FDA Regulatory Fundamentals in 2 Days
"This event offers a unique combination of experienced faculty, a comprehensive and up-to-date program, and concise and practical content. For any practitioner in the FDA space who wants to get a powerful learning boost in a compact package, this is a great program to attend."
And as our second co-chair, Christopher M. Mikson, Partner at Mayer Brown, states:
"The ACI Boot Camp is the perfect way to learn how to navigate the complexities of the FDA regulatory process that is so critical throughout the life cycle of drugs and biologics."
Join this group of domestic and international attendees as they gather to hone their practice and to hear from a stellar faculty, led by a "who's who" of the nation's top food and drug practitioners, in order to understand:
• What to expect during a sponsor meeting with the FDA
• The organization, jurisdiction, functions, and operations of the FDA
• The essentials of the pre-approval, approval, and post-approval process
• The interplay between the FDA and IP and the role of the Hatch-Waxman Act in the patenting of drugs and biologics
• Labeling in the drugs and biologics approval process
• Proactive adverse events monitoring, pharmacovigilance, and risk management, and more
PLUS, attend the pre-conference workshop on FDA Fundamentals and a discussion on What to Expect During a Sponsor Meeting with the FDA, to seamlessly join the main conference AND delve deep into the exclusivity dispute by joining us for our post-conference workshop on Hatch-Waxman and BPCIA!
ALSO, benefit from the ETHICS component focusing on Ethical Considerations Relevant to Communications with FDA!
Learn more about the program by visiting http://www.AmericanConference.com/