This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market.
We will begin by reviewing the contents of an Investigational New Drug (IND) application, and then follow the process of an IND submission. Next, the contents and approval process of an NDA submission will be discussed. This seminar will also provide a foundation for those who require an understanding of the FDA new drug approval process, and familiarize the attendees with the regulatory landscape in which INDs and NDAs are developed and approved.
Areas Covered in the Session:
- High level overview of the FDA approval process for a new drug
- What is an IND? Identify the key contents of an IND
- What is an NDA? Identify the contents of an NDA
- The FDA IND and NDA review process
- Discovery stage
- Preclinical Testing
- IND Application
- Clinical Trials
- Phases I to IV
- High-level description of medical device process
Who Will Benefit:
- Clinical Trials Associates
- Regulatory Affairs
Fatuga is a social-entrepreneur who is actively engaged in three primary roles/companies: (a) founder/president of Caligeo Clinical OneVision; (b) founder/CEO of Caligeo Clinical CRO; and (c) founder/Executive Director of Atlanta Premier SMO. His professional passion lies in promoting clinical trial opportunities in emerging markets (especially in Africa, the Caribbean, East Asia, and Latin America) and among under-represented population (in the USA). He recently completed his MBA degree from Emory University/Goizueta Business School with a focus on Entrepreneurial ship/Organizational Behavior & Management. He received his M.Sc. in Drug Regulatory Affairs and Health Policies from Massachusetts College of Pharmacy and Health Sciences and BS degree in Neuroscience from Brown University. He has more than 15 years of experience in the clinical research industry. Fatuga began his clinical research career as a study coordinator at Brown University. Since then, he has had leadership opportunities as Clinical Team Manager, Project Lead, QA/QC Manager, Lead CRA, CRA Consultant, Medical Research Associate, and CRA Specialist in a variety of companies such as central imaging facility, Contract Research Organizations (CROs), biotechnology and pharmaceutical companies. Fatuga is currently certified as a Project Management Professional (PMP) and a Clinical Research Associate (CCRA). He is an active member of the International GCP Training Advisory Board for the Association of Good Clinical Practices in Nigeria (AGCPN) and also a member of Nigerian Association of Pharmacist and Pharmaceutical Scientists in the Americas (NAPPSA). Fatuga is also a member of the International Committee/Leadership Team of the National Biotechnology and Pharmaceutical Association (NBPA) which is a US based organization functioning in collaborative efforts to discuss challenges and opportunities of conducting clinical trials with diverse communities as well as addressing the disparity issues in the clinical trial industry.
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As Republican efforts to repeal and replace the Affordable Care Act continue in the background, some Democrats are starting to eye a new health policy goal: implementing a single-payer system. Sen. Bernie Sanders, I-Vt., introduced a single-payer bill in mid-September with 16 Democratic co-sponsors — 16 more than he got when he introduced the bill two years earlier. But how is the health care system funded now, and how would “single-payer” change that?
How health care systems are funded
There are three major components to every health care system, single-payer or not: a patient, a payer (typically an insurance company or the government) and a provider. Here’s how money moves between them:
How multipayer systems work
Virtually all health care systems follow this general pattern, but who the payers are can vary widely. In the U.S. private insurance market, patients typically purchase coverage from one insurance company among many competing insurers. Because different people end up with different insurers, there are multiple payers throughout the U.S. health care system.
How single-payer systems work
In a purely single-payer system, there is, as the name would indicate, just one payer — typically the government. This is analogous to how the United States administers some portions of Medicaid: The government provides coverage, and no private insurers are involved.
Sanders’ bill takes universal coverage close to this extreme: The government insurance would cover so many services with such small copays that private insurance would be almost universally unnecessary. Accordingly, it would also be quite expensive — $32 trillion over 10 years, according to an Urban Institute report. That’s more than a 50 percent increase in federal spending — all federal spending — according to spending projections by the Congressional Budget Office. That would be partially offset by people no longer needing to pay premiums to private insurers, however, and the government’s monopoly could allow it to implement cost-saving measures.
Read More: http://snip.ly/mt3iy#http://www.chicagotribune.com/business/ct-biz-how-single-payer-health-care-works-20171018-story.html
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