European Pharmaceutical Review

DECEMBER 19, 2023

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient.

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Vaccines Communication Immunization Documentation 111

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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Documentation FDA Communication Packaging 52

pharmaphorum

APRIL 16, 2021

IQVIA’s Sarah Rickwood reviews the launch of innovative medicines in 2020 and outlines three key pillars of activity for companies to focus on and address in 2021. It is undeniable that 2020 was a particularly challenging year to launch non-COVID innovative prescription medicines.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

pharmaphorum

MAY 16, 2022

In 2020, USAID launched two policy documents to guide how the agency invests in digital infrastructure as part of its development and humanitarian assistance programmes: Digital Strategy and Vision for Action in Digital Health (aka Digital Health Vision).

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Documentation Vaccines 118

ISPE

AUGUST 30, 2022

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Additional requirements are described in ICH Q7.

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Documentation FDA Packaging Communication 52

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 18, 2022

million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion. Device innovations, connected delivery and regulatory guidance for advanced parenteral systems. 13.00 – 17.00.

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Packaging FDA Documentation Vaccines 52

pharmaphorum

SEPTEMBER 14, 2022

With countless media stories regarding COVID-19 published over a period of several years, it was obvious that people around the globe were tuned in to every step of the fight against the pandemic, eagerly learning about everything from symptoms to vaccine development. based site management organization.

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Vaccines Medical Records Documentation Communication 98

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. The safety and efficacy of mRNA vaccines should be a game changer and is the likely solution to antibiotic-resistant microorganisms and emerging viral pathogens.” Perhaps we will see a universal flu vaccine in the near future. References.

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Vaccines FDA Research Laboratories Documentation 128

pharmaphorum

JANUARY 9, 2023

1 Kenya, for example, entered the pandemic with no human vaccines manufacturing facility and established the BioVax institute for local vaccine manufacture with a major plant investment starting in 2023. For pharma, the impact in critical areas such as the performance of newly marketed innovation has already been documented.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 98

ISPE

SEPTEMBER 11, 2023

3 (2020):e2970. Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” 16 June 2020. www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. New Project: Evolutive Vaccines Facility for Sanofi.” Biotechnology Progress 36, no.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

European Pharmaceutical Review

NOVEMBER 9, 2022

Within recent years this situation has been further exacerbated by the COVID-19 pandemic: both directly, through viral vaccine manufacture; and indirectly, through instability in global supply chains. An analysis performed at the end of 2019 concluded that demand for viral vectors would have surpassed CDMO capacity during 2020.

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Vaccines Documentation Communication Hospitals 115

PQA

MARCH 3, 2023

The second edition of the guide documents real-world SDOH services that are promising for improving the quality and safety of medication use. The appendix documents a host of characteristics and subcategories for the initiatives to aid in ease of identification.

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Vaccines Documentation Community Pharmacies 52

pharmaphorum

DECEMBER 16, 2020

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. — Eric Topol (@EricTopol) December 15, 2020. Both vaccines will be provided free of charge to recipients.

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FDA Vaccines Documentation 98

Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022.

Vaccines 52

Vaccines Documentation Communication 52

Pharmaceutical Technology

NOVEMBER 15, 2022

Within Pfizer’s Covid-19 pipeline, Pfizer and BioNtech’s vaccine Comirnaty is also being used to fight the pandemic. While bivalent formulations of Comirnaty and Moderna’s Spikevax vaccine have both been authorised for use as boosters in the UK and US, their uptake has remained slow. 7)) and the other one in common between the BA.4

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Vaccines Documentation FDA 64

ISPE

NOVEMBER 3, 2022

Okudaira of PMDA agreed that communications may be a driving force of acceptance of new models, and also establishing international convergence documents may help. A 2020 pilot invited external authorities to participate and observe EMA procedures authorizing COVID-19 vaccines and therapeutics.

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Communication FDA Documentation Vaccines 98

pharmaphorum

DECEMBER 19, 2022

So, it was that Poland had to provide the necessary cancer care and, indeed, soon after the war started, it had been decided that refugees would have the same care as Polish patients – despite the difficulties faced by having no Polish documentation. Industry’s learning from the pandemic.

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Documentation Hospitals Communication Vaccines 97

STAT

OCTOBER 16, 2024

But the underlying message to doctors in late 2020 was persistent and urgent: Hit your targets to see more patients. At the time, deaths from Covid-19 were surging, and no vaccine was available. We need to bring in more money. One email trumpeted “ADDITIONAL BONUSES!!

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Documentation Vaccines Insurance 145

Hospital Pharmacy Europe

JANUARY 19, 2023

Overall, there was an 18% reduction in community antibiotic consumption in the EU/EEA in 2020 and this was attributed to changes in health-seeking behaviour. Accompanying leaflets for patients have been developed and also digital versions of the documentation. The results showed that 3.5% received antibiotics.

Community Pharmacies 98

Community Pharmacies Hospitals Communication Medical Schools 98

pharmaphorum

OCTOBER 18, 2021

The development of COVID-19 vaccines required levels of cooperation and pioneering science comparable to the Apollo space programme. Within 12 months of the outbreak, vaccines were being deployed to prevent severe infections, hospitalisation, and death. billion people have been fully vaccinated. COVID-19 vaccine tracker.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 143

pharmaphorum

APRIL 8, 2021

COVID-19 has been a trial-by-fire showing just how quickly drugs and vaccines can be developed under the right circumstances – but there is much to do to ensure this progress is not lost, said speakers at WIRED Health 2021, including the CEOs of BioNTech and BenevolentAI. . We published our hypothesis in the Lancet on February 4 in 2020.

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Vaccines Documentation Communication 90

Pharmaceutical Technology

MAY 11, 2023

The business continuity plan was introduced in 2020 to allow European regulators to prioritise the assessment of Covid-19 therapeutics and vaccines while also handling other responsibilities.

Documentation 52

Documentation Vaccines 52

pharmaphorum

FEBRUARY 19, 2021

Two researchers have suggested that the second dose of Pfizer and BioNTech’s COVID-19 vaccine could be delayed, as this would increase the number of people that can be protected while supplies are limited without compromising its efficacy. . Feature image copyright BioNTech SE 2020, all rights reserved.

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Vaccines Immunization Documentation FDA 72

pharmaphorum

APRIL 22, 2021

Emergent BioSolutions’ difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of millions of doses of Johnson & Johnson’s COVID-19 vaccine. . AZ’s vaccine meanwhile has yet to be approved in the US. An FDA decision is expected tomorrow.

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Vaccines FDA Documentation 52

pharmaphorum

OCTOBER 7, 2020

The FDA may have been blocked from issuing stricter guidelines for emergency approval of COVID-19 vaccines by the Trump administration, but it has still managed to make its new approach public. — Scott Gottlieb, MD (@ScottGottliebMD) October 6, 2020. Industry is also concerned.

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Vaccines FDA Documentation Communication 59

The Thyroid Pharmacist

NOVEMBER 8, 2024

1] Additionally, in 2020, a study was published that also ties the eradication of Blasto to improvement in Hashimoto’s, including a reduction in TSH and TPO, as well as a decrease in a particular pro-inflammatory cytokine (IL-17) thought to have a role in Hashimoto’s pathogenesis. [2] Published 2020 Feb 21. Accessed August 6, 2020. [6]

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Immunization Adverse Reactions Vaccines Hospitals 77

STAT

MARCH 27, 2025

The worker cuts are in addition to roughly 10,000 employees who opted to leave the department since President Trump took office, through voluntary separation offers, according to the documents. Documents viewed by the Journal say essential health services will not be affected. It will also lose five of its 10 regional offices.

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Vaccines Documentation Insurance 107