OASIS DITA Pharma. Initial Meeting 30 July 2009

Transcription

1 OASIS DITA Pharma Initial Meeting 30 July 2009

2 Agenda DITA PCSC Welcome Objectives of today s meeting Introductions Round Robin Expectations of the Group Round Robin Story Boards of Opportunity DITA in Pharma

3 Welcome The OASIS DITA Pharmaceutical Content Subcommittee (DITA Pharma SC) will define DITA topics, maps, associated metadata properties and terminology to streamline design and creation of the complete body of pharmaceutical documentation required to represent a product for scientific and regulatory purposes throughout its lifecycle. Initial objectives are to define topics and maps as required to implement: ICH CTD (Common Technical Document) content specification US IND (Investigational New Drug) content specification EU CTA (Clinical Trial Authorization) content specification FDA Structured Product Labeling content specification EU Product Information Management content specifications. To optimize the value of DITA it is an objective to consider additional topics and maps for facilitating the internal business processes of content design, authoring, document review, submission assembly and regulatory portfolio management. Page 3

4 Vision: A Common Base Format E- Learning Publishing/ presentation tier Paper SPL HTML ectd Open Xml IND CTA ODF PIM NN 1 NN 2 Working tier Frame Maker Excel Custom Apps Browser XMetaL Arbortext InDesign Quark NN 2 NN 1 Repository/ database tier Common Base Format Common Base Metadata Architecture

5 Requirements for a Common Base Format Non-proprietary, open standard Cross -media/-platforms/-products/-vendors/ -companies/-time Tools support and availability Handle existing special pharma standards Adapt to future special pharma standards Handle special company requirements Modular to support re-use Advanced metadata capabilities Field proven Industry acceptance

6 Why DITA as the Common Base Format? Open standard Cross -media/-platforms/-products/-vendors/ -companies/-time Tools support and availability Handle existing and future special pharma standards as well as special company requirements Topic-oriented to support re-use Advanced metadata capabilities Field proven Industry acceptance YOU can influence this!

7 DITA: Handling Special Requirements D as in Darwin : Evolution and inheritance: Specialize and Generalize Built-in flexibility: <data>, <foreign>, and <unknown> elements Extensible: Specializations: Domain vocabularies Domain metadata architectures Domain topic types: Domain vocabularies Domain metadata architecture

8 DITA provides a content supply chain for Regulatory documents Darwin Information Typing Architecture DITA Reusable Topics Clinical Protocols and Reports Study Design: Method of Assigning Patients Indications (Target Labeling) Study Design: Evaluation Criteria-Efficacy Study Design: Evaluation Criteria-Safety Study Design: Dosage Special Populations Composing Publications DITA Map Phase 3 Clinical Study Report Synopsis Investigational Plan Treatments Special Populations Statistical Methods Single Source Publishing Administrative Summaries Quality Nonclinical Study Reports Clinical Study Reports Website Website Website Website Website...

9 in pharma today, topic and document based content must co-exist With DITA, submission management begins with the content supply chain Approved Topics Reusable Topics *.dita Clinical Protocols and Report Topics Indications (Target Labeling) Content Design to Re-use or Re-purpose Composing Publications DITA Map Phase 3 Clinical Study Report Introduction Study Design: Method of Assigning Patients Study Objectives Study Design: Evaluation Criteria-Efficacy Study Design: Evaluation Criteria-Safety Study Design: Dosage Special Populations Investigational Plan Study Patients Efficacy Evaluation Darwin Information Typing Architecture DITA Departmental Stewardship New Topics Reusable Topics New Topics for Clinical Study Report Disposition of Patients (summary) Protocol Deviations (summary) Document & Topic Based Authoring Complement Each Other Safety Evaluation Project Stewardship New Documents Medical Writing - Internal Medical Writing - External Pre- Review & Approval Take A Supply Chain Approach To Authoring Tasks Efficacy Results Primary (full) Safety Results Exposure Table (full) Safety Results Serious AE Table (full) On Demand Review & Approval

10 planning and content design of the clinical content supply chain begins when a drug candidate is being considered for continuation into clinical development and continues throughout the product s lifecycle Clinical Project Planning & Management Research & Development Marketing Development Operating Committee Tier 1 Markets Indications Primary Submission Strategy Secondary Tier 2 Markets Dosage & Administration Primary Secondary Clinical Strategy Clinical Studies Determined by Development Strategy Target Studies Study Design Indication Dosage and Administration Use in Specific Populations Number/Location of Study Centers Study Phase Objectives (Primary, Secondary) Criteria for Evaluation: Efficacy Criteria for Evaluation: Safety Content Architect Determines the Set of Topics Needed Clinical Dossier Driven by Development Plan Protocol and Study Report Topics Standard Topic Library for Product Standard Topic Library for Protocols Dose Form & Strength Indication Standard Topic Library for Reports Treatment Published Documentation Standard DITA Maps *.ditamap Content Architect Documents Published from DITA Maps Published Protocol Study Design Clinical Phase 3 Protocol Outline Protocol Synopsis Protocol Amendment Protocol Published Study Report Study Report Clinical Phase 3 Standard DITA Maps *.ditamap Study Report (Interim) Study Report (Abbreviated) Study Report (Synopsis) Study Report (Full) Study Report (Data Listings)

11 planning and content design for topic-based content continues through each regulatory submission and is integrated with that of the functional areas and content design Submission Planning & Management Research & Development Marketing Submission Strategy Tier 1 Markets Tier 2 Markets Rest of World Submission Strategy Target Labeling Target Product Profile Indications and Usage Use in Specific Populations Dosage Form & Strength Pharmacology Studies Toxicology Studies Clinical Studies Available Submission Documents Submission Content Is Driven By Regulatory Strategy Content Plan Module 1 Administrative Module 2 Summaries Module 3 Quality ectd DTD Module 4 Nonclinical Study Reports Transformation Module 5 Clinical Study Reports DITA Maps Track & Implement The Submission Content Plan Non-eCTD Electronic Submission Market X Common Module 1 Technical Administrative Document Market Y Regulatory Submissions to Markets Module 1 Administrative Module 2 Summaries Module 2 Summaries Module 3 Quality Module 1 Administrative Module 3 Quality Module 4 Nonclinical Study Reports Module 2 Summaries Module 4 Nonclinical Study Reports Module 5 Clinical Study Reports Module 3 Quality Module 5 Clinical Study Reports Module 4 Nonclinical Study Reports Module 5 Clinical Study Reports