XTalks

APRIL 21, 2023

It highlights the importance of ethical standards, due diligence and regulatory compliance, and underscores the potential risks associated with over-hyped or fraudulent startups. Life science startups face unique challenges given the highly regulated and complex nature of the industry.

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pharmaphorum

JANUARY 6, 2023

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. The post 6 research and development life sciences predictions for 2023 appeared first on.

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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.

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Gene Therapy Protein Genetic Disease Gene 105

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).

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Clinical Trials Clinical Trials Compliance Trials 98

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.

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Clinical Trials Clinical Trials Compliance Trials 105

FDA Law Blog

JULY 30, 2024

By Sara M Keup & Véronique Li, Senior Medical Device Regulation Expert — The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week. Advertising Challenges in Life Sciences.

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Life Science Regulation Compliance 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?

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Sales Marketing Life Science Compliance 90

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]

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Regulation Medicine Generic Drugs Containment 98

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.

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Regulation Compliance Medicine Manufacturing 52

Cloudbyz

SEPTEMBER 11, 2024

This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to life sciences organizations worldwide. This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to life sciences organizations worldwide.

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Life Science Clinical Trials Clinical Trials Compliance 52

Cloudbyz

AUGUST 13, 2024

In the rapidly evolving landscape of life sciences, the need for robust, efficient, and compliant pharmacovigilance (PV) solutions has never been greater. In this blog, we’ll explore how these solutions are transforming pharmacovigilance and why they are becoming the go-to choice for forward-thinking life sciences companies.

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Life Science Compliance Drugs Marketing 52

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

Outsourcing Pharma

APRIL 11, 2023

OSP spoke to Vladamir Penkrat, head of safety and regulatory and Shuba Rao a senior director at Indegene, a life sciences digital company about a paper they recently published called 'Challenges and Future of PV Compliance' about the direction compliance is headed and how they would convert risk-based approaches into a confidence-based assurances. (..)

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Compliance Life Science Regulation Marketing 52

Cloudbyz

MARCH 30, 2023

In today’s digital age, life sciences organizations are collecting, storing, and processing vast amounts of sensitive data, including personally identifiable information (PII) and protected health information (PHI). As such, it’s becoming increasingly challenging for organizations to manage and secure this data.

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Life Science Containment Regulation Clinical Trials 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. # # #.

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Life Science Compliance Sales Regulation 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.

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Life Science Compliance Packaging Packaging 52

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

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.

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Development Regulation Production Life Science 104

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.

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Clinical Trials Clinical Trials Life Science Trials 130

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.

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Drugs Life Science Compliance Branding 98

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.

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Regulation Compliance Medicine Life Science 52

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.

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Life Science Cosmetics Regulation Drugs 40

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.

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Clinical Trials Clinical Trials Trials Compliance 98

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.

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Marketing Life Science Business Development Compliance 59

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.

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Life Science Compliance Regulation Clinical Trials 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 ).

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Regulation Compliance Marketing Licensing 52

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.

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Compliance Medicine Regulation Life Science 40

XTalks

FEBRUARY 5, 2025

Metseras approach involves designing NuSH analog peptides that stimulate key hormones involved in appetite regulation and energy metabolism, providing targeted solutions that aim to address the root causes of obesity. MET-097i, Metseras leading GLP-1 receptor agonist (GLP-1 RA), showed up to 11.3%

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Hormones Bioavailability Clinical Trials Clinical Trials 59

XTalks

DECEMBER 16, 2024

With the integration of human intelligence (HI) with AI, the field is discovering new efficiencies and maintaining, or even improving, the rigor required for quality and compliance. Writers act as the ultimate quality controllers to verify the clinical relevance and regulatory compliance of AI outputs.

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Compliance Clinical Research Clinical Trials Clinical Trials 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.,

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Regulation Compliance Production Life Science 52

Drug Channels

SEPTEMBER 13, 2021

Thought-leaders and colleagues from federal agencies, bio/pharma manufacturers, consultants, industry trade associations and law firms will gather to discuss key insights on how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices.

Drugs 75

Drugs Compliance Life Science Manufacturing 75

pharmaphorum

OCTOBER 19, 2022

Emma Hyland, VP strategy, commercial content at Veeva Systems, tells us modular content is the most significant wave of innovation hitting the content world in life sciences, and rightly so because HCPs’ needs and expectations have changed. “There isn’t a one-size-fits-all for how the life sciences industry creates content.

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Life Science Production Compliance Pharma Companies 97

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.

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Regulation Trials Compliance Drugs 52

pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders? About the authors.

Life Science 98

Life Science Medicine Regulation Compliance 98

pharmaphorum

OCTOBER 4, 2022

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). peer-reviewed clinical studies or clinical practice guidelines) meet Criterion 2 and are not medical devices subject to FDA regulation and oversight.

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Development Regulation Cosmetics Life Science 105

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.

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Clinical Trials Clinical Trials Trials Life Science 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?—

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Life Science Clinical Trials Clinical Trials Regulation 52