Hospital Pharmacy Europe

JANUARY 25, 2024

Professor Nicola Stoner, chair of the RPS Consultant Pharmacist Group, said: ‘This document sets out an ambitious and exciting vision for the role of the consultant pharmacist following our very successful consultant pharmacist summit last year.

Documentation 98

Documentation Hospitals 98

pharmaphorum

MARCH 16, 2021

In a review of the documents, the BMJ said they showed concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. The documentation was not complete and the leaks did not show how the agency’s concerns were satisfied, the BMJ added.

Vaccines 133

Vaccines Documentation 133

pharmaphorum

JANUARY 13, 2021

The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records. Since then the agency has been investigating the incident involving the theft of documents that formed part of BioNTech’s filing for the BNT-162b vaccine.

Vaccines 66

Vaccines Documentation 66

The FDA Law Blog

FEBRUARY 7, 2024

In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. Thus, such persons are subject to identification, recordkeeping, and reporting requirements.

Controlled Substances 116

Controlled Substances Documentation 116

IDStewardship

APRIL 13, 2023

The most recent CARB addresses the years 2020-2025, building upon the initial one released in 2015. An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here.

Hospitals 236

Hospitals Documentation Communication Patient Care 236

The Checkup by Singlecare

DECEMBER 13, 2022

Noor Ali, MD, founder at Dr. Noor Healthcare Advisor , says that it also includes “strong supportive documents, [like] medical evidence, clinical notes, professional statements,” and more. If you are including documents, include a list of what you are sending here. Write short, factual statements. Do not include emotional wording. .

Insurance 98

Insurance Documentation Insurance Coverage HIPAA 98

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 76

Adverse Reactions Documentation Medical Schools Packaging 76

pharmaphorum

DECEMBER 10, 2020

FDA reviewers have already concluded that the vaccine is safe and effective in a briefing document ahead of the Vaccines and Related Biological Products Advisory Committee’s meeting. Feature image copyright BioNTech SE 2020, all rights reserved.

Vaccines 89

Vaccines Documentation FDA 89

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.

Pharmaceutical Companies 81

Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 81

Omnicell

SEPTEMBER 5, 2022

Today at Omnicell-Illuminate 2020, the first-ever digital conference focused on technology-driven medication management, I had the pleasure to reveal a comprehensive look at Omnicell’s product roadmap and strategic vision for supporting customer success in achieving zero-error medication management.

Omnicell 52

Omnicell Documentation Patient Care 52

pharmaphorum

JULY 27, 2022

Of all products approved by the European Medicines Association (EMA) between 2017 and 2020, 68% are currently available in England, a figure that stands at 54% in Scotland. In addition, the median time between regulatory approval and the first patient receiving a first dose was 247 days in 2020 – an increase of 25 days since 2018.

Documentation 97

Documentation FDA 97

pharmaphorum

NOVEMBER 20, 2020

Based on current projections the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 It is one of 11 vaccines that are in phase 3 development, including contenders from Moderna, Novavax and AstraZeneca, according to the World Health Organization’s regularly updated tracker document.

Vaccines 84

Vaccines Documentation FDA 84

European Pharmaceutical Review

AUGUST 1, 2022

The HMA/EMA Big Data Steering Group, set up in May 2020 to advises both the EMA and HMA on the implementation of ten priority recommendations highlighted by the Big Data Task Force, reviews its workplan annually to cover any new emerging topics.

Documentation 92

Documentation 92

pharmaphorum

NOVEMBER 1, 2021

The document says that Sleepio shows promise as a treatment for insomnia in primary care that could be an alternative medicines and sleep hygiene advice, but it is uncertain whether it will be cost-saving for the NHS. The consultation document is open for comment until 29 November, with final recommendations schooled by 12 May next year.

Documentation 57

Documentation 57

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.”

Documentation 86

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 86

The FDA Law Blog

FEBRUARY 29, 2024

The PTO’s ORDER TO SHOW CAUSE points out that: According to the published Federal Register Notice of July 17, 2020, Lilly requested withdrawal “(revocation)” of its BLA for the human biological product LARTRUVO® (olaratumab). According to documents in the PTO’s Patent Center, Lilly has not yet filed a response.

FDA 59

FDA Documentation 59

pharmaphorum

FEBRUARY 8, 2022

In briefing documents released by the FDA reviewer, the agency has made it clear that the Chinese clinical results filed in support of the PD-1 inhibitor do not meet the criteria for foreign data fled in support of a marketing application in the US. .”

FDA 52

FDA Documentation Chemotherapy 52

Pharmaceutical Technology

JULY 15, 2022

The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin. California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form.

Insurance 131

Insurance Documentation Packaging 131

pharmaphorum

JUNE 3, 2021

An earlier consultation that closed on 18 December 2020, covered methods. And anyone interested in a game of policy bingo will be able to mark off all the important policy documents and every agency too. Read below for a preview: NICE has never stood still since it started its work in 1999.

Documentation 98

Documentation 98

ISPE

SEPTEMBER 15, 2022

12 of February 2020 again received 2,000 comments from public consultation. The first draft for comments from industry stakeholders was published in 2017 and generated 6000 comments.

Documentation 97

Documentation FDA 97

pharmaphorum

DECEMBER 8, 2022

Instead, there are hints from other documents that are published by the government about just what the LSC is there to do. The Life Sciences Industrial Strategy Update , published in January 2020, updating on the second Life Sciences Sector Deal from 2018, also mentions the LSC. Pandemic (November 2020). Terms of reference.

Documentation 99

Documentation 99

Pharmaceutical Technology

SEPTEMBER 15, 2022

The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database.

Vaccines 108

Vaccines Documentation Compounding FDA 108

pharmaphorum

FEBRUARY 10, 2021

The project is coordinated by the University of Bologna and funded by the European Union’s Horizon 2020 research and innovation programme that involves more than a dozen partner institutions, including Italian startup InSilicoTrials.

Packaging 61

Packaging Documentation Hospitals 61

pharmaphorum

APRIL 15, 2021

It will also include a directory of healthcare professionals and a digital document vault to store records, with the entire suite operating within Microsoft’s Cloud for Healthcare platform.

Documentation 93

Documentation Insurance 93

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).

Documentation 107

Documentation Vaccines 107

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.

Vaccines 52

Vaccines Documentation Community Pharmacies 52

pharmaphorum

FEBRUARY 28, 2022

The analysis also suggests that rare diseases impose a substantial economic burden that can be reduced with availability of new treatments – the lack of treatment was associated with a 21% increase in total costs PPPY, according to the document.

Documentation 98

Documentation Hospitals 98

The Checkup by Singlecare

OCTOBER 16, 2023

Below, we detail the 14 categories of conditions that qualify for SSA disability in adults and what you may be expected to provide for documentation for each. The SSA also requires persuasive medical documentation from a healthcare provider. (This is not to be confused with Medicare Part A and Part B.)

Documentation 105

Documentation Immunization Mayo Clinic Insurance 105

pharmaphorum

JANUARY 25, 2023

The positive advisory committee vote wasn’t guaranteed, particularly as a briefing document published by the FDA ahead of the meeting questioned the validity of combining data from the two studies, as well as what it said was a “limited” safety database for the drug.

FDA 52

FDA Documentation 52

pharmaphorum

DECEMBER 29, 2022

According to court documents cited by Reuters, annual sales of Exforge in the US were over $400 million before generic versions reached the market. In 2020, it also paid $345 million to resolve a series of cases brought by the federal government under the Foreign Corrupt Practices Act (FCPA).

Specialty Pharmacies 52

Specialty Pharmacies Documentation FDA 52

The FDA Law Blog

OCTOBER 3, 2022

HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. Today, these two documents are key in navigating speaker programs in the industry. See 42 U.S.C. 1320a-7b(b).

Documentation 105

Documentation 105

The deprescribing.org Blog

APRIL 14, 2021

From October 2020 to January 2021, Amy worked with Dr. Barbara Farrell in the Bruyère Continuing Care Geriatric Day Hospital and with her Deprescribing Research Team as part of her postgraduate PharmD training. Document, document, document. Today we have another blog post for you. Discharge medication reviews.

Community Pharmacies 52

Community Pharmacies Documentation Hospitals Communication 52

pharmaphorum

AUGUST 27, 2021

The draft document covers the use of Darzalex (daratumumab) as an add-on to standard induction treatment with Takeda’s Velcade (bortezomib) plus thalidomide and dexamethasone given to patients prior to a stem cell transplant. .”

Documentation 52

Documentation 52

pharmaphorum

DECEMBER 14, 2022

The top-line result wasn’t backed up by overall mortality data however, viewed as being crucial to the take-up of the drug if approved, and Amgen ducked out of the alliance shortly after the results were made public towards the end of 2020. There was also no impact on quality-of-life measures.

FDA 52

FDA Documentation Labelling 52

pharmaphorum

FEBRUARY 12, 2021

If 2020 was the year that cemented the role of virtual advisory boards and virtual engagement in many forms, then we believe that 2021 will be the year of ‘virtual co-creation’. The benefits of virtual advisory boards (VABs) in replacing face-to-face advisory discussion with KOLs and HCPs are now clear and established.

Documentation 57

Documentation 57

Hospital Pharmacy Europe

JUNE 8, 2023

They examined possible changes using three different methods: the history of tracked changes on ClinicalTrials.gov ; self-reported changes noted in the article; and changes reported within the protocol, including all available protocol documents.

Documentation 52

Documentation Communication Patient Care Hospitals 52

pharmaphorum

NOVEMBER 24, 2022

Other proposals in the EMA’s 2020 big data document – prepared in collaboration with the Heads of Medicines Agencies – included measures to enhance guidance and resources within the EU regulatory network for data quality and data discoverability and to build up computing and analytical capacity.

Documentation 52

Documentation Insurance Hospitals 52