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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Compliance Clinical Development Development Clinical Trials 52

Cloudbyz

APRIL 14, 2023

To ensure that the implementation of ChatGPT in clinical trial operations management complies with 21 CFR Part 11 requirements, the following steps should be taken: Validation: Validate the ChatGPT system and any software that interacts with it to ensure its accuracy, reliability, and consistent intended performance.

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Compliance Clinical Trials Clinical Trials Trials 52

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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pharmaphorum

JANUARY 4, 2022

PRISYM ID provides regulated content and label management solutions designed specifically for life science companies and medical device manufacturers, improving patient safety and health outcomes whilst ensuring regulatory compliance. The post PRISYM ID Achieves Zebra Technologies Validation appeared first on.

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Life Science Clinical Trials Clinical Trials Compliance 52

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. 3d) 209 (FCA), at paras. 5] Merck Frosst Canada Inc.

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Regulation Compliance Medicine Manufacturing 52

Pharma in Brief

JANUARY 10, 2022

The Federal Court of Appeal ( FCA ) has affirmed a decision of the Federal Court ( FC ) finding that a patent concerning glatiramer acetate ( GA ) is valid and would be infringed under the Patented Medicines (Notice of Compliance) Regulations. Pharmascience challenged the validity of the asserted claims. Background.

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Trials Compliance Regulation Life Science 52

Cloudbyz

JUNE 21, 2023

Validate and Clean Data: Prior to export, perform thorough data validation and cleaning to ensure data quality and integrity. Implement quality checks, including range validation, missing data checks, and consistency checks, to identify and resolve any anomalies or discrepancies.

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Clinical Trials Clinical Trials Compliance Trials 66

Pharma in Brief

APRIL 19, 2022

The Federal Court has allowed an infringement action concerning sitagliptin phosphate monohydrate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The Court dismissed allegations of obviousness and insufficiency, and it found the asserted claims to be valid and infringed. Obviousness.

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Pharma in Brief

JUNE 14, 2022

The Federal Court has allowed an infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The 770 Patent is Valid. Background. Janssen Inc. Janssen ) markets OPSUMIT® in Canada for the treatment of pulmonary arterial hypertension ( PAH ). Obviousness.

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ACRP blog

JANUARY 11, 2024

At a basic level, it isn’t hard to be in compliance to protect sites from audit risks when inspectors show up and you have your study source and regulatory documents in an electronic system,” Riddle notes.

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Compliance Regulation Packaging Packaging 59

Worldwide Clinical Trials

APRIL 4, 2024

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. Global Impact of ICH M10 Validation Guidelines Harmonization of bioanalytical validation methods is crucial in a world where pharmaceuticals are developed and approved across different regions.

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Clinical Trials Clinical Trials Compliance Development 196

Cloudbyz

MAY 15, 2024

The Cloudbyz eClinical platform, comprising CTMS, eTMF, EDC and Safety & Pharmacovigilance, can significantly enhance compliance with these guidelines. Continuous monitoring and real-time updates ensure that trials adhere to the established protocols and regulatory requirements, improving compliance and data integrity.

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Compliance Laboratory Information Management System Clinical Trials Clinical Trials 52

Pharma in Brief

FEBRUARY 3, 2021

The Court’s decision concerned the claims of two patents asserted against each of the Defendants in infringement actions under the Patented Medicines (Notice of Compliance) Regulations ( Regulations ): Canadian Patent No. The 202 Patent: compound and use claims valid and infringed. The 171 Patent claims tablet formulations of apixaban.

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In-Vivo Regulation Compliance Life Science 52

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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Clinical Trials Clinical Trials Compliance Regulation 52

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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Compliance Regulation Marketing Production 52

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., Cloudbyz builds products and services with security, privacy, compliance, and transparency in mind.

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Compliance Clinical Trials Clinical Trials Regulation 52

Pharmaceutical Technology

AUGUST 30, 2022

Verista is a Life Sciences business, technology and compliance firm specializing in systems, quality, and validation solutions throughout the product lifecycle. Verista is a leading life sciences business, technology and compliance company that enables clients to improve health and improve lives. The Verdict.

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Life Science Compliance Manufacturing Marketing 130

pharmaphorum

MARCH 2, 2021

So efficiency, compliance, and patient care have been compromised. They help companies improve the quality of their clinical products, reduce the time it takes to get a product to market and ensure compliance with industry standards and regulations. Validation to check forms have been filled in accurately. What is an EDC system?

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Clinical Trials Clinical Trials Trials Compliance 116

Pharma in Brief

MARCH 9, 2022

The Federal Court has decided an infringement action concerning risedronate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). 188 Patent Valid But Not Infringed. Allergan Inc. 2,602,188 (the 188 Patent ), which is listed on the Patent Register against ACTONEL DR®. Claims Construction.

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Production Regulation Containment Compliance 52

Drug Channels

SEPTEMBER 18, 2023

Showcasing high level discussions on access strategy, patient interactions, case management, compliance practices and more, this two-and-a-half-day event helps navigate complex compliance hurdles to advance and enhance your patient-oriented programs. Offer not valid on workshop only or academic/non-profit registrations.

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Compliance Drugs Medicine Marketing 66

The Pharma Data

NOVEMBER 4, 2020

Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible. Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you.

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Trials Compliance Regulation 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.

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Clinical Trials Clinical Trials Trials Compliance 80

Cloudbyz

APRIL 11, 2023

Validation The E2B gateway is also capable of validating data before it is transmitted. This validation process checks the data for errors or missing information, ensuring that the data is complete and accurate before it is sent. The gateway must ensure that the data is complete, accurate, and consistent before transmission.

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Compliance Manufacturing Drugs Marketing 52

Cloudbyz

SEPTEMBER 19, 2023

Compliance and Audit Trail : Generative AI maintains an audit trail of data extraction, providing transparency and accountability. This is crucial for regulatory compliance and audit purposes. GDPR, HIPAA) is paramount. GDPR, HIPAA) is paramount.

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Compliance Clinical Trials Clinical Trials Clinical Research 84

Rethinking Clinical Trials

JUNE 22, 2023

He highlighted some key points to help researchers comply with the new policy: Scope: The policy applies to all NIH-supported research generating scientific data of sufficient quality to validate and replicate research. Where: For suggested repositories, see NIH-supported data repository list. “The

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Worldwide Clinical Trials

APRIL 8, 2024

Mitigation of Placebo Effects and Reporting Inaccuracies : In-house teams are adept at implementing strategies to minimize the risks associated with heightened placebo and nocebo response, inconsistent and inaccurate data reporting, as well as patient compliance issues, thereby preserving the trial’s scientific validity.

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Clinical Research Trials Clinical Trials Clinical Trials 184

Cloudbyz

AUGUST 18, 2023

In the dynamic realm of pharmacovigilance, where safety and compliance are paramount, choosing the right solution can profoundly impact operational efficiency and patient well-being. Additional Features: Multi Region Support: Cloudbyz Safety & PV Solution supports multiple regions from a user access perspective.

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Compliance Licensing Licensing Production 52

Cloudbyz

MARCH 5, 2023

Provide Data Validation: Data validation should be performed to ensure that data entered into the eCRF is within the acceptable range or conforms to pre-defined rules. Cloudbyz EDC is a scalable solution and meets all the essential regulatory compliance requirements such as FDA- 21 CFR Part 11, GCP, GAMP5, HIPAA, and EU- GDPR.

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Clinical Trials Clinical Trials Compliance Trials 78

FDA Law Blog

FEBRUARY 9, 2024

For these devices that do not have market authorization and are only used for remote data collection in a clinical investigation, if the sponsor conducts verification and validation activities consistent with the guidance to demonstrate the DHT is “fit-for-purpose,” FDA does not intend to assess sponsors’ compliance with design controls.

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Compliance Manufacturing Containment Regulation 105

Cloudbyz

MARCH 15, 2023

The Cloudbyz EDC platform combines an intuitive user interface with advanced data security, intelligent data validation, real-time data monitoring, analytics, and compliance with global regulatory standards. Compliance & Regulation: Full compliance with FDA 21 CFR Part 11, GDPR, HIPAA, and other global regulatory standards.

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Clinical Research Research Clinical Trials Clinical Trials 52

Cloudbyz

APRIL 5, 2024

Data Security and Compliance Challenge: Ensuring data security and compliance with regulations like HIPAA and GDPR is critical and challenging, given the sensitive nature of clinical trial data. Best Practice: Implement real-time data validation rules within the EDC system to catch errors or inconsistencies early.

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Clinical Trials Clinical Trials Regulation Compliance 86

Pharma in Brief

JANUARY 17, 2024

The Federal Court of Appeal ( FCA ) held that it is abuse of process for a generic or biosimilar manufacturer to split its case across multiple notices of allegation ( NOAs ) under the Patented Medicines (Notice of Compliance) Regulations ( Regulations ). In the trial related to invalidity, the 335 Patent was found to be valid.

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Regulation Compliance Manufacturing Production 52

Pharma in Brief

FEBRUARY 28, 2024

PMS ) sought a Notice of Compliance to market a generic version of INVEGA SUSTENNA ® (the PMS Product ). Janssen commenced an infringement action under section 6 of the Patented Medicines (Notice of Compliance) Regulations. The Federal Court ( FC ) found the claims of the 335 Patent valid. Pharmascience Inc. ( v Janssen Inc.

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Compliance Production Regulation Marketing 52

Advarra

OCTOBER 31, 2023

A key first step in a phased approach is risk assessment: Before conducting any clinical research, assess any potential risks to patient safety, data integrity, and regulatory compliance. Study Conduct Monitoring quality and compliance is the bedrock of a ready QMS during study conduct.

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Compliance Clinical Research Trials Clinical Trials 52

Cloudbyz

MAY 24, 2023

This is where unified clinical trial management solutions come into the picture, enhancing efficiency, reducing time to market, and ensuring high-quality, scientifically validated consumer products. This includes trial design, participant recruitment, data collection and analysis, and regulatory compliance.

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Clinical Trials Clinical Trials Production Trials 52

Pharma Tutor

SEPTEMBER 24, 2020

Pharmacists strive to eliminate medication errors and ensure strict patient compliance to achieve desired therapeutic outcomes. While dispensing the prescription Pharmacists enhance efficacy and safety of medication by motivating patients for compliance of dosage regimen. In this plight patient counselling assumes eminent role.

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Compliance Medicine Drugs 56

pharmaphorum

JULY 28, 2022

That means maintaining regulatory readiness – because having cGMP compliance problems with the FDA can significantly exacerbate the problem. Until the company is found to be in compliance, there will not be a normal distribution of drug products. In addition to her FDA experience, Ms.

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