ACI’s 23rd FDA Boot Camp
The American Conference Institute’s popular FDA Boot Camp, now in its 23rd iteration, is slated to take place at the Omni Parker House Boston in Boston, MA from Thursday, September 18 to Friday, September 19, 2014. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.
The 23rd edition of the FDA Boot Camp will be co-chaired by Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, and Arnold & Porter LLP’s Daniel A. Kracov. Attendees will be regaled by a stellar cast of presenters who will share their knowledge and provide critical insights on a host of topics, including:
quoted from the FDALaw Blog found here
The 23rd edition of the FDA Boot Camp will be co-chaired by Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, and Arnold & Porter LLP’s Daniel A. Kracov. Attendees will be regaled by a stellar cast of presenters who will share their knowledge and provide critical insights on a host of topics, including:
- The organization, jurisdiction, functions, and operations of FDA
- The essentials of the approval process for drugs, biologics, and devices, including: INDs, NDAs, BLAs, OTC Approval, 510(k) submissions, and the PMA process
- for drugs and biologics and the clearance process for devices
- The classification of devices and the concept of “risk-based” classification
- The role of the Hatch-Waxman Amendments in the patenting of drugs and biologics
- Labeling in the drug and biologics approval process
- cGMPs and other manufacturing concerns relative to products liability
- Proactive adverse events monitoring and signal detection
- Recalls, product withdrawals, and FDA oversight authority
quoted from the FDALaw Blog found here
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