The Pharma Data

MAY 3, 2021

Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . .

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pharmaphorum

JULY 22, 2022

for an Improved, Efficient and Contaminant-Free Cleanroom. From the new operating practices that keep the product as sterile as possible, to the developments in technology that are enabling this to happen. Key Reasons to attend: Learn how to maximise the latest cleanroom technologies to modernise your contamination control strategy.

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Contamination Pharmacy Production Engineer 52

World of DTC Marketing

FEBRUARY 28, 2021

SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. So should we forget all that because they developed a COVID vaccine? The answer is NO.

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Vaccination Vaccine Contamination Compliance 180

XTalks

APRIL 19, 2023

Researchers at McMaster University in Canada have developed a rapid Salmonella test for detecting contamination in chicken and other foods, which could help to reduce the cost of food processing and improve food safety. Traditionally, Salmonella detection was done through a series of tests that could take several days to complete.

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Bacteria Contamination Regulation Engineer 98

pharmaphorum

MARCH 19, 2021

Since the third quarter of last year DeepVerge’s scientists have been working to transform an AI-based water contamination detection system into a unit that tests for the presence of the coronavirus. A femtogram is 0.000000000000000001 kilograms.

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XTalks

JUNE 7, 2022

They are caused by bacteria, viruses, parasites or chemical substances entering the body through contaminated food or water. An estimated 420,000 people in the world die every year after eating contaminated food, with children under five years old carrying 40 percent of the foodborne disease burden. How to Get Involved .

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Contamination Bacteria Regulation Development 98

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

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XTalks

NOVEMBER 2, 2020

The requirements come from two specific FSMA regulations: the Preventive Controls for Human Food (PC Human Food ) and Produce Safety. And under three FSMA regulations, suppliers may also use third-party audits to verify their activities. Related: Is the FDA Doing Enough to Regulate Added Chemicals in Foods?

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Regulation Contamination Development Production 98

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Clinical Research Compliance Research Regulation 52

XTalks

AUGUST 21, 2020

Michel Nielen, professor of food safety at Wageningen University & Research, in the Netherlands wanted to create a fundamental change in the world of food monitoring, so he and his team coordinated the FoodSmartphone project which is developing ways to detect food quality and safety using smartphones. But it’s not enough. Traceability.

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Regulation Big Data Contamination Production 110

pharmaphorum

JUNE 8, 2022

Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0 Bioprocess Research & Development. Cleanroom Managers. Regulatory Affairs Managers. Production Managers. Quality Systems Managers.

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Compliance Contamination Manufacturing Production 52

The Pharma Data

OCTOBER 30, 2020

The fifth meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (IHR) (2005) regarding the coronavirus disease (COVID-19) took place on Thursday, 29 October 2020 from 12:30 to 16:05 Geneva time (CEST). Proceedings of the meeting. Diagnostics, therapeutics, and vaccines 10.

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Regulation Vaccination Vaccine Compliance 52

XTalks

MAY 18, 2023

Cornell University researchers have been making strides in the development of a revolutionary tool to combat dangerous pathogens in commercial dry food manufacturing plants. Steam is also employed for sterilizing equipment and preventing contamination during packaging processes. Their solution? Superheated steam. Instances of E.

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Manufacturing Contamination Production Packaging 52

XTalks

OCTOBER 21, 2022

The review explains how local health departments can prioritize retail food regulations if unprecedented public health emergencies occur in the future. A contamination at a retail establishment has the potential to greatly impact public health. Routine food safety inspections experienced significant disruptions throughout the pandemic.

Regulation 52

Regulation Contamination Manufacturing Development 52

XTalks

NOVEMBER 4, 2022

The ability to rapidly test and detect these pathogens on food and processing equipment allows for immediate intervention and remediation that can reduce widespread contamination that results in loss of product, foodborne illness and subsequent devastating economic impact to the food producers associated with product recalls.”.

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Contamination Bacteria Production Packaging 97

Pharmaceutical Technology

DECEMBER 20, 2022

From partnerships to open-source technology and data transparency, the culture behind therapeutic development and delivery is shifting towards one that embraces teamwork. Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety.

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Regulation Contamination Manufacturing Production 130

XTalks

DECEMBER 1, 2021

Not only can the PD100 ensure produce is safe to eat, but it can also help users develop better fruit and vegetable washing habits over time. Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? It comes equipped with a wireless charging station and lasts for six hours per charge.

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Contamination Packaging Packaging Regulation 98

XTalks

JUNE 5, 2023

Related: World Food Safety Day 2022: Theme, History and Ways to Get Involved The HACCP system traces its roots to the 1960s, developed initially by the National Aeronautics and Space Administration (NASA) and Pillsbury to provide safe, long-lasting food for space missions.

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Regulation Contamination Production Development 52

Drug Discovery World

OCTOBER 5, 2022

The company has developed modular technology that can print multi-material and highly complex tissue structures in 3D, providing all the basic features needed for bioprinting. The market is growing strongly as accelerated technological, material, and methodological developments expand the potential applications for 3D bioprinting.

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Drugs Regulation Manufacturing Medicine 52

Roots Analysis

OCTOBER 24, 2023

Different Types of HPAPIs The new generation of APIs being developed are highly complex in nature, including peptides, HPAPIs, oligonucleotides and sterile APIs. This precaution is taken to prevent any potentially harmful contaminant from escaping the production area.

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Manufacturing Hormones Contamination Containment 40

Camargo

AUGUST 5, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. This prospectively developed comparative evidence was used to great advantage by Astellas as RWE in its submission for this new approval.

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Development Production Regulation Clinical Trials 232

XTalks

MAY 11, 2023

Related: Abbott Baby Formula Plant Under Investigation by the DOJ Symptoms of Cronobacter Sakazakii Infection Infants are particularly vulnerable to Cronobacter sakazakii infections, as their immune systems are still developing and their digestive tracts are not fully formed.

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Bacteria Doctors Doctor Contamination 98

XTalks

APRIL 3, 2024

This development, announced earlier this week, introduces a significant twist in the ongoing saga of the H5N1 virus , which has been affecting birds globally and in the US since early 2022. The detection of HPAI in dairy cows marks a concerning development for the US dairy industry.

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Genotype Contamination Bacteria Development 45

FDA Law Blog

DECEMBER 13, 2021

Subpart E of the PSR was specifically developed to address agricultural water quality control. The regulated industry criticized the complexity and the one-size-fits-all approach of Subpart E. susceptibility of the produce to surface adhesion or internalization of contaminants); Environmental conditions (e.g., 26, 2022.

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Compliance Contamination Regulation Development 52

The Pharma Data

DECEMBER 30, 2020

Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. Using the contaminated mouthwash can result in “oral and, potentially, systemic infections requiring antibacterial therapy.

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Contamination Vaccination Vaccine Pharmacy 52

XTalks

SEPTEMBER 13, 2022

In April, the FSIS announced that the New Jersey-based company Lakeside Refrigerated Services was recalling over 120,000 pounds of ground beef products that may be contaminated with E. The public health alert comes as some federal health authorities in the country are investigating an outbreak of E. While most E.

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Bacteria Packaging Packaging Production 98

FDA Law Blog

OCTOBER 31, 2021

SB 343 adds additional requirements; it requires that California’s Department of Resources Recycling and Recovery (CalRecycle) update regulations that require disposal facilities to provide information on recycling data. Instead, companies must be aware of the specific nuances and requirements in California and developments in other states.

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Packaging Packaging Containment Production 52

FDA Law Blog

NOVEMBER 30, 2022

According to the Realtor, these CIP qualification discrepancies “may lead to contamination” and “…over time [lead to] to adulterated [Gamunex] product and significant risk of patient harm.” These CIP equipment qualification reports were provided to the FDA in support of its PAS and PAI to approve the new facility.

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FDA Approval Manufacturing Compliance Contamination 72

pharmaphorum

MARCH 22, 2022

The efforts underway to strengthen the manufacturing process across the industry have become more important than ever, as the therapies the industry is developing increase in complexity. However, with a number of deals and investments being made in the space, the demand is there to develop more efficient methods of training and manufacturing.

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Manufacturing Production Contamination Gene Therapy 137

XTalks

NOVEMBER 2, 2021

It also found detectible levels of phthalates in food handling gloves, which researchers said could be a source of contamination. The study found higher levels of chemicals in fast-food items containing meat, such as hamburgers and chicken burritos, while cheese pizza had the lowest levels.

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Containment Hormones Contamination Packaging 96

XTalks

FEBRUARY 21, 2022

The BioNTainers will not only be equipped to manufacture BioNTech’s COVID-19 vaccine, but also other mRNA vaccines to address the needs in Africa, such as BioNTech’s investigational malaria and tuberculosis vaccines if they reach successful development and approvals.

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Vaccination Vaccine Production Manufacturing 105

XTalks

JUNE 7, 2021

World Food Safety Day was founded mainly to draw attention to the contamination of food and water, the people it impacts and ways to reduce risks. Recognizing the systemic connections between them and meeting the terms laid out in the UN’s Sustainable Development Goals will help meet the food safety needs of the future, the FAO suggests.

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Contamination Production Development Regulation 64

The Pharma Data

FEBRUARY 18, 2022

A review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter. “As Most people with salmonellosis develop diarrhea, fever and abdominal cramps. Source link: [link].

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Production Bacteria Containment Cosmetics 40

XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Trulicity (Dulaglutide) Trulicity sales in 2022: $7.439 billion Company/Developer: Eli Lilly & Co.

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Sales Insulin FDA Approval Drugs 52

Cloudbyz

NOVEMBER 3, 2021

Before deploying collected samples for a project, small portions from those samples are retained as a precautionary measure, to account for any potential destruction or contamination of the originally designated portions of the samples. Let’s use the easiest example of a sample. Reflecting, not directly predicting.

Biobanking 52

Biobanking Clinical Research Contamination Research 52

pharmaphorum

NOVEMBER 24, 2022

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. million to deliver – as well as demanding specialist skills to maintain to industry standards – their widespread development has been slow. Meeting strict standards.

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XTalks

NOVEMBER 7, 2022

However, Dr. Bahassi reported that the selection of CTCs using this method is often not very efficient and the CTC population is usually highly contaminated with leukocytes. During the webinar, Dr. Bahassi gave a brief schematic of how personalized, targeted assays can be developed to detect somatic mutations from cfDNA ( Figure 1 ).

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