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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.
Description: Elizabeth Garrard, Chief Safety Officer of the Drug Safety Alliance, explains how statistical signal detection can aid pharmacovigilance and offers tips on how to manage signal detection throughout the lifecycle of a product. Garrard covers:
What is – and isn’t – a signal;
Methods for identifying signals;
Data sources; and
ypes of questions that can be answered by using data mining methods.