TMF Plus and eCTD Plus 2018

  • 04-07 Dec 2018
  • Miami, FL, United States

Description

TMF Plus and eCTD Plus 2018 is a workshop that covers topics such as:

  • Industry best practices and their use and adoption
  • The purpose and value of documents, files and data as assets in a drug development program
  • The complete life cycle of regulatory content
  • Paper and digital formats and understand transitioning from paper
  • The benefit and challenges of partnering with CROs and FSPs
  • Best Practices for Essential Documents in their handling and storage
  • How regulations govern the repositories that retain Essential Documents
  • Common models, including metrics, to demonstrate oversight of partners
  • The newly released regulations, guidelines, and industry best practices and gain an awareness of their impact
  • The factors to assess in determining whether or not to retain a record
  • The eCTD and the basic tools for eCTD implementation
  • Knowledge of the CTD/eCTD and its propose and
  • What constitutes a Submission Ready Document
  • Knowledge of the tools (software process) utilized before, during, after eCTD publishing
  • Various Standard Operating Procedures recommended for an organization to perform compliant eCTD publishing processes
  • The various tools associated with document/submission publishing and evaluating those tools against your companys needs while assuring regulatory compliance
  • Outsourcing eCTD tasks and the associated benefits risks
  • The various processes and best practices associated with quality regulated content management
  • The newly released regulations, guidelines, and industry best practices and gain an awareness of their impact
  • Your organization of the significant drivers impacting quality regulated content and document/submission publishing
  • ECTD format submission mandates Regulatory agencies (US, EU, Canada, etc.)

TMF Plus and eCTD Plus 2018 brings together:

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

Past Events

Important

Please, check "TMF Plus and eCTD Plus" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Operations, Quality assurance
Health & Medicine: Medical device, Medical laboratories, Pharma
Technology: Information Technology (IT)

Other Events with Similar Categories

Other Events with Similar Location or Organizer

Featured Conferences & Exhibitions