Group Expanded Access vs Individual Compassionate Use (Ax-S Pharma) скачать в хорошем качестве

Group Expanded Access vs Individual Compassionate Use (Ax-S Pharma)

Expanded Access Programs in the USA are primarily large-group programs that enroll hundreds or thousands of patients, each under one centralized protocol. Single-Patient "Compassionate Use" is very different. Learn the fundamentals in this 4-minute explainer created by Expanded Access policy advisor, Jess Rabourn. Expanded Access Programs (EAPs) are treatment-use clinical trials for medically suitable patients who cannot get into the regular clinical trials for a particular new therapeutic, diagnostic, or vaccine product. Website - https://www.axspharma.com San Francisco Bay Area, California, US Our flagship event, the Expanded Access Summit® was launched in 2017 to provide a best-practices forum for thought leaders in industry, healthcare, and public policy. The Summit has become the world’s largest and most influential annual conference on pre-market access to medicines. The third annual Expanded Access Summit was held Jan. 27-29, 2020 at the National Press Club, Washington DC and featured Anthony Fauci, MD (NIAID), Janet Woodcock, MD (FDA), Chris Austin MD (NCATS), Michael Kurilla MD, PhD (NCATS), Peter Hutt (Author, Food and Drug Case Law), Robert Walker (BARDA) and 30 other high level officials and experts. For years, conferences in this topic struggled to advance the field. Instead of addressing the fundamental barriers, many focused on ways for life science companies and health systems to say “No” to stakeholders seeking treatment access. They perpetuated unfounded perceptions of EAPs impeding clinical research, and they failed to examine the true feasibility factors of successful access programs. That’s why we created the Expanded Access Summit. It’s why we invited the highest level of leadership from industry, clinical care, patient advocacy, and government. The goal is to continually establish new best practices, dispel prevailing myths, and to break through the most stubborn barriers to innovation. Check back for our advanced expanded access workshop on -Data Collection/ Discovery -Cost recovery and payers -Non-interference with research trials -Collaboratively Sponsored Expanded Access What we covered today is pre-approval access in the expanded access regulations in the United States. We also covered the main differences between the single patient form and group form of expanded access. https://axspharma.com/covid-19-vaccines/ https://axspharma.com/real-world-data... https://axspharma.com/access-to-healt... https://axspharma.com/expanded-access... LinkedIn --   / axspharma   #ExpandedAccess #clinicaltrials