AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 12, 2024

In a significant move to enhance trade facilitation and streamline compliance with foreign trade regulations, the Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce & Industry, has announced amendments to the export obligation period for several import items.

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Compliance Regulation Drugs Clinical Trials 182

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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Compliance Clinical Trials Clinical Trials Trials 98

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

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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Compliance Clinical Trials Clinical Trials Manufacturing 97

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

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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Compliance Regulation Manufacturing Contamination 98

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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Compliance Regulation 116

Pharmaceutical Technology

JUNE 5, 2023

Right now, it’s compliance by checkbox, in a static way. Regulators need to work together with industry to certify hot patches to quickly fix vulnerabilities while maintaining pharmaceutical quality,” adds Fracchia. Pharmacies have also received EU General Data Protection Regulation (GDPR) fines for not being in compliance,” he adds.

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Genomics Genome Compliance Regulation 276

pharmaphorum

JULY 12, 2024

Stay informed about the upcoming EU Artificial Intelligence Act, which will regulate AI use in compliance with EU standards. Learn how this legislation may impact your organisation's AI initiatives.

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Compliance Regulation 110

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 82

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 79

Cloudbyz

MAY 17, 2024

As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation. Companies will need to adeptly navigate these regulations to balance innovation with compliance.

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Life Science Clinical Trials Clinical Trials Trials 102

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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Regulation Research Production Cosmetics 97

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

FDA Law Blog

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M. s John W.M.

Cosmetics 59

Cosmetics Compliance Production Regulation 59

Pharma Mirror

SEPTEMBER 6, 2023

Compliance with complex laws and regulations, like Direct-to-Consumer Advertising (DTCA) Rules or the Health Insurance Portability and Accountability Act (HIPAA), can be quite daunting. And it is not hard to see why.

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Life Science Marketing Compliance Branding 130

FDA Law Blog

FEBRUARY 7, 2024

The CSA and regulations promulgated by DEA regulate the sale, import, and export of tableting machines the same as they regulate List I chemicals. The regulations also require detailed information about each transaction involving a tableting machine, including the date, name and address, quantity, method of transfer, etc.

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Sales Regulation Compliance Production 116

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. However, in recent years, there has been a noticeable decline in the number of these letters being issued.

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Marketing Compliance Regulation Drugs 97

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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Compliance Manufacturing Regulation In-Vitro 64

XTalks

JULY 26, 2024

They ensure efficiency, compliance and profitability. Wherefour , a leader in ERP solutions, is transforming and simplifying how food and beverage companies manage production and compliance. They help manage complex operations, track inventory and ensure regulatory compliance.

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Compliance Manufacturing Production Packaging 52

XTalks

AUGUST 12, 2024

Given that no safe level of lead exposure has been established, the FDA takes a proactive role in monitoring and regulating lead levels in food to protect public health. The FDA’s regulatory framework, including action levels and compliance policy guides, provides clear directives for the industry.

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Contamination Compliance Regulation Production 105

Camargo

SEPTEMBER 8, 2021

devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA. Final Regulation Issued for “Intended Use”.

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Development Regulation Production Drugs 186

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

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

Worldwide Clinical Trials

APRIL 3, 2024

Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity. Keeping abreast of changes in regulatory frameworks guarantees compliance and minimizes regulatory-related delays.

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Trials Clinical Trials Clinical Trials Compliance 204

Cloudbyz

APRIL 17, 2024

Some of which are listed below: Regulatory and compliance challenges: One of the biggest challenges in the adoption of DCT platforms is the regulatory and compliance landscape. The regulations around clinical trials are complex and require strict adherence to ensure the safety of patients and the reliability of the data.

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Clinical Trials Clinical Trials Trials Compliance 105

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

APRIL 27, 2023

Regulatory automation in clinical trial operations has the potential to dramatically improve the efficiency, accuracy, and compliance of clinical trials, leading to faster development and approval of new therapies. It is essential to engage employees and educate them on the benefits and limitations of automation.

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Clinical Trials Clinical Trials Trials Compliance 98

FDA Law Blog

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” Document all corrective actions and follow-up to ensure sustained compliance. Conduct internal audits to identify and address compliance issues before inspections.

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Compliance Bioequivalency Cosmetics Regulation 111

pharmaphorum

DECEMBER 28, 2022

In turn, the acquiring company will help the novel drugs navigate the complexities and costs of regulations and benefit from market access and economies of scale. These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts.

Compliance 119

Compliance Regulation Manufacturing Licensing 119

World of DTC Marketing

FEBRUARY 28, 2021

When asked what the pharma industry can do to improve its reputation, Arnold pointed to the defense industry, which has “succeeded in instilling a strong ethics culture in each firm in the industry via cooperation and strong ethics and compliance programs,” he said. The pharmaceutical industry can and should do the same. Ethical leadership!

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Vaccination Vaccine Contamination Compliance 180

Pharmaceutical Technology

JULY 29, 2022

These countries either have a guidance document that was put out by the regulatory authority, or the ethics committee itself will have eConsent guidance based on what the national signature laws, data privacy laws, and clinical trial regulations will allow.". Did they open it, immediately sign and close it?

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Compliance Clinical Trials Clinical Trials Trials 130

Outsourcing Pharma

JUNE 13, 2024

CluePoints, a leading provider of AI-driven software solutions for Clinical Data Review, has secured significant investment from EQT for its continued growth.

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Compliance Clinical Trials Clinical Trials Trials 80

Pharmaceutical Technology

NOVEMBER 24, 2022

Regulators will push metaverse companies to plug the known privacy issues associated with the underlying technologies. Although platform developers will adopt privacy by design to appease regulators, data privacy concerns will increasingly surface as these platforms mature in the coming years. China’s tech regulators.

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Regulation Development Compliance Research 130

Pharmaceutical Technology

JUNE 23, 2022

Regulators will push metaverse companies to plug the known privacy issues associated with the underlying technologies. Although platform developers will adopt privacy by design to appease regulators, data privacy concerns will increasingly surface as these platforms mature in the coming years. China’s tech regulators.

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Regulation Development Compliance Research 130

Cloudbyz

NOVEMBER 13, 2023

Managing this data efficiently is paramount to maintaining data integrity and ensuring regulatory compliance. Improved Regulatory Compliance Medical technology companies operate within a highly regulated environment, and compliance with various global regulatory standards, such as FDA’s 21 CFR Part 11, is non-negotiable.

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Clinical Trials Clinical Trials Trials Compliance 104

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers. Discover the leading direct-to-consumer pharmaceutical marketing companies.

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Marketing Compliance Production Doctors 130