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The criticality of compliance

Pharma Phorum

Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. So, with mandates in place, how do manufacturing facilities meet these compliance goals?

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Upholding regulatory compliance in decentralised trials

Pharma Phorum

Integrating a full-service platform model, typically provided by CROs, which allows sponsors to maintain data confidentiality compliance and separation from directly identifiable patient data. His focus has been on compliance in clinical trials, through training and auditing.

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Is Apple that naive when it comes to compliance?

World of DTC Marketing

There are many reasons for non-compliance and non-adherence: Cost and affordability, lack of understanding/comprehension of advice, language barriers, cognitive abilities, fear of asking for clarification, or other reasons. The post Is Apple that naive when it comes to compliance?

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Hidden compliance risks for life sciences companies

Pharma Phorum

The life sciences history industry has some unique challenges when it comes to compliance. But if you think third party compliance risks are bad, don’t take your eye off fourth and fifth parties, says Allan Matheson.

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5 HIPAA Compliance Tips For Healthcare Professionals

Pharma Mirror

They can deal with other healthcare franchises, which also need compliance. There are more reasons why health professionals should have a HIPAA compliance program in their clinics and offices.

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Pay Transparency Backlash: the Harm of Reluctant Compliance

BioSpace

Pay Transparency Backlash: the Harm of Reluctant Compliance 2/27/2023

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Achieve compliance through year-end pharma annual requirements

Bio Pharma Dive

Receive drug conversion and submission services by our expert staff, to remain compliant with the FDA

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Healthcare data management: resolving consent, compliance, and privacy issues

Pharmaceutical Technology

Furthermore, data regulations around the world add another burden of compliance and need careful management. A customised solution to ensure data regulation compliance.

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A Message to Pharma CIOs: Optimizing Salesforce Improves Security and Compliance

Pharma Phorum

However, issues like compliance, governance and security often are. These problems tend to be the most severe in the oldest and largest Salesforce orgs, and can result in slow performance, reduced agility, sluggish adoption, misalignment and even compliance and security issues.

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Compliance to convenience: understanding the latest innovations in capsule formulation

Pharmaceutical Technology

Fixed-dose combination (FDC) systems aim to increase patient compliance in therapies involving two or more active drugs. The post Compliance to convenience: understanding the latest innovations in capsule formulation appeared first on Pharmaceutical Technology.

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Data Integrity and Compliance With CGMP

Pharma Tutor

Data Integrity and Compliance With CGMP. Read more about Data Integrity and Compliance With CGMP Log in or register to post commentsData integrity refers to the completeness, consistency, and accuracy of data.

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Exploring new technology integrations to make research compliance altogether better

Forte Research Systems®

Clinical Research Technologies Compliance and Regulatory Efficient Clinical TrialsSince joining forces a year ago, Advarra and Forte have worked to ensure altogether better research, integrating Advarra’s CIRBI platform and Forte eReg.

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Digitalize hip and knee replacement surveys to save time and improve compliance, research finds

Scienmag

Latest News Compliance Digitalize finds Hip improve knee replacement research save surveys timeA study led by the University of Exeter, published in BMJ Open, modelled an alternative to the current patient-reported outcome measures (PROMs) questionnaire. Since 2009, all patients who have undergone hip or knee surgery are asked to complete the document, to assess how effective the procedure has been. The programme, which costs upwards of an […].

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As FDA inspections return, upholding compliance and maintaining GMP readiness is more crucial than ever

Pharma Phorum

With attention and resources focused elsewhere during the pandemic, it’s likely that many facilities may have slipped into a state of non-compliance, which may result in unsuccessful inspections. Doing so means that businesses can check their compliance before an FDA inspection.

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Experts to come together for compliance event ‘validation ready’ global labeling systems  

Pharma Phorum

Experts to come together for compliance event . This one-hour event is particularly suited to those in industry roles such as compliance, regulatory affairs and quality assurance, or anyone who needs to understand what best practice looks like in a global labeling system.

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NABP Hopes to Fill a Key Gap in DSCSA Compliance: Local Pharmacies

Pharmaceutical Commerce

The Pulse online service will provide free resources to enable pharmacy to meet drug traceability rules.

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Anne Walsh to Moderate FDLI Compliance and Enforcement Panel

FDA Law Blog

s Anne Walsh will be moderating “Updates in Litigation Risks: Product Liability, Private Litigation, and Consumer Class Actions,” at the upcoming Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December 9-10. Hyman, Phelps & McNamara, P.C.’s

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Exicure, Inc. Regains Compliance with Nasdaq Minimum Bid Price Requirement

BioTech 365

Regains Compliance with Nasdaq Minimum Bid Price Requirement Exicure, Inc. Regains Compliance with Nasdaq Minimum Bid Price Requirement CHICAGO–(BUSINESS WIRE)–Exicure, Inc. Exicure, Inc.

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EVALUATION OF PROCESSED FOOD ACCEPTANCE AND ITS REGULATORY COMPLIANCE IN ASIAN COUNTRIES

Pharma Tutor

EVALUATION OF PROCESSED FOOD ACCEPTANCE AND ITS REGULATORY COMPLIANCE IN ASIAN COUNTRIES. admin. Mon, 11/14/2022 - 17:09. Avdesh Thassu. MPharm (Nat. Chem.); MBA(Mkt.). Associate Vice President. Global Regulatory Affairs, Emami Limited athassu@hotmail.com. Articles

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COVID-19: Compliance to household mixing restrictions in England decreased with each lockdown

Scienmag

Latest News Compliance COVID19 decreased England household lockdown mixing restrictionsHousehold mixing significantly decreased in the first lockdown in England and remained relatively low in the second lockdown, but increased during the third lockdown, reports a study published in Scientific Reports. The authors observed that the increase in household mixing by mid-February 2021 during the third lockdown coincided with the wider COVID-19 vaccine rollout across England. […].

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FDA Issues Two Draft Guidances for DSCSA Compliance 

Pharmaceutical Commerce

The EPCIS communications standard is “recommended,” and trading partners are identified.

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Systech Partners with Spherity on Facilitating DSCSA Compliance

Pharmaceutical Commerce

Features an ATP solution to allow for efficiency.

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Life sciences promotional content management for speed, compliance and insight

Pharma Phorum

The life sciences landscape is moving at a rapid pace, which in turn is increasing the demands on marketers to create innovative, digital content faster while maintaining industry compliance.

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Nutra Pharma Provides Business and Compliance Updates

BioTech 365

Nutra Pharma Provides Business and Compliance Updates Nutra Pharma Provides Business and Compliance Updates Nutra Pharma is providing updates regarding their business plans, accounting and compliance Plantation, Florida, July 26, 2021 (GLOBE NEWSWIRE) — Nutra Pharma Corporation (OTC Pink: NPHC), … Continue reading → GlobeNewswire

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10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements is Just Days Away

FDA Law Blog

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. By Kurt R.

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InMed Pharmaceuticals Receives Nasdaq Notification Regarding Minimum Bid Price Compliance

BioTech 365

InMed Pharmaceuticals Receives Nasdaq Notification Regarding Minimum Bid Price Compliance InMed Pharmaceuticals Receives Nasdaq Notification Regarding Minimum Bid Price Compliance VANCOUVER, British Columbia, July 12, 2022 (GLOBE NEWSWIRE) — InMed Pharmaceuticals Inc.

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Hand Hygiene Compliance Rate During the COVID-19 Pandemic

JAMA Internal Medicine

This quality improvement study assesses hand hygiene compliance rates in a hospital with an automated hand hygiene monitoring system during the COVID-19 pandemic

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Q&A: AI’s place in leveraging compliance data for clinical trials

Outsourcing Pharma

Compliance data generated from the documentation of interactions with HCPs can be leveraged using AI and ML to the benefit of stakeholders across the industry, according to IQVIA.

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Neovasc Regains Compliance with Nasdaq Minimum Bid Price Rule

BioTech 365

Neovasc Regains Compliance with Nasdaq Minimum Bid Price Rule Neovasc Regains Compliance with Nasdaq Minimum Bid Price Rule VANCOUVER and MINNEAPOLIS, May 16, 2022 (GLOBE NEWSWIRE) — via NewMediaWire – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) announced … Continue reading → GlobeNewswire

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Johnson & Quin Achieves HIPAA Security Compliance Assessment

BioTech 365

Johnson & Quin Achieves HIPAA Security Compliance Assessment Johnson & Quin Achieves HIPAA Security Compliance Assessment NILES, Ill.–(BUSINESS –(BUSINESS WIRE)–#colorinkjet—Johnson & Quin, a full-service direct mail production and mailing services company, has successfully achieved the HIPAA Security Compliance Assessment which certifies … Continue reading → Business Wire

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Improving Patient Compliance and Retention in Oncology Clinical Trials

ERT

In this blog, we explore how, by understanding patients’ preferences and meeting their expectations, sponsors can simplify their participation and improve compliance and retention to accelerate important oncology clinical trials.

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MEDIROM Healthcare Technologies Inc. Regains Compliance with Nasdaq Listing Standard

BioTech 365

Regains Compliance with Nasdaq Listing Standard MEDIROM Healthcare Technologies Inc. Regains Compliance with Nasdaq Listing Standard NEW YORK, April 22, 2022 (GLOBE NEWSWIRE) — MEDIROM Healthcare Technologies Inc. MEDIROM Healthcare Technologies Inc. Nasdaq CM: MRM), a holistic healthcare company based … Continue reading → GlobeNewswire

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Transforming Medical Affairs with fact-based solutions and improved compliance

Pharma Phorum

The panelists will share best practices for making fact-based decisions that meet compliance restrictions, using powerful market insights gained from multiple data sources, to optimize strategic planning and ultimately drive product success. Medical Affairs" Pharma Compliance

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Sharps Compliance Announces Change to Board of Directors

BioTech 365

Sharps Compliance Announces Change to Board of Directors Sharps Compliance Announces Change to Board of Directors HOUSTON, May 24, 2021 (GLOBE NEWSWIRE) — Sharps Compliance Corp. NASDAQ: SMED) (“Sharps Compliance” or the “Company”), a leading full-service national provider of comprehensive … Continue reading → GlobeNewswire

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Sharps Compliance Corp. Announces Proposed Public Offering of Common Stock

BioTech 365

Sharps Compliance Corp. Announces Proposed Public Offering of Common Stock Sharps Compliance Corp. 25, 2021 (GLOBE NEWSWIRE) — Sharps Compliance Corp. Announces Proposed Public Offering of Common Stock HOUSTON, Aug. Nasdaq: SMED), a full service provider of waste management, today … Continue reading → GlobeNewswire

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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

Pharma Phorum

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.

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Sharps Compliance To Present at ROTH Virtual London Conference

BioTech 365

Sharps Compliance To Present at ROTH Virtual London Conference Sharps Compliance To Present at ROTH Virtual London Conference HOUSTON, June 16, 2021 (GLOBE NEWSWIRE) — Sharps Compliance Corp. Nasdaq: SMED) announced today that David P. Tusa, President and Chief Executive … Continue reading → GlobeNewswire

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Cognito Therapeutics Appoints Jennifer Newberger as Head of Regulatory and Compliance

BioTech 365

Cognito Therapeutics Appoints Jennifer Newberger as Head of Regulatory and Compliance Cognito Therapeutics Appoints Jennifer Newberger as Head of Regulatory and Compliance CAMBRIDGE, Mass.–(BUSINESS

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Regulatory Compliance Coverage & Reference between FDA 21 CFR Part 11 and EU Annex 11

Cloudbyz

To ensure continued compliance to these regulations, it is imperative for clinical researchers to understand the similarities and differences between these regulations. Until recently, clinical trials have been performed in a mostly paper-based processes.

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Three Day Virtual Pharmaceutical SOP Writing, Training and Compliance Course, July 25-26, 2022 – ResearchAndMarkets.com

BioTech 365

Three Day Virtual Pharmaceutical SOP Writing, Training and Compliance Course, July 25-26, 2022 – ResearchAndMarkets.com Three Day Virtual Pharmaceutical SOP Writing, Training and Compliance Course, July 25-26, 2022 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “SOP Writing, Training and Compliance in the Pharmaceutical … Continue reading → Business Wire

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Exicure, Inc. Announces Receipt of Nasdaq Notice of Non-compliance and Implementation of One-for-Thirty Reverse Stock Split

BioTech 365

Announces Receipt of Nasdaq Notice of Non-compliance and Implementation of One-for-Thirty Reverse Stock Split Exicure, Inc. Announces Receipt of Nasdaq Notice of Non-compliance and Implementation of One-for-Thirty Reverse Stock Split CHICAGO–(BUSINESS WIRE)–Exicure, Inc.

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Christopher Phillips Named Chair of the BioUtah Regulatory, Compliance and Quality Committee

BioTech 365

Christopher Phillips Named Chair of the BioUtah Regulatory, Compliance and Quality Committee Christopher Phillips Named Chair of the BioUtah Regulatory, Compliance and Quality Committee Fluidx’s regulatory and clinical affairs director will take the reins of the Regulatory, Compliance and Quality … Continue reading → Business Wire

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Medexus Receives Notice of Compliance to Commercialize Treosulfan in Canada

BioTech 365

Medexus Receives Notice of Compliance to Commercialize Treosulfan in Canada Medexus Receives Notice of Compliance to Commercialize Treosulfan in Canada TORONTO and CHICAGO, June 28, 2021 (GLOBE NEWSWIRE) — Medexus Pharmaceuticals Inc. the “Company” or “Medexus”) (TSX: MDP) (OTCQX: MEDXF) today … Continue reading → GlobeNewswire