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?

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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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

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.

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 […].

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.

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.

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.

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. […].

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

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.

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

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.

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

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

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

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.

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

FDA Issues Two Draft Guidances for DSCSA Compliance 

Pharmaceutical Commerce

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

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

 Opentrons Labworks, Inc. Appoints Chief Financial Officer, and Chief Legal and Compliance Officer

BioTech 365

Appoints Chief Financial Officer, and Chief Legal and Compliance Officer Opentrons Labworks, Inc. Appoints Chief Financial Officer, and Chief Legal and Compliance Officer LONG ISLAND CITY, N.Y.–(BUSINESS Opentrons Labworks, Inc.

Systech Partners with Spherity on Facilitating DSCSA Compliance

Pharmaceutical Commerce

Features an ATP solution to allow for efficiency.

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

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.

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

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

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.

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.

RemSleep Holdings Inc. Engages New Senior Director for Regulatory Compliance and New Regulatory Testing Company

BioTech 365

Engages New Senior Director for Regulatory Compliance and New Regulatory Testing Company RemSleep Holdings Inc. Engages New Senior Director for Regulatory Compliance and New Regulatory Testing Company Tampa, FL, July 22, 2022 (GLOBE NEWSWIRE) — RemSleep Holdings … Continue reading → GlobeNewswireRemSleep Holdings Inc.

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.

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

Sharps Compliance To Be Acquired By an Affiliate of Aurora Capital Partners

BioTech 365

Sharps Compliance To Be Acquired By an Affiliate of Aurora Capital Partners Sharps Compliance To Be Acquired By an Affiliate of Aurora Capital Partners Transaction Provides a Significant Premium to Shareholders and A Strong Partner to Support Future Growth HOUSTON, … Continue reading → GlobeNewswire

FDA Pharmaceutical Quality Management Webinar: Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible – ResearchAndMarkets.com

BioTech 365

FDA Pharmaceutical Quality Management Webinar: Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible – ResearchAndMarkets.com FDA Pharmaceutical Quality Management Webinar: Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Pharmaceutical Quality Management – … Continue reading → Business Wire

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.

Titan Medical Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Rule

BioTech 365

Titan Medical Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Rule Titan Medical Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Rule TORONTO, June 29, 2022 (GLOBE NEWSWIRE) — Titan Medical Inc.

Global Sterile Filtration for Life Science Market to 2027 – Need for Regulatory Compliance Presents Opportunities – ResearchAndMarkets.com

BioTech 365

Global Sterile Filtration for Life Science Market to 2027 – Need for Regulatory Compliance Presents Opportunities – ResearchAndMarkets.com Global Sterile Filtration for Life Science Market to 2027 – Need for Regulatory Compliance Presents Opportunities – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Sterile Filtration … Continue reading → Business Wire

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.

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

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

Legacy Health Selects Wolters Kluwer to Standardize Medication Compounding and Ensure USP Compliance Across Eight Locations

BioTech 365

Legacy Health Selects Wolters Kluwer to Standardize Medication Compounding and Ensure USP Compliance Across Eight Locations Legacy Health Selects Wolters Kluwer to Standardize Medication Compounding and Ensure USP Compliance Across Eight Locations Simplifi 797 supports the health system’s initiative to … Continue reading → Business Wire

Tiziana Life Sciences Ltd. Announces Annual Report Filed to Regain Nasdaq Compliance

BioTech 365

Announces Annual Report Filed to Regain Nasdaq Compliance Tiziana Life Sciences Ltd. Announces Annual Report Filed to Regain Nasdaq Compliance Form 20-F Filed on May 23, 2022 Following Receipt of Notice from Nasdaq Regarding Filing Deadline … Continue reading → GlobeNewswireTiziana Life Sciences Ltd.

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

Aeterna Zentaris Regains Compliance with Nasdaq Minimum Bid Price Requirement

BioTech 365

Aeterna Zentaris Regains Compliance with Nasdaq Minimum Bid Price Requirement Aeterna Zentaris Regains Compliance with Nasdaq Minimum Bid Price Requirement CHARLESTON, S.C., March 22, 2021 (GLOBE NEWSWIRE) — Aeterna Zentaris Inc. NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a … Continue reading → GlobeNewswire