Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Food and Drug Administration (FDA).

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BioPharma Reporter

JANUARY 29, 2024

Naturally with more and more people using it for work, new regulations on data use and management are starting to appear. Always the buzz theme at pharma conferences, the subject of artificial intelligence (AI) continues to crop up more and more frequently.

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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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XTalks

FEBRUARY 26, 2024

Key developments in food regulations in 2024 are expected, focusing on safety, transparency and public health. For stakeholders in the food industry, understanding and adapting to these regulations is not just a matter of compliance but a strategic imperative for business success.

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FDA Law Blog

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. By John W.M. Clinical Trials.

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ACRP blog

JANUARY 11, 2023

Compliance can feel like a mild distraction at best, or a mass of red tape that slows forward progress. You know it’s important to adhere to regulations that protect your own interests as well as those of your participants, so you slog through it. Health Care Compliance Association® (HCCA®) was established to do just that.

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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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FDA Law Blog

DECEMBER 7, 2023

Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing. By Steven J.

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ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

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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 81

XTalks

DECEMBER 7, 2023

These tools are designed to assist stakeholders in achieving compliance before the deadline of January 20, 2026. It extends recordkeeping obligations beyond current regulations to those who manufacture, process, pack or hold FTL foods.

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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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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. The post Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance appeared first on Advarra.

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Cloudbyz

APRIL 25, 2023

This comprehensive guide delves into the essentials of pharmacovigilance regulatory reporting, highlighting its significance in maintaining drug and device safety, and ensuring compliance with regulatory requirements. Different types of reports have specific timelines for submission, and delays may result in regulatory actions or penalties.

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Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. In 1997, FDA released regulations providing guidance on the use of electronic systems. Un-specified identified Agency regulations. There are many factors in how Part 11 regulations affect software.

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Advarra

DECEMBER 14, 2023

b)) Categorized within the investigational plan regulations, there is a specific emphasis on accurate and complete documentation of all trial activities. This enables higher levels of training compliance over the course of study conduct, as well as the necessary understanding of trial activities to perform the right task at the right time.

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pharmaphorum

FEBRUARY 22, 2024

Discover how AI, automation, and blockchain technologies are revolutionising pharmaceutical case processing in compliance with FDA regulations. Explore the benefits of these advancements in this insightful article.

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BioTech 365

DECEMBER 2, 2021

Global High-Integrity Pressure Protection System (HIPPS) Markets 2021-2025: Rise in Midstream Infrastructure and Compliance to Stringent Industrial Regulations Driving Growth – ResearchAndMarkets.com Global High-Integrity Pressure Protection System (HIPPS) Markets 2021-2025: Rise in Midstream Infrastructure and Compliance to Stringent Industrial (..)

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pharmaphorum

FEBRUARY 4, 2021

However, issues like compliance, governance and security often are. These problems tend to be the most severe in the oldest and largest Salesforce orgs, and can result in slow performance, reduced agility, sluggish adoption, misalignment and even compliance and security issues. Security, Governance and Compliance are important .

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Cloudbyz

MAY 17, 2022

Though the regulations around electronic records and signatures, such as FDA 21 CFR part 11 and EU Annex 11 , have been published for a long time, their application has amplified manyfold in the recent times. The post Regulatory Compliance Coverage & Reference between FDA 21 CFR Part 11 and EU Annex 11 first appeared on CLOUDBYZ.

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Outsourcing Pharma

APRIL 11, 2023

OSP spoke to Vladamir Penkrat, head of safety and regulatory and Shuba Rao a senior director at Indegene, a life sciences digital company about a paper they recently published called 'Challenges and Future of PV Compliance' about the direction compliance is headed and how they would convert risk-based approaches into a confidence-based assurances. (..)

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Compliance Life Science Regulation Marketing 52

Cloudbyz

MAY 24, 2023

Clinical trial data management audits serve as a critical tool to evaluate and validate the accuracy, completeness, and integrity of the data, as well as compliance with regulatory requirements. Regulatory Compliance: Verification of compliance with applicable regulatory guidelines (e.g., auditors, regulatory authorities) 2.13.Regulatory

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BioPharma Reporter

JANUARY 29, 2024

Naturally with more and more people using it for work, new regulations on data use and management are starting to appear. Always the buzz theme at pharma conferences, the subject of artificial intelligence (AI) continues to crop up more and more frequently.

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Compliance Pharma Conference Regulation Marketing 52

pharmaphorum

JULY 21, 2022

The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. On top of this, some regulations have changed, plunging more facilities into the possibility of not complying. Doing so means that businesses can check their compliance before an FDA inspection.

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Cloudbyz

MAY 17, 2022

Though the regulations around electronic records and signatures, such as FDA 21 CFR part 11 and EU Annex 11 , have been published for a long time, their application has amplified manyfold in the recent times.

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Cloudbyz

MAY 17, 2022

Though the regulations around electronic records and signatures, such as FDA 21 CFR part 11 and EU Annex 11 , have been published for a long time, their application has amplified manyfold in the recent times.

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Compliance Regulation Clinical Research Clinical Trials 52

FDA Law Blog

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. By Sophia R.

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pharmaphorum

APRIL 28, 2021

Experts to come together for compliance event . Speakers at the 24 May 2021 event entitled ‘True Validation Ready Labeling – What it Really Means’ include Phil Dray, Test Manager at PRISYM ID, and two further independent experts who have long experience in cloud-based systems and regulatory compliance. . .

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FDA Law Blog

JUNE 23, 2022

Karst — The American Conference Institute and Council for Responsible Nutrition are hosting the 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements live in New York next week, June 29-30.

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Cloudbyz

APRIL 14, 2023

21 CFR Part 11 is a regulation set by the US Food and Drug Administration (FDA) that outlines the criteria for electronic records and electronic signatures to be considered as reliable, trustworthy, and equivalent to paper records. Address any identified issues promptly and maintain records of review findings and corrective actions taken.

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Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., Because of this, they need to stay abreast of these rapidly developing requirements and have systems in place to ensure data compliance and protection. The Global Reach of EACs and CECs.

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XTalks

APRIL 16, 2024

Related: FDA Food Regulations 2024: Navigating the Changing Landscape Interacting with seasoned experts provides a unique opportunity to benchmark and elevate an organization’s food safety practices. Understanding and implementing new regulations is paramount in maintaining safety standards and protecting public health.

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FDA Law Blog

MARCH 15, 2023

s Ricardo Carvajal will be moderating a panel on “The Use of Bioactive Substances in Food and Dietary Supplements” during the Food and Drug Law Institute (FDLI) Food and Dietary Supplement Safety and Regulation Conference. Hyman, Phelps & McNamara, P.C.’s

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Advarra

JULY 26, 2022

Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act. The post CBD Research: A Dive into the Regulations of Cannabis Research appeared first on Advarra.

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pharmaphorum

DECEMBER 21, 2023

Patient-centric advertising using zero-party data can provide effective and personalised healthcare marketing while ensuring compliance with legal regulations and industry standards.

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FDA Law Blog

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

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Pharma in Brief

APRIL 25, 2021

Proposed PM(NOC) Amendments Restore Balance by Expanding PM(NOC) Regulation Protections. 1] Regulations Amending the Patented Medicines (Notice of Compliance) Regulations (“ Proposed PM(NOC) Amendments ”). [2] Interested persons have 30 days to make representations concerning the Proposed PM(NOC) Amendments. [1]

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