TMF Plus and eCTD Plus

Date	Dec 4, 2018
Time	11:00 PM EDT
Cost	$199287.00
Online

Round out your “cradle to grave”, authoring through archive understanding of Regulatory Information (content, documents, submissions and dossiers). The companion course, eCTD Plus occurs the 2 days immediately after this course: eCTD Plus: Concepts, Processes, & Tools for eCTD Publishing.

Learning Objectives:

1. Recognize the purpose and value of documents, files and data as assets in a drug development program
2. Identify industry best practices and their use and adoption
3. Distinguish paper and digital formats and understand transitioning from paper
4. Demonstrate an understanding of the complete life cycle of regulatory content
5. Discuss Best Practices for Essential Documents in their handling and storage.
6. Discuss the benefit and challenges of partnering with CROs and FSPs
7. Describe common models, including metrics, to demonstrate oversight of partners
8. Understand how regulations govern the repositories that retain Essential Documents
9. Identify the factors to assess in determining whether or not to retain a record
10. Comprehend the newly released regulations, guidelines, and industry best practices and gain an awareness of their impact.

Round out your “cradle to grave”, authoring through archive understanding of Regulatory information (content, documents, submissions, and dossiers). The companion course, TMF Plus occurs the 2 days immediately prior to this course: TMF Plus: Requirements, Best Practices and Tools to Manage Regulated Documents, Files, Submissions, & Dossiers.

Learning Objectives:

1. Knowledge of the CTD/eCTD and its propose and construct
2. Describe the eCTD and the basic tools for eCTD implementation
3. Knowledge of the tools (software & process) utilized before, during, & after eCTD publishing
4. Understand what constitutes a Submission Ready Document
5. Understand the various tools associated with document/submission publishing and evaluate those tools against your company’s needs while assuring regulatory compliance.
6. Learn various Standard Operating Procedures recommended for an organization to perform compliant eCTD publishing processes
7. Understand the various processes and best practices associated with quality regulated content management
8. Develop an understanding of outsourcing eCTD tasks and the associated benefits & risks
9. Inform your organization of the significant drivers impacting quality regulated content and document/submission publishing
10. Comprehend the newly released regulations, guidelines, and industry best practices and gain an awareness of their impact. Learn about eCTD format submission mandates – Regulatory agencies (US, EU, Canada, etc.)

Who Should Attend:

• Records Management Specialists at Sponsors, CROs, FSPs, Vendors, Clinical Sites
• Personnel involved in set up, maintenance, and auditing of the Trial Master File
• Project and/or Study Managers
• Project and/or Clinical Trial Assistants
• Clinical Operations Administrators
• Clinical Research Monitors
• Quality Assurance Personnel
• Compliance Auditors
• Consultants working in the life science industry involved in managing regulated content

• eCTD Publishers and Content Providers at Sponsors, CROs, Service Providers, Software Providers
• Regulatory Operations Personnel
• Regulatory Affairs Professionals
• Anyone new to the eCTD Delivery Paradigm
• Professionals preparing eCTD Marketing Applications for any Global Adopting Agency
• Research and Development Professionals
• Clinical Research Professionals
• Medical and Technical Writers
• Submission Document Authors
• Project Managers
• IT Professionals .