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.

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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. This could challenge the swift market introduction of innovative AI solutions, potentially leading to prolonged development timelines and increased costs.

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Camargo

SEPTEMBER 8, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”.

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pharmaphorum

FEBRUARY 4, 2021

Jennifer Mercer is Co-founder and CEO of Metazoa, developers of Snapshot, an admin and developer tool for companies with complex Salesforce orgs that is used by over 60% of Fortune 100 companies. . However, issues like compliance, governance and security often are. Security, Governance and Compliance are important .

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Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. In 1997, FDA released regulations providing guidance on the use of electronic systems. Un-specified identified Agency regulations. There are many factors in how Part 11 regulations affect software.

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Advarra

DECEMBER 14, 2023

While a study may continue after a citation is issued, resources must be allocated to develop a corrective and preventative action (CAPA) plan to address the issue. b)) Categorized within the investigational plan regulations, there is a specific emphasis on accurate and complete documentation of all trial activities.

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Cloudbyz

JUNE 16, 2023

Clinical trials are crucial for advancing medical research and developing innovative treatments. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. They generate a vast amount of valuable data, which needs to be securely archived for future reference and analysis.

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Clinical Trials Clinical Trials Compliance Trials 71

Advarra

MAY 28, 2024

In recent years, the use of single institutional review board (sIRB) review has gained significant traction in the world of research ethics and compliance. Local Considerations in sIRB Implementation Local context, expertise, compliance, and collaboration are all critical factors to sIRB success.

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Cloudbyz

MAY 24, 2023

Clinical trials play a crucial role in advancing medical research and developing new treatments and therapies. Clinical trial data management audits serve as a critical tool to evaluate and validate the accuracy, completeness, and integrity of the data, as well as compliance with regulatory requirements.

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WCG Clinical

SEPTEMBER 7, 2023

This investment supports efficient site activation; it also maintains compliance as new site staff are brought on board and allows existing staff the opportunity to refer to the training should questions arise. Supports compliance by ensuring documentation is consistently available. Request a consultation today.

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Cloudbyz

APRIL 20, 2023

The European Union (EU) Clinical Trial Regulation (CTR) No 536/2014, which came into effect in January 2022, has significantly changed the clinical trial landscape in the EU. This blog post outlines 10 key aspects of the new regulation that sponsors should be aware of when planning and conducting clinical trials in the EU.

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pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. Food and Drug Administration (FDA) regulation as a medical device.

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Pharma Marketing Network

JULY 13, 2023

Your website is your online storefront, so it’s important to choose the best web development company to create it. In the pharmaceutical industry, where trust and credibility are essential, it’s especially important to choose a web development company that understands the specific needs of your business. Trust your gut.

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FDA Law Blog

JUNE 23, 2022

Karst — The American Conference Institute and Council for Responsible Nutrition are hosting the 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements live in New York next week, June 29-30.

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Cloudbyz

APRIL 19, 2023

Introduction: The new European Union (EU) Clinical Trial Regulation (CTR), Regulation (EU) No 536/2014, came into force in January 2022, replacing the previous EU Clinical Trials Directive (2001/20/EC). This eliminates the need for multiple submissions, streamlining the process and reducing the administrative burden on trial sponsors.

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Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., Because of this, they need to stay abreast of these rapidly developing requirements and have systems in place to ensure data compliance and protection.

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FDA Law Blog

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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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks.

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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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Camargo

NOVEMBER 15, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. While not fatal to the application, this development is certainly a setback for the sponsor, primarily in terms of a delay in approval. Jenny Fielder.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Drug Discovery World

MARCH 21, 2023

The In Vitro Diagnostic Regulation (IVDR) came into effect in May 2022. The regulation aims to ensure patients’ safety, provide a more transparent framework for IVDs and deliver access to innovative medical technologies. However, this process is currently complex and uncoordinated.

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WCG Clinical

DECEMBER 13, 2023

Dietary Supplements in Research Studies When used as investigational products in a study, dietary supplements may be subject to varying regulations and requirements. In this paper, we will examine what sponsors/investigators need to consider when designing a study with dietary supplements to ensure compliance with the FDA requirements.

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Worldwide Clinical Trials

APRIL 3, 2024

As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution. Targeted Outreac h: Developing relationships with KOLs specializing in your indication can create a referral pipeline for suitable trial participants.

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XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace.

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XTalks

DECEMBER 4, 2023

But today, with a rise in molecularly targeted therapies, oncology development has shifted to identifying an optimal biologic dose that balances toxicity with efficacy. Project Optimus is intended to reform the dose optimization and dose selection paradigm in oncology drug development,” says Dr. Confeld.

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Cloudbyz

MAY 14, 2024

Security Accreditations Request recent audit reports to validate ISO 27001 or SOC2 compliance. Legal and Regulatory Compliance Check for compliance with requirements such as PCIDSS, GDPR, HIPAA, etc., Secure methodologies prevent vulnerabilities in software development. and confirm that relevant employees are certified.

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Advarra

JUNE 26, 2023

This blog provides key insights and guidance for sponsors and sites as they work to mitigate risks and ensure compliance for a successful FDA inspection. The inspections are usually done prior to a first market application for new drug applications or routine inspections for ongoing compliance.

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Cloudbyz

APRIL 24, 2023

Integrating ESG in Drug Development Strategy for Pharmaceutical Companies Environmental, Social, and Governance (ESG) considerations are becoming increasingly important for businesses across industries, including pharmaceuticals. These savings can be redirected toward research and development, ultimately driving innovation and growth.

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Camargo

OCTOBER 14, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The FDA has also recently launched the Software Pre-Certification Pilot Program to provide an efficient regulatory framework for developers of SaMD products.

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The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

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Pharma in Brief

OCTOBER 4, 2022

Sandoz ) are engaged in litigation under the Regulations relating to Bayer’s drug, ADEMPAS (riociguat). The Court recognized the need to develop a coherent theory on both infringement and validity and potential difficulties relating to matters such as witness availability and testing. Background.

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Regulation Trials Compliance Drugs 52

Cloudbyz

APRIL 27, 2023

Regulatory automation in clinical trial operations has the potential to dramatically improve the efficiency, accuracy, and compliance of clinical trials, leading to faster development and approval of new therapies. It is essential to engage employees and educate them on the benefits and limitations of automation.

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FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. As a Principal Medical Device Regulation Expert, Adrienne will continue to provide consulting to medical device and combination product manufacturers. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, and QSR compliance.

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FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. By John W.M. Truly, these are complex considerations.

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Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders. This may involve conducting regular audits and assessments to maintain compliance.

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Cloudbyz

MAY 15, 2024

An eSource system not only facilitates the electronic collection and management of clinical trial data but also ensures compliance with regulatory standards, enhances participant management, and optimizes data integrity and reporting processes.

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