Now get all the training you need – all in one place, and all for one low price!
The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!
If you are already a Training Pass member login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video click the "Download Presentation" link.
Description: Einar Bjornsson, Professer of Gastroenterology and Hepatology at Landspitali University Hospital, explains how to use data capture methods to minimize drug-induced livery injury risks without risking patients. He covers:
When DILI is most likely to occur;
Drug factors in DILI outcomes;
Phase I vs. Phase II reactions; and
A comparison of compounds with significant and nonsignificant hepatic metabolism.
Description: Josh Feldstein of the Center for Applied Value Analysis makes the case for using comparative cost effectiveness (CCE) research and value analytic models to help demonstrate a product’s value to purchasing decisionmakers. Feldstein discusses:
Training needed to conduct effective CCE research;
Learning from programs already in use in the EU, Canada and Australia;and
Integrating medical statistics and health economics to create a value analytic model.
Description: Attorney Chad Landmon presents strategies for achieving FDA approval of an ANDA by using Paragraph IV certification instead of costly and lengthy patent litigation. Landmon covers such topics as:
Understanding the FDA’s bioequivalence requirements;
How to craft an ANDA that directly addresses the patent infringement issue; and
Speakers: Frederick H. Branding RPh JD, Principal Attorney, Olsson, Frank, Weeda, Terman, Bode and Matz P.C. and Cathy L. Burgess, Partner, Olsson, Frank, Weeda, Terman, Bode and Matz P.C. Health Care Group
Description: Attorney Joan Antokol explains how to ensure the right language is written into a clinical trial agreement indemnification clause to protect the sponsor in the event a malpractice lawsuit is filed. Using case studies and examples of clauses from actual clinical trial agreements, Antokol examines:
The impact of the current research landscape on indemnification;
IRB and Ethics Committee requirements; and
Factors to consider when deciding the scope of indemnification needed for a clinical trial.
Description: International compliance experts Steven Datlof and Elisabethann Wright examine the differences between medical device reporting requirements in the EU and the U.S., addressing who needs to report adverse events, when they should be reported and to what authority? Datlof and Wright look at:
The differences from the perspectives of manufacturers, user facilities and importers;
Premarket and postmarket reporting requirements; and
Reporting voluntary recalls and corrections and removals.
Description: Compliance expert and former FDA investigator Martin Browning presents the EU’s revised rules for managing risks throughout the life of any computerized systems used in a regulated activity, from simple spreadsheets to complex networks. Annex 11, revised in 2011, is the European counterpart to U.S. Part 11 rules for use of electronic systems in manufacturing. Browning explains:
The principals and scope of Annex 11;
Differences between Annex 11 and Part 11;
How the revised rules incorporate standard IT practices; and
How they differ from the original Annex 11 provisions that had been in place for nearly 20 years.