Online Safety Community

Orchestrating a Successful eCTD

Event Details

Orchestrating a Successful eCTD

Time: April 18, 2018 from 1pm to 2:30pm
Location: Training Doyens 26468 E Walker Dr
City/Town: Aurora
Website or Map: https://bit.ly/2ulRggh
Phone: +1-720-996-1616
Event Type: webinar, :, life, science
Organized By: Training Doyens
Latest Activity: Mar 27

Export to Outlook or iCal (.ics)

Event Description

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 2017, the eCTD will be required in the US for all marketing applications.

WHY SHOULD YOU ATTEND

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

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.)

LEARNING OBJECTIVES

Get all the information needed for implementing the mandated requirements of the CTD/eCTD.

WHO WILL BENEFIT

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

SPEAKER

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.

For more detail please click on this below link:

https://bit.ly/2ulRggh

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

 

Comment Wall

Comment

RSVP for Orchestrating a Successful eCTD to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted events
15 hours ago
Adam Fleaming posted a blog post

Simple but [Important Things] to Remember About FDA Trainings

When you work in an industry that is regulated by the FDA, one thing that is as certain as day and night is the fact of FDA regulation. Of course, this is as obvious as saying that solar power is derived from the sun and is as silly as asking if the FDA regulates FDA-regulated industries! The point being made is that regulation is the essence of the FDA’s existence. The FDA has been created to regulate certain industries with the intention of ensuring safety and reliability of the products.This…See More
15 hours ago
Training Doyens posted events
17 hours ago
John Robinson posted events
Friday

Forum

Safety - A Prerequisite 12 Replies

Whether working at home or outside, to observe safety should be our pre-requisite. The employer before anything must be sure of the safety of its employees especially the ones working in mines or any…Continue

Tags: products, safety

Started by Enna Henry. Last reply by Jen McDade 18 hours ago.

5 TECHNOLOGY-BASED LONE WORKER SAFETY SOLUTIONS

ABOUT 75% OF EMPLOYEES IN NORTH AMERICA ARE MOBILE WORKERS. ADVANCES IN COMMUNICATIONS TECHNOLOGY MEANS THESE WORKERS CAN WORK ANYWHERE AT ANY TIME. THESE NEW TECHNOLOGIES ALSO MEAN THESE MOBILE…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 31.

Road Safety Solutions 14 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Jen McDade May 31.

Remote Monitoring

Get "Safe Assets and Sound Productivity" Through Remote Monitoring.Visit:…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 23.

Python Condition Objects Tutorial in 2018 1 Reply

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren. Last reply by Jim Chesters May 15.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service