Quality Matters

APRIL 25, 2024

As the new lead for USP’s International Government and Regulatory Affairs team, I have been inspired to learn about USP’s historic involvement – as a partner, resource, and ally – in supporting India’s emergence as such an important source of medications for the world. kristine.gates… Thu, 04/25/2024 - 13:30 Supply Chain

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

Quality Matters

APRIL 17, 2023

Pharmacopeia (USP) support the availability of safe, quality medicines, regulatory efficiencies, and a strong global medicine supply chain. In low- and middle-income (LMIC) countries, regulators often lack access to quality standards and related resources due to budget constraints or complex procurement procedures.

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PharmaState Academy

AUGUST 9, 2023

Regulatory Compliance: Ensure all branding activities comply with your country’s relevant laws, regulations, and industry guidelines, particularly the impending UCPMP on India. 8) Budget Management: Guage how effectively she manages the marketing budget and allocates resources for maximum impact.

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Documentation Packaging Communication 52

Integra X Files

MAY 22, 2023

Medical device and drug manufacturers have joined in as well and provided funding to encourage legislative and regulatory relief. There are both regulatory and legislative paths to reform of the prior authorization system. Begin tracking the resources you, or your prescribers, commit to carrying out PA requests.

Insurance Coverage and Processing 94

Insurance Coverage and Processing Health Insurance Companies 94

European Pharmaceutical Review

MAY 2, 2023

The growing issue of inequitable access is not just an issue of developing or emerging countries either; significant disparities in medicine availability exist within Europe where the time between regulatory approval (marketing authorisation) and true access for patients can vary from a few days to 2.5

Clinical Pharmacology 104

Clinical Pharmacology Compounding Communication Pharmaceutical Companies 104

pharmaphorum

DECEMBER 9, 2021

She rotated through regulatory affairs, external innovation, and self-care R&D. A true advocate for diversity and inclusion, she also sits on the EMEA Leadership Team for Johnson & Johnson’s LGBT+ employee resource group. Heather’s passion for integrated wellness goes beyond her day-to-day responsibilities.

Packaging 105

Packaging Drug Development 105

Pharmaceutical Technology

SEPTEMBER 2, 2022

For a large company with a lot of resources and an established commercialisation framework, the cost and effort required to add another product into their existing infrastructure may be minor. More often than not, the decision depends on the size of a launcher’s operational base. De-risking drug launch.

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Putting Patients First Blog

JULY 3, 2023

We hear consistently from patient groups and product sponsors that one of the primary barriers to collecting quality patient experience data is the lack of tools, resources, and training for patients, sponsors, and other stakeholders on how to achieve quality patient experience data. He is reachable via e-mail at egascho@nhcouncil.org.

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pharmaphorum

JANUARY 25, 2021

It has been thrilling to watch how COVID-19 has catapulted the pace of collaboration among regulatory agencies. To date, we have seen significant cross-industry collaborations to develop standards and new regulatory guidance for acceptable RWE use cases. public education. clinical trial diversity. real-world evidence (RWE).

Communication 124

Communication Drug Development 124

pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. The most important thing is that you have a framework to be able to identify them, pick them up quickly and around that regulatory framework. We know that there are 3.5

Vaccines 111

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 111

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintain documentation. Regulatory requirements will be harder to comply with. – Estimation of resources required to bring about the change. – Conduct regulatory assessments.

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Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. Regulatory requirements will be harder to comply with. – Estimation of resources required to bring about the change. – Specify urgency.

Documentation 52

Documentation Packaging Communication Customer Service 52

Putting Patients First Blog

OCTOBER 15, 2023

Much like with the federal regulatory process, it would be helpful to have an accessible docket to what requests have been submitted and where they are in the scoring process. The second step is to provide CBO with sufficient resources to process the many proposals to decrease health care spending. Sincerely, Randall L.

Insurance Coverage and Processing 40

Insurance Coverage and Processing 40

European Pharmaceutical Review

SEPTEMBER 29, 2022

Today, manufacturers of pharmaceutical products marketed in the US are required to comply with current good manufacturing practice (cGMP) standards, which represent a regulatory minimum on quality. cGMP standards promote manufacturing and process quality by ensuring that drug products meet the “safe and effective” criteria set forth by FDA.

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Nursing Homes Pharmaceutical Manufacturing Department of Veterans Affairs Dosage 86

pharmaphorum

MAY 18, 2021

Pre-commercial & Emerging pharma companies may not think they have the resources to match the launch strategies of big pharma. Smaller companies tend to think that they are missing the resources to use similar launch strategies as big pharma, but with the right efficiencies, they can make considerable savings on marketing budgets.”.

Drug Development 52

Drug Development 52

PharmaShots

MAY 24, 2023

Mechanism of Action: CFTR stimulants Originator: Vertex Pharmaceuticals First Approvals: Below mentioned are the first approvals of Trikafta from different regulatory agencies. Regulatory requirements and policies may differ, potentially delaying access to Trikafta in certain regions.

Insurance Coverage and Processing 56

Insurance Coverage and Processing Hospitals Dosage Pharmaceutical Companies 56

Putting Patients First Blog

FEBRUARY 8, 2024

The NHC is a unique and ready resource on this critical topic. Created by and for patient organizations over 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. Conclusion The NHC values this opportunity to engage in this critical dialogue on AI in health care.

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PharmaShots

FEBRUARY 14, 2023

Our partnership is part of DTA’s Resource Partner Program, which the organization launched to accelerate the development and post-marketing success of clinically evaluated DTx by building a network of commercialization and product development service providers.

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Diabetes Communication 40

PharmaShots

FEBRUARY 14, 2023

Our partnership is part of DTA’s Resource Partner Program, which the organization launched to accelerate the development and post-marketing success of clinically evaluated DTx by building a network of commercialization and product development service providers.

Diabetes 40

Diabetes Communication 40

pharmaphorum

NOVEMBER 30, 2022

The Veeva Systems Summit is about sales, medical, and marketing – the commercial side of things, but on the development side Veeva also works in clinical data, clinical operations, regulatory, quality, and safety – and it is starting to connect the functional areas. Excellence, coordination, and connection.

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Communication 98

Viseven

MAY 15, 2023

References & Resources. Powered by modular content, eWizard allows your company to reuse pre-approved content blocks and tremendously simplify medical, legal, and regulatory affairs for e-detailing. Images, video, and audio help sales reps engage HCPs with an engaging story. Navigation Menu.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Communication 52

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

Regulatory affairs professionals with significant expertise in diagnostics are already in short supply. Thus, it is unclear how FDA will have resources to field pre-submissions and the anticipated premarket submissions. This would require a massive increase in staffing and training. [8] of 510(k) decisions, respectively. [13]

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Research Laboratories Documentation 69

PharmaShots

MARCH 9, 2023

Since its launch in 2016, Tivic Health has obtained three regulatory clearances for ClearUP, including FDA 510(k), FDA De Novo, and CE Mark, four patents, and numerous awards. Designation: Vice President and Chief Corporate Affairs Officer Previous company: Pfizer (10 yrs. LinkedIn Total experience: 35 yrs.

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Clinical Pharmacology Immunity Immunization Pharmaceutical Companies 40

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. We also have some strong chapters in the European and US Pharmacopeias for rapid and alternative microbiological methods, but the regulatory part is lagging.

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Vaccines Research Laboratories Documentation Compounding 128

Putting Patients First Blog

JANUARY 10, 2024

Furthermore, to complement these enhancements, it is imperative to integrate comprehensive, user-friendly educational resources on HealthCare.gov. These resources should aim to clarify insurance terms and concepts, aiding consumers in navigating the complexities of selecting a health plan.

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Insurance Coverage and Processing Communication Documentation Diabetes 40

PharmaState Academy

FEBRUARY 1, 2024

Pharma Marketing, Brand Management, Product Management, Medical Affairs, Medicomarketing, CEO, Director, VP, Managers, Pharma Sales and Interested Professionals. Gain insights into HCP learning needs: Understand why continuous learning is crucial for doctors and the benefits of providing valuable resources. Why you should attend?

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Packaging 52

PharmaState Academy

JUNE 7, 2023

Pharma Marketing, Sales, Medical Affairs, Medicomarketing, CEO, Director, and other teams Why you should attend? Gain insights into HCP learning needs: Understand why continuous learning is crucial for doctors and the benefits of providing valuable resources. What will you learn?

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Packaging 52

PharmaState Academy

JULY 13, 2023

How to develop a proactive and innovative mindse t to get the right career growth opportunities.

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Packaging 98

PharmaState Academy

NOVEMBER 30, 2023

Pharma Marketing, Brand Management, Product Management, Medical Affairs, Medicomarketing, CEO, Director, VP, Managers, Pharma Sales and Healthcare Professionals, including Researchers, Analysts, Strategists, and Decision-makers. Why you should attend?

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Packaging 59

PharmaState Academy

OCTOBER 8, 2023

Attendees will receive exclusive access to E-books, certificates of each sessions, and resources to further enhance their personal development journey. Advanced methodologies such as Six Sigma Practical skills in risk management, regulatory compliance, and continuous improvement.

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Packaging Hospitals 52

PharmaState Academy

MARCH 16, 2023

(For Event Reminders) Company Department Select Department Administration Clinical Research College (Passout Fresher) College (Student) Engineering F&D Finance Human Resources IT Manufacturing Marketing Medical Affairs Medicomarketing Packaging Pharmacovigilance Quality Assurance Quality Control R&D Regulatory Affairs Sales Supply Chain Training (..)

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Packaging 98

PharmaState Academy

MARCH 16, 2023

Medical Affairs, Medicomarketing, Pharma Marketing, Sales, CEO, Director, and other teams. Register Now Speakers Dr. Santosh Jha Head Medical Affairs, Oncology at Growth Emerging Markets Region, Takeda Pharma. Why you should attend? How to create a more effective sales force? Improving ROI with Omnichannel approach.

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Packaging 80

PharmaState Academy

JULY 25, 2023

(For Event Reminders) Company Department Select Department Administration Clinical Research College (Passout Fresher) College (Student) Engineering F&D Finance Human Resources IT Manufacturing Marketing Medical Affairs Packaging Pharmacovigilance Quality Assurance Quality Control R&D Regulatory Affairs Sales Supply Chain Training Ware House (..)

Packaging 52

Packaging 52

PharmaState Academy

AUGUST 22, 2023

(For Event Reminders) Company Department Select Department Administration Clinical Research College (Passout Fresher) College (Student) Engineering F&D Finance Human Resources IT Manufacturing Marketing Medical Affairs Packaging Pharmacovigilance Quality Assurance Quality Control R&D Regulatory Affairs Sales Supply Chain Training Ware House (..)

Packaging 52

Packaging 52

Putting Patients First Blog

NOVEMBER 14, 2023

In the subsequent sections, the NHC will offer general comments and recommendations aimed at ensuring the comprehensive and equitable implementation of these regulatory updates, with responses to specific questions starting on page 15. b)(3), emphasizing the prohibition of discriminatory methods in the allocation of scarce medical resources.

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Communication Bioethics Hospitals Documentation 40

PharmaState Academy

MARCH 17, 2023

Medical Affairs, Medicomarketing, Pharma Marketing, Sales, CEO, Director, and other teams. Register Now Speakers Dr. Santosh Jha Head Medical Affairs, Oncology at Growth Emerging Markets Region, Takeda Pharma. After event - "The Certificate" along with "3CPhE Learning Points" will be available on the payment of Rs.

Packaging 52

Packaging 52

PharmaState Academy

APRIL 12, 2023

To understand key account business, Understanding how to sell in key accounts, Understand the potential of key account selling Register Now Speakers Dr. Santosh Jha Head Medical Affairs, Oncology at Growth Emerging Markets Region, Takeda Pharma.

Packaging 52

Packaging 52