Preparing for the New eCTD Mandates

Conference

Preparing for the New eCTD Mandates:
Mastering the Tools and Strategies

Bethesda, MD • June 10-11, 2014

Agenda

 

DAY ONE

8:00 a.m. – 9:00 a.m.

Continental Breakfast/Registration

9:00 a.m. – 9:15 a.m.

Introduction, Logistics and Overview of Day 1 Learning Objectives

9:15 a.m. – 10:00 a.m.

What is an eCTD Submission for the US?
(eCTD, SPL, CDISC)

  • What is new as a result of FDASIA 2012 and PDUFA V, MDUFA III, GDUFA and BsUFA?
  • What are the steps for preparing to submit an eCTD?
  • Communication with regulatory authorities
  • eCTD pilot
  • Electronic Submission Gateway (ESG) pilot
  • What do regulatory authorities do with your eCTD?
  • What are the consequences of submitting a noncompliant eCTD?
  • At what phase in product development can I begin submitting eCTDs?
     

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Where Do the Contents of an eCTD Come From?

  • Documents:
    • Inside authors
    • Outside suppliers (CROs, CMOs, contract writers)
    • Regulatory affairs
  • Data:
    • Biostatistics and data management
    • Manufacturing quality control
    • CROs
  • XML Overview — What a Sponsor Needs to Know About XML in the Context of eCTD
    • What is XML?
    • How is XML used in eCTD submissions, labeling and study reports?
    • Who produces XML and why?
    • What are a sponsor’s responsibilities for the validity of the XML content of their submissions? When outsourcing submission publication? When publishing using in-house systems?
    • What is the impact of submission publishing workflow on XML validation?
    • Regulatory Product Submissions (RPS) — the next generation of XML for eCTD
  • How do I integrate the eCTD culture within my company?
     

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:30 p.m.

Issues About Content of eCTD Submissions

  • FDA Automated Submission Receipt (ASR) process and the impact of noncompliance
  • Top 10 errors FDA encounters with eCTD submissions
  • Standards for document authoring
  • Standards for data management and biostatistics workflow
  • Electronic data capture and case report forms (CRFs)
  • Standards for scanning
  • Content review and approval, including electronic signatures
  • Content management during the lifecycle of the drug development process
  • Coupling regulatory strategy with document management and eCTD life cycle management
     

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:00 p.m.

How to Produce Your eCTD

  • Demonstration of an eCTD submission system
  • Outsourcing
  • Purchasing and implementing an in-house eCTD publishing system
  • Combination
  • Budget and timeline recommendations
  • What if I don’t have an electronic document management system (eDMS)?
     

4:00 p.m. – 4:30 p.m.

Q&A and Review Learning Objectives

DAY TWO

8:00 a.m. – 9:00 a.m.

Continental Breakfast/Registration

9:00 a.m. – 9:15 a.m.

Introduction, Logistics and Overview of Day 2 Learning Objectives

9:15 a.m. – 10:00 a.m.

Best Practices in Use of MS Office — Including Demonstration on How to Use MS Word

  • Templates
  • Cross references
  • Tables of contents/tables/figures/listings/appendices
  • Publication references
     

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Best Practices in Use of Adobe Acrobat Professional

  • Characteristics of submission-ready PDF files
    • All agency requirements for PDF files
    • File format
    • Security
    • Open to bookmarks + page
    • Inherent zoom
    • Absolute path vs. relative path for intradocument cross references and bookmarks
    • Tables of contents
    • Page numbering
    • Levels of bookmarks
    • Amount of hyperlinking
  • If you must scan to create PDF files?
  • What are the consequences of noncompliant PDF files from the perspective of global health authorities?
     

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:30 p.m.

Overview of Leading eCTD Submission Publishing Systems

  • Vendors
    • Accenture/Octagon ViewPoint
    • Aspire
    • CSC/ISI eCTDXpress
    • Ennov eCTD
    • Extedo
    • Liquent Insight/S-Cubed
    • Lorenz
    • Mission3
    • TAKE Solutions
  • Validation and Review tools for eCTD submissions
    • GlobalSubmit
    • Extedo GLOBALvalidator and EURS is Yours
    • Lorenz eCTD Validator
    • CDISC or SAS datasets review tools
       

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:00 p.m.

  • Break Out Session — Conduct an eCTD readiness assessment for your company and present your findings and recommendations
     

4:00 p.m. – 4:30 p.m.

Q&A and Review Learning Objectives