment Registration data. Documents/ Content Under Focus XML with initial monolithic Schema, standard set by HL7 Format Began with Rx Products in 2005, expanded to OTC and Animal Health in 2009 Approach Improve Patient Safety through improved information access, improved Import/Export controls. Driver Structured Product Labeling (FDA) Dimension SmPC, Outer & Inner Labelling and Package Leaflet, Annex II XML with componentized Schema (only submit/review) the content impacted Optional for centralized products beginning with a Pilot phase (few Sponsors and EMA) Efficiency in managing large volume of labeling content for industry and regulators (due to translations) Product Information Management (PIM)
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 5 Labeling – Before and After PIM Leading up to PIM (to 2009) • High level of Interests in immediate and long-term SCM solutions • Strong desire for Compliance and reduce redundancy in managing labeling content • Enterprise solutions were largely a Large Pharma focus • High level of anxiety about how companies will handle the change 2009 - Present • Deep sigh of relief  • Focus shifted back to the Business at hand • Trending to re-vive concepts of PIM (re-usable components) • Still a Large Pharma focus? • High level of anxiety about how companies will handle the change
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 6 Building the Business case 6
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 7 How do We Do this? • We think there’s content re- use • We feel like we copy and paste all day long! • We spend countless hours in meetings, calls, etc. reviewing documents and sometimes it’s the same information • Isn’t there an easier way to do this? 7
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 8 Construct a Theory for Your business User Support needed for such and approach would be Pre- Clinical, CMC, Med Writing, Labeling, etc Toxicology Report PK Report Stability IMPD Scaling Report Pharmacology Summary Toxicology Summary PK Summary Clinical Overview Non-Clin Overview Investigator Brochure Protocol Clinical Summary Report Label
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 9 Consider the Strategic Challenges for a Move to Structured Content • How could we manage rapid growth and pressure to deliver content across the organization while moving to Structure Content • Who goes first? All-in, or Phase-in? • How do we respond to agency questions/reviews? • Does similar content exist? • What/when/how do we migrate? • Stakeholders • How do we build consensus/interest in SCM? • Will this improve the operating model? • How do we support it? • Can we leverage with Partnerships? – Partners want/need visibility into the product regulatory status
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 10 System Considerations SCM Regulatory Medical Writing Labeling Packaging and Artwork CTD CMC Clinical Nonclinical Authoring Submission Publishing RIM Analytics Performance Management Analytics Review Workflow ReportsContent Mgt. Document Mgmt System Uses and Outputs Information Mgmt System Consider how it will fit in the Overall Architecture of the Company
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 11 Proof Points and ROI • Follow the complaints and pain points – show how to make it better • Perception or reality? • What are your resources doing to manage content? – How much is Strategic? – How much is Operational? • How much time is being spent maintaining and updating tracking tools? – Translate into costs and risks • Is the information relevant (timely, accurate) and reliable? – What is the cost of it not being timely, accurate, etc?
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 12 Common Evaluation Strategies Proof of Concept (POC) Pros: • Laser focus • Prioritized participation Cons: • Limited time to digest results • May not get breadth of feedback desired Consider: • Need to manage timing and user comfort levels with results Best Use Case: • Cross-functional teams participating in role-based activities Pros: • Participants can share experiences • Instructor can quickly respond to issues or questions Cons: • Time commitment may exclude key users Consider: • Need to exercise full process Best Use Case: • Small user audience with an agreed outcome Workshop Sandbox Pros: • Free-form • Use for special circumstances • Good for information gathering Cons: • Success criteria and expectations for participation must be agreed up front Consider: • Need to police user activities to ensure effectiveness Best Use Case • System upgrades, confirm specific business requirements
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 13 Labeling
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 14 Harmonized Labeling Main driver for Structured Content and Labeling: • Need for Consistency • Compliance • Improved Communication • Version Control • Impacts of a change to Current Label • Submission Process • Analytics on what is truly regional
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 15 Regulatory Review Process Approval Letters Redlined Versions Supportive Documents Agency/Division Regulatory Action Reviewer Questions
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 16 Impact of External Production Cycle Develop Design Approval ManufactureTransport Sell Disposal Supply Chain Regulators Labeling and Packaging Throughout the Continuum
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 17 Additional Regional Challenges Anatomy of Product Information in EU High volume of common/related content to edit and maintain in very restricted timelines Product Formulation Strength Presentation
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 18 Sample re-Use study with 1 Product across CDS, USPI and Eu SMPC 1 8
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 19 Content Re-Use Scenario
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 20 Labeling Content Reuse 75% of the EUPI content is reused content from the CDS 53% of the USPI content is reused content from the CDS
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 21 Medical Writing
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 22 Slightly Different Business Case Process • Medical Writing has a far more linear process than Labeling • Regulatory Review and negotiation process in not an issue as it is in labeling, e.g. many branched versions • Translations not as big an issue Productivity • Document Production is the key issue with a Limited number of Medical Writers • Shorten the time to produce documents, e.g. Protocol to the CSR • Faster you can complete the set of documents without sacrificing quality • Auto-mate re-use, e.g. Study Design across Protocols or within a Study • Keep up with the pace of Drug Development and Innovation
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 23 Content Re-Use Scenario
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 24 Mapping Content Reuse • Just in doing Section-to-section mapping, we have seen around 60% of content reuse opportunities • Greater gains come with improved Granularity • Belief that over time, document creation can be largely auto-mated once the upstream documents are approved • Contextual authoring is key, e.g. Prospective vs. Retrospective
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 25 Change Management and Lessons Learned 2 5
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 26 Prior to Implementation • Think about what to say about xml • Most staff use MS Word daily • xml highly structured • Do the Users need to know about xml? • Pharmacists, Doctors, and PhD’s – are you really interested in making them love Technology? • Program Management • Set up a Program Management office with all Stakeholders • Senior Management support essential for Program • Migration • Progressive Quality Control – reduce the need for QC over time • Initially let the Business User check the content, be involved in its creation and manipulation (Builds trust) • Ensure all Internal systems are prepared for xml 2 6
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 27 Granularity • How do you want to manage the content? How much can your Users take? • Often in Pharma Authors are scientific and medical experts, not technology experts • Content mapping can add insights into what level of granularity adds the most value • Beware the IT trap – conceptual is not always actionable • Words and phrases are not always useful chunks of content when placed in the context of complex Prorams or Large Product Portfolios • Large product portfolios can produce spider-webs of content • The system needs to map to the Process • Great ideas are not always what supports the business 2 7
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 28 Infrastructure Challenges Document Management (DMS) vs Content Management (CMS) Companies often have invested capital and resources heavily in DMS • Investment includes training and access across the Enterprise • Enterprise needs access to the content • Lack of interest in new systems (technology fatigue)
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 29 Key Considerations for Adoption • Flexible as possible, and compliant with any correctly formed schema. Office Open XML is one of the world’s most widely-used, comprehensive set of technical elements – doesn’t mean it meets regulatory standard, e.g. SPL • Be careful of imbedded tagging that could impact submissions • Think through document-oriented vs. form-oriented content creation. Some solutions lean in one direction more than the other, while some provide equal support for both. • This could dictate the amount of Change Management
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 30 Key to Sustaining a Project • Key Roles – Champion on the management team who understands and can communicate the vision and value – Business Lead acts as conduit among users, management and external vendors – Infrastructure Lead represents internal IT processes Champion Business Lead Infrastructure Lead
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 31 Project Champion • Executive leadership role that assigns and communicates project priority over other initiatives (Titles: VP or Senior Director of Regulatory) • Responsible for funding of project and budget justification • Understands the value of SCM and can articulate it in terms of company objectives (compliance, new markets, portfolio expansion, etc.) • Make sure the champion is communicating & visible – You may have to draft communications on their behalf – Communicate milestone achievements and project updates – Recognize individual contributions throughout the project • Communications (up the management chain and across the organization) must be prioritized
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 32 Business Lead • Acts as the hub of all project-related activities and communications (Titles: Senior Manager or Director of Regulatory) • Keeps the Champion apprised of project status • Ensures communication between/among users, vendors and management • Make sure the business lead is committed to the project and not overcommitted to other projects from a resourcing perspective • Role requires an articulate manager who can bridge strategy and operations • Role requires in-depth understanding of business requirements and ability to discern requirements from “nice-to-haves”
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 33 Infrastructure Lead • IT role represents IT policies and procedures for the organization (Titles: Senior Manager or Director of IT, Information Services or Informatics) • Valuable component in vendor assessments and key to any migration or integration discussions • Responsible for managing IT support of the project and the ultimate solution • Role must be able to liaise with user communities and understand (global) support requirements • Role must be able to align business objectives with current infrastructure requirements • Need 20% commitment for due diligence; workload may decrease if SaaS solution is selected
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 34 User Support • Project must include updated SOPs and policy documents that address the ongoing requirements of RIM • JIT and role-based training • Job aids, FAQs, quick tips • How will regulatory information be maintained? – Internal or external resources – Identify information chain of custody, ownership and quality checks
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 35 Technology/Infrastructure • On-premise vs. SaaS (Software-as-a-Service) – Look at security controls, system and user administration – internal or external resourcing? – Cost and challenges of supporting systems internally • SaaS Environment – Evaluate vendor data redundancy plans, SLA for system outages, back-up and recovery processes, triage processes, support contracts – Make sure support levels are clearly outlined in the contract
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 36 Wrap Up • Industry seems interested in SCM • Do not under-estimate the impact • Start with a vision, and build a team who can deliver to it • Communication and key stakeholders can win • High-value target: – Simple use case can prove invaluable • Did you solve what you set out to solve? • Don’t forget the users (from planning through deployment)
  • ©2014 Virtify, Inc. Company Confidential | All Rights Reserved. | Page 37 Questions?