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.

Compliance 59

Compliance Pharmaceuticals Marketing 59

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.

Regulations 111

Regulations Compliance 111

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.

Compliance 52

Compliance Marketing Regulations 52

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.

Compliance 64

Compliance Laboratories FDA Regulations 64

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.

Compliance 59

Compliance Production Packaging Government 59

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.

Compliance 52

Compliance Research Regulations 52

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.

FDA 111

FDA Compliance Laboratories International 111

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.

Compliance 110

Compliance Marketing Production 110

Perficient: Drug Development

MARCH 12, 2024

Whether it’s streaming processes, improving citizen services, or ensuring compliance, our specialized knowledge positions us as a go-to partner for government projects. Looking Ahead We are excited about the new opportunities the Government Specialization brings and are committed to continuing our journey of innovation and excellence.

Government 105

Government Compliance 105

Perficient: Drug Development

AUGUST 12, 2024

Enhanced Security and Compliance Security and compliance are top priorities for any integration platform. Azure Integration Services benefits from Azure’s robust security features and compliance certifications.

Compliance 105

Compliance Licensing Licensing Production 105

Quanticate

SEPTEMBER 30, 2024

In any clinical trial conduct, recording and storing data in a controlled, consistent, and reproducible manner for data retrieval and analysis is a necessity for regulatory compliance and clinical study success.

Clinical Trials 98

Clinical Trials Compliance Trials 98

ASPET

AUGUST 21, 2024

ICH established S7B and E14 guidelines in 2005 to prevent drug-induced torsade de pointes (TdP), effectively preventing the development of high-risk drugs. However, those guidelines unfortunately hampered the development of some potentially valuable drug candidates despite not being proven to be proarrhythmic.

Compliance 100

Compliance Pharmacokinetics Drugs Engineering 100

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

In response, we learned that only about seven – and certainly less than 10 – RIEs for manufacturing compliance have been performed at drug facilities in the last 30 months.

FDA 105

FDA Compliance Clinical Trials Drugs 105

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.

Regulations 59

Regulations Compliance 59

BioPharma Drive: Drug Pricing

JULY 3, 2023

iliomad Health Data can help you maintain GDPR compliance. What is the GDPR and why does it matter to your life sciences company.

Compliance 98

Compliance Trials Science 98

Perficient: Drug Development

JUNE 4, 2024

By leveraging self-hosted runners for deployment, organizations can optimize control, customization, performance, and cost-effectiveness while meeting compliance requirements and integrating seamlessly with existing infrastructure and tools. Here are few advantages of self-hosted runners as given below.

Compliance 105

Compliance Packaging Regulations 105

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

The settlement agreement states that the government took into account eBay’s compliance investments, implying that eBay was given some credit that may have reduced the amount of the fine. Also, DEA and DOJ contend, eBay did not verify purchaser’s identification as required by the regulations.

Regulations 116

Regulations Compliance Government Production 116

SCIENMAG: Medicine & Health

FEBRUARY 1, 2024

Current screening methods, like glucose tolerance tests, are in after 24 weeks of pregnancy and have limitations in patient compliance and accuracy. Early detection and treatment of GDM are crucial to prevent adverse outcomes. Credit: BGI […]

Compliance 86

Compliance Treatment 86

Collaborative Drug

AUGUST 15, 2023

The CDD Vault SaaS platform empowers researchers to capture experimental data digitally, foster real-time collaboration, and ensure regulatory compliance. The ELN also facilitates the creation of standardized experiment protocols through templates, ensuring compliance and reproducibility.

Science 89

Science Research Compliance International 89

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

Compliance 97

Compliance FDA Drugs Pharmaceuticals 97

Conversations in Drug Development Trends

JUNE 13, 2024

The study focused on several key factors: DNA Yield and Quality Sample Stability Assay Outcomes Patient Compliance DNA Yield and Quality The study found that blood samples typically yield a higher quantity of DNA compared to buccal swabs. Buccal swabs had a compliance rate of 95%, compared to 69% for blood samples.

DNA 72

DNA Compliance Clinical Trials Trials 72

Collaborative Drug

AUGUST 15, 2023

The CDD Vault SaaS platform empowers researchers to capture experimental data digitally, foster real-time collaboration, and ensure regulatory compliance. The ELN also facilitates the creation of standardized experiment protocols through templates, ensuring compliance and reproducibility.

Science 81

Science Research Compliance International 81

Quanticate

MAY 30, 2024

The ALCOA principles guide and model a company’s policies and procedures to help ensure that regulatory compliance is being maintained, and adheres to policies such as GCP and GMP. The ALCOA principles play a critical step in ensuring data integrity and compliance is of an excellent standard.

Clinical Trials 59

Clinical Trials Compliance Trials FDA 59

Perficient: Drug Development

JANUARY 19, 2024

The container technology also supports varying levels of technical acumen, business continuity, security, and compliance.

Compliance 118

Compliance Marketing Licensing Licensing 118

Perficient: Drug Development

JULY 28, 2023

Data Security and Compliance : Handling employee data requires strict adherence to data security and compliance standards. It is crucial to communicate openly with employees about the data being collected and ensure that all insights gathered are used ethically and responsibly.

Compliance 97

Compliance Production Regulations 97

BioPharma Drive: Drug Pricing

JUNE 20, 2024

RxPass, which fills prescriptions for generic drugs, is now available to more than 50 million Medicare members after Amazon brought it into compliance with the insurance program’s regulatory standards.

Compliance 64

Compliance Drugs 64

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.

Drug Development 59

Drug Development Compliance Pharmaceutical Companies Drugs 59

Chemical Biology and Drug Design

APRIL 16, 2023

The advantages of TEs include increased patient compliance, bypassing first-pass metabolism, including non-toxic raw components, being a noninvasive method of drug delivery, being more stable, biocompatible, biodegradable, and administered in semisolid form. In the presence of ethanol and an edge activator, skin permeability can increase.

Drugs 100

Drugs Compliance Research Marketing 100

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.

Drug Development 52

Drug Development Compliance Clinical Trials Trials 52

DrugBank

OCTOBER 30, 2024

  Enhanced Security and Compliance In the pharmaceutical and healthcare industries, security is paramount. Snowflake ensures that DrugBank’s data packages meet the highest standards of security and compliance, giving you peace of mind when handling sensitive data.

Production 75

Production Clinical Trials Packaging Compliance 75

Fierce BioTech

SEPTEMBER 23, 2024

Apply the Power of Automation to GxP Systems This timely whitepaper explores the capabilities life sciences companies should expect from an end-to-end automation solution to streamline compliance, increase reliability, and reduce costs. Download now. Download now.

Compliance 52

Compliance Science 52

Quanticate

JUNE 7, 2024

Discover how Risk-Based Quality Management (RBQM) optimizes clinical data management for improved safety, efficiency, and regulatory compliance in clinical trials

Clinical Trials 59

Clinical Trials Compliance Trials 59

BioPharma Drive: Drug Pricing

DECEMBER 11, 2023

Research from Everest Group shows how life sciences leaders are investing in process mining to speed time-to-market, improve regulatory compliance and drive innovation.

Science 64

Science Compliance Marketing Research 64

Perficient: Drug Development

MARCH 22, 2024

This track emphasizes modernizing your data platform, ensuring regulatory compliance, and unlocking (and trusting) the potential of AI, setting the stage for insightful, data-driven decisions and truly impactful applications of emerging tech. Data Insight : Data is the engine driving intelligent decision-making.

Government 105

Government Compliance Engineering Production 105

ASPET

NOVEMBER 30, 2023

Pulmonary function evaluated using a flexiVent showed a downward shift in the PV loop, decreases in static compliance and inspiratory capacity, increases in respiratory elastance and tissue elastance. Further, VEGFA levels were reduced in the lung. These changes are consistent with an ALI phenotype.

Compliance 100

Compliance Laboratories Therapies Research 100

Drug Channels

MARCH 6, 2023

Experts from across the industry will discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Plus, assess how companies are internally planning for these changes.

Drugs 84

Drugs Compliance Science Government 84

Fierce BioTech

JULY 15, 2024

This webinar explores the regulatory landscape, emphasizing compliance strategies for industries producing pharmaceuticals, medical devices, and related products. Click here to login. Listing Image Alcami_ListingLogo_250x190.png On Demand Start Date Thu, 09/12/2024 - 11:00

Compliance 52

Compliance Laboratories Pharmaceuticals Regulations 52