2020 Annual Breakouts Poll Annual 2020 Breakout SessionsPlease enable JavaScript in your browser to complete this form.Name *FirstLastPlease select no more than 10 of the following sessions. *Issues and Topics in Litigation Challenging FDA Actions under the Administrative Procedure Act (APA)Privacy and Cybersecurity Issues Facing FDA-Regulated CompaniesManaging Recalls, Internal Investigations, and Brand ManagementDue Diligence During and After Mergers and Acquisitions for Life Science CompaniesFDA’s Emergency Use Authorizations (EUAs): Authorities, Enforcement Discretion Policies, and What Happens NextLegal Liability: New Theories for Novel Drugs and Devices and Liability Related to COVID-19Smashing the Regulatory Status Quo: FDA’s Embrace of 21st Century Regulatory Science, Modernization of the New Drugs Regulatory Program, and Actions in Light of COVID-19New Processes, Standards, and Opportunities Under the Over-the-Counter Monograph ReformContinued Reliance on Foreign Active Ingredient Manufacturing and Production: Manageable Risk or Public Health Concern?Sponsor Use of Real-World Evidence and Patient Experience Data (PED) in Drug Development, Review, and Post-Market MonitoringExamining the State of Drug Importation and Drug PricingImplications and Applications of FDA’s Regulatory Framework for Software as a Medical DeviceInnovative and Breakthrough Devices and Diagnostics and Evolving Regulatory PathwaysEuropean MDR and IVDR: Ready, or Not?FDA’s Case for Quality in Medical Devices and Harmonization of Quality System RegulationCombination Products: Updates in Reliability Requirements, Compliant and Safety Data, and Reporting“Breaking Through” on Biosimilars: Regulatory Challenges and Barriers to EntryCell and Gene Therapy – Regulatory Frameworks and Exclusivity ConcernsTrends in Biologic and Biosimilar LitigationThe New Era of Smarter Food Safety: What Does it Include and How Will it Be Achieved?Labeling and Marketing of Innovative FoodsFood for Thought: Personalized Nutrition, “Functional Foods”, and FDA RegulationEmerging Technologies: Regulatory Oversight of Intentional Genomic Alterations in AnimalsAntimicrobial Resistance and Stewardship in Veterinary MedicineCannabis and CBD Regulatory Update: Where We Are and What’s Next?MessageVote Kiana Walker2020-06-30T14:08:15-04:00
