e-Consent: An Idea Whose Time Has Come

This presentation discusses the key elements to consider in implementing e-informed consent. Based on currently implemented online trial consents, crucial steps in the implementation process will be described.

Drawing from current national and international trial experience with electronic multimedia informed consent and the research literature on multimedia consent, presenters will discuss key lessons learned concerning subject and trial characteristics that impact on implementation of electronic consent and its’ success in a clinical trial. The session discusses a decision path for determining if e-consent can be effectively implemented for a trial.

e-Consent: An Idea Whose Time Has Come was presented by Dr. Susan Brink, ConsentSolutions, Inc. & Jovianna DiCarlo, Accugenex Technologies, Inc. and aired on 2008-12-03. For more details, or to download this event please visit our site at www.fxconferences.com

Electronic vs. Paper Data Capture: Which Option is Best for Your Trial?

There are many factors that come into play when deciding whether to employ electronic or paper data capture (EDC or PDC) for data management of a clinical trial. Most people focus on the perceived benefits of EDC, mainly relating to the ability to look at data on an ongoing basis. But there are other aspects that require consideration, such as set-up time, cost, and whether there are patient-generated data. These considerations are particularly important for small companies who run few trials, and therefore do not have in-house data management capabilities.

This presentation covers all aspects of EDC vs. PDC, describing the pros and cons of each for different situations. For example, what is the most cost-effective solution for a medical device company that runs one trial a year on average, has no in-house data management capability, and whose trials involve few patients, long follow-up periods, and patient-generated data? Conversely, what is the best solution for an in-vitro diagnostics company that performs large studies of several thousand patients with a very small case report form, almost no follow-up period, and the requirement to import large amounts of laboratory data?

Electronic vs. Paper Data Capture: Which Option is Best for Your Trial? is being presented by Helen Colquhoun, CEO, with Pleiad Inc. and airs on Wednesday, February 24, 2010. For more details or to register, please visit our site at www.fxconferences.com

Communicating Complex Technical Information to Non-Technical Audiences

If you are a scientist, researcher, QA/QC, or product development expert, you are dealing with complex concepts, specialized material, and information that may have taken years to master. But sooner or later, you need to communicate what you know to audiences who are not as technically experienced and knowledgeable as you: your company’s management, regulatory bodies and the general public.

This challenge is difficult. On the one hand, you need to ensure that what you communicate is technically correct and appropriately precise. On the other hand, you need to make complex ideas clear, easy to understand and memorable. How do you strike that balance, and tread that fine line between talking over the head of your audience and "dumbing down" your presentation to the extent that your core message is lost or distorted? This audio conference provides attendees with proven techniques for meeting the communication challenge.

Communicating Complex Technical Information to Non-Technical Audiences was presented by Karl Keller, Principal, with Communication Partners and aired on 2009-05-21. For more details or to download this event, please visit our site at www.fxconferences.com

The 2010 MDD Revisions and What They Mean for Translation

Companies are scrambling to meet the new requirements of the 2010 European Medical Device Directive (MDD). One of the most challenging components of the new directive is the increased focus on language translation for software and labeling. The updated MDD states that software that is integral to the operation of a medical device must be translated into the languages of the countries in which the device will be sold. In the past, companies have been able to avoid software translation by stating that the great majority of professional device users can read English.

Software translation is no small feat. It can be expensive, time-consuming and a minefield for errors. But it doesn't have to be this way. Through implementing some best practices and avoiding common pitfalls, software translations can go smoothly. Notified bodies are now placing particular emphasis on the risks presented by inaccurate labeling and translations. Inaccuracies in labeling and IFUs can lead to incorrect use of a device, resulting in injury, death, notified body action, lawsuits and bad publicity. The root causes of inaccurate translations are many, but fortunately, these can be sidestepped through careful preparation, translator screening and efficient processes.

This presentation focuses on the implications of the 2010 MDD for translation. It also covers specific best practices and common pitfalls in software translation and labeling translation, and looks at some of the most common root causes of inaccurate labeling and how to avoid them.

The 2010 MDD Revisions and What They Mean for Translation is being presented by Jason Heaton, with ForeignExchange Translations and airs on Wednesday, February 17, 2010. For more details or to register, please visit our site at www.fxconferences.com

Achieving Global Registration of Complex Biosimilars

Similar biological medicinal products (biosimilars) became a reality in Europe when the CHMP adopted positive opinions for the two human growth hormones Omnitrope and Valtropin. Since then, more than ten marketing authorization applications for biosimilar products have been approved. However, there have also been failures. Currently, there are biosimilar products being developed for the more complex biopharmaceuticals such as monoclonal antibodies, and soon those will be submitted for registration.

This audio conference details the relevant regulatory procedures, regulations, guidelines and regulatory experience to date with complex biosimilars. The speaker identifies and discusses the challenges (CMC, non-clinical and clinical) concerning the demonstration of biosimilarity for complex biosimilars, and proposes possible global development plans.

Achieving Global Registration of Complex Biosimilars is being presented by Robert Blakie, Director & General Manager, with ERA Consulting (UK) Ltd. and airs on Thursday, February 25, 2010. For more details or to register, please visit our site at www.fxconferences.com