6-Hour Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

Description

The eCTD struggle is real. Regulatory submissions must conform to the electronic common technical document (eCTD) format to be successfully received and reviewed by health authorities. And while this might seem simple, this complex technical process is actually rife with risk if you lack expertise in medical writing and regulatory publishing.

Every regulatory professional should have a solid understanding of the standards, groundwork, expertise and technology required to submit compliant eCTD submissions. This begins with understanding what will be accepted and what will not. Put yourself and your company a step ahead of competitors by understanding the technical skills and regulatory requirements necessary to meet the impending eCTD mandates.

Background:

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled the implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. As of May 2017, the eCTD is required in the US for all submissions.

Agenda

CTD > eCTD

• Overview of the drug development program and source of relevant submission documents
• Discussion of the roles and responsibilities for CTD preparation
• Review of the CTD content & format requirements
• Implementing tools for the project management of CTD preparation and publishing

eCTD Prepararation

• Technical requirements for an eCTD submission
• Document naming requirements
• Building the folder structure
• Publishing each document, module & submission
• Tools for tracking and managing eCTD content
• Performing quality checks on the eCTD
• Lifecycle management: Updating content (amendments, supplements, variations, etc.)

Why You Should Attend :

This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.

• Stay ahead of competitors by understanding technical skills and regulatory requirements necessary to meet the impending eCTD mandates.
• Gain a solid understanding of the standards, groundwork, expertise, and technology required to submit compliant eCTD submissions.
• Learn the differences between the CTD and eCTD and how to prepare for the transition.
• Understand the roles and responsibilities for CTD and eCTD preparation.
• Learn the technical requirements for an eCTD submission, including document naming requirements and building the folder structure.
• Discover tools for tracking and managing eCTD content, as well as performing quality checks on the eCTD.
• Gain knowledge on updating eCTD content, including amendments, supplements, variations, and more.
• Learn best practices for preparing SOPs, training authors, selecting appropriate vendors, and building an eCTD submission project plan.
• Understand the FDA receipt and review process, as well as document management and archival.
• Get expert advice from industry professionals on how to navigate the complex technical process of eCTD submission.
• Network with peers and industry experts to exchange ideas, experiences, and insights.
• Get an opportunity to ask questions and receive answers in real-time from industry professionals.

Specific Topics:

• Preparing your SOPs
• Training authors
• Selecting appropriate vendors
• Submission project plan
• Building the eCTD
• FDA receipt and review process
• Updating the eCTD
• Document management and archival

Target Audience

• Regulatory professionals
• Medical writers
• Publishers
• Quality assurance professionals
• Drug development professionals
• Biotech and pharmaceutical industry professionals
• Professionals involved in global development programs
• Individuals involved in submission document preparation
• Professionals responsible for submission project management
• Individuals responsible for updating content (amendments, supplements, variations, etc.)
• Individuals responsible for tracking and managing eCTD content
• Individuals responsible for performing quality checks on the eCTD
• Individuals responsible for document management and archival
• Professionals looking to gain knowledge on technical skills and regulatory requirements necessary to meet the impending eCTD mandates
• Anyone who wants to learn about the differences between the CTD and eCTD and how to prepare for the transition.