Complimentary Training –
The eCTD Publishing Process

This training was conducted on January 3rd, 2014 at 1 PM Eastern.

We will cover the basic process of taking your source documents and converting them into a submitable eCTD. We will cover the steps Aquila follows as well as how to estimate the time necessary. This training is critical for any sponsor that plans to create an eCTD and wishes to minimize the time, expense and most importantly the risk of their project.

The slides for this training is available here: The eCTD Publishing Process – PDF

UPCOMING – FDA Forms for eCTD

As of May 5th, 2017 the FDA began mandating eCTD for all approved applications. But in addition the FDA now also mandates signed fillable forms.

This training will explain this new requirement and describe how you can electronically sign the forms for submission.

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eCopy for Medical Devices

In 2013 the FDA began requiring an electronic version of all medical device submissions known as, “eCopy”. In Aquila’s last training, Aquila discussed the eCOPY format, FDA changes and developments that gave us several things to consider when creating our eCopy submissions. The FDA’s CDRH office published a revision to present “e-Copy for Medical Devices” in December of 2015. Stay tuned with Aquila for the latest on “eCopy”

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eCTD Around the World

The training provides an overview of eCTD around the world. We will discuss the impact that eCTD is having upon other global regulatory organizations as well as pharmaceutical and biologic companies

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503B – Compounding Pharmacy Submissions

In 2014 Compounding Pharmacies were allowed to register as Outsourcing Facilities which saves the company from many regulatory requirements.

One consequence of 503B registration is the submission of distribution data. This training covers the regulatory requirements, the data needed, and some lessons learned from the first submission deadline.

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ACA6004 Submissions

In 2012 the Affordable Care Act was signed into law. This law includes new reporting requirements like ACA6004. Learn about the new submission type, what is required, and what information you will need.

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AU and the eCTD

This training provides a brief review of Australian eCTD protocol and structure.
Australia has recently joined other world countries and will be submitting their drug approval applications to the Australian Therapeutic Goods Association, (TGA) in eCTD format. Australia joins the United Kingdom, the United States and Japan, all of whom are mandated to submit via eCTD.

Complimentary Training – Australia and eCTD

CDISC – The FDA Data Standard

In 2013 the FDA said they planned to require CDISC for data submission. This training will discuss the regulatory requirements, provide a description of CDISC standard and offer some considerations for integrating it into your application.

Complimentary Training – CDISC – The FDA Data Standard

eCTD Accelerator – Templates

This exciting product is being released by Aquila to fill the unmet need of a cost effective eCTD Template solution. Our new template system has a variety of unique features including being actively maintained! Sponsors will never have out of date templates again!

Complimentary Training –
eCTD Accelerator – Templates

The eCTD Publishing Process

We will cover the basic process of taking your source documents and converting them into a submitable eCTD. We will cover the steps Aquila follows as well as how to estimate the time necessary. This training is critical for any sponsor that plans to create an eCTD and wishes to minimize the time, expense and most importantly the risk of their project.

Complimentary Training – The eCTD Publishing Process

The FDA’s ESG

Many Sponsors have expressed concern and confusion regarding the FDA’s ESG system. Aquila discusses the ESG system and how sponsors use it. We then provide instructions for setting up your own FDA ESG account.

Complimentary Training – The FDA’s ESG

FDA Updated M1

In August of 2013 the FDA released a new M1 specification. Learn about the dramatic changes and how this will affect your eCTD publishing.

Complimentary Training – Review of New FDA Module 1

The GUDID

This training explores, “The Global Unique Device Identification Database”. “GUDID” is a database administered by the FDA that will serve as a reference catalog for every device with an identifier.

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Marketing Materials in eCTD

After release of the FDA’s module 1 update, it is now possible to submit your Marketing Materials through eCTD. This training will assist you in submitting your marketing materials electronically.

Complimentary Training – Marketing Materials in eCTD

Navigating eCTDs

This training provides an overview of eCTD history and structure. It then demonstrates how to navigate in an eCTD as well as a number of tips.

Complimentary Training – Navigating eCTD

MS Word – Tips and Tricks

The regulatory author uses many tips and tricks in MS Word. Aquila University will explore the more common and the not so common tips and tricks used as a publishing tool by the regulatory author.

Complimentary Training – MS Word – Tips and Tricks

Electronic Signatures

Many small sponsors are unsure what electronic signatures are and how to use them. This training will discuss the different types of electronic signatures and how to use some advanced Adobe features for signing your documents.

Complimentary Training – Electronic Signatures

Paper Publishing

While the FDA strongly recommends electronic publishing in the eCTD format, some sponsors still wish to submit with paper. Paper publishing has a number of specific formatting and ‘linking’ requirements that many regulatory personnel are unaware of. This training will cover all the structure and formatting requirements for a CTD based paper submission to the FDA.

Complimentary Training – Paper Publishing

Paper to eCTD Conversion

In January of 2013 the FDA released a draft guidance requiring that all applications be submitted electronically. Not only is it soon to be required but eCTD is often cheaper and faster than traditional paper publishing.

However, if the conversion isn’t done correctly, you could spend far more than you need to or worse yet, damage your application.

This training will provide the background you need to change your paper applications to eCTD.

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Publishing System – Desktop

The Desktop Publishing method will be the third publishing method we will discuss in our series on Publishing Methods. We will discuss the pros and cons of Desktop Publishing and other features related to this method.

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Publishing System – Enterprise

This training provides an overview of Enterprise based publishing systems. It is part one of a four part training series on publishing systems. Since Aquila does not market publishing software you can be assured of a non-biased review of the different systems included in the series. We will cover the advantages and disadvantages related to the Enterprise system as well as other helpful information.

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Publishing System – Publishing Partners

The training provides an overview of working with a Publishing Partner (Outsourcing) and is the last of our four part series. We will explore the advantages and disadvantages related to utilizing Publishing Partners and discuss what types of organizations are best served by outsourcing.

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Publishing System – SaaS

This training is the third of a four part series on Publishing methods. We shall be discussing SaaS Publishing in this session and will explore its advantages and disadvantages amongst other important features and options.

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QC eCTDs The Easy Way

The QC process takes anywhere from 5-10% of the total publishing time. This training teaches the sponsor what to check, potential areas of confusion and helps minimize the time commitment required to verify your sequence.

Complimentary Training – QC eCTDs

RPS – The Future of eCTD

Regulated Product Submission is a major update to eCTD. This new standard will lead to radical changes to the well known standard and will trigger reassessments of the software and workflows around submission publishing.

Complimentary Training “RPS – The Future of eCTD” is Available Here

Selecting Your Publishing System

This training covers the common system types as well as the advantages and disadvantages of each. Since Aquila does not market publishing software you can be assured of a non-biased review of the different options.

Complimentary Training – Selecting Your Publishing System

Stability and the 21st Century – eStability

Like submissions, labeling and adverse event reporting, Stability reporting is now moving to an electronic XML based submission format. eStability is under development but this training will show you what is to come for CMC.

Complimentary Training – Stability and the 21st Century – eStability”

Using eCTD Accelerator – Viewer

Aquila provides a freeware eCTD viewer called Aquila’s eCTD Accelerator – Viewer. While this software is carefully designed to maximize the ease of use, we provide this training to answer any questions the user may have.

Complimentary Training – Using Aquila’s eCTD Accelerator – Viewer

Using SPL (Structure Product Label)

SPL (Structured Product Label) is the format the FDA uses to receive electronic labels. This widely used format is extremely complex and changes frequently. This training will cover the basics of SPL and some important pointers for creating the labels.

Complimentary Training – Using SPL (Structured Product Label)

Complimentary Training – The eCTD Publishing Process

This training was conducted on January 3rd, 2014 at 1 PM Eastern.

The slides for this training is available here: The eCTD Publishing Process – PDF

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Complimentary Training –
The eCTD Publishing Process