Healthcare IT Today

JANUARY 3, 2025

Check out our community’s Pharma predictions: Dave Latshaw, CEO at BioPhy The competitive dynamics of the pharmaceutical industry will undergo substantial reorganization in 2025. The pharmaceutical industry is poised for a transformative shift in 2025, with artificial intelligence becoming deeply embedded in core operations.

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Pharmaceutical Industry FDA Compliance Regulatory Compliance 92

Dot Compliance

FEBRUARY 5, 2025

These records are essential for ensuring consistency, safety, and compliance in the pharmaceutical industry. Each step in the process plays a role in maintaining compliance and preventing product recalls, making BMR review a vital part of quality assurance.

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Compliance Pharmaceutical Industry Regulatory Compliance FDA 59

HIT Consultant

OCTOBER 13, 2024

In addition to regulatory fines triggered by compliance violations, failing to manage data accurately could lead to issues like the sale of expired medications, causing harm to patients. Best practices for managing pharmaceutical data Again, there are no simple solutions for streamlining data management in the pharmaceutical industry.

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Governance Pharmaceutical Industry Compliance 98

Dot Compliance

MARCH 20, 2025

These documents capture the detailed processes that ensure the safety, efficacy, and quality of pharmaceutical products. By thoroughly documenting every step of the manufacturing process, BMR and BPR not only ensure compliance with regulatory standards but also facilitate continuous improvement and innovation.

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Compliance Pharmaceutical Industry Regulatory Compliance 59

Dot Compliance

NOVEMBER 8, 2024

In the pharmaceutical industry, a leading Corrective and Preventive Action (CAPA) process is essential for ensuring product quality and regulatory compliance. Step 3: Risk Assessment Assess the potential impact of the identified problem on product quality, patient safety, and regulatory compliance.

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Regulatory Compliance Pharmaceutical Industry Compliance 52

HIT Consultant

JANUARY 21, 2025

This shift addresses the rising volume and complexity of inquiries and ensures compliance, builds trust and transforms the way MI is shared across the healthcare ecosystem. Pharmaceutical companies face mounting pressures as the MI landscape evolves. Wheres the Information Coming From? Whats next?

Compliance 52

Compliance Pharmaceutical Industry 52

Dot Compliance

NOVEMBER 20, 2023

In the pharmaceutical industry, ensuring the safety and quality of drugs is paramount. For companies in the manufacturing, processing, packing, or holding of drugs, compliance with 21 CFR Part 210 and 21 CFR Part 211 is not just a regulatory requirement; it’s the key to producing safe and effective pharmaceutical products.

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FDA Compliance Pharmaceutical Industry Regulatory Compliance 52

HIT Consultant

MARCH 28, 2024

What You Should Know: – Verix , a leader in AI-powered commercial operations solutions for the pharmaceutical industry, has announced the launch of its revolutionary GenAI Database Explorer.

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Pharmaceutical Industry Compliance 104

HIT Consultant

AUGUST 20, 2024

AI-driven monitoring systems can track patient compliance with the trial protocols, alerting researchers to any deviations that could impact the results. The regulatory landscape for pharmaceuticals is complex and ever-changing, with different regions imposing varying requirements for drug approval.

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Compliance Pharmaceutical Industry Regulatory Compliance 111

HIT Consultant

MARCH 21, 2024

Director of Business Development at IQVIA The healthcare industry is no stranger to workforce shortages, and the pharmaceutical industry may be next to experience disruptions brought on by labor challenges. Scott Fonseca, Sr. According to the U.S. PV teams can turn to automation to manage the impact of workforce shortages.

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Pharmaceutical Industry Regulatory Compliance Compliance 97

Healthcare IT Today

MARCH 25, 2024

This results in a non-adherence rate of approximately 70%, resulting in an estimated annual revenue loss of $637 billion for the pharmaceutical industry. This is the first pharmaceutical platform that enables the free flow of real-time information with Redi Health’s unique compliance architecture.

Health Outcomes 123

Health Outcomes Pharmaceutical Industry Compliance 123

HIT Consultant

FEBRUARY 1, 2024

Mike Szczesny, Owner & VP of EDCO Awards & Specialties Influencer marketing in the pharmaceutical industry is a complex issue with reasonable arguments on multiple sides. On the one hand, leveraging individual patients’ personal experiences and narratives may help bring an authentic voice to product messaging.

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Pharmaceutical Industry FDA Public Health Regulatory Compliance 111

HIT Consultant

JULY 25, 2022

Lauren Ohlsson, Lead of Industry Solutions, Pharmaceutical and Healthcare, at VDX.tv. Consumers continue to cut ties with traditional TV and cable services, prompting industries like the prescription pharmaceutical industry to evolve their marketing mix to accommodate emerging media. . this year. .

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Pharmaceutical Industry FDA Compliance 98

Dot Compliance

SEPTEMBER 11, 2022

The following is a list of some of the most prevalent rules and regulations that apply to the Pharmaceutical Quality Management System (QMS). Organization for International Standardization (ISO): ISO is a global organization that creates standards for a variety of sectors, including the pharmaceutical industry.

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Pharmaceutical Industry Compliance FDA Regulatory Compliance 52

HIT Consultant

DECEMBER 19, 2023

In addition, the strict regulatory requirements in the healthcare industry mean that IDP systems must ensure patient privacy protection and maintain audit trails. This is essential for optimizing communications with sites and ensuring regulatory compliance.

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Pharmaceutical Industry Regulatory Compliance Compliance 105

HIT Consultant

AUGUST 16, 2023

Accelerating the Adoption of IDMP-O to Simplify and Standardise data Assets “Fluree is a perfect fit for pharmaceutical organizations seeking to balance regulatory compliance with innovation and accelerate drug discovery, efficacy and efficiency,” said Eliud Polanco, Fluree president. years, with only a 7.9% years, with only a 7.9%

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Pharmaceutical Industry Regulatory Compliance FDA Compliance 52

HIT Consultant

MAY 31, 2023

The pharmaceutical industry has experienced a wave of accelerated consolidation since 2010. In 2019, the industry saw a record-breaking 1,276 pharmaceutical M&A’s , representing a total value surpassing $411 billion.

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Pharmaceutical Industry Hospitals Telemedicine FDA 96

Dot Compliance

OCTOBER 25, 2024

In the pharmaceutical industry, it is essential to ensure product quality, patient safety, and regulatory compliance. By combining these two disciplines, organizations can achieve a higher level of quality and compliance. Regulatory Compliance: Demonstrate a robust risk management approach to meet regulatory standards.

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Regulatory Compliance Pharmaceutical Industry Compliance 52

HIT Consultant

MAY 30, 2024

With more than a decade of effort, the pharmaceutical industry has established agreed-upon methods and technologies to exchange transaction information, verify product information, and track products throughout the supply chain, thus improving the security of the U.S. drug supply chain.

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Pharmaceutical Industry Compliance FDA Hospitals 52

Dot Compliance

NOVEMBER 27, 2024

It serves as a comprehensive model for ensuring consistent product quality and compliance with regulatory requirements. We’ll also explore how leveraging ICH Q10 can go beyond compliance to offer a competitive edge in the pharmaceutical industry. What is ICH Q10?

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Regulatory Compliance Compliance Pharmaceutical Industry Public Health 59

HIT Consultant

NOVEMBER 17, 2021

Improving Protocol Compliance. Together, these risks pose a threat to protocol compliance and, in turn, to the integrity of the study. Improvements in protocol compliance have the potential to translate into reduced rates of data variation and loss, thereby impacting the overall quality of the study. About Robert Geckeler.

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COVID-19 Pharmaceutical Industry Informed Consent Compliance 97

Dot Compliance

JULY 12, 2024

Implementing an electronic quality management system (eQMS) is crucial for organizations in the pharmaceutical industry. Below are ten of the reasons why an eQMS is critical for pharmaceutical companies: 1. Regulatory Compliance The eQMS helps ensure compliance with regulatory standards.

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Pharmaceutical Industry Regulatory Compliance FDA Compliance 52

Healthcare IT Today

JANUARY 8, 2024

It is key for pharmaceutical companies to recognize that efficiency does not override compliance, patient safety or regulatory standards. The AI revolution has been and will continue to redefine the pharmaceutical industry in 2024, promising transformative outcomes for patients. Dave Latshaw, CEO at BioPhy 1.

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Pharmaceutical Industry Due Diligence Compliance Regulatory Compliance 93

HIT Consultant

SEPTEMBER 5, 2023

In the Internet age, HIPAA has taken on a new level of importance, with digital products flooding the consumer healthcare and pharmaceutical industries. In light of the new HIPAA guidance, CDPs have quickly become the top choice for healthcare digital marketers who need sanitizing behavioral tracking to achieve compliance.

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HIPAA Electronic Medical Records Pharmaceutical Industry Compliance 98

Dot Compliance

SEPTEMBER 30, 2022

The following is a list of some of the most prevalent rules and regulations that apply to the Pharmaceutical Quality Management System (QMS). The ISO is a global organization that creates standards for a variety of sectors, including the pharmaceutical industry. For cGMP compliance, the FDA audits authorized drug manufacturers.

FDA 52

FDA Pharmaceutical Industry Compliance 52

Healthcare IT Today

DECEMBER 15, 2023

However, it is crucial to consider the compliance of chatbots with security standards. Non-Compliance with Cybersecurity by Medical Professionals No modern technologies will protect against hacker attacks if your password is everywhere “1234” or your date of birth. Currently, ChatGPT does not meet HIPAA standards.

Electronic Medical Records 126

Electronic Medical Records Doctors HIPAA Hospitals 126

Verisys

FEBRUARY 7, 2024

The more you know about the people in your organization, the safer you are from risks that could damage your company, your reputation, or your compliance.The regulations in the pharmaceutical industry are understandably strict, and to ensure your organization is compliant, every member of your team must be thoroughly vetted.

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Licensing Compliance Compliance Framework Fraud 52

HIT Consultant

AUGUST 18, 2021

Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA. The pandemic has given rise to new norms in drug development that will influence the future of the industry as we know it. Industry and regulatory professionals can continue to pursue growth rather than revert to the status quo once the pandemic has effectively ended.

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COVID-19 COVID-19 Vaccine Pharmaceutical Industry FDA 52

HIT Consultant

DECEMBER 18, 2023

However, it is crucial to consider the compliance of chatbots with security standards. Non-compliance with Cybersecurity by Medical Professionals No modern technologies will protect against hacker attacks if your password is everywhere “1234” or your date of birth. Currently, ChatGPT does not meet HIPAA standards.

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Electronic Medical Records Doctors HIPAA Pharmaceutical Industry 105

Healthcare IT Today

JULY 6, 2023

It employs state-of-the-art security measures to ensure the privacy and compliance of sensitive patient information. Gradient Health is building capabilities that will allow for rapid and game-changing advancements in the medical and pharmaceutical industries.”

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Pharmaceutical Industry Compliance 52

Dot Compliance

JANUARY 20, 2022

As a result, pharmaceutical companies of all sizes need quality management systems built to address a slew of unique challenges and regulatory oversight. The key framework for creating a QMS that can handle the demands of the pharmaceutical industry is the International Conference on Harmonisation (ICH) Q10 model.

Compliance 52

Compliance Pharmaceutical Industry Public Health Regulatory Compliance 52

Dot Compliance

FEBRUARY 1, 2022

The global pharmaceutical industry has seen its share of challenges in recent years, from manufacturing and supply chain bottlenecks to growing demand for faster delivery of drugs to the marketplace. The post Future Trends and Regulatory Challenges in Pharma appeared first on Dot Compliance. References.

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COVID-19 Vaccine FDA Pharmaceutical Industry COVID-19 52

Natalia Mazina

OCTOBER 22, 2023

There is even a conference on reducing environmental impact of pharmaceutical industry – Clean Med Conference. Just think of the potential impact some of these practices could make. With over 6 billion prescriptions filled each year in U.S., pharmacy environmental impact is a serious matter.

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Pharmaceutical Industry Regulatory Compliance Compliance 52

SQA

APRIL 12, 2023

The ISPE APQ Guide: Cultural Excellence is the fifth and final guide in the series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. It is a valuable companion to this APQ Guide.

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FDA Compliance Pharmaceutical Industry 40

SQA

APRIL 12, 2023

The ISPE APQ Guide: Cultural Excellence is the fifth and final guide in the series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. It is a valuable companion to this APQ Guide.

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FDA Compliance Pharmaceutical Industry 40

Bill of Health

MAY 22, 2023

Comparison of Research Spending on New Drug Approvals by the National Institutes of Health vs the Pharmaceutical Industry, 2010-2019. Lessons from Canada’s Notice of Compliance with Conditions Policy for the Life-Cycle Regulation of Drugs. Galkina Cleary E, Jackson MJ, Zhou EW, Ledley FD. JAMA Health Forum. J Law Biosci.

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Pharmaceutical Industry Medicare Medicare Medicaid 162

SQA

JUNE 3, 2024

Additional findings included concerns with respect to document control, records management, and lack of compliance with Standard Operating Procedures (SOPs). Evidence of compliance as described in Article 117, must be provided by requesting an opinion from a Notified Body (NB) appropriately accredited for the issuance of such an opinion.

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FDA COVID-19 Licensing Nurses 40