eCTD Submissions of IND/NDA to the US FDA, EU and Canada

  • Speaker:Peggy J. Berry
  • Duration:90Min
  • Product Code:GRC-90215

$289

refer

Refer Friends


Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. 

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.  

Description

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 implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.  Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

Areas Covered:

  • 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 format requirements
  • Discussion on the successful transition from other formats to the CTD
  • Implementing tools for the project management of CTD preparation and publishing
  • Technical requirements for an eCTD submission
  • Document naming requirements
  • Building the folder structure
  • Performing “pre-publishing” work for each document
  • Tools for tracking and managing eCTD content
  • Performing quality checks on the eCTD
  • Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)       

Handouts:

  • eCTD Software Vendors
  • eCTD Vendor Requirements

Target Job Title:

  • Regulatory Affairs
  • Quality Assurance
  • Pharmacovigilance
  • Project Management
  • Regulatory Operations
  • Anyone responsible for providing content for the CTD

Instructor:

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development.  She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.  Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).  She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992).  In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society.  She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

Available Options

Recording: Access the training Recording for 6 months from any location

$329

CD: Shipped within 2 working days

$409

5 Member Group: 5 can Attend Live Meeting Online from any location globally

$2,649

10 Member group: 10 can Attend Live Meeting Online from any location globally

$3,839

Related Products

FDA's GMP Expectations for Phase I and First-In-Man Clinical Trials

FDA's GMP Expectations for Phase I and First-In-Man Clinical Trials

If you are unable to attend the Live meeting then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. Why you should attend:Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development.  Explore and discuss ways to develop and implement strategies for your GMP documentation.What is the topic about:This webinar will rev..

$289

Preparing Compliant eCTD Submissions:  Are you prepared for upcoming FDA mandate on e-submissions?

Preparing Compliant eCTD Submissions: Are you prepared for upcoming FDA mandate on e-submissions?

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications.Why You should Attend The Session:This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.  Description:The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic p..

$279