Last Chance to Register for San Diego, August 19-20

This is the ONLY eCTD Training that lets you walk through a sample submission!

Workshop Details
The new and emerging regulatory trends surrounding eCTD submissions have caused companies to examine their current processes and procedures. The eCTD Approval Workshop will discuss current regulatory guidelines, how to submit your first eCTD, and communication with regulatory agencies. There will also be hands on session including a step-by-step guide to creating your first eCTD. Your day will consist of four 90-minute sessions and will include catered breakfast and lunch. Our goal is for you to leave the workshop with a working knowledge of how to create eCTDs within your organization that will be accepted at the agency.

Register here for the workshop.

Hands-On Session
PharmaReady is the only eCTD training that allows you to walk step by step through an actual submission. Giving you the experience you need before you actually submit.

Workshop Materials
Along with the knowledge gained at this training each attendee with receive a 180 page detailed training booklet to take with them when they leave. As well as unlimited access to all Whitepapers authored by PharmaReady, including eCTD Validation: How to Ensure Your Submission Will Be Accepted At The Agency, by Harv Martens of the ICH M2 Committee.

About The Trainers
The PharmaReady team has extensive experience getting eCTD’s approved at various regulatory agencies. Recently, we publicly released in free webinar the most recent interpretation by the FDA of how they interpret leaf lifecycle. You can expect this kind of expertise and progressive material to be part of the eCTD Approval Workshop.

Register here for the workshop.

Session 1
Fundamentals of Electronic Submissions and eCTD

Regulatory Guidance

eCTD Technicalities

Gap Analysis (in-house current regulatory operations vs recommended eCTD based regulatory operations)

Session 2
Creating your first eCTD Submission

Step by Step guide to assemble an eCTD Submission (with a sample submission demonstration)

Do’s and Don’ts

Tips to increase regulatory operations efficiency

Review process

Session 3
Communication with Agency

How to send the submission and what to expect from the Agency in response

How to continue to create and manage more eCTD submissions.

Session 4
Hands on Workshop

Follow the instructions to create your first eCTD Submission

Questions and Answers

Assessment of Training

Attendee one-on-one time as needed