pharmaphorum

MAY 4, 2021

In 2020, life science firms accounted for a third of the SEC’s enforcement actions. Against this backdrop, it’s surprising that many life sciences companies — particularly small- to medium-sized ones — still don’t have a firm grip on their whole universe of partner risks.

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Documentation Pharmaceutical Companies Pharmaceutical Companies Hospitals 111

pharmaphorum

OCTOBER 28, 2020

A 2020 survey from DrugsDisclosed.com of 3,346 users of prescription and over the counter (OTC) medicines from the UK and the Nordics revealed that: more than three-quarters of patients do not trust advice from pharmaceutical companies about their medication; 81% feel the pharmaceutical industry influences prescription decisions; and.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Hospitals 119

pharmaphorum

JANUARY 9, 2023

For pharma, the impact in critical areas such as the performance of newly marketed innovation has already been documented. Some of the more resilient launches since 2020 have had these benefits to health systems. More remains to be addressed, and not just by conventional pharmaceutical companies.

Vaccines 98

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 98

European Pharmaceutical Review

FEBRUARY 2, 2023

Between 2000 and 2020, Asian companies outperformed European companies for new approvals of CEPs, increasing their number CEPs from 183 to 2,369. This left pharmaceutical companies in Europe with no European API supply source, and only a few suppliers in Asia.

Generic Medicine 111

Generic Medicine Packaging Documentation Pharmaceutical Companies 111

European Pharmaceutical Review

FEBRUARY 1, 2024

Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.

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pharmaphorum

SEPTEMBER 28, 2022

“For example, in early 2020, we enrolled somewhere between 3,000 to 3,500 participants each week. In March 2020, when the pandemic hit, we had to pause in-person recruitment. Martin is also the primary author of the pivotal FDA guidance document Collection of Race and Ethnicity Data in Clinical Trials. About the author.

FDA 98

FDA Documentation Dosage Pharmaceutical Companies 98

Pharmaceutical Technology

NOVEMBER 4, 2022

In June, the Association of the British Pharmaceutical Industry (ABPI) sent an open letter to the Conservative leadership, including Truss and Sunak, which warned that the UK is slipping behind its global competitors in the race to become a life sciences superpower. UK’s competitive potential.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 93

Omnicell

JANUARY 10, 2023

There was bipartisan support for the program at the hearing and support for measures such as requiring pharmaceutical companies to publish their prices in a password protected site on HRSA's website. Four of the five staffers originally involved in the investigation now work for or lobby for the pharmaceutical industry.

Hospitals 96

Hospitals Omnicell Insurance Documentation 96

ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

OCTOBER 5, 2022

These, along with other similar claims, meant Biogen owed potential damages of $1,036,900,151 to the US and the various States, as per court documents. Ferry describes a popular solution among pharmaceutical companies. The $900 million dollar settlement was previously announced in June but has only been finalized this month.

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 59

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

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FDA Documentation Compounding Pharmaceutical Companies 103

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. The responsibility of printing paper leaflets is currently a key regulatory obligation for pharmaceutical companies. Article 63 EMA (29 January 2020).

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Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 98

Viseven

JULY 16, 2024

Source: Deloitte Combining these types of health data allows pharmaceutical companies to understand a person’s health and genetic profile better, thereby improving the quality of healthcare products and services. Pharma companies deal with enormous amounts of health data. What Is Health Data Management?

Health and Personal Care Stores 52

Health and Personal Care Stores HIPAA Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. ” Tony Cundell: Contract manufacturing organisations (CROs), start-up companies, established pharmaceutical companies and regulatory agencies are having difficulty recruiting and retaining technically-trained personnel. References.

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Vaccines FDA Research Laboratories Documentation 128

The People's Pharmacy

MAY 8, 2023

According to the ProPublica report: “The percentage of overseas manufacturers that hadn’t been inspected within five years, or which have never once been inspected, has grown from 30% in 2020 to more than 80% in 2022.” There have been problems with records in the past: deceit, falsification of documents and even outright fraud.

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FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

Pharma Marketing Network

APRIL 30, 2021

In a separate panel, Jenn Horonjeff, PhD, who is founder and CEO of Savvy Cooperative, stressed the importance of pharmaceutical companies engaging with those communities in culturally-sensitive ways.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation FDA 52

ISPE

MARCH 7, 2023

A pharmaceutical quality system (PQS) is a management system used to direct and control a pharmaceutical company with regard to quality. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Press Release.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

JULY 10, 2023

ChatGPT: “In a pharmaceutical software engineering context, data integrity refers to the accuracy, consistency, and reliability of data stored in computerized systems. This is a crucial aspect of pharmaceutical software as it directly impacts patient safety. Advances in Neural Information Processing Systems 33 (2020): 1877–901.

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Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 5, 2023

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. International Journal of Pharmaceutics 581 (2020). doi:10.1016/j.ijpharm.2020.119297

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

Hospital Pharmacy Europe

JANUARY 18, 2023

A patient access scheme or commercial arrangement associated with the NICE guidance is a way for pharmaceutical companies to lower the acquisition cost to the NHS to improve its cost-effectiveness, so enabling patients to gain access to high-cost medicine treatments. The NHS price for dupilumab excluding VAT is £1,264.89 Conclusion.

Hospitals 52

Hospitals Medical Records Documentation Pharmaceutical Companies 52

ISPE

JULY 6, 2023

3 , 5 , 6 Historically, the highest number of FDA approvals—60% of total marketed CM drugs—occurred from 2018 to 2020 (see Table 1) and although 2021 approvals decreased to pre-2018 levels, 2022 saw two approvals: 13% of total marketed CM drugs. 12 (December 2020):2874–89. 19 , 26 , 27 1 a b c Lovells, H., doi:10.1021/acs.oprd.0c00383

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 10, 2023

Scope The scope of the assessment was for country approvals received in the calendar years 2018–2020. On this basis, country approvals covering 2016–2020 were included in the analysis. Data were collected for over 5,900 postapproval CMC changes that translated to 20,000 country submissions with approvals in 2016–2020.

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