thought leadership

APRIL 14, 2025

Ensuring patient safety and compliance with pharmacovigilance (PV) regulations is a critical responsibility for marketing authorization holders (MAHs). While these countries are centrally located in Europe, they each have distinct national regulations that must be met.

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Perficient: Drug Development

FEBRUARY 12, 2025

The industry faces numerous challenges, including protecting sensitive data, navigating evolving regulations, and outdated legacy systems. This transformation will require a delicate balance between innovation and compliance, ensuring that advancements in AI contribute to a secure and efficient payments landscape.

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Compliance Regulations Production Government 52

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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Compliance Regulations Government International 52

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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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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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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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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Advarra

NOVEMBER 14, 2024

Strengthened regulatory compliance: Different countries have varying regulatory requirements and expectations. A globally diverse DMC ensures the trial adheres to local regulations while maintaining high ethical standards. This compliance is crucial for the successful regulatory approval and dissemination of trial results.

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Clinical Trials Trials International Clinical Research 97

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

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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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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PPD

DECEMBER 16, 2024

Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in todays demanding market.

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Drug Patent Watch

FEBRUARY 12, 2025

Collaboration with Regulatory Experts : Working with regulatory experts who have in-depth knowledge of the generic drug development process can help you navigate the complex regulatory landscape and ensure compliance with all relevant regulations.

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Drug Development Drugs Compliance Regulations 67

ACTO

DECEMBER 17, 2024

These councils bring together diverse expertise from scientists and researchers, data analysts and technology specialists, regulatory compliance experts, as well as commercial operations leaders. a walled garden of sorts), ensures data sovereignty and compliance with regional regulations.

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Perficient: Drug Development

JANUARY 30, 2025

Regulations like the General Data Protection Regulation (GDPR) in the EU, the California Consumer Privacy Act (CCPA) in California, and other global privacy laws mandate that businesses protect the privacy of individuals and ensure their data is stored and processed securely.

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FDA Law Blog: Biosimilars

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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Perficient: Drug Development

MARCH 25, 2025

Look for folks who: Actually understand the data (a rare breed, cherish them) Can handle details without going cross-eyed Won’t melt down when stuck between the rock of compliance and the hard place of IT Bonus: Give them a fancy title like “Data Integrity Czar.”

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Government Compliance Regulations 52

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

JANUARY 6, 2025

Legal Compliance Many countries have regulations and laws that mandate accessibility in public services, including healthcare. Adopting braille and large print is not just a matter of best practice but also legal compliance, ensuring that healthcare providers meet the required standards for accessibility.

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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

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. These risks face fewer regulations but must meet certain standards to ensure ethical use.

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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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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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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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Fierce BioTech

FEBRUARY 12, 2025

Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement. Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement.

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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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Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD).

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ASPET

AUGUST 21, 2024

This review details the onset mechanisms of drug-induced TdP, including I Kr inhibition, pharmacokinetic factors, autonomic regulation and reduced repolarization reserve. It also explores the utility of proarrhythmic surrogate markers (J-T peak , T peak -T end and terminal repolarization period) besides QT interval.

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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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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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Clinical Trials Regulations Trials FDA 52

PPD

JULY 16, 2024

Staying current with PV-relevant regulations and regulatory guidance can be challenging and often requires an FSP PV RI team that spans multiple countries and languages. In three years of tracking safety reporting compliance with this client, their annual China EC Compliance rates averaged over 99%.

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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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Drug Patent Watch

DECEMBER 30, 2024

Manufacturing and Quality Control : The PMDA evaluates the manufacturing process and quality control measures of the generic drug to ensure compliance with Japanese regulatory standards. Pharmaceutical Regulations in Japan 2020. Freyr Solutions. 11 Must-know FAQs about the Drug Approval Process in Japan.

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ProRelix Research

APRIL 17, 2025

Indiaprovidesanidealsettingforsuchcost-savingstrategiesduetoseveralkeyfactors: Economic Benefits Conducting trials in India can reduce costs by up to 60%comparedtoWesterncountries.Labor costs,participantrecruitment,hospitalinfrastructure,andadministrativefeesaresignificantly lower. […] The post Outsourcing Clinical Trials to India: Global Regulation, (..)

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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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Compliance Clinical Research International Research 52

Drug Patent Watch

FEBRUARY 26, 2025

However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA). Regulatory compliance : Biologics are subject to strict regulatory requirements, including those related to manufacturing, labeling, and marketing.

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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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