Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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XTalks

APRIL 24, 2023

The natural mold inhibitor is just the latest in Corbion’s wide range of offerings, which include food innovations, specialty ingredients and packaging products. Related: Is Fiber Based Packaging the Next Trend in Sustainable Food Packaging? Here’s everything you need to know about this burgeoning food industry innovator.

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Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? But now it’s a warning in their package insert.

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ACRP blog

AUGUST 1, 2023

Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the Association of Clinical Research Professionals (ACRP) to the U.S.

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ACRP blog

AUGUST 1, 2023

Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the Association of Clinical Research Professionals (ACRP) to the U.S.

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Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Improved Scalability As research organizations grow, so do their needs.

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XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. So probably the biggest change for us on our packaging labels is we have to redo all that and add sesame.”.

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Cloudbyz

MAY 24, 2023

The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis. Let’s delve into how these solutions can accelerate research and bring products to market faster.

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Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. While Part 11 is widely known, this blog explains how it fits in with your research software. In 1997, FDA released regulations providing guidance on the use of electronic systems.

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Pharmaceutical Technology

MARCH 10, 2023

Freeze-drying systems companies help in the verification and validation monitoring of the freeze-drying process to comply with the latest regulations and good automated manufacturing practice (GAMP) guidelines.

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The Pharma Data

MAY 17, 2021

In a separate Research Letter, Simon J. Gunter, MPhil, and his colleagues at the PORTAL research group provides an analysis of the effect of market exclusivity of drugs under FDA’s Unapproved Drug Initiative (UDI).

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Cloudbyz

MARCH 3, 2023

Mid-size Clinical Research Organizations (CROs) play a significant role in the pharmaceutical and biotech industry by providing various services such as study design, clinical trial management, data management, and biostatistics. This can make it challenging to ensure compliance with the latest regulations and guidelines.

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ACRP blog

JANUARY 11, 2024

As the saying goes, “With great power comes great responsibility,” and with so many clinical study site leaders now taking technological powers into their hands that were traditionally held by sponsors, some of them and their staff may be surprised to find the awesome responsibilities that come packaged with the deal. View complete schedule.

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XTalks

APRIL 18, 2024

In this episode of the Xtalks Food Podcast, Sydney talks about the discovery of elevated lead levels in cinnamon products, which has prompted a closer look at food safety practices and regulations. Cinnamon can become contaminated with lead through various pathways. This allows for a holistic approach to tackling diet-related health issues.

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XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. Also in this episode, Sydney talks about the recent approval of house crickets in food products in the European Union (EU).

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Camargo

JANUARY 12, 2022

While this type of meeting was previously limited to discussions of products regulated by the Center for Biologics Evaluation and Research (CBER), INTERACT meetings will also encompass those regulated by the Center for Drugs Evaluation and Research (CDER) under PDUFA VII. Receipt of Background Package.

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Drug Discovery World

FEBRUARY 27, 2024

The epigenome is a system of reversible marks that regulate how the DNA is read, translated, and used. The epigenetic system can selectively package regions of the DNA away, making them inaccessible and, therefore, less active. T-cells use epigenetic programs to regulate their maturation.

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XTalks

MAY 9, 2023

If you’re considering a career in clinical research, read on to learn more about this rewarding career. A clinical trial manager is responsible for overseeing the planning, conduction and completion of clinical trials in accordance with applicable regulations, guidelines and protocols. What Does a Clinical Trial Manager Do?

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Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Remember, only those questions listed in the package will be discussed during the INTERACT meeting.

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pharmaphorum

MAY 4, 2022

With recent developments in industry regulations and guidance, the 2022 agenda will give an international insight into the global regulatory environment and leading FDA representatives will address the key standards to be aware of in injectable device development. Primary Packaging material designers. Secondary packagers.

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Pharmaceutical Technology

NOVEMBER 21, 2022

However, despite this significant market share, the Japanese market is likely to become a less attractive market for international pharmaceutical companies based on recent findings from the Office of Pharmaceutical Industry Research (OPIR).

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pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines.

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XTalks

AUGUST 12, 2020

A pool of over 1,000 US consumers asked to identify the healthier options based on whole grain content made the wrong choice 47 percent of the time for bread, up to 37 percent for crackers and 31 percent for cereal, the researchers said. Related: Move Over Nutrition Labels, Carbon Footprint Labels are Coming to a Snack Near You.

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Pharmaceutical Technology

NOVEMBER 21, 2022

However, despite this significant market share, the Japanese market is likely to become a less attractive market for international pharmaceutical companies based on recent findings from the Office of Pharmaceutical Industry Research (OPIR).

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FDA Law Blog

MARCH 28, 2022

Circuit held that products that simultaneously meet both the FD&C Act’s general “drug” definition and its more-restrictive “device” definition must be classified and regulated as “devices,” FDA issued an “ Immediately in Effect Guidance ” to implement the decision as applied to ophthalmic products.

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WCG Clinical

NOVEMBER 3, 2023

HHS and FDA regulations require that the study participant is provided with “A description of any reasonably foreseeable risks or discomforts to the subject;” (45CFR 46.116(a)(2)) (21 CFR 50.25(a)(2)) It is not sufficient to direct participants to the package labeling for a drug instead of adding the risks to the consent form.

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FDA Law Blog

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” See, e.g., 42 CFR § 430.0.

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pharmaphorum

NOVEMBER 26, 2020

He told Sky News that additional costs, bureaucracy and delays could follow a no-deal Brexit, or an agreement failing to address the complexity of drug regulation. As companies begin to seek approval from the regulator for new COVID-19 vaccines, it’s critical that we get the roll out right.

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XTalks

SEPTEMBER 22, 2020

MIT engineers have designed a food sensor , made from an array of silk microneedles, that can pierce through the plastic packaging of foods to sample for bacterial contamination and spoilage. The Velco-like device pierces the packaging and the food via silk microneedles that suck in material through capillary action.

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Advarra

JULY 19, 2022

If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. The sponsor is the pharmaceutical company conducting the trial.

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XTalks

APRIL 14, 2021

New research published in Science Advances has suggested that a natural cyan blue extracted from red cabbage could replace synthetic blue dyes in food. Food coloring is an essential part of the food and beverage industry; however, some research suggests that using synthetic dyes is not healthy for the consumer. 1, FD&C Blue No.

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XTalks

AUGUST 31, 2020

Importation of contaminated food and food packaging is a feasible source for such outbreaks and a source of clusters within existing outbreaks,” according to the study’s abstract. The study counters a World Health Organization statement from August 13 that reported food or food packaging had not been linked to the transmission of COVID-19.

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Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. . The IND goes into effect; and .

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XTalks

NOVEMBER 9, 2022

Since highly processed foods have become more prevalent in recent decades, researchers are still working to understand the full impact of these dietary shifts. Researchers found that the consumption of such foods may be the attributable cause of death in a significant percentage of deaths in the Brazilian population. .

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Cloudbyz

JANUARY 27, 2021

For the last many years, although the virtual trial has found its popularity, sponsors and researchers have always been hesitant to embrace it wholeheartedly for many reasons. Technologies like artificial intelligence and clouds are used heavily to seamlessly flow electronic data from the patient to hospitals and research centers.

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Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict. Quality control release testing.

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Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. What is the top regulatory concern when a single-arm study is employed? Simply, BIAS.

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