ISPE

AUGUST 7, 2023

She explained how the pandemic conditions reinforced the need to be agile in dealing with supply and demand as well as meeting the needs of citizens, how trust, built in “better times,” helped. Cooke highlighted three important drivers that helped overcome the pandemic’s challenges – adaptation, trust, and collaboration.

Vaccines 52

Vaccines Communication 52

Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted The companies have also commenced rolling submission for conditional marketing authorization from the European Medicines Agency (EMA) for this Omicron BA.4/BA.5-adapted

Vaccines 52

Vaccines FDA Dosage 52

pharmaphorum

NOVEMBER 30, 2020

According to press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first bodies to approve the vaccine. As reported by pharmaphorum, the MHRA’s forthcoming spilt from the EMA could potentially allow it to be more agile in its decision-making after Brexit.

Vaccines 70

Vaccines 70

European Pharmaceutical Review

NOVEMBER 15, 2022

The original iteration of ISPE GAMP 5 was released in 2008 arriving in the nascent stages of what has become the cloud revolution and certainly before the widespread adoption of agile development methodologies, meaningful augmented reality, machine learning and artificial intelligence use cases in the life sciences industry. FDA, 2022. .

Documentation 84

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 84

Pharmaceutical Technology

MARCH 23, 2023

These changes come following a public consultation with the Healthcare Research Authority, to which a government response was published on March 21. In a press release, Marc Bailey, MHRA’s Chief Science and Innovation Officer, said “Our world-first Covid-19 approvals showed how important it is to ensure that regulation is flexible and agile.

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pharmaphorum

JUNE 17, 2022

. “We are experiencing increased adoption of decentralisation in the oncology space,” according to Dr Shaalan Beg, vice president of oncology at Science 37 and a co-author of the report. “Oncology studies are often challenging for patients who suffer from cancer and treatment side effects,” he said.

Communication 72

Communication 72

European Pharmaceutical Review

JULY 21, 2023

There are four ways: Establish strong regulatory partnerships: Collaborate with regulatory authorities to establish clear guidelines, harmonise regulations, and streamline processes across different regions and countries. How can these issues be addressed?

Vaccines 94

Vaccines FDA Communication Hospitals 94

pharmaphorum

JULY 21, 2022

Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. This doesn’t necessarily mean that all risks are off the table; however, it ensures that an agile framework is in place to help ensure systems and processes can manage and adjust accordingly to any external factor or regulatory changes.

FDA 90

FDA Pharmaceutical Companies Pharmaceutical Companies 90

European Pharmaceutical Review

JUNE 30, 2023

Additionally, growth of emerging markets in regions like Latin America and Asia-Pacific means that there is great potential for the market to expand, the authors wrote. Agilent Technologies Inc. Key players in the global PAT market include: PerkinElmer Inc. Shimadzu Corporation Mettler-Toledo International Inc.

Compounding 90

Compounding 90

ISPE

MARCH 3, 2023

At the upcoming 2023 ISPE Europe Annual Conference, you will have an excellent opportunity to hear about GAMP ® 5 directly from the authors, discuss the content of the guide with peers and regulators, and ask all the questions you did not get answers to until now. Link them through a TM, otherwise the FDA will give you a 483!”

Documentation 98

Documentation FDA 98

pharmaphorum

JULY 6, 2022

Of the 23 that received conditional marketing authorization in Europe, 10 (43%) went on to receive regular approval, and just one (4%) was withdrawn. The past decade has seen record numbers of new oncology therapy authorizations in the US and Europe. About the author.

FDA 97

FDA 97

pharmaphorum

MAY 13, 2022

Ultimately, it’s about meeting people where they want to be met and allowing for more agile, interactive, personalised and informed engagement. About the author. “Now two years into the pandemic, we’re taking – we’re thinking ahead, how we can continue reimagining our engagement model.

Pharmaceutical Companies 127

Pharmaceutical Companies Pharmaceutical Companies Vaccines FDA 127

Omnicell

SEPTEMBER 5, 2022

Pulling together a cohesive internal team to support the criteria of the project can also be difficult, as these key players need to be agile, with deep knowledge of both the organization and the new technology. Assumptions made in the analysis are not reflective of the position of any entity other than the author(s).

Communication 52

Communication Omnicell Hospitals 52

pharmaphorum

OCTOBER 26, 2021

The rather inflexible, old-fashioned regulatory regime in Europe should be modernised in order to attract investment, and to improve agility and flexibility”. The rather inflexible, old-fashioned regulatory regime in Europe should be modernised in order to attract investment, and to improve agility and flexibility.”. About the author.

Generic Medicine 115

Generic Medicine 115

pharmaphorum

JANUARY 12, 2022

It suggests enabling a “more agile, centralised” framework by removing “unnecessary interfaces” between the EC, EMA, working parties, and committees, and allowing member states to “bring forward their expertise”. About the author. Enhancing expediting pathways that support innovation is also recommended in the report.

FDA 98

FDA Vaccines 98

European Pharmaceutical Review

APRIL 2, 2024

Pharma Horizons: Environmental Monitoring About the authors Evelyn Der joined Genentech, a member of the Roche Group, in 1999 and currently is in the Analytical Sciences chapter of Roche. Lindsey is a highly skilled analytical scientist with a track record of developing and implementing technology to build agility for biologic products.

Method Validation 87

Method Validation Medical Schools 87

pharmaphorum

JANUARY 18, 2022

David Rhew, MD, global chief medical officer and VP of healthcare at Microsoft, tells us, “Using Microsoft technology, CVS Health will develop a more agile, digital-first technology foundation.” About the author. The post CVS Health and Microsoft alliance: an example of an extended partnership appeared first on.

Prescription Filling 118

Prescription Filling Insurance 118

Pharmaceutical Technology

JUNE 5, 2023

He points to the US Department of Defense investments in biomanufacturing and the Section 215 of the National Defense Authorization Act, which requires any future biomanufacturing investments to go hand-in-hand with cybersecurity investments to assess the threats and maintain the integrity of that process.

HIPAA 110

HIPAA Insurance Pharmaceutical Companies Pharmaceutical Companies 110

PharmaShots

JUNE 26, 2023

The company also works with multiple regulatory authorities on marketing applications for bulevirtide in other parts of the world 4. The regulatory submissions are under review with multiple health authorities, incl. of treatment, incl. in clinical studies. of treatment, incl. in clinical studies. vs 7.9mos.) & & 2EPs incl.

Adverse Reactions 40

Adverse Reactions Hospitals FDA 40

pharmaphorum

OCTOBER 12, 2022

By integrating a SaaS platform, it becomes possible to validate data faster by employing a more agile methodology. About the author. A non-compliance scenario can be highly disruptive, requiring a great amount of time, effort, and cost for a plant to recover from – and to revert to its licensed state.

Documentation 98

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 98

ISPE

JUNE 27, 2023

This group is also connected with US regulators e.g., Biomedical Advanced Research and Development Authority (BARDA), UK colleagues in MHRA, and Pharmaceutical Inspection Co-operation Scheme (PIC/s) as well as other agencies.

Communication 52

Communication FDA Vaccines 52

pharmaphorum

OCTOBER 19, 2022

In these communities, the challenges are discussed, and pharma leaders confer about the agile content supply chain, providing insight into what users have experienced and learned. Agile collaboration internally and externally. This is a shared evolution.

Communication 89

Communication Pharmaceutical Companies Pharmaceutical Companies 89

pharmaphorum

APRIL 21, 2021

If NICE is to remain a “beacon of evidence-based medicine”, it must become more agile, more flexible, and more ready to adapt – and COVID-19 has proved that it is more than capable of doing so. About the author. How do you get the right balance between the dynamism in response and the rigour and scientific evaluation you need?

Documentation 59

Documentation 59

European Pharmaceutical Review

DECEMBER 23, 2022

First, we are adopting an agile mindset across the business: in 2021, we upskilled over 16,000 Sanofi employees – with courses offered for different levels, with an emphasis on an agile mindset, not just the methodology. About the authors. To address this, we’re focused on two aspects: mindset and tools.

Vaccines 82

Vaccines Communication 82

pharmaphorum

APRIL 1, 2021

Exeevo is a unified, intelligent and agile digital ecosystem for life sciences organisations to revolutionise health experiences for healthcare teams and patients in their journey towards sustainable health outcomes. About the author. Isn’t this a great time to incentivise based on the behaviour that really matters? About Exeevo.

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DiversifyRx

MAY 1, 2024

By staying agile and responsive to changing conditions, pharmacy owners can effectively navigate uncertainties and seize opportunities as they arise. By providing valuable information on health topics, medication management, and wellness practices, pharmacy owners can position themselves as trusted authorities in their field.

Compounding 52

Compounding Communication 52

pharmaphorum

AUGUST 4, 2021

With digital health solutions becoming more agile and customizable, they can not only address the common challenges that exist across all types of rare diseases, but also provide increasingly personalized support to meet each individual patient’s needs, ensuring clinicians have better oversight and help ensure treatment is as effective as possible.

Patient Care 145

Patient Care FDA 145

pharmaphorum

MAY 18, 2021

But with the proper planning and an agile approach, they can be more successful than they realise, says Veeva’s Ian Hale. Agile, scalable and data-driven. Companies should be agile, scalable, and data-driven to make the right decisions at the right time,” says Hale. About the author.

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52

pharmaphorum

OCTOBER 12, 2021

COVID-19 offers a “unique opportunity” to build healthcare systems that are both agile enough to deal with future crises and strong enough to overcome existing challenges. About the author. Value-based, person-centred healthcare is the key to system resilience – and now is the time to make it happen.

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European Pharmaceutical Review

JUNE 29, 2022

From our front row view of the pandemic these past three years, our mission necessitated that we leverage our years of vaccine expertise to help global health authorities address, control and eradicate the severe acute respiratory syndrome coronavirus 2 (SARS?CoV-2).

Vaccines 83

Vaccines Documentation 83

pharmaphorum

FEBRUARY 15, 2021

In many ways our small size and agility was our strength. We have also encouraged our Firestarters to enrol in Agile skills programmes. About the author. Starting out, one of my biggest fears was how to keep pace with the Pparma ‘Big Boys’ with so much work to do. But I soon realised that was an excuse.

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pharmaphorum

MARCH 10, 2022

I think that demonstrates the importance of getting an agile, balanced approach to peer review.”. About the author. A paper summarising the results of a clinical trial that appeared to show ivermectin could reduce COVID-19 death rates by more than 90%, for example, was later withdrawn over “ethical concerns”. “I Changing culture.

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pharmaphorum

MAY 17, 2022

It also provides the freedom for entrants to explore a variety of sub-divisions in an agile, fast-moving, and global business, and to sharpen their own understanding of the areas that interest them. About the author: Dr. James Burt is CEO of Pharmanovia.

Pharmaceutical Companies 72

Pharmaceutical Companies Pharmaceutical Companies 72

pharmaphorum

AUGUST 4, 2022

As we’ve seen over the last few years, remaining agile in a fast-changing industry landscape is a priceless attribute. About the Author. Raising the profile. When it comes to recruitment, the pharmaceutical industry should be well placed to capitalise on a society that now has healthcare front of mind.

Customer Service 97

Customer Service Vaccines 97

pharmaphorum

JUNE 11, 2021

New technologies and improved data flows among areas – for example, for production planning – are seen as essential to increased agility and will consequently become more widely used. About the author. Treat them as such.

Vaccines 111

Vaccines HIPAA Immunization 111

European Pharmaceutical Review

DECEMBER 22, 2022

Small biotech companies with transformative ideas are part of the RNA revolution, having the agility to test and advance new product candidates quickly, making them well placed to address unmet clinical needs. About the authors. He is the inventor of 15 patents/applications and has authored over 120 scientific publications.

Vaccines 105

Vaccines Immunization Hospitals 105

pharmaphorum

NOVEMBER 20, 2022

When coupled with transparency, the agility of a CRO, and when grounded in science, a vaccine can quickly demonstrate its global potential in tackling public health challenges. About the author. Ultimately, this can support the goal of helping patients through effective therapies.

Vaccines 93

Vaccines Immunization 93