URGENT PANDEMIC INFORMATION

In light of the pandemic situation all of our 2021 events are cancelled. We will inform customers directly when the events are rescheduled.    
COVID CANCELLED: Project Management in Human Resources,   Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference,   Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers,   Cambridge MA, Feb 2-4, 2021
COVID CANCELLED: US Immigration Compliance Strategies,   Boston MA, Feb 15-18, 2021
COVID CANCELLED: Project Management Training,   Boston MA, Mar 3-5, 2021
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COVID CANCELLED: SharePoint Technology Conference,   Boston MA, May 26-28, 2021
COVID CANCELLED: Employment Laws Certificate Program,   Boston MA, Jun 7-9, 2021
Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .    
TENTATIVE: 21 CFR Part 11 Compliance,   Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance,   Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation,   Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021,   Boston MA, Dec 7-9, 2021

Boston Professional Events List


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


Date
Jun 03, 2021 - 11:00 AM - Jun 04, 11:00 AM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  

Overview
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 2021, the eCTD will be required in the US for all marketing applications.


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


Lecture 1 - 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
Lecture 2 - 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.)


Who Will Benefit


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


Speaker Details


Speaker Profile 

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.


 Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]
 

Event Categories
Keywords: pharmaceutical




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