The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products. They are the government agency responsible for reviewing, approving and regulating medical products, including pharmaceutical drugs and medical devices.
This presentation describes the new process by which the Centers for Medicare and Medicaid Services (CMS) will establish the prices the Agency pays for clinical diagnostic laboratory tests.&n...
A recent clinical trial of the AR inhibitor enzalutamide in patients with TNBC included an exploratory endpoint using RNA sequencing to identify a genomic signature of patients likely to resp...
Screening for cervical cancer represents one of the greatest successes achieved in disease prevention. Cytology has been central to cervical cancer screening programs for over 50 years and ha...
Psychiatric disorders are among the leading causes of disability worldwide. One fifth of the population will suffer from a psychiatric disorder in their lifetime. Antipsychotic and antidepres...
Launched in early 2015, the Precision Medicine Initiative (PMI) takes advantage of the progress made in genomic testing – progress largely driven by rapid advances in DNA sequencing tec...
This panel will discuss quality requirements of ancillary materials used in cell therapy manufacturing, relevant standards and how requirements vary by phase. Participants will learn wh...
The Alliance for Regenerative Medicine (ARM) is the preeminent global advocate for regenerative and advanced therapies. ARM fosters research, development, investment and commercialization of ...
Vitamin D3 supplementation can effectively remedy the current epidemic of vitamin D deficiency, especially within the African-American population and the elderly of any ethnicity. Racial disp...
Most of the tests performed for patient care use automated colorimetric and immunoassay methods in the clinical laboratories. Clinical labs are regulated by CLIA and are routinely inspected b...
DATE: October 5, 2016
TIME: 10:00am PT, 1:00pm ET
Sepsis, a host-mediated response to a systemic infection, is a leading cause of mortality worldwide (1). Early recognit...
Melanoma arises in the pigment producing cells (melanocytes) and is the deadliest of the skin cancers. It accounts for nearly 200,000 new cases of cancer each year worldwide and in the U.S. o...
DATE: September 8, 2016
TIME: 8:00am PST, 11:00am EST
The FDA’s 21 CFR Part 11 guidance on the use of electronic records for data retention or submission is clear. With ...
Community acquired pneumonia affects over 5 million Americans and 6 million Europeans annually. Typically 5-10% will be admitted to hospital. It is a condition that more often affects the eld...
Despite FDA-approved vaccines and antivirals, seasonal and pandemic influenza remains a serious threat associated with substantial morbidity and mortality. The present modalities and va...
Stem cells, specifically induced pluripotent stem cells (iPSCs), offer exciting potential for the future of cell therapy and regenerative medicine. More recently, genetic engineering of stem ...
Following attendance of this virtual event, participants should appreciate the changing epidemiology of trichomoniasis and clinician ordering patterns on the basis of improved laboratory...
The 68Ge / 68Ga generator is new to radiopharmacy practice but it will be a big part of our future world. The time will come in the not too distant future when we will be able to compou...
July 13, 2016, 8:00am PT, 11:00am ET, 4:00pm GMT
Changes in the classification standard, ISO 14644-1:2015, will have an impact on both the number of sample points needed to classif...
The Centers for Medicare and Medicaid Services (CMS) is about to gather reimbursement data from laboratories to recalculate the clinical laboratory fee schedule. The process and potenti...
I will be discussing the following subjects in my presentation: Update from 2015 PAMA Proposed (or Final Rule) FDA Regulation of LDTs Change to Physician Payment and impact on diagn...
Emerging technologies facilitate basic science research, but their value in regulatory applications requires rigorous assessment and consensus within the research community. Next-generation s...
In vitro translation (IVT) using mammalian cell extracts is a quick and convenient alternative to in vivo mammalian protein expression. Thermo Fisher has developed IVT systems from two mammal...
In this webinar the speaker discusses the approach taken by the Food and Drug administration in their pre-market review of in vitro diagnostic tests. The legal bar passed by congress in...
Cancer remains the second leading cause of death in the United States. Most tumors arise from a myriad of genetic changes that dysregulate cell growth and prompt survival. Ident...
This presentation describes the new process by which the Centers for Medicare and Medicaid Services (CMS) will establish the prices the Agency pays for clinical diagnostic laboratory tests.&n...
A recent clinical trial of the AR inhibitor enzalutamide in patients with TNBC included an exploratory endpoint using RNA sequencing to identify a genomic signature of patients likely to resp...
Screening for cervical cancer represents one of the greatest successes achieved in disease prevention. Cytology has been central to cervical cancer screening programs for over 50 years and ha...
Psychiatric disorders are among the leading causes of disability worldwide. One fifth of the population will suffer from a psychiatric disorder in their lifetime. Antipsychotic and antidepres...
Launched in early 2015, the Precision Medicine Initiative (PMI) takes advantage of the progress made in genomic testing – progress largely driven by rapid advances in DNA sequencing tec...
This panel will discuss quality requirements of ancillary materials used in cell therapy manufacturing, relevant standards and how requirements vary by phase. Participants will learn wh...
The Alliance for Regenerative Medicine (ARM) is the preeminent global advocate for regenerative and advanced therapies. ARM fosters research, development, investment and commercialization of ...
Vitamin D3 supplementation can effectively remedy the current epidemic of vitamin D deficiency, especially within the African-American population and the elderly of any ethnicity. Racial disp...
Most of the tests performed for patient care use automated colorimetric and immunoassay methods in the clinical laboratories. Clinical labs are regulated by CLIA and are routinely inspected b...
DATE: October 5, 2016
TIME: 10:00am PT, 1:00pm ET
Sepsis, a host-mediated response to a systemic infection, is a leading cause of mortality worldwide (1). Early recognit...
Melanoma arises in the pigment producing cells (melanocytes) and is the deadliest of the skin cancers. It accounts for nearly 200,000 new cases of cancer each year worldwide and in the U.S. o...
DATE: September 8, 2016
TIME: 8:00am PST, 11:00am EST
The FDA’s 21 CFR Part 11 guidance on the use of electronic records for data retention or submission is clear. With ...
Community acquired pneumonia affects over 5 million Americans and 6 million Europeans annually. Typically 5-10% will be admitted to hospital. It is a condition that more often affects the eld...
Despite FDA-approved vaccines and antivirals, seasonal and pandemic influenza remains a serious threat associated with substantial morbidity and mortality. The present modalities and va...
Stem cells, specifically induced pluripotent stem cells (iPSCs), offer exciting potential for the future of cell therapy and regenerative medicine. More recently, genetic engineering of stem ...
Following attendance of this virtual event, participants should appreciate the changing epidemiology of trichomoniasis and clinician ordering patterns on the basis of improved laboratory...
The 68Ge / 68Ga generator is new to radiopharmacy practice but it will be a big part of our future world. The time will come in the not too distant future when we will be able to compou...
July 13, 2016, 8:00am PT, 11:00am ET, 4:00pm GMT
Changes in the classification standard, ISO 14644-1:2015, will have an impact on both the number of sample points needed to classif...
The Centers for Medicare and Medicaid Services (CMS) is about to gather reimbursement data from laboratories to recalculate the clinical laboratory fee schedule. The process and potenti...
I will be discussing the following subjects in my presentation: Update from 2015 PAMA Proposed (or Final Rule) FDA Regulation of LDTs Change to Physician Payment and impact on diagn...
Emerging technologies facilitate basic science research, but their value in regulatory applications requires rigorous assessment and consensus within the research community. Next-generation s...
In vitro translation (IVT) using mammalian cell extracts is a quick and convenient alternative to in vivo mammalian protein expression. Thermo Fisher has developed IVT systems from two mammal...
In this webinar the speaker discusses the approach taken by the Food and Drug administration in their pre-market review of in vitro diagnostic tests. The legal bar passed by congress in...
Cancer remains the second leading cause of death in the United States. Most tumors arise from a myriad of genetic changes that dysregulate cell growth and prompt survival. Ident...
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