Webinars

Webinar

Right-to-Try or Right-to-Ask? Understanding Right-to-Try and FDA’s Expanded Access

This webinar explores both Right-to-Try legislation and existing FDA Expanded Access Programs, including understanding sponsor responsibilities under these programs and when products may be eligible for these programs, evaluating options such as treatment protocols, treatment INDs, and emergency use, and discussing development risks associated with participation in these programs.

Webinar

Development Advice for CBD Products

Cannabadiol (CBD) products have been in news a lot recently, but what does it take to bring a CBD product to market for an unmet medical need? This webinar discusses development considerations for CBD and other cannabis-derived products from a clinical, preclinical (pharmacology/toxicology), CMC, and regulatory perspective.  The webinar also reviews challenges and lessons learned from the development and approval of Epidiolex of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

Webinar

Improving Diversity in Clinical Research

Racial and ethnic minorities are under-represented in clinical trials. We’ll discuss who is participating in clinical trials, why diversity is important, and solutions on what sponsors, CROs, and investigators/clinical sites can do to increase diversity in clinical research.

Webinar

The Evolving Role of Clinical Data Management

Technology and data sources are rapidly changing, and clinical data management has to change too in order to keep pace.  This webinar will examine the effect of technology advancements on the future responsibilities of clinical data managers and discusses the needs introduced by the application of new technologies and broader data source availability.