Cloudbyz

NOVEMBER 22, 2024

Cloudbyz’s inclusion in this respected benchmark report underscores its dedication to advancing clinical trial management through robust, innovative technology designed to optimize data collection, ensure regulatory compliance, and streamline trial processes. “We To learn more, visit www.cloudbyz.com.

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

ACRP blog

JANUARY 8, 2024

Few industries have a need to understand the complexities of compliance more than clinical research. The importance of compliance in clinical research cannot be stressed enough. This year’s Compliance Institute features more than 100 educational sessions across 14 unique learning tracks. This is a sponsored message.

Compliance 59

Compliance Clinical Research Research Licensing 59

The Pharma Data

NOVEMBER 23, 2020

On February 7, 2020 the NYSE American notified the Company that it accepted the Company’s plan to regain compliance before November 25, 2020 , the end of the compliance plan period. This date has now been extended to May 25, 2021. About Synthetic Biologics, Inc. Synthetic Biologics, Inc.

Compliance 52

Compliance Licensing Licensing Clinical Trials 52

Pharmaceutical Technology

JUNE 2, 2023

Under the notice of compliance with conditions (NOC/c) policy, AB Science received authorisation from Health Canada to file a new drug submission for masitinib to treat ALS. This helps to prevent generic competition for eight years after initial approval. According to AB Science, approximately 3,000 Canadians are now living with ALS.

Compliance 130

Compliance Licensing Licensing Drugs 130

pharmaphorum

DECEMBER 28, 2022

These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts. Post-acquisition compliance. Companies must comply with the regulations, but how compliance is achieved can be somewhat different. She joined NSF in 2017.

Compliance 119

Compliance Regulation Manufacturing Licensing 119

FDA Law Blog

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years.

Licensing 45

Licensing Licensing Pharmacy Regulation 45

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. Co-Authors: Jenny Fielder.

Development 242

Development Bioequivalency Generic Drugs Production 242

Fossil Remedies

AUGUST 31, 2022

There are various prerequisites and legal compliances before launching a pharma company. Another important thing is company registration and DLN (Drug License Number). You will require an agreement and licenses. You are required to get licenses and approvals to launch a pharma manufacturing company.

Pharma Companies 98

Pharma Companies Licensing Licensing Manufacturing 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. Evolution of the Regulations Coming into force (1993–1997).

Regulation 52

Regulation Compliance Medicine Manufacturing 52

Pharmaceutical Technology

JUNE 30, 2022

Plus, there is no need to obtain import licenses for IMP and additional approval is needed for comparators, laboratory kits and biosamples. As part of its efforts towards the harmonisation of global standards, Georgia made Good Distribution Practice (GDP) licenses a requirement last year. Expert partners.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Licensing 130

Worldwide Clinical Trials

FEBRUARY 21, 2024

Unflinching attention to detail is required to manage AME study participants In AME studies, our top priority is balancing participant comfort and compliance with high-quality data collection. Here are a few of our lessons learned: 1.

Clinical Trials 200

Clinical Trials Clinical Trials Pharmacy Trials 200

XTalks

MAY 5, 2022

Meanwhile, The Paleo Diet is seeking partners for a new licensing program, which will see it lend its trademark through full-branded and co-branded agreements. Available licensing categories include raw ingredients, prepared foods, meal delivery, software, services, personalized health care and consumer packaged goods (CPGs).

Packaging 98

Packaging Packaging Licensing Licensing 98

Cloudbyz

MARCH 31, 2024

This shift is not merely technological but represents a fundamental rethinking of how clinical trials are conducted, promising to enhance efficiency, compliance, and the overall quality of research outcomes. The disjointed nature of these systems also poses risks to data integrity and auditability, critical factors in regulatory compliance.

Clinical Trials 103

Clinical Trials Clinical Trials Trials Compliance 103

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. Cost Management Challenge: EDC systems can be expensive, with costs associated with software licensing, training, and maintenance.

Clinical Trials 105

Clinical Trials Clinical Trials Regulation Trials 105

Pharma Business Blog

MAY 10, 2020

Aggravating factors considered by OFAC were: – Failing to seek appropriate advice; – No existing compliance program; – “Reckless in actions” to sell to Cuba; – Management knowledge about the transactions; and. – Subsidiary of ERBER Group, a “commercially sophisticated” company.

Compliance 52

Compliance Licensing Licensing Sales 52

Cloudbyz

MAY 11, 2023

Regulatory, Ethics, and Compliance Regulatory, ethics, and compliance costs include fees for submissions to regulatory authorities and ethics committees, as well as costs associated with maintaining compliance throughout the trial.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Compliance 98

pharmaphorum

APRIL 28, 2022

billion licensing deal with Biohaven for rights to oral migraine drug rimegepant is approaching a payoff after the European Commission approved the drug. Pfizer’s $1.2 According to GlobalData, Qulipta has the edge when it comes to data on migraine prevention rates and has a broader range of available doses.

Drugs 98

Drugs Marketing Compliance Licensing 98

Cloudbyz

JUNE 2, 2023

Direct costs include purchasing or licensing the EDC software, hardware acquisition (servers, devices), and system installation. Taking a Closer Look at the Costs Beyond the primary investments related to the purchase or license of the EDC software, there are other vital considerations.

Clinical Trials 94

Clinical Trials Clinical Trials Laboratory Information Management System Compliance 94

Camargo

SEPTEMBER 15, 2020

Sponsors can mitigate the risk of such interruptions by ensuring that their API suppliers and CMOs have good compliance records with the FDA. This could have a major impact on biopharma companies seeking to license their 505(b)(2) drugs to innovators, as they may see a lower product valuation than previously expected.

Development 130

Development Production Drugs Compliance 130

FDA Law Blog

JUNE 30, 2022

The FDA’s proposed licensing rule would implement a long-awaited provision of the 2013 Drug Supply Chain Security Act (“DSCSA”) that establishes the requirement for national license standards for WDDs and 3PLs. We have all long grappled with the multitude of state licensing obligations. 6,708 (Feb. 1) In general. –No

Regulation 52

Regulation Licensing Licensing Drugs 52

Worldwide Clinical Trials

AUGUST 9, 2024

An import license is necessary for any intellectual property or equipment used during the trial. The NMPA and CDE also require compliance with China’s data protection regulations, including the Personal Information Protection Law.

Trials 200

Trials Clinical Trials Clinical Trials Regulation 200

Cloudbyz

SEPTEMBER 5, 2024

The right solution can streamline operations, ensure compliance, and ultimately safeguard patient well-being. This guide offers a comprehensive approach to choosing the best drug safety solution for your organization, focusing on key factors such as scalability, compliance, and ease of use. Data Encryption: Both at rest and in transit.

Compliance 52

Compliance Drugs Regulation Marketing 52

pharmaphorum

OCTOBER 16, 2020

These might be licensed drugs that could hold potential for a patent extension, or drugs which failed efficacy trials for an intended indication. It is estimated that, worldwide, just 400 treatments are licensed for 7000 known rare conditions, which tend to be determined by a very specific genetic factor.

Trials 105

Trials Clinical Trials Clinical Trials Life Science 105

WCG Clinical

APRIL 3, 2023

“Each business day, the new FDAnews will deliver precisely what pharmaceutical and medical device manufacturers have told us they need to know about regulatory compliance and good manufacturing practices,” said Terri Moench, RPh, MS, President, Research Solutions for WCG. Learn more at fdanews.com.

Drugs 52

Drugs Compliance Manufacturing Regulation 52

FDA Law Blog

JANUARY 11, 2024

Some of the other (but not all…) topics of interest at this day-long conference presented by US and Puerto Rico industry thought leaders include: Experiences and Challenges of Puerto Rico State Licensing Internal Investigations: Monitoring, Compliance, Enforcement Actions The State of the Pharmaceutical Industry in Puerto Rico Navigating Global Turbulence: (..)

Drugs 59

Drugs Compliance Licensing Licensing 59

pharmaphorum

SEPTEMBER 29, 2022

Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.

Development 104

Development Regulation Production Life Science 104

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Compliance 40

XTalks

AUGUST 25, 2020

Having a good history of compliance with the FDA could help manufacturers avoid import delays. While facilities may be approved on the basis of other measures — like compliance history and data from foreign agencies — if an inspection is required, it’s possible that it won’t be conducted during the review cycle.

Manufacturing 89

Manufacturing Clinical Trials Clinical Trials Production 89

Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing. • Indirect tax point of view b.)

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Fossil Remedies

SEPTEMBER 20, 2019

It is important to know about the license requirements, compliance requirements and other aspects well. You can read about it on various websites. Ask experts if you have some specific queries. The more you study about it, the better you are prepared for it.

Pharma Production 75

Pharma Production Production Marketing Compliance 75

FDA Law Blog

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

Cloudbyz

JUNE 1, 2023

Compliance: Salesforce’s data centers comply with a number of industry standards, including ISO 27001, SOC 2, and PCI DSS. Comprehensive Compliance Salesforce offers a comprehensive suite of compliance features to ensure data privacy, security, and adherence to various industry regulations. government data).

Compliance 97

Compliance Development Branding Production 97

pharmaphorum

OCTOBER 4, 2022

Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.

Development 105

Development Regulation Cosmetics Life Science 105

Cloudbyz

AUGUST 16, 2024

eCRFs have become a cornerstone in modern clinical trials, offering a digital platform that not only streamlines data entry and management but also enhances data accuracy, security, and regulatory compliance. Regulatory Compliance: Facilitates adherence to regulatory standards, such as 21 CFR Part 11. How are eCRFs validated?

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

Cloudbyz

MARCH 4, 2023

Improved Reporting: The platform can help CROs generate accurate and timely reports, reducing the risk of errors, and improving compliance. By providing a comprehensive solution, it eliminates the need for multiple software solutions, reducing the cost of licensing, maintenance, and integration.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 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

XTalks

JUNE 5, 2023

Furthermore, patients should only purchase Ozempic, Wegovy or other medications from licensed healthcare providers or pharmacies. Patients are advised to discuss any concerns regarding these medications with healthcare providers or pharmacists.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98