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eCTD Software Training


Train before selecting your eCTD software provider:

Whether or not you choose to invest in eCTD regulatory consulting, many private organizations and professional groups offer very effective eCTD regulatory training programs for all levels of Regulatory Affairs employees. While it is unlikely that you will learn much about a particular eCTD software package, eCTD regulatory training courses will provide valuable guidance regarding the specific applications and tools that your drug company will need for a successful transition to eCTD submissions. In addition, it is a must to ensure that your staff is sufficiently trained and prepared for their new regulatory compliance responsibilities.

For those entirely new to eCTD, a good regulatory training program should include some or all of the following:

  • The types of applications which can be or are required to be filed in eCTD format;
  • Regulatory agencies which accept eCTD submissions, including a discussion of the differences between US and international eCTD submissions;
  • An in-depth discussion of the XML backbone and eCTD modules;
  • An overview of eCTD requirements and guidances, including file naming conventions, folder structures, study tagging files, meta data, etc;
  • Hands-on experience using eCTD software and tools

The best regulatory training programs will include a hands-on session, where your staff can gain experience working with some of the more popular eCTD software and tools while preparing a mock eCTD submission. Such programs tend to last more than one day and are costlier than, for example, a series of regulatory training teleconferences. However, giving your regulatory staff the ability to practice prior to your purchase of eCTD software will prove to be invaluable. Plus, these regulatory training sessions will help you understand your company's particular eCTD software needs.

Train during your transition to eCTD submissions:

In addition to investing in a good regulatory training program prior to your transition to eCTD submissions, it is important that you continue to train your staff both during and after your transition.

Many eCTD software providers will offer customized, hands-on training for your specific package of software and tools. It is essential that you take advantage of this, and to schedule enough time to learn as much as you can about your new software. Additionally, a competent software provider's training group should be able to answer most or all of your questions about eCTD submission requirements and best practices. It would be a good idea to schedule at least a week of training for as much of your regulatory (and IT) staff as possible. An ideal schedule might include 4 hour morning sessions, followed by 1-2 hours of trainer availability for questions that may arise during practice runs.

Train after your transition to eCTD submissions:

Your investment in eCTD regulatory training should not fade away after your transition to eCTD sbmissions. Requirements and standards are constantly changing and novel, less-expensive software aplications and submission tools are constantly being developed and released.

Continuing to provide ongoing regulatory training opportunites for you staff is a great way to develop your business processes and enhance your eCTD submission efficiency. It is also the most effective way to keep your pharmaceutical company up to date with current eCTD guidlines and specifications.

 

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