eCTD Seminars and Workshops

Most times that I type a search string into Google that includes the acronym "eCTD", the search result includes at least a few advertisements for eCTD training sessions, seminars, and/or workshops designed to inform industry workers of varying experience levels. I have had the pleasure of attending a few of these and my experiences have been mostly positive. I implore the readers of this blog to share their experiences, both positive and negative, in the comments section of this post. Here are some questions. Help me out with some answers!

• Have you attended any eCTD workshops during your career? Why or why not?
• What type of organization delivered the workshop (e.g. independent consultant, technology vendor, a business partner)?
• What experience level was assumed for attendees of the workshop/seminar (e.g. novice, intermediate, advanced)?
• What was your impression of the experience? Did the presenters do anything that jumped out at you as special (e.g. technology demonstration, hands on session)?
• Was their anything disappointing about the experience (e.g. too sales-y, too simple)

As I mentioned, my experiences have been mostly positive, but I have heard negative feedback about workshops and seminars that other regulatory professionals have attended.

If executed well, I think that eCTD workshops and seminars can be extremely beneficial to organizations looking to make the transition to eCTD. I was recently asked my opinion about the viability of eCTD workshops in Europe, and I have included my opinion on planning these seminars below.

"The [idea] that you are proposing is a popular one on the US West Coast, as many smaller companies here are interested in making the transition to eCTD. I expect that some of the considerations that companies must take into account are common across all regions when transitioning to eCTD.

Internal education about the eCTD standard can take time depending on an organization's existing familiarity. Often times senior management must be sold on the benefits of eCTD before they will sign off on a change that will cost thousands of dollars in training, consulting, and software. To achieve the maximum possible efficiency gain by transitioning to eCTD, a company's regulatory staff will also need to get buy in from other divisions like Clinical and CMC so that internal templates are being used effectively and review processes can function smoothly."

Again, please leave comments on your experiences. Even if you've never been to an eCTD workshop or seminar, I'm still interested to know how you learned what you know about eCTD...the internet?..coworkers?..conference sessions?