Alta Sciences

NOVEMBER 4, 2024

Case Study: How to Ensure Safety While Manufacturing Highly Potent APIs aasimakopoulos Mon, 11/04/2024 - 17:37 Highly potent active pharmaceutical ingredients (API) require careful attention to safety and handling during formulation and manufacturing.

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Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. As the harmonization effort advances, the focus will likely shift toward refining guidelines and regulations for vulnerable populations, including children, pregnant women, and prisoners. The coming year is expected to be no different.

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PPD

APRIL 14, 2025

As of mid-2024, this includes at least 650 Phase I-IV trials, with about 430 of those already ongoing. To that end, the PI can ensure patients understand the science of appetite and metabolic regulation, for example, to relieve some of the self-imposed expectations for instant weight loss or other quick signs of success.

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The Pharma Data

JUNE 6, 2025

billion in 2024 to $24.8 As pharma companies grapple with mounting pressure from regulators, payers, and evolving market dynamics, the CSO model offers a compelling alternative to traditional, fully in-house sales forces. Equally important is regulatory compliance.

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Perficient: Drug Development

NOVEMBER 19, 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 15, 2024

And this year is especially interesting, as 2024’s U.S. election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. HCOs cannot simply repurpose hastily-constructed solutions from earlier mandates as a foundation for future compliance.

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Perficient: Drug Development

NOVEMBER 12, 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 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 15, 2024

And this year is especially interesting, as 2024’s U.S. election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. HCOs cannot simply repurpose hastily-constructed solutions from earlier mandates as a foundation for future compliance.

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Fierce BioTech

OCTOBER 15, 2024

A Pharma Marketers' Roadmap to Data Privacy Compliance : Are You Ready for 2025? swheeler Tue, 10/15/2024 - 19:53 Thu, 11/21/2024 - 13:00 Resource Type Webinar Ben Chapman Duration 60 minutes Join for an insightful webinar on the evolving privacy landscape impacting pharma marketers in 2025.

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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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Broad Institute

JANUARY 24, 2024

Terra is now generally available on Microsoft Azure By Allessandra DiCorato January 24, 2024 Breadcrumb Home Terra is now generally available on Microsoft Azure Terra on Microsoft Azure expands support for enterprises and data scientists across the globe. Compliance agreements: Terra can now sign HIPAA Business Associate Agreements for U.S.

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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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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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Fierce BioTech

OCTOBER 26, 2023

Are you struggling to keep track of privacy and compliance regulations across multiple countries and grant types? Join a team of medical grants experts to learn about common grantmaking challenges and tools for tackling them in 2024. Listing Image Bonterra-LogoListing-12072023.png On Demand Start Date Thu, 12/07/2023 - 14:00

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Perficient: Drug Development

JUNE 19, 2024

Our risk and regulatory compliance experts, Carl Aridas and Chandni Patel, have just returned from XLoD 2024 in New York. The event brought together the world’s top financial institutions and regulators to discuss the future of non-financial risk and control.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

(HP&M) proudly announces that Director Anne Walsh will be a featured panelist at the highly anticipated 2024 Women’s White Collar Defense Association (WWCDA®) Leadership Retreat and Annual Attorney Meeting. The event is set to take place from March 4-6, 2024, in San Francisco, California.

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FDA Law Blog: Biosimilars

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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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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Agency IQ

NOVEMBER 10, 2023

The FDA announced it intends to delay enforcement of cosmetic facility registration and cosmetic product listing requirements to July 1, 2024, from the current deadline of December 29, 2023 as required by Modernization of Cosmetics Regulation Act or MoCRA.

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Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence The announcement of significant amendments to the New York State Department of Financial Services (NYSDFS) regulations on December 1, 2023, represents a pivotal moment for entities operating within New York’s financial sector.

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Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence Perficient’s Risk and Regulatory Center of Excellence (CoE) remains at the forefront of evolving financial rules and regulations, ensuring readiness to tackle emerging challenges and safeguard financial institutions and its customers.

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FDA Law Blog: Biosimilars

JANUARY 8, 2024

Claud — As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. Assessing risks in regulated industry requires the appropriate depth and breadth of regulatory expertise. By John W.M.

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Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

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Advarra

MARCH 19, 2024

The Food and Drug Administration’s (FDA’s) February 2024 draft guidance Use of Data Monitoring Committees in Clinical Trials signals a significant shift in approach. Open for public comment until April 15, 2024, this draft seeks to modernize and clarify the agency’s expectations for DMC oversight.

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Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. but the U.K.

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Fierce BioTech

JULY 15, 2024

Nitrosamines in Focus: Regulatory Requirements and Best Practices dwunderlin Mon, 07/15/2024 - 11:10 Thu, 09/12/2024 - 10:00 Resource Type Webinar Chris Williams Chad Bastian Duration 60 Minutes Nitrosamines, potent carcinogens, have prompted stringent regulations for their detection and control in various products.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. Walsh’s unique perspectives on navigating the challenges and opportunities presented by advertising and promotion regulations worldwide. Before joining HP&M, Ms.

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Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. However, a producer may also choose to apply for independent compliance with the requirements.

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Perficient: Drug Development

DECEMBER 27, 2023

Once published by regulators, Perficient’s Risk and Regulatory CoE will be here to walk our clients through the changes. YOU MAY ENJOY: Regulatory Reporting in Financial Services Modernizing CRA Regulations Managing compliance risk frameworks in alignment with existing risk profiles is crucial as customer needs evolve.

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Agency IQ

JUNE 17, 2024

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

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Drug Patent Watch

DECEMBER 10, 2024

These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug. Regulatory agencies also conduct inspections and audits to ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines. ” U.S.

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Fierce BioTech

APRIL 11, 2024

Benefits: Gain insights into GMP compliance, understand critical considerations for storage optimization, and learn about Alcami's unique capabilities. png Listing Introduction Discover the critical factors driving GMP compliance with five crucial considerations for pharmaceutical storage. On Demand Start Date Wed, 05/22/2024 - 12:00

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Drug Channels

SEPTEMBER 16, 2024

Informa Connect's Patient Support Services Congress November 20-21, 2024 | Hilton Penn’s Landing, Philadelphia, PA Drug Channels readers save 10%* with code 24DC10. Tailored Tracked Content for a Customizable Experience Compliance and Legal Innovation and Operations And more! All rights reserved.

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Perficient: Drug Development

OCTOBER 15, 2024

Lets talk about data governance in banking and financial services, one area I have loved working in and in various areas of it … where data isn’t just data, numbers aren’t just numbers … They’re sacred artifacts that need to be protected, documented, and, of course, regulated within an inch of their lives.

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Agency IQ

SEPTEMBER 1, 2023

EPA publishes amendments to PCB regulations The Environmental Protection Agency has finalized a suite of regulations related to polychlorinated biphenyls, including extraction, disposal, and cleanup regulations. PCB-specific regulations are codified in the Code of Federal Regulations. a closed system) uses of PCBs.

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