Pharmaceutical Technology

OCTOBER 25, 2022

Otherwise, theoretically, they could be in breach of regulations.”. Furthermore, data regulations around the world add another burden of compliance and need careful management. A customised solution to ensure data regulation compliance. Breaches of HIPAA in the US can result in fines of up to $50,000.

Compliance 130

Compliance Regulation Doctors Doctor 130

pharmaphorum

MAY 4, 2021

The life sciences history industry has some unique challenges when it comes to compliance. But if you think third party compliance risks are bad, don’t take your eye off fourth and fifth parties, says Allan Matheson. A decade ago, life sciences firms were early adopters of robust compliance technology — far ahead of other industries.

Life Science 111

Life Science Compliance Regulation Marketing 111

Cloudbyz

AUGUST 30, 2024

Given the critical nature of this data, ensuring its security and compliance with regulatory standards is paramount. Regulatory Penalties: Non-compliance with data protection regulations can lead to hefty fines and legal actions. Two of the most significant regulations are GDPR and HIPAA. ISO 27001, SOC 2).

Compliance 97

Compliance Clinical Trials Clinical Trials Trials 97

Pharma Marketing Network

MARCH 6, 2025

But heres the challenge: strict industry regulations make social media advertising tricky for pharma marketers. This article explores effective social media advertising strategies tailored for pharmaceutical marketing executives , helping them navigate compliance and create impactful campaigns. but not in the EU.

Compliance 52

Compliance Branding Marketing Regulation 52

pharmaphorum

SEPTEMBER 6, 2024

Understanding the impact of Medtech regulations on balancing innovation and safety is crucial for the industry. Discover how compliance with regulations plays a vital role in fostering innovation while ensuring patient safety in the field of medical technology.

Regulation 94

Regulation Compliance 94

Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Risk Mitigation CDMOs help mitigate risks associated with regulatory compliance by ensuring that products meet the required standards.

Compliance 98

Compliance Manufacturing Production Regulation 98

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.

Compliance 188

Compliance Regulation Drugs Clinical Trials 188

Cloudbyz

AUGUST 30, 2024

The introduction of Clinical Trial Management Systems (CTMS) has revolutionized how trials are conducted by streamlining operations, enhancing regulatory compliance, and reducing the risk of errors. Managing these trials efficiently while ensuring compliance with stringent regulatory standards is paramount to their success.

Compliance 93

Compliance Clinical Trials Clinical Trials Trials 93

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

Generic Drugs 100

Generic Drugs Drugs Compliance Regulation 100

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).

Clinical Trials 98

Clinical Trials Clinical Trials Compliance Trials 98

XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

Protein 105

Protein Gene Therapy Genetic Disease Gene 105

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.

Compliance 96

Compliance Clinical Trials Clinical Trials Trials 96

Pharma Marketing Network

FEBRUARY 19, 2025

The key lies in personalization, strategic segmentation, and strict adherence to industry regulations. This guide explores the best strategies for boosting engagement while ensuring compliance , helping pharma brands connect with their audiences more effectively. What are the biggest compliance risks in pharma email marketing?

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Compliance Marketing Branding Regulation 72

Drug Patent Watch

JANUARY 29, 2025

Factors such as raw material sourcing, manufacturing costs, regulatory compliance, and distribution networks all contribute to the final price of the generic medication. Regulatory compliance is another significant factor influencing the affordability of generic medications. Sounds straightforward, right?

Generic Drugs 78

Generic Drugs Production Compliance Drugs 78

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.

Compliance 97

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.

Clinical Trials 94

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.

Compliance 98

Compliance Regulation Manufacturing Contamination 98

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.

Compliance 99

Compliance Pharma Conference Regulation Marketing 99

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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Genome Genomics Regulation Compliance 276

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.

Compliance 88

Compliance Drugs Regulation Marketing 88

XTalks

DECEMBER 9, 2024

The draft also formalizes withdrawal procedures for non-compliance, including delayed studies or failure to confirm benefits. Notably, the FDA can now mandate that confirmatory trials begin before approval, ensuring proactive validation of clinical benefits.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

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.

Compliance 110

Compliance Regulation 110

Drug Patent Watch

DECEMBER 10, 2024

Enhanced Regulatory Compliance : Integrated CDMOs can provide comprehensive supervision over all research, development, and manufacturing initiatives, ensuring compliance with strict regulatory guidelines set by entities like the FDA and EMA.

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Manufacturing Development Drugs Compliance 96

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.

Compliance 116

Compliance Regulation 116

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.

Life Science 102

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.

Regulation 97

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.

Compliance 59

Compliance Clinical Research Production Regulation 59

Pharma Packaging Solutions

OCTOBER 29, 2024

As a premier provider of medical device packaging solutions, we recognize the prime importance of adhering to global regulations while creating packaging solutions that protect both products and patients. International Standards and Classifications Compliance doesn’t end with the EU GMP certifications.

Packaging 52

Packaging Packaging Regulation Pharma Packaging 52

FDA Law Blog

FEBRUARY 18, 2025

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. What does it mean for FDA staff?

Compliance 76

Compliance Licensing Licensing Drugs 76

Drug Patent Watch

DECEMBER 11, 2024

Regulatory Compliance and Quality Assurance Regulatory compliance and quality assurance are essential aspects of CDMO selection. Pharmaceutical companies should evaluate a CDMOs compliance with industry standards and regulations, ensuring that they have a robust quality assurance system in place.

Compliance 98

Compliance Development Manufacturing Production 98

Pharma Marketing Network

FEBRUARY 19, 2025

But as powerful as RTB is, pharma brands must navigate strict regulatory challenges to ensure compliance with FDA and GDPR guidelines. This guide breaks down the role of RTB in pharma marketing, its benefits, compliance challenges, and best practices to help you maximize ad efficiency and ROI.

Compliance 52

Compliance Marketing Branding Regulation 52

Drug Patent Watch

FEBRUARY 19, 2025

Quality Assurance is a team effort : From manufacturers to regulators, QA professionals, and beyond, everyone plays a critical role in ensuring the quality and safety of generic drugs. But what exactly does Quality Assurance entail?

Generic Drugs 92

Generic Drugs Drugs Contamination Manufacturing 92

Pharma Marketing Network

FEBRUARY 19, 2025

Regulatory restrictions, privacy laws, and strict compliance rules make it one of the most challenging industries to navigate digitally. This guide breaks down the best practices, compliance challenges, and innovative tactics to help pharma marketers optimize their digital ad campaigns. Heres how to maximize your reach and compliance.

Compliance 52

Compliance Branding Regulation Marketing 52

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.

Life Science 130

Life Science Marketing Compliance Branding 130

XTalks

NOVEMBER 15, 2024

These RXR receptors play a key role in regulating transcription pathways involved in inflammation and immune responses, among other cancer hallmarks, to modulate the tumor microenvironment. MDS are a group of blood disorders caused by abnormal development of blood cells in the bone marrow.

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Trials HR Immune Response FDA Approval 105

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