American Conference Institute’s Third Annual
FDA Boot Camp Devices Edition
Basic training in core regulatory concepts specific to medical devices
Tuesday, November 05 to Wednesday, November 06, 2013
Millennium Knickerbocker Hotel, Chicago, IL
The clearance and approval process…pre-approval concerns…product labeling… clinical trials and IDEs…MDRs… QSRs… post-market controls…recalls and withdrawals…enforcement – all are critical aspects in the commercialization process for medical devices, which are governed by FDA law and regulation. Recent court cases, and high-profile trials concerning FDA-regulated products have made it clear that it is essential for attorneys who do not have regulatory practices — but who do deal with FDA-regulated medical devices — to have a familiarity with these concepts. The changing business dynamics of the life sciences industry have also made it critical for business executives, policy analysts and securities experts who work in this field to have a clear understanding of the dynamics of the FDA.
Litigation as well as numerous other legal, business, and policy decisions concerning FDA-regulated medical devices often hinge on what happened during the pre-approval, approval, or post-approval periods.
Many products liability lawyers, patent counsel, business and investment experts, medical and regulatory affairs professionals, and those involved in pricing and reimbursement — despite their tenure in working with FDA-regulated devices — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period. Whether you are a products liability or patent litigator, in-house counsel, in-house business development or federal affairs professional, or new to regulatory practice, FDA Boot Camp – Devices Edition will provide you the insights you need.
Boost your medical device FDA regulatory IQ. Learn about the FDA approval process and the ins and outs of post-approval challenges
ACI’s Third Annual FDA Boot Camp – Devices Edition
has been designed to give you a strong working knowledge of core FDA competencies. A distinguished faculty of top FDA regulatory device experts — a “Who’s Who of the FDA Bar” — will share their knowledge and give you critical insights on:
The organization, jurisdiction, functions, and operations of the FDA
An overview of medical device regulations
The classification of devices and the concept of “risk-based” classification
Clinical trials and IDEs
The 510(k) clearance process – what you need to know now and what to expect in the future
The premarket approval process (PMAs) and drug labeling and promotion
General post-market controls and MDRs
QSRs vs. cGMPs and ISO
Mitigating the impact of enforcement actions
Recalls, product withdrawals, and FDA oversight authority