American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on September 27-28 in Boston, MA. ACI faculty will help attendees:
• Review the clinical trial process and how the results are used;
• Understand market exclusivities and protections, including Hatch-Waxman, orphan exclusivity, pediatric exclusivity, and protection for biologics;
• Evaluate follow-on applications (Hatch-Waxman ANDAs and BPCIA aBLAs);
• Review the labeling process and how to use it as a defense in products litigation;
• Understand the different pathways for expedited approval;
• Consider the uniqueness of combination products and companion diagnostics;
• Understand the respective roles of the FDA and PTO in the patenting of drug and biological products;
• Evaluate patents and generate of validity opinions;
• Review Commissioner Gottlieb's actions as his one-year anniversary approaches;
• Examine current Good Manufacturing Practices and their scope of importance in pharmaceutical and biological product commercialization;
• Understand the FDA's regulations and relevant guidance regarding labeling, advertising, and promotion;
• Review FDA compliance requirements, enforcement mechanisms, and best practices; and
• Examine adverse events monitoring, pharmacovigilance, risk management, and recalls.
In particular, ACI's faculty will offer presentations on the following topics:
• Clarifying the Clinical Trial Process for Drugs and Biologics
• Navigating the Approval Process for Drugs and Biologics
• Drugs and Biologics: Labeling
• Exploring the Expedited Approval Process
• Unique Considerations in the Approval of Combination Products and Companion Diagnostics
• Patents and Related IP Protections and Mechanisms
• Hatch-Waxman and BPCIA Overview
• Ripped from the Headlines: Breaking News and Emerging Trends Impacting FDA Practice
• Current Good Manufacturing Practices ("cGMPs") for Drugs and Biologics
• Promotion, Off-Label Communications, and First Amendment Concerns
• Enforcement
• Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls
In addition, two pre-conference workshops will be offered on the afternoon of September 26, 2018, from 1:00 pm to 4:00 pm and 4:15 to 5:15, respectively. The first workshop is entitled "FDA Pharmaceutical Law 101: Introduction to the Fundamentals," and the second workshop is entitled "Resolving Ethical Challenges Encountered during the Drug Approval Process." One post-conference workshop on "Skills Session: Tips and Strategies for Communicating with FDA" will be offered on September 28, 2018 from 2:00 to 5:00 pm.
An agenda for the conference and information regarding the workshops can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee is $2,295 (conference alone), $3,395 (conference and all three workshop). Patent Docs readers are entitled to a 10% discount off of registration using discount code P10-999-PTD18. Those interested in registering for the conference can do so here, by e-mailing [email protected], or by calling 1-888-224-2480.
Patent Docs is a media partner of ACI's FDA Boot Camp.
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