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

Apr 22, 2021 - 03:00 PM EST
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$899


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

Date

Time

Duration

22-April-2021

3 PM EST

4 Hrs.

23-April-2021

3 PM EST

4 Hrs.

 

Total Duration

8 Hrs.

Mode of Delivery

Online

ASQ equivalent CEU

0.8


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.

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. 

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

           LEARNING METHODOLOGY:

Topic

Delivery mode

Presented By

Date

Time

Duration

Module 1:

Understanding the CTD format

Live class

CW Expert

22nd April 2021

3.00 pm ET

2 hrs

Q&A Session

15 mins

Module 2:

Managing preparation of the CTD

Live class

CW Expert

22nd April 2021

5.00 pm ET

2 hrs

Q&A Session

15 mins

Module 3:

Putting the CTD into eCTD format

Live class

CW Expert

23rd April 2021

3.00 pm ET

2 hrs

Q&A Session

15 mins

Module 4:

Technical aspects of the eCTD & lifecycle management

Live class

CW Expert

23rd April 2020

5.00 pm ET

2 hrs

Q&A Session

15 mins

Online Assessment

Final assessment and certificate

Online test

 

 

 

30 mins

Program Features:

1.       Online course delivery – Live instructor-led training delivered by top industry experts

2.       Q&A after every session

3.       Unlimited access to learning videos in case you miss the live classroom session

4.       Soft copy of learning materials

5.       Assessment at the end of the course; CCU certificate upon successful completion

6.       Lifetime access to the learning platform with thousands of courses and 1-on-1 access to experts

Webinar Events
Attend Live Webinar
Apr 22, 2021 - 03:00 PM EST

Duration: 8 Hours

Single Attendee


Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version


Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version


Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session




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