Less than a year into the world’s identification of a novel pathogen, there are hundreds of treatments and vaccines in various stages of pre-clinical and clinical research. While nearly all of them are still being studied, many of these potential COVID-19 treatments are being made available to patients outside of clinical trials. Regulators have tried to accommodate the need to conduct clinical research differently during a pandemic, and to balance the need to generate evidence with the desperation doctors and seriously ill patients face.
Further investigation has shown some experimental treatments to be disappointing, but the latest positive research on vaccines has sent stock markets soaring and fueled hopes for an end to the pandemic. With this backdrop, the decision about authorizing the nation’s first COVID-19 vaccine is being discussed by industry leaders, public health experts, and government regulators, with medical and nursing staff likely at the front of the line for the first vaccine doses.
During this complimentary webinar, Bass, Berry & Sims attorneys Clint Hermes and Nesrin Tift will cover the following topics:
- Pathways for unapproved drugs/devices, including “traditional” expanded access, Emergency Use Authorizations and clinical trials.
- Regulatory framework for doing research during COVID-19, including guidance from OHRP and the FDA.
- COVID-19 therapies and vaccines, with a deeper dive on vaccine research and the pending decision to authorize one prior to full licensure
The webinar will take place on December 1, 2020, from 12:00 PM – 1:30 PM CST.
Who Should Attend?
- In-house legal counsel.
- Regulatory affairs specialists.
- Clinical research personnel.
- Institutional review board members.
- Research directors.
- C-level executives, consultants and principals in the healthcare industry.
Submit questions upon registration or email them to Meg Reinsch.
This program is approved for 1.5 hours General Tennessee CLE credit. Please provide your BPR number upon registration, and Bass, Berry & Sims will report your participation to the Tennessee CLE Commission at the conclusion of the program. Certificate of completion and other necessary application forms provided for use in other jurisdictions.