European Pharmaceutical Review

JANUARY 2, 2024

While advantages to the Quality by Design approach is clear and practical implementation of Quality by Design is encouraged by publication of public guidance documents ICH Q8(R2) – ICH Q14, the industry has not yet fully embraced the QbD approach in Marketing Authorisation Applications (MAAs) for European market approval, the authors noted.

Documentation 105

Documentation 105

European Pharmaceutical Review

JULY 1, 2022

A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. To overcome these concerns, Pluta presents the process and documentation activities undertaken by one company.

Documentation 105

Documentation 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

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

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

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 225

Communication Medical Records Documentation 225

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

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

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

Pharma Marketing Network

MAY 9, 2025

This article uncovers the hidden elements of market access success, revealing what it takes to move from FDA approval to formulary inclusion, provider buy-in, and patient adoption. A value document submitted to payers outlining clinical data, economic models, and patient impact to support formulary inclusion. What is an AMCP dossier?

Packaging 52

Packaging Documentation Communication FDA 52

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

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

Pharma Marketing Network

APRIL 16, 2025

In this article, we explore how data-driven marketing empowers pharma brands to be more precise, predictive, and effective in their outreach efforts. As privacy regulations evolve, customer expectations change, and AI-driven technologies emerge, pharma marketers must adapt or risk becoming irrelevant.

HIPAA 59

HIPAA Documentation Pharmaceutical Companies Pharmaceutical Companies 59

European Pharmaceutical Review

APRIL 10, 2025

This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products. billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment.

Packaging 59

Packaging Documentation Communication 59

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

The FDA Law Blog

APRIL 22, 2025

DEAs Office of Administrative Law Judges has a website containing forms and links to a variety of helpful legal resources, including instructions on filing documents. We also regularly blog on DEA administrative cases and procedures (see here ), and our HPM attorneys have authored articles (see here and here ) on the DEA hearing process.

Controlled Substances 52

Controlled Substances Documentation 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

ISPE

SEPTEMBER 8, 2023

The document is based on a number of reports from the EU Commission and aims to ensure citizens’ trust in AI systems. AI Technical Documentation and GAMP ® 5 In GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) 2 , Article 11 1 describes the technical documentation needed.

Documentation 52

Documentation 52

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

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

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

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

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Hospital Pharmacy Europe

JANUARY 23, 2025

Share best practice All you need to do to be considered for publication is submit an an abstract of up to 100 words, sending it via email to Hospital Healthcare Europes secondar care content director Andrea Porter with the subject line: HHE article submission.

Hospitals 52

Hospitals Patient Care Documentation 52