European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

European Pharmaceutical Review

NOVEMBER 15, 2022

Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that. There is also encouragement to use tools where possible to increase validation efficiency and defect detection. .

Documentation 98

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 98

Hospital Pharmacy Europe

AUGUST 17, 2023

GoCART aims to promote patient access to novel cellular therapies, bringing together different stakeholders, including healthcare professionals, health authorities, pharmaceutical companies, patient representatives, health technology assessment bodies, reimbursement agencies and medical non-profit organisations. GoCART Coalition.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

Pharmaceutical Technology

JULY 5, 2022

Mentions of the future of work within the filings of companies in the pharmaceutical industry were 373% higher between April 2021 and March 2022 than in 2016, according to the latest analysis of data from GlobalData. Of the document's 1,725 sentences, seven (0.4%) referred to the future of work.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

STAT

NOVEMBER 18, 2022

… Pharmaceutical companies could be made to disclose prices and deals for products they make to fight future global health emergencies, under new rules that would govern a World Health Organization-backed pandemic accord , Reuters reports.  A Or you may want to take stock of your life. But be safe. Enjoy, and see you soon.

FDA 97

FDA Documentation Compounding Pharmaceutical Companies 97

European Pharmaceutical Review

FEBRUARY 2, 2023

This left pharmaceutical companies in Europe with no European API supply source, and only a few suppliers in Asia. When looking at the costs for labour, energy and water, companies in China and India can enjoy savings of 20 to 60 percent compared to their European competitors.

Generic Medicine 111

Generic Medicine Packaging Documentation Pharmaceutical Companies 111

pharmaphorum

DECEMBER 28, 2022

So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness? Any purchasing company would ideally like to integrate their acquisitions into their company seamlessly.

Documentation 119

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 119

pharmaphorum

OCTOBER 5, 2022

As we close in on Frontiers Health 2022, pharmaphorum is chatting with members of the Steering Committee to give you a sneak peek of what to expect in Milan. So, in France, if I’m under an oncology medication, I have an app, and there’s an improved survival documented in the RCP. Interested in signing up?

Documentation 98

Documentation Pharmaceutical Companies Pharmaceutical Companies 98

ISPE

SEPTEMBER 28, 2023

billion in 2022. It's no wonder that global pharmaceutical companies are increasingly sourcing innovation through alliances and partnerships with their peers in California. California accounted for 15–18% of patents granted in core life sciences applications between 2018 and 2022. billion in 2019 to $17.3

Hospitals 98

Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

JANUARY 9, 2023

Regulatory divergence became apparent in 2022 and could increase in 2023. For pharma, the impact in critical areas such as the performance of newly marketed innovation has already been documented. More remains to be addressed, and not just by conventional pharmaceutical companies. Pharma’s starting to wake up to this.

Vaccines 98

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 98

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. Eurostat (2022) “Internet access and use statistics – households and individuals.”

Packaging 98

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 98

ISPE

NOVEMBER 28, 2022

ISPE Advancing Pharmaceutical Quality Program Complete. Mon, 11/28/2022 - 08:17. ISPE Advancing Pharmaceutical Quality Program Complete. 28 November 2022. ISPE is pleased to announce the complete Advancing Pharmaceutical Quality Program (APQ) Program is now available with the release of the fifth and final guide.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

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 Insurance Omnicell Documentation 96

pharmaphorum

APRIL 16, 2021

The longer term impact of 2020 on clinical trial activity, given widely documented pauses on trials, will only be evaluable in coming years. The longer term impact of 2020 on clinical trial activity, given widely documented pauses on trials, will only be evaluable in coming years.”

Pharmaceutical Companies 95

Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

pharmaphorum

APRIL 11, 2022

Pharmaceutical companies have said they will try to carve months off the time between approval and launch for new medicines in Europe, and reduce disparities between access between countries. — EFPIA (@EFPIA) April 11, 2022. Learn more [link] #WeWontRest pic.twitter.com/4ReXX0GE1h.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

OCTOBER 27, 2022

The Guidance applies to all member companies of EFPIA and IFPMA, but also acts as useful guidance for all pharmaceutical companies as to how the authorities will interpret the legislative provisions to social media channels. The Guidance applies to both product-related and therapeutic-area-related activities.

Communication 98

Communication Packaging Documentation Pharmaceutical Companies 98

Pharmaceutical Technology

JANUARY 27, 2023

In an email to Pharmaceutical Technology , he further described the therapy as “the most important advance for treatment of TTP since the documentation of effectiveness of plasma exchange in 1991”. However, it is consistent in regards that it simply seeks provider attestation opposed to actual documentation,” he added.

Documentation 52

Documentation Immunization Pharmaceutical Companies Pharmaceutical Companies 52

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.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

ISPE

JULY 6, 2023

1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed.

Documentation 52

Documentation FDA Dosage Pharmaceutical Companies 52

The Checkup by Singlecare

APRIL 5, 2024

When the Food and Drug Administration (FDA) approved Mounjaro (tirzepatide) in 2022 to treat Type 2 diabetes, some people hailed the GIP and GLP-1 medication as the next great antidiabetic drug. Pharmaceutical companies typically only provide prescription drug samples to healthcare providers, who keep them in the office for patients to use.

Insurance 59

Insurance Compounding Pharmacies Compounding Insurance Coverage 59

Pharmaceutical Technology

SEPTEMBER 23, 2022

generic drugs at both small development companies and multinational pharmaceutical companies. This unique pedigree gives the company a foundational understanding of how to launch products at every stage of development. Avéma’s newest facility in Miami, which will come online in October 2022, will add 135,000 sq.

Packaging 59

Packaging Controlled Substances FDA Documentation 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.

FDA 103

FDA Documentation Compounding Pharmaceutical Companies 103

ISPE

JULY 6, 2023

One of the most important components of SRM is the company’s risk appetite statement. This document is approved by the firm’s board of directors and sets the tone for risk-taking at the company by key risks and setting risk tolerances for how much risk the board is willing to take across all business activities. November 2022.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 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. Pharmaceutical Engineering 43, no. Pharmaceutical Engineering 42, no.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

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.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

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.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation 98

ISPE

MARCH 7, 2023

link] As emphasized at the recent UN Climate Change Conference COP27 (held at the end of 2022 in Sharm el-Sheik, Egypt), international focus is now on implementation. 3 , 4 Most companies have some existing initiatives underway, but many do not yet have a fully comprehensive and integrated program. October 2015. link] 2 United Nations.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

Pharmaceutical Technology

FEBRUARY 1, 2023

Pharmaceutical companies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. However, RSV has proven to be fully capable of undergoing mutations and viral escape when challenged with pharmaceuticals.

Vaccines 64

Vaccines Documentation Pharmaceutical Companies Pharmaceutical Companies 64

ISPE

JULY 6, 2023

Although it has been widely adopted in other industries, the pharmaceutical industry has yet to do so, and most drug production still relies on the longstanding batch manufacturing process. 3 As the pharmaceutical industry shifts its focus to biologics, the investment in CM elements in industry is expected to increase considerably.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 7, 2023

The Global Use of Medicines 2022.” Increasing the Circularity of Packaging Along Pharmaceuticals Value Chain.” 8 (2022): 4715–4731. The Pharmaceutical Industry in Figures. Key Data 2022.” link] 4 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Hedberg, M.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

Omnicell

JANUARY 10, 2023

5376, the Inflation Reduction Act of 2022 (IRA), was passed via partisan votes by both chambers of Congress and signed into law by President Joe Biden. proposed an amendment to the IRA that would have required pharmaceutical companies to rebate the government any excess costs above the negotiated prices (presumably paid by providers).

Hospitals 52

Hospitals Omnicell Pharmaceutical Companies 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. guidance/ta534 (accessed November 2022). Conclusion.

Hospitals 52

Hospitals Medical Records Documentation 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. 5 In addition, there are human elements to consider.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

SEPTEMBER 10, 2023

Pharmaceutical Engineering 42, no. 1 (January/February 2022). link] 6 International Pharmaceutical Regulators Programme. Consequently, comparing results across companies and through time will establish an increasingly robust perspective of trends in global approval durations. Cauchon, T. Hedberg, M. Braathen Holm, J.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98

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.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 52