Tag: online learning

Prezi: The Zooming Presentation Editor

Posted on by Valentina Rosa

Prezi is being hailed (by some) as the next great app for creating meeting presentations (or prezis) live and on the web. For people who make their living in marketing communications and learning & development, it’s worth giving Prezi a test drive.

Unlike PowerPoint and its ilk, Prezi doesn’t involve creating discrete slides. Instead, it’s a Web-based “canvas.” Prezi users group their images, text, and video in various ways, and then zoom back and forth between topics during their talks. According to the website, once a presentation is downloaded, it works on any computer, even without Internet access. (I’ve not tested this claim.)

The Prezi Academy offers a step-by-step tutorial in using the product, as well as helpful hints on presenting and publishing. You can also browse popular prezis to see what others have created with the product.

Prezi offers free accounts, but a fee is required to work offline and to remove Prezi’s corporate branding. Prezi is also available for the iPad.

So, are marketing communications and learning & development professionals going to turn away from PowerPoint and flock to Prezi? Not likely in my opinion, but worthy of some exploration.

FDA Basics for Industry

Posted on by Valentina Rosa

The FDA has launched a new web site called FDA Basics for Industry to help companies save time and resources in their interactions with the agency. The website includes basic information about the regulatory process, including information that is frequently requested by industry. According to FDA Commissioner Peggy Hamburg, “the goal [of FDA Basics for Industry] is to improve communication between FDA and industry by making basic information about the regulatory process more accessible and user friendly to industry.”

This short video should be of value to any professional in the regulatory writing, regulatory consulting, or medial writing fields.

Recognizing the Value of User Assistance

Posted on by Valentina Rosa

WritersUA has been using the tagline of “Better UX through Better UA” for many years, perhaps since the late 1980s and early 1990s when they were known as WinHelp Writers. (It’s too long ago to trust my memory on this fact. Joe Welinske, president of WritersUA, could probably help me out.)

For the uninitiated, “UX” means “user experience” and “UA” means “user assistance.” What is user assistance? Wikipedia defines it as:

“a general term for guided assistance to a user of a software product. The phrase incorporates all forms of help available to a user. Assistance can also automatically perform procedures or step users through the procedure, depending on the question that the user asked. The term is broader than online help, and includes procedural and tutorial information.” (1)

I like the general Wikipedia definition especially the phrase “all forms of help available to a user.” Our best customers understand the benefits of making an investment in quality UA to improve their customers’ experience. They don’t want to overburden their technical/customer support teams; reduce the bottom line; or risk damage to the company’s reputation if their customers are not happy. Anyone who purchases electronics with technical documentation translated into Chinglish or Japanglish has experienced these frustrations first-hand.

In terms of TRA360, user assistance includes our technical documentation and learning & development practices. Let me know if can help YOU.

Notes

(1) http://en.wikipedia.org/wiki/User_Assistance

(2) Ibid.

New FDA Guidance on INDs: What You Need To Know

Posted on by Valentina Rosa

The FDA typically issues a new guidance when the agency is seeing errors in submissions and a lack of understanding in industry and academia. Most recently, the agency observed these trends regarding when and why the academic research community and industry must prepare an Investigational New Drug (IND) application before studies of a drug or biologic can begin in human subjects. In response, FDA released a new guidance document in October 2010 entitled “Investigational New Drug Applications – Determining Whether Human Research Studies Can Be Conducted without an IND.” The document totals just 19 pages.

Clients in our regulatory consulting & writing practice have told us that the new guidance provides an understanding of:

  • Three characteristics of research studies that create an IND requirement
  • Six criteria that must be met for a clinical investigation to be IND-exempt
  • When and if studies on healthy volunteers or studies using only a few subjects require an IND
  • When studies conducted outside the U.S. require an IND

Our clients also found the “Frequently Asked Questions” at the end of the guidance extremely valuable.

After reading the new guidance you should be able to create a checklist and determine whether your study requires an IND. Spend the time, read the guidance, and make a plan.