Perficient: Drug Development

OCTOBER 28, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility. Fraud screening.

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Perficient: Drug Development

MARCH 26, 2024

Accessibility compliance is crucial to providing equal access to all users, including those with disabilities. Importance of Accessibility Compliance Accessibility compliance ensures that websites are usable by individuals with disabilities, such as vision impairments, mobility issues, or cognitive challenges.

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sptlabtech

OCTOBER 31, 2024

Keep reading to learn some of the latest updates and enhancements in firefly software, designed to improve usability and ensure compliance with regulatory standards. Improved sample and data management with barcode scanning To improve data management and ensure compliance, firefly now supports barcode scanning and capture.

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Fierce BioTech

OCTOBER 15, 2024

A Pharma Marketers' Roadmap to Data Privacy Compliance : Are You Ready for 2025? As state laws continue to shape advertising practices, understanding the nuances of compliance and data ethics is crucial. As state laws continue to shape advertising practices, understanding the nuances of compliance and data ethics is crucial.

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Perficient: Drug Development

NOVEMBER 1, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Perficient: Drug Development

NOVEMBER 4, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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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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thought leadership

OCTOBER 31, 2024

On January 31, 2022, the EU Clinical Trials Regulation 536/2014 (CTR) came into force with a transition period of three years. Now, as that transition period comes to a close, the process and need for registering new clinical trials is old news to sponsors, however there's one more step needed to ensure compliance.

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Perficient: Drug Development

OCTOBER 24, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Quanticate

AUGUST 19, 2024

In recent years the requirement for maintaining a robust audit trail has become crucial for ensuring data integrity, transparency, and compliance with regulatory requirements. An audit trail is a comprehensive log that records all activities, including modifications, additions, and deletions of data, within a clinical trial.

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Agency IQ

APRIL 12, 2024

BY WALKER LIVINGSTON, ESQ The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. The finalized rule includes new individual limits for some PFAS and gives water systems five years to be able to comply with the drinking water contaminant levels.

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Perficient: Drug Development

MAY 30, 2024

The world’s leading financial institutions and regulators come together at XLoD to discuss the future of non-financial risk and control. They want to know how AI and machine learning can enhance the capabilities of compliance, legal, and risk professionals in managing non-financial risk.

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Agency IQ

APRIL 12, 2024

EPA releases final PFAS drinking water regulations – with five-year compliance timeline The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. Part 141 and contains the implementing regulations from the act. The SDWA is administered by the EPA at 40 C.F.R.

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Perficient: Drug Development

NOVEMBER 14, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan.

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FDA Law Blog: Biosimilars

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.

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Perficient: Drug Development

AUGUST 17, 2023

The ripple effect will be essential as EV penetration continues to rise in the United States, although it also opens a whole new area of regulatory compliance with batteries which was not as big of a factor when EV penetration was much lower. What Can OEMs Do to Manage Changing Battery Regulations?

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Perficient: Drug Development

NOVEMBER 21, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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SCIENMAG: Medicine & Health

JUNE 30, 2023

Compliance is critical for large economies, industry regulations, and enterprise operations. BGI Genomics prioritizes compliance management and strictly follow laws, regulations, and international practices while conducting business globally.

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FDA Law Blog: Biosimilars

OCTOBER 14, 2024

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. California Stem Cell Treatment Center, Inc., Stem Cell Clinic, LLC , 998 F.3d

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FDA Law Blog: Biosimilars

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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FDA Law Blog: Biosimilars

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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FDA Law Blog: Biosimilars

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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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

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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Perficient: Drug Development

SEPTEMBER 11, 2023

Already reviewed by Perficient, BES provides a secure and efficient portal to exchange documents, information, and communications for consumer compliance and Community Reinvestment Act (CRA) examinations. By the time people started speaking of Y2K , regulators were accepting documents from the bank prior to starting the onsite examination.

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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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Advarra

FEBRUARY 13, 2024

By enabling collaboration in a shared document, staff can avoid the need to manage multiple versions of a document, saving time and potentially increasing compliance. SSO also has the ability to enhance user accountability and compliance within an organization. SSO can also benefit team members accessing systems via mobile devices.

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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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ProRelix Research

JUNE 27, 2024

In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […] The post Food and Dietary Supplements Clinical Trials Regulations in USA appeared first on ProRelix Research.

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thought leadership

MARCH 25, 2024

The PIPL aims to "protect the rights and interests of individuals", "regulate personal information processing activities" and "facilitate reasonable use of personal information".

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thought leadership

SEPTEMBER 23, 2024

Whether it’s pharmaceuticals, vaccines, or other veterinary products, companies must navigate complex regulations to bring their products to market and keep them there.

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thought leadership

FEBRUARY 29, 2024

This assurance is not left to chance but is meticulously governed by a set of regulations known as GxP. In the complex world of drugs and medical devices, where every pill, syringe, and implant holds the potential to impact lives profoundly, ensuring the utmost safety, efficacy, and quality is paramount.

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Perficient: Drug Development

NOVEMBER 27, 2023

In the dynamic environment of highly regulated industries like healthcare and financial services, leaders often balance competing goals to delight customers while cutting costs. This comparison enables your teams to assess process effectiveness and identify deviations that require attention due to inefficiencies and/or non-compliance.

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FDA Law Blog: Biosimilars

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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Drug Patent Watch

OCTOBER 24, 2024

With the majority of generic drugs manufactured overseas, ensuring compliance with regulatory standards is crucial. This article delves into the complexities of generic drug regulation, highlighting the challenges faced by the U.S. Food and Drug Administration… Source

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The Premier Consulting Blog

DECEMBER 28, 2023

1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This blog post discusses how device studies are classified and explores scenarios where DVDs qualify for exclusion from IDE regulations. b) Exempt studies that do not require an IDE.

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