Cloudbyz

AUGUST 30, 2024

Given the critical nature of this data, ensuring its security and compliance with regulatory standards is paramount. Regulatory Penalties: Non-compliance with data protection regulations can lead to hefty fines and legal actions. Here are key strategies to ensure compliance within CTMS.

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Compliance Clinical Trials Clinical Trials Trials 96

Pharmaceutical Technology

OCTOBER 28, 2024

Ahead of the upcoming DSCSA November deadline, pharma companies reimagine track-and-trace to tackle the US counterfeit drug landscape.

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Compliance Pharma Companies Drugs 130

pharmaphorum

JULY 17, 2024

Discover how artificial intelligence is revolutionising drug development and compliance in the pharmaceutical industry with these four impactful ways.

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Compliance Development Drugs 107

pharmaphorum

JANUARY 22, 2024

Pharma waste management is crucial for balancing cost, compliance, and environmental responsibility in the healthcare industry. Explore strategies and best practices for effectively managing pharmaceutical waste, while ensuring regulatory compliance and minimising environmental impact.

Compliance 111

Compliance 111

Pharmaceutical Technology

AUGUST 22, 2023

Qualifyze has secured $12m to improve supply chain compliance in the pharmaceutical sector using technological and audit data.

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Compliance 130

Pharma Mirror

JANUARY 3, 2022

They can deal with other healthcare franchises, which also need compliance. There are more reasons why health professionals should have a HIPAA compliance program in their clinics and offices. The post 5 HIPAA Compliance Tips For Healthcare Professionals appeared first on Pharma Mirror Magazine.

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Compliance Licensing Licensing 130

pharmaphorum

APRIL 30, 2024

Discover strategies for enhancing compliance and resilience in pharmaceutical supply chains through effective monitoring, due diligence, and understanding the impact on the industry. Find out more.

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Compliance 99

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 15, 2023

The National Accreditation Board for Testing and Calibration Laboratories (NABL) has issued clarification on NABL accredited Conformity Assessment Body (CAB) combined International Laboratory Accreditation Co-operation (ILAC) Mutual Recognition Arrangement (MRA) mark for effective compliance.

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Compliance Clinical Trials Clinical Trials Clinical Research 156

pharmaphorum

OCTOBER 12, 2022

Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data.

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Compliance Manufacturing Life Science Production 103

Pharmaceutical Technology

JUNE 23, 2023

CDMOs face growing challenges to keep up with QA and compliance. The regulatory framework governing medicine development is in flux.

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Compliance Medicine Development 130

World of DTC Marketing

SEPTEMBER 12, 2022

There are many reasons for non-compliance and non-adherence: Cost and affordability, lack of understanding/comprehension of advice, language barriers, cognitive abilities, fear of asking for clarification, or other reasons. The post Is Apple that naive when it comes to compliance? Oh, to live in an ideal world.

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Compliance Doctor Doctors Production 166

XTalks

JULY 9, 2024

In the dynamic landscape of clinical trials, ensuring compliance and maintaining high-quality standards are paramount. The field of quality and compliance in clinical trials is undergoing significant transformations driven by technological advancements, regulatory changes and evolving industry practices.

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Compliance Clinical Trials Clinical Trials Trials 59

Cloudbyz

AUGUST 13, 2024

In the realm of clinical trials, regulatory compliance is a cornerstone that ensures the integrity, reliability, and safety of collected data. For EDC systems, compliance is particularly critical because these systems manage vast amounts of sensitive data electronically.

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Compliance Clinical Trials Clinical Trials Regulation 52

Pharmaceutical Commerce

JULY 25, 2023

With FDA’s compliance deadline only three months away, the tech-supply chain partnership is expected to help manufacturers and wholesalers meet the Nov. 27 deadline.

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Compliance Manufacturing 98

ACRP blog

AUGUST 7, 2024

Within the clinical research enterprise, as can be seen elsewhere in business and regulatory landscapes, the terms “quality” and “compliance” often intersect, creating what some feel is a symbiotic relationship crucial for organizational success.

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Compliance Clinical Research Production Regulation 59

Advarra

OCTOBER 22, 2024

The challenge of educating this new community involves the need to balance theoretical knowledge with practical experience, which enables them to ensure ethical compliance and adapt to evolving research methodologies. The post Educating New Researchers: Mastering Human Subjects Research and Ethical Compliance appeared first on Advarra.

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Compliance Research Regulation 52

ACRP blog

JUNE 30, 2023

Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. She concluded that “a proactive approach to clinical trial billing compliance can help mitigate these risks.”

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Compliance Clinical Trials Clinical Trials Trials 111

ACRP blog

JANUARY 8, 2024

Few industries have a need to understand the complexities of compliance more than clinical research. The importance of compliance in clinical research cannot be stressed enough. This year’s Compliance Institute features more than 100 educational sessions across 14 unique learning tracks. This is a sponsored message.

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Compliance Clinical Research Research Licensing 59

pharmaphorum

MAY 10, 2024

The 2nd mRNA Quality Control & Compliance Summit 2024 returns this June 25-27 Boston, MA. With world-class speakers from the likes of CureVac, Intellia Therapeutics, Zipcode Bio, Tessera Therapeutics, and many more

Compliance 52

Compliance 52

Pharmaceutical Commerce

SEPTEMBER 6, 2024

Bernstein, President of Bernstein Rx Solutions, LLC, comments on industry’s preparedness for DSCSA compliance and provides an update as to where pharma is in terms of RFID label adoption. In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G.

Compliance 52

Compliance 52

Pharmaceutical Technology

OCTOBER 10, 2024

At CPHI Europe, an expert discussed the promise of gummies as a drug delivery system and their unique manufacturing challenges.

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Drug Delivery Systems Drug Delivery Compliance Drugs 130

Cloudbyz

SEPTEMBER 10, 2024

In today’s fast-paced medical device industry, ensuring patient safety and meeting regulatory compliance is more crucial than ever. According to industry studies, 90% of medical device trials are delayed due to challenges related to data management and regulatory compliance.

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Compliance Trials Clinical Trials Clinical Trials 52

Imperical Blog

DECEMBER 13, 2023

But here come the holidays – will your study participant compliance waver during these busy times? Patient recruitment, retention, and compliance with study… The post 3 Tips to Avoid the Holiday Season from Impacting Participant Compliance appeared first on Imperial Clinical Research Services Blog.

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Compliance Clinical Research Trials Research 59

ACRP blog

FEBRUARY 28, 2024

To get the latest information and insights on a broad spectrum of topics, Health Care Compliance Association® (HCCA®) invites you to join us for our 28th Annual Compliance Institute , April 14–17. The city of Nashville, Tenn., Those who attend the virtual conference option can network with an anticipated 1,000 virtual attendees.

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Compliance Research Clinical Research Clinical Trials 59

Cloudbyz

JUNE 5, 2023

In the fast-paced world of clinical research, managing essential Trial Master Files (TMFs) efficiently, while ensuring quality and compliance, is paramount. In this blog, we will explore how generative AI can revolutionize electronic Trial Master File (eTMF) management, unlocking new levels of efficiency, quality, and compliance.

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Compliance Clinical Trials Clinical Trials Trials 96

pharmaphorum

AUGUST 1, 2023

How pharma can improve regulatory compliance with AI-based technology Mike.Hammerton Tue, 01/08/2023 - 08:00 Bookmark this

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Compliance 98

Drug Patent Watch

AUGUST 28, 2024

The EU’s Good Manufacturing Practice (GMP) guidelines provide the minimum standards for API manufacturing, and compliance with these guidelines is mandatory for all manufacturers and importers of APIs intended for the EU market.

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Compliance Manufacturing Medicine Marketing 58

Pharma Marketing Network

OCTOBER 13, 2023

Understanding digital compliance, navigating ad regulations, leveraging digital tools, and complying with pharma regulations are all important steps in ensuring successful marketing campaigns. Understanding Digital Compliance In order to stay compliant, pharma marketers must understand the digital compliance landscape.

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Compliance Regulation Marketing Engineer 52

Fierce Pharma

AUGUST 10, 2023

After Pfizer allegedly fired a compliance manager for raising the flag on potential fraud activity in China, the former employee is hitting back. Frank Han, Pfizer's former director of global compliance analytics, has filed a civil complaint against the drugmaker.

Compliance 98

Compliance 98

pharmaphorum

MAY 4, 2021

The life sciences history industry has some unique challenges when it comes to compliance. But if you think third party compliance risks are bad, don’t take your eye off fourth and fifth parties, says Allan Matheson. A decade ago, life sciences firms were early adopters of robust compliance technology — far ahead of other industries.

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Life Science Compliance Regulation Marketing 109

XTalks

JULY 18, 2024

This episode of the Xtalks Food Podcast features an interview with with Matt Brown, CEO of Wherefour, a cloud-based ERP (enterprise resource planning) platform that helps food and beverage companies, large and small, solve production and compliance issues. Matt discusses his background and what led him to lead Wherefour.

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Compliance Production Regulation 52

Cloudbyz

JUNE 16, 2023

Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Purpose of Clinical Trial Data Archiving: Compliance: Regulatory authorities require clinical trial data to be retained for a specific duration to demonstrate compliance with guidelines and regulations.

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Clinical Trials Clinical Trials Compliance Trials 94

Outsourcing Pharma

OCTOBER 16, 2023

AI start-up, Leucine, claims ânot fit for purposeâ compliance protocol processes are hindering the ability to deliver life-saving drugs faster.

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Compliance Drugs Regulation Marketing 92

ACRP blog

JANUARY 11, 2023

Compliance can feel like a mild distraction at best, or a mass of red tape that slows forward progress. Health Care Compliance Association® (HCCA®) was established to do just that. As a nationally recognized association, HCCA is the authority on healthcare compliance and ethics, so you don’t have to be.

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Compliance Clinical Research Research Regulation 52

Pharmaceutical Technology

AUGUST 22, 2022

Fixed-dose combination (FDC) systems aim to increase patient compliance in therapies involving two or more active drugs. The post Compliance to convenience: understanding the latest innovations in capsule formulation appeared first on Pharmaceutical Technology. To find out more about Procaps softgels, download the whitepaper. [1]

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Compliance Bioavailability Containment Branding 130

Cloudbyz

AUGUST 19, 2024

Compliance with their regulations is mandatory for manufacturers seeking to market their devices globally. Regulatory compliance: Labels must comply with the regulations of the country in which the device is marketed, including language requirements, symbols, and content.

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Compliance Manufacturing Regulation Marketing 52

FDA Law Blog

NOVEMBER 30, 2023

The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), The conference will also include its annual panel discussion with FDA’s Center Compliance Directors. Blumberg Memorial Lecture. next week, on December 6-7, 2023.

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Compliance Life Science Marketing Medicine 59