Biologics: Global premarket and postmarket issues surrounding biologic products, including updates, new developments, unique issues, successes and challenges facing regulatory professionals. Some sessions focus on recent and future legislation and regulatory activities that are being developed globally.

Clinical: Variety of clinical and clinical trial issues, including new legislation and guidances, clinical trial design and management, and ethical and clinical data issues.

Combination Products: Emerging issues and regulatory requirements regarding the development, approval and postapproval processes for combination products.

Devices: Global premarket and postmarket issues involving medical devices and in vitro diagnostics, including potential future initiatives, regulatory insights, regulatory changes and implications of new regulations on regulatory professionals.

Drugs: Global premarket and postmarket issues involving pharmaceuticals, including brand name, generic, and over-the-counter (OTC) drugs, and how those issues affect regulatory professionals.

Regulatory Business: Critical business tools and skills for RA professionals, including project management, team development, leadership, effective thinking, communication skills and qualities such as ethics.