European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

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pharmaphorum

AUGUST 16, 2021

Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials. In 2019, Formedix collaborated with a UK-based consortium interested in observing early safety data. I can’t imagine that pharmaceutical companies will return to the ways of the past.

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pharmaphorum

JANUARY 27, 2023

Having previously spoken with Dr Mullen three years ago when she was country medical director for the UK & Ireland at GSK – on the topic of patient centricity and embedding that focus within the core of a pharmaceutical company – our recent interview provided some interesting insights into the changing landscape of the industry.

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pharmaphorum

APRIL 16, 2021

Taking the longer term view of the last seven years, 2020 was a rather good year for innovative medicine approvals in both the US and Europe – an improvement on 2019, even with the extra approvals of COVID treatments and the first of the vaccines accounted for. ” In the UK and France, HTA decision making slowed down.

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European Pharmaceutical Review

SEPTEMBER 22, 2022

11 have recently conducted an analysis of international HTA submissions from 2011-2019 to determine the acceptability of single arm clinical studies and ECs as part of the drug reimbursement process. NICE DSU technical support document 18: methods for population-adjusted indirect comparisons in submissions to NICE. Patel et al.

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ISPE

SEPTEMBER 28, 2023

billion in 2019 to $17.3 It's no wonder that global pharmaceutical companies are increasingly sourcing innovation through alliances and partnerships with their peers in California. The sub-standard heights were discovered during the initial document review and site assessment. billion in 2022.

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pharmaphorum

MAY 26, 2022

Ukrainian pharmaceutical companies are struggling to perform their duties in pharmacovigilance as Russia launched a wide-scale war in Ukraine. Russia’s full-scale invasion of Ukraine has already affected the global pharmaceutical industry a lot. This platform made work easier for many pharmaceutical companies.

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Pharmaceutical Technology

NOVEMBER 4, 2022

In his first speech as the PM, Sunak indicated a return to the original 2019 Conservative manifesto. At the time of its publication, the document prioritised the finalisation of Brexit above all else. For the life sciences and pharmaceutical sector, the Conservative government promised £34 billion ($38.98

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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.

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The People's Pharmacy

MAY 8, 2023

In fiscal year 2019, the year before the COVID-19 pandemic limited travel and movement, the FDA inspected 37% of the nearly 2,500 overseas manufacturers; in 2022, the agency only inspected 6% of around 2,800.” Because of lax standards or outright fraud, the FDA has tried harder to visit drug companies in that country.

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Pharmaceutical Technology

JANUARY 27, 2023

In 2019, Cablivi became the first FDA-approved , nanobody-based medicine for acquired thrombotic thrombocytopenic purpura (aTTP), an ultra-orphan condition that causes blood clots in small blood vessels around the body. However, it is consistent in regards that it simply seeks provider attestation opposed to actual documentation,” he added.

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ISPE

NOVEMBER 1, 2022

Quality management maturity (QMM) entered the discussion on ways to address the challenges in 2019 in the FDA report, “ Drug Shortages: Root Causes and Potential Solutions. ” We are now at a point where challenges have created opportunities: challenges spur innovation, he said. Next Slide ??. Michael Kopcha. Thomas Wozniewski. Robert Weker.

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European Pharmaceutical Review

JANUARY 13, 2025

5 However, the benefits are well documented. Evolving from traditional propellants to low-GWP propellants is a complex process as the active ingredient is held in the devices solution or suspension and therefore has an impact on the entire formulation of the inhaler. Pulmonary Pharmacology & Therapeutics. 2024; 85: 1-9. Cited 2024August].

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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.

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ISPE

MARCH 7, 2023

link] 4 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” Published November 2019. PDA Journal of Pharmaceutical Science and Technology 73, no.

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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. April 2019. 9 US Food and Drug Administration. Blumenthal, I.

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European Pharmaceutical Review

JULY 1, 2022

Although there are currently no set metrics or prescribed areas of focus, there are several key areas that pharmaceutical companies can pinpoint when measuring the S in ESG. For pharmaceutical companies, ensuring that human rights are protected by offering transparency and performing due diligence in global supply chains is key.

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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. In 2019, FDA released the draft guidance Quality Considerations for Continuous Manufacturing.

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ISPE

JULY 6, 2023

Vertex continued to invest in CM with two additional approved drugs—Symdeco/Symkevi in 2018 and Trikafta in 2019—with the same indication. 25 These are the type of transforming incentives that pharmaceutical companies need because typically tax and regulatory incentives have been the main drivers affecting cost and time to market.

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ISPE

SEPTEMBER 10, 2023

In the dynamic global environment, the approval times for postapproval changes can be expected to change over time and may well differ between pharmaceutical companies based on different practices and approaches. The proposals are consistent with WHO GRP. Published March 2020. www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf

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Pharmaceutical Technology

JUNE 8, 2023

Of the world’s 20 largest pharmaceutical companies, 17 have launched programmes tailored towards increasing medication access in low- and middle-income countries – up from just eight in 2010. Figure 1: Social media posts from pharmaceutical firms mentioning “environment”. A similar theme is evident in company filings.

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