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).

Compliance 89

Compliance Clinical Trials Clinical Trials Trials 89

pharmaphorum

FEBRUARY 4, 2021

However, issues like compliance, governance and security often are. That’s why CIOs and CTOs working within the life sciences industry need to include Salesforce org management as a key component of their standard operating procedures. This will help ensure consistency and compliance across the entire enterprise. .

Compliance 104

Compliance Life Science HR Development 104

FDA Law Blog

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. life sciences industry. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C.

Life Science 40

Life Science Cosmetics Regulation Drugs 40

Cloudbyz

MARCH 28, 2023

This solution is designed to meet the unique needs of clinical research organizations (CROs) and pharmaceutical companies, offering a range of features to help them streamline their operations, manage clinical trials, and ensure compliance with regulatory requirements.

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

XTalks

JULY 5, 2022

Employee retention and motivation is a challenge that all life science companies face. A corporate compliance training program is a part of many onboarding programs to ensure employees are up to date with the latest rules and regulations they must adhere to while working for the company.

Life Science 52

Life Science Compliance Packaging Packaging 52

The Pharma Data

DECEMBER 15, 2020

FAIRFAX, VA, December 15, 2020 /24-7PressRelease/ — Quality and Regulatory Compliance requirements can present impediments to progress. Our combined experience cuts across most industries with a specialization in US FDA Quality System Regulations and ISO 13485:2016 Quality Management System Requirements. # # #.

Life Science 52

Life Science Compliance Sales Regulation 52

Pharma Marketing Network

APRIL 21, 2021

Darshan Kulkarni and Marc Banjak, General Counsel at Dova Pharmaceuticals, discuss sales compliance in the life sciences. Sales and marketing representatives in the life science industry must comply with state and federal regulations. What are these regulations and how should you navigate them?

Sales 90

Sales Marketing Life Science Compliance 90

FDA Law Blog

SEPTEMBER 26, 2023

(HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Jeff joins HP&M from Compliance Architects where he served as Vice President of Business Development.

Marketing 59

Marketing Life Science Compliance Business Development 59

Pharma in Brief

APRIL 25, 2021

Proposed PM(NOC) Amendments Restore Balance by Expanding PM(NOC) Regulation Protections. 1] Regulations Amending the Patented Medicines (Notice of Compliance) Regulations (“ Proposed PM(NOC) Amendments ”). [2] Interested persons have 30 days to make representations concerning the Proposed PM(NOC) Amendments. [1]

Regulation 98

Regulation Medicine Generic Drugs Containment 98

Drug Discovery World

MAY 8, 2024

Fiona Maini , Senior Director Global Compliance & Strategy, at Medidata looks at the rise of artificial intelligence (AI) and machine learning (ML) within life sciences and the applications for the technology in clinical trials.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Regulation 64

Pharma in Brief

APRIL 20, 2021

As we reported , the Guidelines were released by the PMPRB on October 23, 2020 and are intended to implement amendments to the Patented Medicines Regulations that were passed in August 2019. At the time they were released, the Guidelines were scheduled to take effect together with the amendments to the Regulations on January 1, 2021.

Compliance 40

Compliance Medicine Regulation Life Science 40

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.

Clinical Research 52

Clinical Research Compliance Research Regulation 52

Pharma in Brief

JANUARY 26, 2021

A defendant in a patent infringement action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations was allowed to amend its defence to include invalidity allegations not found in the Notice of Allegation. The proposed amendments are not prohibited by the Regulations. Background.

Regulation 52

Regulation Compliance Medicine Life Science 52

Cloudbyz

MARCH 17, 2023

Life science companies conducting clinical trials must adhere to GCP guidelines to ensure the safety and well-being of study participants and maintain the integrity of the clinical trial data. In this blog post, we will explore the types of alerts on GCP violations that life science companies conducting clinical trials should set up.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

Pharma in Brief

OCTOBER 4, 2022

Sandoz ) are engaged in litigation under the Regulations relating to Bayer’s drug, ADEMPAS (riociguat). The Court’s decision highlights the prejudice to innovators that can result when generics change the focus of their defences within tight procedural timelines imposed by the 24-month stay. Background.

Regulation 52

Regulation Trials Compliance Drugs 52

Pharma in Brief

MAY 4, 2023

The Ontario Superior Court ( ONSC ) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations ) brought by Apotex Inc. The Court conducted a purposive interpretation of the Regulations and found that Apotex did not meet the statutory requirements for damages.

Regulation 52

Regulation Sales Production Compliance 52

pharmaphorum

JUNE 10, 2021

The latest version of the PRISYM 360 cloud-based labeling solution has achieved certification for the GS1 standards utilized by the medical device and life science industries. GS1 oversees a system of globally recognized open standards for unique identifiers that can be used throughout the supply chain to enhance traceability.

Life Science 52

Life Science Compliance Regulation Clinical Trials 52

Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry. Fiona Maini, Senior Director Global Compliance and Strategy at Medidata “AI is dominating conversations across the drug discovery process.

Genome 139

Genome Genomics Life Science Gene Therapy 139

FDA Law Blog

MARCH 6, 2024

Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Prior to HP&M, John served 15 years at the Department of Justice, serving most recently as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.

Cosmetics 59

Cosmetics Compliance Generic Drugs Regulation 59

pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

Development 103

Development Regulation Production Life Science 103

Pharma in Brief

AUGUST 24, 2022

Importantly, the ONCA decision reaffirms that innovators are not liable beyond damages available under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations ) for the legitimate exercise of their rights under the Patent Act and the Regulations. Background. Eli Lilly Canada Inc.

Regulation 52

Regulation Compliance Life Science Sales 52

Pharma in Brief

NOVEMBER 16, 2020

On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance ( NOC ) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ).

Regulation 52

Regulation Compliance Marketing Licensing 52

Cloudbyz

APRIL 3, 2023

This can help protect patient privacy, ensure compliance with data protection regulations, and reduce the risk of data breaches. Ensuring Compliance: Life sciences organizations are subject to various data protection regulations, including GDPR, HIPAA, and CCPA.

Clinical Research 52

Clinical Research Research Compliance Regulation 52

Pharma in Brief

MARCH 9, 2021

The Federal Court of Appeal has affirmed one of the last judgments granting a prohibition order under subsection 6(1) of the pre-September 2017 Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations ). Background. ZYTIGA® (abiraterone acetate or AA ) is a drug marketed in Canada by Janssen Inc.,

Regulation 52

Regulation Compliance Production Life Science 52

Pharma in Brief

OCTOBER 22, 2023

Consequently, the new owner was properly added as a defendant to an on-going action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ). Rather, the Court found that the transfer of an NOA is implicit from the scheme of the Regulations and underlying policies.

Regulation 52

Regulation Drugs Compliance Manufacturing 52

Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

Clinical Trials 130

Clinical Trials Clinical Trials Life Science Trials 130

Pharma in Brief

JANUARY 26, 2022

The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). the PMS Product ). In that case, Manson J.

Regulation 52

Regulation Trials Production Compliance 52

Pharma in Brief

JULY 25, 2022

The Guide provides a detailed review of the key regimes, including: Data protection market exclusivity; The Patented Medicines (Notice of Compliance) Regulations (PMNOC), linking generic market access to patent rights; Certificate of Supplementary Protection (CSP) exclusivity; Biologics; and. Drug pricing and market access.

Life Science 52

Life Science Compliance Regulation Marketing 52

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 86

Drugs Life Science Compliance Branding 86

The Pharma Data

NOVEMBER 10, 2020

Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

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 ). The same reasoning applies under the Regulations.

Regulation 52

Regulation Compliance Manufacturing Production 52

pharmaphorum

OCTOBER 5, 2020

regulated content and label management?solutions, Steve Grimison, SVP Global Development at PRISYM ID, commented: “As a leader in labeling software solutions for the Life Sciences and Medical Device industries, PRISYM ID is constantly evolving its products and services. “We Wokingham, United Kingdom —?30?September?2020?—

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR.

Regulation 52

Regulation Drugs Vaccination Vaccine 52

Pharma in Brief

NOVEMBER 18, 2020

The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC , 2020 FCA 188 , the Court dismissed Amgen’s appeal from the Federal Court’s decision declaring certain claims in Amgen’s Canadian Patent No.

Regulation 52

Regulation Trials Protein Compliance 52

pharmaphorum

JANUARY 4, 2022

This assures our Life Sciences customers that our application supports their critical printing needs and reduces both the risk and the deployment time.”. PRISYM ID’s unique products and technologies are used to assure compliance globally, for 10 million+ medical device, clinical trial and pharmaceutical products annually. .

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

Cloudbyz

MARCH 1, 2023

Clinical trials are a critical component of drug development in the life sciences industry. Enhanced Compliance: Digitization enables compliance with regulatory requirements. This can help to ensure that the financial aspects of the trial are being managed in compliance with regulatory requirements.

Clinical Trials 88

Clinical Trials Clinical Trials Trials Compliance 88

Cloudbyz

APRIL 6, 2023

Cloudbyz offers a range of clinical research management solutions that are integrated with various clinical trials processes, connecting them internally and externally with stakeholders from the life sciences, medical devices, and CRO sectors.

Life Science 52

Life Science Compliance Clinical Research Clinical Trials 52