Pharmaceutical Technology

NOVEMBER 1, 2022

The medicines regulators in Europe have a strategy for 2025 where the second pillar is data and digitalisation, so we are trying to transform medicines regulation to be data-driven,” says Peter Arlett, Head of Data Analytics and Methods Task Force at EMA. Arlett explains that Darwin EU is playing a collaborative role in this goal.

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BioPharma Reporter

OCTOBER 5, 2023

Sharp, a commercial pharma packaging and clinical trial supply services firm, has acquired Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO).

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Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Regulatory decisions and clinical trial news.

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Camargo

OCTOBER 20, 2021

From the regulator’s point of view, combination products are not restricted to combined biologics, drugs, and/or devices formed into a single entity (like a drug-eluting coronary artery stent). This will benefit both the FDA and the sponsor in a win-win situation.

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Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

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Clinical Trials Clinical Trials Trials Regulation 52

Camargo

OCTOBER 15, 2020

As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider. To approve a product, the FDA requires substantial evidence of effectiveness, consisting of adequate and well-controlled (A&WC) trials. What is the top regulatory concern when a single-arm study is employed?

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Camargo

AUGUST 11, 2021

However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during the development process. Meeting Package Due. Meeting Type. Meeting Purpose. Meeting Timing 1. from receipt of request).

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Cloudbyz

AUGUST 15, 2024

Randomization and Trial Supply Management (RTSM) play a pivotal role in the successful execution of clinical trials. As the complexity of clinical trials continues to increase, especially with the rise of multi-center, adaptive, and decentralized trials, the need for robust RTSM systems has become more critical than ever.

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Clinical Trials Clinical Trials Trials Compliance 52

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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Cloudbyz

MAY 24, 2023

This is where unified clinical trial management solutions come into the picture, enhancing efficiency, reducing time to market, and ensuring high-quality, scientifically validated consumer products. A delay in trials or approval can significantly impact the product’s success and the company’s bottom line.

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Clinical Trials Clinical Trials Production Trials 52

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. Scope and design of definitive animal trials and clinical trials.

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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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pharmaphorum

JUNE 18, 2021

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well.

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Production Regulation Manufacturing Packaging 98

XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. In a recent webinar, Dr. Vassallo discussed the operational considerations for complex cell therapy clinical trials.

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Clinical Trials Clinical Trials Trials Gene Therapy 52

Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. In terms of the influence caused by negative changes in international investment in Japan, the pharmaceutical companies that decided to lower their business priority in Japan reported lower pharmaceutical sales.

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Pharmaceutical Technology

AUGUST 30, 2022

Oswaldo Cruz Foundation will package the drug in its facility in Rio de Janeiro before supplying it to the Brazilian public health system; the company is also involved in clinical trials for the drug’s possible use as Covid-19 prophylaxis.

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Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . In addition to granting new drug approvals, the FDA is also the gatekeeper for whether a sponsor can conduct the clinical investigations necessary to gather the data required for drug approval. The IND goes into effect; and .

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pharmaphorum

JULY 22, 2021

All of our processes, and also those of the entire healthcare ecosystem, including regulators, had to be accelerated. The company remained in close and frequent communication with regulatory agencies to accelerate procedures for the evaluation and authorisation of the clinical trials. days compared to placebo for all patients.

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XTalks

AUGUST 29, 2022

The pre-clinical and clinical data they showcased at the meeting indicate that their cytokine immunotherapies are safe, potent and work for longer than other cytokine drugs for cancer. Based on these findings, Cytimmune will be moving these candidates into early clinical trial testing. What Are Nanomedicines?

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Clinical Trials Clinical Trials Trials Drugs 95

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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pharmaphorum

JANUARY 28, 2021

The Covid-19 pandemic has put further pressure on clinical trial suppliers to be fleet of foot in getting products dispatched when a new patient is recruited, as studies for vaccines have been set up and run at unprecedented speed. . To find out more about the webinar and to register, visit [link] .

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pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

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Clinical Trials Clinical Trials Compliance Trials 52

Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. In terms of the influence caused by negative changes in international investment in Japan, the pharmaceutical companies that decided to lower their business priority in Japan reported lower pharmaceutical sales.

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Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations.

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Camargo

JULY 30, 2021

They immediately stood up and said, “No, we’re doing six clinical trials in pediatrics now, specifically in the infant population, for something called pulmonary hypertension in these kids.” But now it’s a warning in their package insert. There were six Pfizer people in the audience.

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pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork. PRISYM ID is a part of the award-winning Zebra® PartnerConnect program. About PRISYM ID. Media Contact: Andrew Baud, Distil,?

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies.

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Camargo

JUNE 4, 2021

The new product, Zynrelef, is the first modified-release formulation for pain that will be labeled as extended-release; in the three Phase 3 clinical trials, it demonstrated pain reduction through 72 hours. A sponsor has arranged for the start of its clinical studies, and some of the sites are outside of the US.

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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.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

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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Clinical Research Research Clinical Trials Clinical Trials 52

pharmaphorum

NOVEMBER 11, 2022

Several decisions are made in the early stages of clinical development that have key implications for entering markets successfully. However, for payers, as well as regulators, healthcare professionals, and patients, a new mode of action is not a value driver. Many therapies will be first in class with novel modes of action.

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pharmaphorum

NOVEMBER 16, 2020

EMA executive director Guido Rasi has ended his second term at the helm of the EU medicines regulator, with Emer Cooke taking the wheel and becoming the first women in the role. Cooke is returning to the EMA after a four-year period as head of medicines regulation at the World Health Organization (WHO). Emer Cooke.

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XTalks

MAY 30, 2023

The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. There are also several ECG patches currently in clinical trials that could soon enter the market.

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Keep thorough records of approvals for future reference.

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The Pharma Data

AUGUST 24, 2020

The National Medical Products Administration has granted approval to the West China Hospital of Sichuan University in Chengdu to begin a clinical trial. The news comes after China said that companies and organisations must prove to regulators that vaccines have 50% efficacy. Conor Kavanagh. Source link.

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pharmaphorum

APRIL 11, 2022

Innovative ‘next-generation’ medicines are met with a series of hurdles such as increased cost of development, regulatory challenges and delays, and longer and more complex clinical trials. And it all fuels the debate: are medicines a cost or an investment? The answer to this question comes back to our definition of value.

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Cloudbyz

AUGUST 9, 2023

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. Let’s delve into why this method is paramount for the transformation of clinical research management.

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