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 75

Adverse Reactions Documentation Medical Schools Packaging 75

Pharmaceutical Technology

AUGUST 26, 2022

Earlier this month, the World Health Organisation (WHO) released a new guidance document with a strategic plan to counter TB on a national level. Sequella is a US-based pharmaceutical company that develops antibiotics to address drug resistant infections. Sequella is developing SQ-109 for the treatment of pulmonary tuberculosis.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation 98

pharmaphorum

FEBRUARY 10, 2021

Pharmaceutical companies will need new standard operating procedures (SOP) to cover activities such as collaborative working, and new documentation to reflect changes in language. While the 2021 version makes provision for support from AQPs, it will take time for these people to be recruited, trained, and monitored. “In

Documentation 111

Documentation Pharmaceutical Companies Pharmaceutical Companies 111

pharmaphorum

JANUARY 27, 2023

Having previously spoken with Dr Mullen three years ago when she was country medical director for the UK & Ireland at GSK – on the topic of patient centricity and embedding that focus within the core of a pharmaceutical company – our recent interview provided some interesting insights into the changing landscape of the industry.

Pharmaceutical Companies 111

Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 111

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. Even with the vaccine roll-out, further waves of COVID infection and lockdowns mean these vital drivers of launch performance remain impacted in 2021, and even beyond.

Pharmaceutical Companies 95

Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

pharmaphorum

AUGUST 31, 2021

Still, in 2021, we have seen the industry evolve and develop strategies on how to establish a viable ECA. Beyond the FDA, other institutions have documented what industry standards should look like in assessing RWD in a regulatory context. Furthermore, ECAs are well-documented in the post-approval setting.

FDA 89

FDA Insurance Coverage Documentation Insurance 89

Pharmaceutical Technology

NOVEMBER 4, 2022

In a more recent report, the ABPI found that the number of Phase III industry trials fell by 48% between 2017 and 2021. At the time of its publication, the document prioritised the finalisation of Brexit above all else. For the life sciences and pharmaceutical sector, the Conservative government promised £34 billion ($38.98

Documentation 93

Documentation Pharmaceutical Companies Pharmaceutical Companies 93

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. The responsibility of printing paper leaflets is currently a key regulatory obligation for pharmaceutical companies. Eurostat (2022) “How many citizens had basic digital skills in 2021?”

Packaging 83

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 83

pharmaphorum

MAY 14, 2021

This article appears in our digital magazine, Deep Dive: Market Access 2021. Practically though, there are risks of additional processes and requirements (and expense) for pharmaceutical companies. Experts from ICON give us their views on the past, present and future of NICE’s standing on the world stage.

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies 59

pharmaphorum

OCTOBER 5, 2021

This was also one of the key messages from the recent Healthcare Automation and Digitalization Congress (AUTOMA+) 2021, at which I led a round-table discussion on the ‘prevention versus treatment’. For radical innovation thinking to be successful, all healthcare companies and providers must respond and adapt to the patient of the future.

Hospitals 132

Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 132

pharmaphorum

OCTOBER 18, 2021

2 And, as of September 2021, there are 22 COVID-19 vaccines in use globally 3 , and over 2.3 Regulators and pharmaceutical companies are investigating cloud-based platforms to enable the real-time sharing of data. Last accessed: October 2021. Last accessed: October 2021. Last accessed: October 2021.

Vaccines 143

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 143

Pharma Marketing Network

APRIL 30, 2021

At this year’s Reuters Pharma Clinical 2021, I joined over 500 global leaders in clinical research as they discussed many of these issues under the theme, “rebuild clinical trials in the image of patient need.”. How do we increase the diversity of clinical trials?

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation FDA 52

ISPE

NOVEMBER 1, 2022

International convergence is another area in which the FDA is a participant, including in initiatives related to viral safety (ICH Q5A), CM (ICH Q13), quality risk management (QRM; ICH Q9), analytical procedure development (APD; ICH Q2/14), pharmaceutical product life-cycle management (ICH Q12), and common technical document (ICH M4Q).

FDA 98

FDA Insurance Chemotherapy Documentation 98

Viseven

SEPTEMBER 14, 2023

Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. Technologies allow pharmaceutical companies to collect and analyze a massive amount of data to ensure proper drug safety.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmacy Procurement 52

The Checkup by Singlecare

MARCH 7, 2024

A 2021 study found an estimated $220 billion of medical debt in the United States spread across 20 million people. Here are some things you’ll need to do when filing for bankruptcy: Get your financial documents in order. File the documents in the proper court. Submit the required documents.

Insurance Coverage 98

Insurance Coverage Insurance Hospitals Documentation 98

ISPE

JULY 6, 2023

1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Published July 2021. ICH Harmonised Tripartite Guideline Q13: Continuous Manufacturing of Drug Substances and Drug Products.”

Documentation 52

Documentation Dosage FDA Pharmaceutical Companies 52

ISPE

JULY 5, 2023

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. National Academies Press, 2021. Journal of Pharmaceutical Science (9 January 2023).

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

pharmaphorum

JANUARY 9, 2023

For pharma, the impact in critical areas such as the performance of newly marketed innovation has already been documented. More remains to be addressed, and not just by conventional pharmaceutical companies. The pause button was on for major acquisitions throughout 2021 and for most of 2022. Pharma boxed in?

Vaccines 98

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 98

European Pharmaceutical Review

FEBRUARY 2, 2023

The European Commission (EC) conducted a comprehensive assessment 1 in 2021 that revealed that 80 percent of API by volume imported into Europe comes from just five countries, with China supplying 45 percent of the API and the rest coming from India, Indonesia, US and UK.

Generic Medicine 100

Generic Medicine Packaging Documentation Pharmaceutical Companies 100

European Pharmaceutical Review

JULY 1, 2022

Although there are currently no set metrics or prescribed areas of focus, there are several key areas that pharmaceutical companies can pinpoint when measuring the S in ESG. For pharmaceutical companies, ensuring that human rights are protected by offering transparency and performing due diligence in global supply chains is key.

Pharmaceutical Companies 86

Pharmaceutical Companies Pharmaceutical Companies Documentation 86

ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 10, 2023

ChatGPT: “In a pharmaceutical software engineering context, data integrity refers to the accuracy, consistency, and reliability of data stored in computerized systems. This is a crucial aspect of pharmaceutical software as it directly impacts patient safety.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 6, 2023

Although it has been widely adopted in other industries, the pharmaceutical industry has yet to do so, and most drug production still relies on the longstanding batch manufacturing process. 3 As the pharmaceutical industry shifts its focus to biologics, the investment in CM elements in industry is expected to increase considerably.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 7, 2023

A collaborative mindset must prevail between pharmaceutical companies, suppliers, and regulators and include strategic partnerships that go beyond the pharmaceutical sector so we can move together to a more sustainable future. The risks are equally applicable to both privately owned and publicly traded companies.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

Hospital Pharmacy Europe

JANUARY 18, 2023

A patient access scheme or commercial arrangement associated with the NICE guidance is a way for pharmaceutical companies to lower the acquisition cost to the NHS to improve its cost-effectiveness, so enabling patients to gain access to high-cost medicine treatments. TA681, March 2021. Conclusion. www.nice.org.uk/guidance/ta681

Hospitals 52

Hospitals Medical Records Documentation Pharmaceutical Companies 52

ISPE

MARCH 7, 2023

9 December 2021. Increasing the Circularity of Packaging Along Pharmaceuticals Value Chain.” A pharmaceutical quality system (PQS) is a management system used to direct and control a pharmaceutical company with regard to quality. The Global Use of Medicines 2022.” link] 2 Salmenperä, H., Dahlbo, and P.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

Pharmaceutical Technology

MAY 23, 2023

In April, the pilot-level Nordic Pharmaceutical Forum (NPF) initiative, representing Finland, Iceland, Norway, Sweden, and Denmark, released an updated strategy document outlining the region’s plans to establish a joint procurement mechanism for medicines, with a declared focus on advanced therapy medicinal products (ATMPs) such as gene therapies.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 52

Pharmaceutical Technology

JUNE 8, 2023

Of the world’s 20 largest pharmaceutical companies, 17 have launched programmes tailored towards increasing medication access in low- and middle-income countries – up from just eight in 2010. Figure 1: Social media posts from pharmaceutical firms mentioning “environment”. A similar theme is evident in company filings.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 52

ISPE

SEPTEMBER 10, 2023

WHO Expert Committee on Specifications for Pharmaceutical Preparations.” Published 2021. Pharmaceutical Engineering 42, no. link] 6 International Pharmaceutical Regulators Programme. IPRP Strategic Vision 2018–2021. WHO Technical Report Series, No. Accessed 14 June 2023. link] 2 a b Ramnarine, E., Edwards, K.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98