pharmaphorum

MAY 25, 2022

Here, we take a look at the top five takeaways from the document: 1. Companies should still clearly document their reasons for supporting events, including virtual and hybrid international congresses, said the document. The codes still apply. End of the host country. Follow the path of most resistance.

Documentation 105

Documentation Communication Labelling 105

European Pharmaceutical Review

FEBRUARY 22, 2023

Key features of the PDA TR 90 report The document addresses the evolution of contamination control principles towards a holistic approach. The document has 14 sections and five appendices. Ultimately, the new CSS document can help the pharmaceutical manufacturing sector to develop and implement a successful CCS.

Documentation 98

Documentation 98

IDStewardship

APRIL 13, 2023

In this article an infectious diseases pharmacist with experience managing antimicrobial stewardship programs discusses antimicrobial stewardship regulatory standards Authored by: Timothy P. Gauthier, Pharm.D., difficile infection, adverse effects, antibiotic resistance, hospital costs, and hospital length of stay.

Hospitals 246

Hospitals Documentation Communication Patient Care 246

European Pharmaceutical Review

AUGUST 25, 2023

According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. The document highlights that the revision should also consider related changes in other GMP chapters and annexes as well as in other regulatory documents. What is included in the new revision?

Documentation 98

Documentation 98

IDStewardship

SEPTEMBER 2, 2022

In this article an expert in clinical information design provides his insights, discussing reasons why some guidelines do not get used along with solutions to these problems. Article Posted 2 September 2022. CMS also mentions guidelines several times in their 22-page document on new antimicrobial stewardship requirements for hospitals.

Hospitals 130

Hospitals Documentation Formulary Information Medication Guidelines 130

ISPE

OCTOBER 28, 2022

This article discusses the application of GEP to enable more efficient and effective C&Q primarily within the scope of the design and delivery of engineered systems (i.e., Appropriate ECM and document management ensures that proposed changes are identified, assessed for impact, implemented, and verified. System Life-Cycle Processes.

Documentation 98

Documentation 98

European Pharmaceutical Review

DECEMBER 21, 2022

Therefore, characterisation of the microorganism(s) is of utmost importance to LBP quality documentation. This article proposes a tentative approach for a minimum standard requirement for the WGS and bioinformatics analysis of LBPs. Download and read more now… .

Documentation 111

Documentation FDA 111

pharmaphorum

JUNE 3, 2021

This article appears in our digital magazine Deep Dive: Market Access 2021. And anyone interested in a game of policy bingo will be able to mark off all the important policy documents and every agency too. Leela Barham takes stock. Read below for a preview: NICE has never stood still since it started its work in 1999.

Documentation 98

Documentation 98

IDStewardship

MAY 12, 2023

In this article five tips for incoming PGY2 pharmacy residents is provided. BCPS, BCIDP Article posted: 12 May 2023 The ASHP pharmacy residency match phases 1 and 2 have come to a close. Core resources can include society guidelines, ACCP Self Assessment Program chapters , review articles, key specialty books (e.g.,

Communication 130

Communication Documentation Vaccines 130

European Pharmaceutical Review

SEPTEMBER 2, 2022

This article explores just one aspect of the RMP, that of RMMs, and how their effectiveness is measured with Dr Sophie Jouaville, an associate principal at IQVIA working on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

IDStewardship

DECEMBER 13, 2024

In this article an experienced antimicrobial stewardship pharmacist discusses lessons learned from navigating antimicrobial stewardship metrics. BCPS, BCIDP Article posted 13 December 2024 If you cannot measure it, you cannot determine if you have changedit. Disclaimer The views and opinions in this article are those of the author.

Communication 130

Communication Medical Records Documentation 130

European Pharmaceutical Review

JULY 10, 2023

The assessment report of the Committee for Medicinal Products for Human Use (CHMP)’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products offers guidance and recommendations on mitigation and prevention of nitrosamine-contaminated human medicinal products.

Documentation 98

Documentation FDA 98

The FDA Law Blog

DECEMBER 12, 2022

It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop. or other similar or related article” which is “intended for use in the diagnosis of disease or other conditions.” General Wellness: Policy for Low Risk Devices.

Documentation 23

Documentation FDA Communication 23

European Pharmaceutical Review

JULY 17, 2023

New research published in JAMA Health Forum has documented that the US National Institutes of Health (NIH) spent $8.1 billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. This was ~10 percent of reported industry spending.

Documentation 98

Documentation FDA 98

The Honest Apothecary

MAY 5, 2023

In a Forbes article on this topic the author observers “Day-to-day failure to follow through is costing managers long-term credibility with their employees. Fixing Bad Follow-Through The first step to fixing poor follow-through as a leader is to, beginning today, document everything you are expected to do in writing. That is it.

Documentation 105

Documentation 105

IDStewardship

AUGUST 17, 2022

In this article tips for running successful meetings as a pharmacist are provided and discussed. . Article posted 21 August 2022. I like when presentations and documents are sent in advance, but that is not always feasible. Authored By: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP.

Documentation 130

Documentation 130

Pharmaceutical Technology

JULY 19, 2022

In total, the frequency of sentences related to cloud computing between April 2021 and March 2022 was 133% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,422 sentences, 19 (1.3%) referred to cloud computing.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 98

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. This article primarily discusses Appendix D5 Testing of Computerized Systems and Appendix M12 Critical Thinking. The GAMP 5 Second Edition includes: Six completely new appendices.

Documentation 98

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

SEPTEMBER 29, 2022

The FDA has issued multiple guidance documents over the past several years in an attempt to illustrate what is and what is not a medical device, what is subject to enforcement discretion, and what the FDA actively regulates. More information about this process may be found in FDA’s 513(g) Guidance Document. not a medical device, ii.

FDA 104

FDA Documentation 104

ISPE

SEPTEMBER 8, 2023

This article outlines ISPE task teams created reports and a model to examine the challenges surrounding drug shortages, emergency preparedness, and the supply chain of active pharmaceutical ingredients (APIs). This article outlines these initiatives. What do you love about your job?

Documentation 91

Documentation 91

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 11 This requirement directly contradicts what is included in Article 63. Article 63 EMA (29 January 2020). Article 63 Euractiv (26 September 2023). Article 63 PGEU (2023). European Commission (26 April 2023).

Packaging 98

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

JULY 14, 2022

Instant messages should be recognised as EU documents under transparency rules, and recorded and made available for freedom of information requests. Instant messages should be recognised as EU documents under transparency rules, and recorded and made available for freedom of information requests. Full list: [link].

Documentation 52

Documentation Vaccines 52

pharmaphorum

APRIL 6, 2021

It started as a hobby, just a way of documenting my life as a young man with a disability that I could look back on in years to come,” he says. “It Recent articles, for example, have included a look at trolls online and covered Ross’ lockdown diaries. It grew and grew and it is now a real passion of mine.

Documentation 132

Documentation 132

Viseven

JULY 10, 2024

As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences. It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JANUARY 28, 2022

The messages were requested via a freedom if information request by journalist Alexander Fanta of netzpolitik.org, who was following up an article in the New York Times last year which suggested “personal diplomacy” had played a big part in the EU’s order for 1.8 billion doses of Pfizer and BioNTech’s vaccine.

Vaccines 64

Vaccines Documentation 64

Hospital Pharmacy Europe

SEPTEMBER 26, 2023

The PSA had previously raised concerns relating to FtP cases, including timeliness, transparency and clarity of the initial assessment and investigation process, decision-making, ensuring parties were supported to participate in the process and the way risk assessments were documented.

Documentation 105

Documentation Hospitals 105

The Checkup by Singlecare

FEBRUARY 15, 2024

This article will focus on how dogs function as service animals, including the health benefits they provide to their owners and how you may qualify for one. This definition extends to those with a documented history of such an impairment, even if they are not presently experiencing a disability. What is a service animal?

Health and Personal Care Stores 98

Health and Personal Care Stores Documentation Grocery Stores Vaccines 98

Hospital Pharmacy Europe

JUNE 8, 2023

In the absence of transparency, he felt that both the pre-publication reviewers and those reading the final published article would not be aware of any retrospective protocol modifications and thus be unable judge the reliability of the final results. Later work simply re-affirmed this finding.

Documentation 52

Documentation Communication Patient Care Hospitals 52

ISPE

FEBRUARY 13, 2023

Bob also initiated an agreement under which ISPE’s Guidance Documents are made available to PIC/S and WHO inspectors, which is still in place today. Most recently he assisted the regulatory authorities of Saudi Arabia, Russia, China, Jordan, and Philippines in the process to attain PIC/S membership.

Documentation 98

Documentation FDA 98

European Pharmaceutical Review

OCTOBER 3, 2024

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety. Register your details to read more The post How ready are you?

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Documentation 52

pharmaphorum

NOVEMBER 23, 2020

I saw a statistic in a Health Europe article, published in September this year, which reported that 81% of patients do not feel listened to by pharma companies. Through this outcomes measurement tool, patients keep comprehensive diaries of their condition, documenting what aspects of the disease affect them most.

Communication 128

Communication Documentation Vaccines 128

Viseven

DECEMBER 4, 2024

This article will discuss pharmaceutical validation, its benefits, types, and basic recommendations. It also requires documenting the entire process, from raw material sourcing to product launch. Process design should be based on solid evidence and include thorough documentation. Keep on reading!

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 52

pharmaphorum

DECEMBER 31, 2020

With the text of the 1,200-page document now available, it has been confirmed that there will be mutual recognition between the two parties, which means that inspections and certification of good manufacturing practice (GMP) facilities by the UK regulatory authority will be recognised by the EU, and vice versa.

Documentation 52

Documentation 52

pharmaphorum

JANUARY 18, 2022

POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Overview of the workshop: The workshop is aimed to provide an introduction to the key elements of the Medical Device Regulation that Companies affected by article 117 need to consider. Understand and be able to interpret the requirements of Article 117.

Packaging 52

Packaging FDA Documentation Vaccines 52

European Pharmaceutical Review

JUNE 29, 2022

A typical example is the classical biosafety animal testing driven by a collection of guidance documents that often were not revised for decades (eg, ICHQ 5A). startTime=1632749714000 – Article Publication 2022. However, the biosafety testing strategies rely on outdated technologies that have remained unchanged for decades.

Vaccines 98

Vaccines Documentation 98

European Pharmaceutical Review

JUNE 12, 2024

View previous articles in this series : Pioneering the next wave of LBP-based therapeutics Advancing microbiome innovation Live biotherapeutic products: bridging innovations and challenges in manufacturing Navigating the unique CMC challenges of oral anaerobic live biotherapeutics Microbiome innovation: have we forgotten the basics?

Documentation 111

Documentation Labelling Hospitals 111

Board Vitals - Pharmacist

APRIL 22, 2022

Physicians can read a peer-reviewed article planned as a learning activity and certified for credit by an accredited CME provider before publication. This includes a critical review of an assigned journal manuscript or featuring an article within a peer-reviewed, professional journal. Journals . Internet Searching and Learning .

Documentation 52

Documentation 52