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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Perficient: Drug Development

APRIL 8, 2024

To bolster its capabilities and ensure compliance, the bank sought assistance from Perficient in delivering exceptional project and program management services to tackle their significant hurdles.

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thought leadership

JULY 25, 2023

In this post, we’re going to discuss the various types of GxP Compliance Audits, internal versus independent third-party audits.

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thought leadership

AUGUST 10, 2023

Compliance auditing is a crucial process in the pharmaceutical industry, that helps ensure the safety, effectiveness, and high quality of pharmaceutical products and medical devices.

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H1 Blog

NOVEMBER 15, 2023

However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan. In this blog post, we will explore why compliance is critical in medical affairs and how it can make or break successful KOL engagement strategies.

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Perficient: Drug Development

JANUARY 29, 2024

Integrating NLP Algorithms for Compliance To ensure compliance with the Illinois Artificial Intelligence Video Interview Act, employers can integrate NLP algorithms into their video interview processes: Consent Understanding: NLP algorithms can analyze and understand the language used in consent forms, ensuring they are clear and comprehensible.

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FDA Law Blog: Biosimilars

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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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.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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thought leadership

AUGUST 1, 2023

Welcome to Part 2 of our blog series on "What You Need to Know About GxP Independent Compliance Audits." In Part 1 , we discussed the importance of GxP audits, the different audit types, and why utilizing independent auditors is crucial for successful compliance assessments.

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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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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. Regulatory battery compliance cannot be an afterthought for OEMs manufacturing EVs and batteries.

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Advarra

DECEMBER 14, 2023

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. In addition, providing CROs and sponsors visibility to site training compliance allows them to provide additional support and mitigate risk if necessary.

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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. This month, the Federal Deposit Insurance Corporation (FDIC) launches it new Banker Engagement Site (BES) through FDIC connect.

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FDA Law Blog: Biosimilars

NOVEMBER 13, 2023

On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY.

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FDA Law Blog: Biosimilars

JULY 7, 2024

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § Merely providing links to existing MDR training materials for traditional device manufacturers, as the new compliance guide does, fails to meet FDA’s stated objective.

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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

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. By Steven J. There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention.

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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.

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Advarra

SEPTEMBER 8, 2022

After platform review, if a decision is made to validate, staff should generate documentation to ensure Part 11 compliance. As the first requirement in Part 11 compliance, validation is systematic documentation for a system’s requirements. The post Beginner’s Guide to 21 CFR Part 11 Compliance appeared first on Advarra.

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Fierce BioTech

FEBRUARY 13, 2024

Streamlining Compliance: Outsourcing combined services and technology in pharmacovigilance and regulatory affairs Biotech and pharma companies are already tapping into the benefits of outsourcing. They can, however, get much more out of the strategy by leveraging one vendor for both technology and regulatory services.

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thought leadership

MARCH 25, 2024

What is PIPL/PIPA? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region.

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Drug Channels

APRIL 19, 2021

Informa Connect’s Compliance Congress for Specialty Products. June 22-24, 2021 | Virtual Event www.informaconnect.com/specialty-compliance/. Up your compliance game at this important event serving the unique sector of Specialty Products, the 7th annual Virtual Compliance Congress for Specialty Products.

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thought leadership

FEBRUARY 29, 2024

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. This assurance is not left to chance but is meticulously governed by a set of regulations known as GxP.

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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. Finalized trigger levels for compliance monitoring frequency are set at one-half the level of the MCLs (e.g. for the HI). version 2.0).

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The Pharma Data

NOVEMBER 23, 2020

On February 7, 2020 the NYSE American notified the Company that it accepted the Company’s plan to regain compliance before November 25, 2020 , the end of the compliance plan period. This date has now been extended to May 25, 2021. About Synthetic Biologics, Inc. Synthetic Biologics, Inc.

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The Pharma Data

MARCH 9, 2021

Eli Lilly and Company (NYSE: LLY) today announced the upcoming retirement of two executive committee members and the naming of their successors in the company’s manufacturing operations and ethics and compliance organizations. Hernandez and Weems will report to David A.

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Perficient: Drug Development

DECEMBER 18, 2023

In the fast-paced realm of finance, the significance of regulatory risk and compliance management practices cannot be overstated. The Role of Regulatory Risk and Compliance 1. Compliance with these legal obligations is not only mandated by regulatory authorities but also necessary for maintaining an institution’s reputation.

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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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Drug Discovery World

JULY 11, 2024

Download this interactive infographic to: Discover ways to navigate your contamination, compliance, reproducibility, monitoring and scalability challenges Identify which critical factors and equipment you should consider to help succeed in a GMP environment Unlock access to an extensive collection of helpful resources Download now.

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Perficient: Drug Development

AUGUST 4, 2024

Improved Security and Compliance With stringent regulatory requirements in the financial sector, security and compliance are paramount. Regulatory Reporting and Compliance Automation Compliance reporting is often a resource-intensive process.

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Drug Discovery World

JUNE 20, 2024

By employing dPCR-based assays, manufacturers can effectively monitor and control the levels of impurities, ensuring compliance with regulatory guidelines and minimising the risk of adverse effects in patients. The post Event today: Discover residual DNA quantitation using digital PCR appeared first on Drug Discovery World (DDW).

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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Drug Discovery World

JUNE 13, 2024

By employing dPCR-based assays, manufacturers can effectively monitor and control the levels of impurities, ensuring compliance with regulatory guidelines and minimising the risk of adverse effects in patients. The post Webinar: The latest innovative solutions in biotherapeutic manufacturing appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JUNE 6, 2024

By employing dPCR-based assays, manufacturers can effectively monitor and control the levels of impurities, ensuring compliance with regulatory guidelines and minimising the risk of adverse effects in patients. The post Webinar: Leveraging digital PCR-based assays in biotherapy manufacturing appeared first on Drug Discovery World (DDW).

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Drug Discovery World

MAY 30, 2024

By employing dPCR-based assays, manufacturers can effectively monitor and control the levels of impurities, ensuring compliance with regulatory guidelines and minimising the risk of adverse effects in patients. The post Webinar: Advancing biotherapy manufacturing appeared first on Drug Discovery World (DDW).

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FDA Law Blog: Biosimilars

JUNE 10, 2024

It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM) , both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance.

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