pharmaphorum

JULY 7, 2025

Methodological rigour, documented processes, and reproducible results ensure that RWE meets the high standards expected by regulators, payers, and clinicians in every major healthcare market. Equally important is transparency – clarity in how evidence is generated, validated, and applied fosters the trust necessary for widespread adoption.

Pharmaceutical Companies

Pharmaceutical Technology

JUNE 17, 2025

Having a long-term partner, who can help build an ecosystem for the long term help, and this has been well documented in the US, he added. Can pharma tariffs “Make America Manufacture Again”? He cited the example of VIB’s work with Belgian biotech argenx to develop an asthma treatment, ARGX-118, which argenx will now further develop.

Communication

STAT

APRIL 11, 2025

Yesterday, STAT won a National Magazine Award for General Excellence. Good morning, Jason Mast here filling in for Rose.

Vaccines

Pharmaceutical Technology

JULY 3, 2025

Real-world roadblocks (and how to remove them) When you start implementing these requirements, you’ll face practical challenges that don’t appear in regulatory guidance documents. Governance questions emerge immediately: Should you create a dedicated AI oversight committee?

Packaging

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

Pharma Mirror

NOVEMBER 21, 2020

The Hague — To help pharmacists advise people on COVID-19 tests, the International Pharmaceutical Federation (FIP), has today issued a guidance document. The document covers how different types of diagnostic test work and the interpretation of results. COVID-19 tests are available from many different manufacturers and the.

Documentation

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

ISPE

SEPTEMBER 8, 2023

We have 19 committees, councils, and working groups that are doing incredible work bringing visibility to the industry’s regulatory challenges and developing solutions that are delivered through ISPE content outlets: webinars, PE magazine articles, iSpeak blog posts, training materials, conference sessions, and ISPE Guidance Documents.

Documentation

pharmaphorum

MAY 14, 2021

This article appears in our digital magazine, Deep Dive: Market Access 2021. It is still working collaboratively with global health system partners, and more particularly with the MHRA, to design a streamlined process for licensing and evaluating new medicines.”. • Read the full article in pharmaphorum’s Deep Dive digital magazine.

Documentation

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. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation

ISPE

OCTOBER 28, 2022

My primary role is to work with more than 20 ISPE Communities of Practice (CoPs) and Special Interest Groups (SIGs) that generate much of the key ISPE output: Guidance Documents, webinars, PE magazine articles, iSpeak Blog posts, training materials, and conference content.

Documentation

ISPE

MAY 8, 2023

Hence the importance and focus on regional facilities in this edition of PE magazine. These emerging markets, especially Latin America and the India subcontinent, are the ones that can see the most significant increase in pharmaceutical sales over the next three to five years.

Documentation

ISPE

MARCH 8, 2023

To learn more about APQ Guides and other ISPE Guides, visit ISPE.org/publications/guidance-documents Learn More & Buy Meet the ISPE Staff: Tina Li In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. PE Magazine Wants You!

Documentation

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation

Viseven

AUGUST 7, 2024

Therefore, it is always a good idea to include, for example, patient handouts along with healthcare magazine articles. As most documents come in a PDF format, Adobe Acrobat is helpful for this task. They also tend to prefer writers who can produce content for diverse audiences.

Communication

pharmaphorum

MAY 26, 2022

“It’s a very time-consuming process because a person is just sitting, flipping through (medical) magazines and looking if a drug is mentioned in a publication,” says Dmytro Horilyk, Chief Executive Officer at DrugCard, SaaS-platform for automated medical literature monitoring.

Pharmaceutical Companies

ISPE

JANUARY 9, 2023

It was time for ISPE to update this key guidance document to reflect technological progress. Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on.

Documentation

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 This was followed in September 2022 by the publication of the PIC/S’s identical Annex 1. m/s up to 0.54

Documentation

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. 6 (Note: The terms “pharmaceutical” and “pharma” interchangeably employ throughout this article.)

Chemotherapy

ISPE

JANUARY 8, 2023

In this process, documentation regarding the decisions made is important to justify the model and explainability mechanism selection in an audit context. However, it is important to critically reflect the decisions made so far, as more understanding of the use case will be gained once the first models are evaluated.

Communication

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., Accessed 7 September 2021.

Documentation

ISPE

MARCH 7, 2023

Company standards for various aspects of environmental sustainability should be defined in technical documents and procedures that complement Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc.

Health and Personal Care Stores

ISPE

MARCH 15, 2023

There is an increase in those issuing a path to net zero design strategy document, which sets out design parameters covering all aspects of a project from initial concept through the commissioning, post-occupancy surveys, and audits. Accessed 28 December 2022: www.ipa.fraunhofer.de/en/expertise/ultraclean-technology-and-micromanufacturing/cleanliness-suitable-equipment-and-components/Cleanroom-suitable-materials.html

Packaging

ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

Documentation

pharmaphorum

JANUARY 29, 2021

On top of this, there are the well-documented manufacturing challenges that come with such a new field. “I George Underwood is pharmaphorum’s Deep Dive magazine editor. I think we’ve all learnt that we need to spend more time earlier on in developing the industrial processes,” Macrae says. About the author.

Documentation

ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. The assessment may also identify perception concerns. Biological (Viral and Microbial) Risk Progression. Unlock Access to Member-Only Content. Company Name.

Vaccines

ISPE

SEPTEMBER 10, 2023

Existing regulatory frameworks In the 1950s and 1960s, the WHO published documents outlining how countries should set up a regulatory framework to control pharmaceuticals and ensure the safety of their subjects. The proposals are consistent with WHO GRP. Published March 2020. www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf

Documentation

pharmaphorum

APRIL 8, 2021

When we submitted our clinical trial documents, we got feedback within a few days, which sped everything up,” he said. “If George Underwood is the editor for pharmaphorum’s Deep Dive digital magazine. About the author. The post COVID heralds a faster future for drug development (if stakeholders can collaborate) appeared first on.

Vaccines

pharmaphorum

JULY 10, 2025

Despite this decision of the Court of Justice, the European Commission continues to refuse to make the messages public," said Piperea ahead of the vote, which ended with 175 MEPs in favour of censure, 360 against, and 18 abstentions, with nearly 200 MEPs not showing up to cast their ballots.

Pharmaceutical Companies

Pharma Mirror

MARCH 25, 2025

Clinical trials have grown increasingly complex and now require robust solutions to manage data, documentation, and workflows.

Documentation