American Conference Institute is proud to announce that we are bringing our 5th Annual FDA Boot Camp- Devices Edition, back to Chicago on July 26-28, 2017. We specifically tailor this conference to provide regulatory professionals with in-depth coverage of current FDA law and regulations. New for this year, we have a fresh Ripped from the Headlines session, covering key developments in the FDA regulatory bar including cybersecurity, device labeling, off-label promotion, and related First Amendment challenges.
Our stellar faculty of FDA experts – a “Who’s Who of the FDA Regulatory Devices Bar” – will share their knowledge and provide critical insights to help you:
– MASTER the basics of the application an approval processes, including 510(k)s, de novo, and PMAs
– NAVIGATE the complexities of device regulations
– COMPREHEND the organization, structure, jurisdiction, function, and operations of FDA
– LEARN how devices are classified, monitored, and regulated
– RECOGNIZE the pivotal role of labeling and learn how to avoid misbranding and off label promotion
– SEE the importance of cGMPs and QSRs to the post-approval regulatory process
– NAVIGATE the protocols of adverse events monitoring, product withdrawals, and recalls
Our program includes insights from former FDA employees who served as:
– Associate Chief Counsel for Medical Devices
– Associate General Counsel for Enforcement
– Compliance Officer (Consumer Safety Officer)
– Counselor in the Office of the Commissioner
– Engineer, Regulatory Research Officer
– Investigator (Consumer Safety Officer)
– Legislative Analyst
– Regulatory Analyst
– Regulatory Counsel
– Special Assistant to the Chief Counsel
This year we are also honored to have Jonette Foy, Ph.D., Associate Director for Policy (Acting), CDER, FDA presenting a keynote address.
Esteemed Co-Chair and speaker Patricia Kaeding, Chief Regulatory Counsel at GE Healthcare says: “The boot camp is a terrific way for those new or relatively new to medical device regulation to build knowledge and skills. And it’s also valuable for those more experienced as it is an opportunity to hear perspectives and strategies from an array of distinguished experts in FDA law and regulation on a wide-range of top of mind areas and emerging issues.”
Full information on the forum can be found at http://www.AmericanConference.com/FDABootCamp-Devices
Category: Pharmaceuticals / Biotech / Life Sciences
Hear from Top FDA Regulatory Experts at ACI’s 5th Annual FDA Boot Camp- Devices Edition
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American Conference Institute is proud to announce that we are bringing our 5th Annual FDA Boot Camp- Devices Edition, back to Chicago on July 26-28, 2017. We specifically tailor this conference to provide regulatory professionals with in-depth coverage of current FDA law and regulations. New for this year, we have a fresh Ripped from the Headlines session, covering key developments in the FDA regulatory bar including cybersecurity, device labeling, off-label promotion, and related First Amendment challenges.
Our stellar faculty of FDA experts – a “Who’s Who of the FDA Regulatory Devices Bar” – will share their knowledge and provide critical insights to help you:
– MASTER the basics of the application an approval processes, including 510(k)s, de novo, and PMAs
– NAVIGATE the complexities of device regulations
– COMPREHEND the organization, structure, jurisdiction, function, and operations of FDA
– LEARN how devices are classified, monitored, and regulated
– RECOGNIZE the pivotal role of labeling and learn how to avoid misbranding and off label promotion
– SEE the importance of cGMPs and QSRs to the post-approval regulatory process
– NAVIGATE the protocols of adverse events monitoring, product withdrawals, and recalls
Our program includes insights from former FDA employees who served as:
– Associate Chief Counsel for Medical Devices
– Associate General Counsel for Enforcement
– Compliance Officer (Consumer Safety Officer)
– Counselor in the Office of the Commissioner
– Engineer, Regulatory Research Officer
– Investigator (Consumer Safety Officer)
– Legislative Analyst
– Regulatory Analyst
– Regulatory Counsel
– Special Assistant to the Chief Counsel
This year we are also honored to have Jonette Foy, Ph.D., Associate Director for Policy (Acting), CDER, FDA presenting a keynote address.
Esteemed Co-Chair and speaker Patricia Kaeding, Chief Regulatory Counsel at GE Healthcare says: “The boot camp is a terrific way for those new or relatively new to medical device regulation to build knowledge and skills. And it’s also valuable for those more experienced as it is an opportunity to hear perspectives and strategies from an array of distinguished experts in FDA law and regulation on a wide-range of top of mind areas and emerging issues.”
Full information on the forum can be found at http://www.AmericanConference.com/FDABootCamp-Devices