ABA Health Law Webinars and Events: Off-Label Marketing and Free Speech; FDA Medical Device Law Fundamentals
Wednesday, 11/12/14: Off-label Marketing and Free Speech: Caronia and the Future of Speech in Therapeutic Product Promotion
Information:
The landmark decision in U.S. v. Caronia has emboldened drugs and biologics makers to contest charges of off-label marketing, including the currently pending California False Claims Act case regarding unapproved uses of Integrilin. This webinar will focus on Caronia and other First Amendment cases, including IMS Health Inc. v. Sorrell, evaluating the prosecution of off-label promotion against the therapeutic products industries.
The webinar will:
- Provide participants with key factual and procedural information regarding Caronia and related First Amendment cases to provide discussion context
- Present and assess government and industry perspectives to the litigation and future impacts
- Discuss how the cases may practically impact current and future prosecutions as well as actions taken by therapeutic product companies
Webinar
-1.5 CLE credits requested
-Wednesday, 11/12/14
-12:00 PM – 1:30PM Eastern
-$115 – $150 ABA Members; $99 Government
http://shop.americanbar.org/ebus/ABAEventsCalendar/EventDetails.aspx?productId=137218496&sc_cid=PM
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Thursday, 11/20/14: FDA Medical Device Law Fundamentals
Information:
In this webinar, a panel of experienced FDA attorneys will give you an overview of the responsibilities of the FDA and its impact on the medical device and healthcare mobile app approval.
Topics will include:
- An introduction to the FDA and how it’s organized
- The basics of device classification and what qualifies as a medical device and how that applies to mobile apps
- The clinical trial, premarket approval, and 510(k) processes
Panelists will also define many of the acronyms and terms unique to the FDA. Attendees will come away with an understanding of what the FDA is looking for during the review process, as well as key regulatory requirements relating to labeling, post-market issues, advertising, reimbursement, adverse event reporting and recalls, and enforcement.
Webinar
1.5 CLE credits requested
Thursday, 11/20/14
12:00 PM – 1:30PM Eastern
$115 – $150 ABA Members, $99 Government
http://shop.americanbar.org/ebus/ABAEventsCalendar/EventDetails.aspx?productId=138341798&sc_cid=PM
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In Person Program December 11-12: Medical Device & Legal Professionals: A Collaborative Exchange
Information:
A Collaborative Exchange will be held December 11-12, 2014 in Washington, DC hosted with the Medical Device Manufacturers Association. The program brings together general counsel, private practice lawyers and medical device executives to discuss effective compliance programs, best practices and emerging trends in such areas as off-label marketing and mHealth, among others. The faculty will discuss training applicable to the U.S. sales force, international distributors, auditing and what to do when problems arise. Additionally, the program will dedicate a full day to practical demonstrations based on a hypothetical internal investigation that covers identifying the compliance issues, to strategies for settling with the government, which will involve an actual medical device CEO acting as the responsible corporate officer. This practicum day will highlight best practices, effective investigative and settlement strategies, and how to avoid knotty ethical issues.
This program is a must for those who want to interact with medical device executives, those who are responsible for managing compliance programs or those who wish to increase their competency in managing internal investigations. This program is ultimately designed to assist medical device executives and their counsel, in a practical and hands-on manner, with facing the many significant compliance threats of today and tomorrow.
View the brochure: http://shop.americanbar.org/PersonifyImages/ProductFiles/134769832/CE1412MDM_WebBrochure102214.pdf
7.5 CLE credits requested
Thursday and Friday, December 11-12, 2014
$995 General Public
$895 ABA Members
$795 ABA Health Law Section Members
$795 ABA Section of Science & Technology Law Members
$795 Medical Device Manufacturers Association Members
http://shop.americanbar.org/ebus/ABAEventsCalendar/EventDetails.aspx?productId=134769832&sc_cid=PM