Expert insights. Personalized for you.
VirTrial developed the program, using BlueCloud standards, while BlueCloud will provide its global networking infrastructure to Deliver, Distribute, Implement and Track (DDIT ) training competencies and certifications for business and compliance purposes. “We’ll MORE
In a recent webinar, Advarra IRB and research compliance experts discussed key areas to consider when ramping up research in the COVID-19 pandemic’s “new normal.”. General MORE
PRISYM ID provides regulated content and label management solutions designed specifically for life science companies and medical device manufacturers, improving patient safety and health outcomes whilst ensuring regulatory compliance. MORE
NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced that it has regained compliance with … Continue reading → GlobeNewswireHamilton, Bermuda, August 20, 2020 – Auris Medical Holding Ltd. MORE
Sponsors can mitigate the risk of such interruptions by ensuring that their API suppliers and CMOs have good compliance records with the FDA. Senior Director of Regulatory Compliance and Submissions. MORE
Vault QualityDocs is helping global pharma CANbridge to improve processes, reduce compliance risk, and expand clinical trials BEIJING–(BUSINESS WIRE)–Veeva Systems (NYSE: VEEV) today announced that CANbridge Pharmaceuticals Inc., MORE
Download this ebook in collaboration with OSTHUS to find out how to increase laboratory productivity and meet compliance standards while ensuring data quality. MORE
Billing Compliance Budgeting Efficient Clinical Trials Financial ManagementA patient’s standard of care refers to an item or service done as part of their routine care. To address additional assessments outside the participant’s SOC, a coverage analysis is necessary. MORE
People low on openness, neuroticism less likely to comply without strict government policies, study says WASHINGTON – A worldwide survey conducted during the first wave of the COVID-19 pandemic found that people with certain common personality traits were less likely to shelter at home when government policies were less restrictive, according to research published by […]. Medicine & Health Behavior Political Science Public Health Science/Health/Law Social/Behavioral Science MORE
MELBOURNE, Australia, Sept. 01, 2020 (GLOBE NEWSWIRE) — Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) (the “Company”), a leader in the development of genetic risk assessment tests, is pleased to announce that it received notification from the Listing Qualifications Department of the Nasdaq … Continue reading → GlobeNewswire MORE
Patient Support Services Congress. October 27-29, 2020 | VIRTUAL EVENT (All-Digital Format) www.informaconnect.com/patientsupportservicescongress. MORE
This was followed by compliance and then speed and efficiency. This enables companies to manage risk in label production and ensure regulatory compliance.”. Many respondents experience frequent problems and blame human error. Wokingham, United Kingdom — 6 August 2020. MORE
Serious consideration should be given to assure the safety of trial participants while maintaining compliance with good clinical practice (GCP) and minimizing risks to trial integrity. The FDA recently released new guidance on clinical trials in the face of COVID-19. In their published report, FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic , they acknowledged that challenges may arise in ongoing trials. MORE
06, 2020 (GLOBE NEWSWIRE) — Livanta recently rolled out innovative technological solutions to assist healthcare providers in attaining compliance with new Medicare regulations. ANNAPOLIS JUNCTION, Md., A Centers for Medicare & Medicaid Services (CMS) Fiscal Year 2021 Final Rule, … Continue reading → GlobeNewswire MORE
Scottsdale, AZ (February 4, 2020) – VirTrial today announced its international expansion with a newly appointed International Director of Business Development, a network of virtual trial capable research sites across 31 countries, policies supporting GDPR compliance, and product enhancements that support language translation into any left to right reading language. This model is ideally suited for Phase III/Phase IV trials where patient compliance can be assessed from any location. MORE
Maintaining compliance can be a relentless drain on resources. Alternatively, business can make good use of the data collected for… Current features Volume 12 Issue 5 MORE
52 DCTs enable PIs to maintain patient engagement and conduct remote safety check-ins, electronic questionnaires, and medication compliance via video, text, and email. Clinical trials require a significant commitment from patients, particularly in regard to travel time to research sites for regular visits. Consider the additional patient burden involved in clinical trials for patients with paralysis, dementia, or other conditions that make travel difficult or impossible. MORE
Having a good history of compliance with the FDA could help manufacturers avoid import delays. MORE
The coronavirus pandemic has forced a traditionally risk-averse industry tied to legacy systems for regulation and compliance to fully embrace digital solutions in commercial and marketing functions. MORE
Note to Editors: PRISYM ID provides regulated content and label management solutions designed specifically for life science companies and medical device manufacturers, improving patient safety and health outcomes whilst ensuring regulatory compliance. MORE
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. – Development of “formal written policies and procedures” to prevent future violations, This case underscores the importance of global companies maintaining a compliance program. MORE
They have to talk about the possibility of better outcomes and better compliance. MORE
Pharmacists strive to eliminate medication errors and ensure strict patient compliance to achieve desired therapeutic outcomes. While dispensing the prescription Pharmacists enhance efficacy and safety of medication by motivating patients for compliance of dosage regimen. Actually it is patient compliance which is important for optimum therapeutic outcome. About Author Dr. R. Thakur. Email: drramsthakur@gmail.com. ABSTRACT. MORE
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. MORE
These enhancements make it the industry’s first respiratory solution to achieve full compliance with standards issued by the American Thoracic Society and European Research Society (ATS / ERS) in 2019. MORE
Join Informa Connect-CBI’s 6th Edition Drug Pricing Transparency Congress to discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Informa Connect-CBI’s 6th Edition Drug Pricing Transparency Congress. November 16-17, 2020 | Virtual Event www.informaconnect.com/drug-pricing-transparency. Drug Channels Readers: View the complete agenda and register today. MORE
Senior Director of Regulatory Compliance and Submissions. Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. MORE
19, 2020 06:00 UTC. BOCA RATON, Fla.–( MORE
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. MORE
We’ll be hosting two live webinars where you can g ain insights on the draft guidance, and how to reduce data variability and increase patient compliance in blood pressure monitoring. . MORE
The theme of the event is ‘Exploring Agile Contamination Control Strategy’, where the two-day conference will be co-chaired by James Drinkwater, Head of Aseptic Processing Technologies & GMP Compliance, F Ziel GmbH and Jim Polarine, Senior Technical Service Manager, STERIS Corporation. MORE
As regular readers know, I believe the 340B Drug Pricing Program needs to evolve into a more transparent, properly regulated program. That’s why I’m especially glad to share today’s guest post from Jeremy Docken, Founder and CEO at Kalderos. MORE
Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ LUMEVOQ is a gene therapy to treat vision loss due to the rare, mitochondrial genetic disease, Leber Hereditary … Continue reading → Business Wire MORE
Learn how to achieve immediate improvements in key quality performance areas such as document control efficiency, training management compliance, corrective and preventive action effectiveness and human error mitigation. MORE
He said: “If you can get a CE mark [indicating compliance with the relevant legislation] for a bad test as there is no scrutiny on whether it works, it is just a marketing claim that is registered and we are left in a Wild West of antibody testing.”. MORE
When a trial is completed, the valuable and extensive data it has produced must be archived – an exercise crucial both to regulatory compliance and to any future efforts at repurposing. This percentage rose to 65% amongst QA, compliance, legal and regulatory professionals. MORE
NHS Test and Trace will make regular contact with those isolating to check compliance. But compliance isn’t the only problem. Prosecutions could follow in “high-profile and egregious” cases of non-compliance. Image copyright. PA Media. MORE
Richner is an experienced public health policy professional with over 30 years of experience in Medical Devices, Reimbursement Strategy and Health Care Policy. MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel and BERLIN, Oct. 19, 2020 (GLOBE NEWSWIRE) — ReWalk Robotics. MORE
Led by founder and CEO, Dr. Connie Wan , SGC redefines a household staple into a drug delivery platform to significantly increase patient’s medication compliance with its convenient and easy to take gummy medications. SEATTLE , Oct. MORE
3) Co-ordinated enforcement: Cooperation between those responsible for enforcing the rules locally, at Member state level or EU wide combined with ‘passporting’ (meaning compliance with the rules in one state covers the whole EU) thus increasing confidence for businesses and citizens that they can trade EU wide. And it reduces the costly need to establish compliance systems for multiple countries. MORE
Gain insights on reducing data variability and increasing patient compliance in blood pressure monitoring. EMEA Webinar 09/22 – 8:00 am PT | 11:00 am ET | 5:00 pm CEST. MORE
Compliance Related Topics Forte Research Systems®
AUGUST 11, 2020
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.
Journal for Clinical Studies
OCTOBER 16, 2020
Maintaining compliance can be a relentless drain on resources. Alternatively, business can make good use of the data collected for… Current features Volume 12 Issue 5
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Scienmag
OCTOBER 15, 2020
People low on openness, neuroticism less likely to comply without strict government policies, study says WASHINGTON – A worldwide survey conducted during the first wave of the COVID-19 pandemic found that people with certain common personality traits were less likely to shelter at home when government policies were less restrictive, according to research published by […]. Medicine & Health Behavior Political Science Public Health Science/Health/Law Social/Behavioral Science
BioTech 365
OCTOBER 14, 2020
Vault QualityDocs is helping global pharma CANbridge to improve processes, reduce compliance risk, and expand clinical trials BEIJING–(BUSINESS WIRE)–Veeva Systems (NYSE: VEEV) today announced that CANbridge Pharmaceuticals Inc.,
ERT
JULY 29, 2020
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.
BioTech 365
AUGUST 20, 2020
NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced that it has regained compliance with … Continue reading → GlobeNewswireHamilton, Bermuda, August 20, 2020 – Auris Medical Holding Ltd.
Drug Channels
AUGUST 21, 2020
As regular readers know, I believe the 340B Drug Pricing Program needs to evolve into a more transparent, properly regulated program. That’s why I’m especially glad to share today’s guest post from Jeremy Docken, Founder and CEO at Kalderos.
Forte Research Systems®
JULY 21, 2020
Billing Compliance Budgeting Efficient Clinical Trials Financial ManagementA patient’s standard of care refers to an item or service done as part of their routine care. To address additional assessments outside the participant’s SOC, a coverage analysis is necessary.
Forte Research Systems®
JUNE 25, 2020
In a recent webinar, Advarra IRB and research compliance experts discussed key areas to consider when ramping up research in the COVID-19 pandemic’s “new normal.”. General
BioTech 365
OCTOBER 5, 2020
Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ LUMEVOQ is a gene therapy to treat vision loss due to the rare, mitochondrial genetic disease, Leber Hereditary … Continue reading → Business Wire
BioTech 365
OCTOBER 6, 2020
06, 2020 (GLOBE NEWSWIRE) — Livanta recently rolled out innovative technological solutions to assist healthcare providers in attaining compliance with new Medicare regulations. ANNAPOLIS JUNCTION, Md., A Centers for Medicare & Medicaid Services (CMS) Fiscal Year 2021 Final Rule, … Continue reading → GlobeNewswire
Drug Channels
OCTOBER 5, 2020
Patient Support Services Congress. October 27-29, 2020 | VIRTUAL EVENT (All-Digital Format) www.informaconnect.com/patientsupportservicescongress.
VirTrial
OCTOBER 14, 2020
VirTrial developed the program, using BlueCloud standards, while BlueCloud will provide its global networking infrastructure to Deliver, Distribute, Implement and Track (DDIT ) training competencies and certifications for business and compliance purposes. “We’ll
Pharma Tutor
SEPTEMBER 24, 2020
Pharmacists strive to eliminate medication errors and ensure strict patient compliance to achieve desired therapeutic outcomes. While dispensing the prescription Pharmacists enhance efficacy and safety of medication by motivating patients for compliance of dosage regimen. Actually it is patient compliance which is important for optimum therapeutic outcome. About Author Dr. R. Thakur. Email: drramsthakur@gmail.com. ABSTRACT.
Pharma Phorum
OCTOBER 15, 2020
The coronavirus pandemic has forced a traditionally risk-averse industry tied to legacy systems for regulation and compliance to fully embrace digital solutions in commercial and marketing functions.
ERT
SEPTEMBER 9, 2020
We’ll be hosting two live webinars where you can g ain insights on the draft guidance, and how to reduce data variability and increase patient compliance in blood pressure monitoring. .
ERT
AUGUST 31, 2020
Gain insights on reducing data variability and increasing patient compliance in blood pressure monitoring. EMEA Webinar 09/22 – 8:00 am PT | 11:00 am ET | 5:00 pm CEST.
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. Senior Director of Regulatory Compliance and Submissions.
VirTrial
FEBRUARY 4, 2020
Scottsdale, AZ (February 4, 2020) – VirTrial today announced its international expansion with a newly appointed International Director of Business Development, a network of virtual trial capable research sites across 31 countries, policies supporting GDPR compliance, and product enhancements that support language translation into any left to right reading language. This model is ideally suited for Phase III/Phase IV trials where patient compliance can be assessed from any location.
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. – Development of “formal written policies and procedures” to prevent future violations, This case underscores the importance of global companies maintaining a compliance program.
Pharma Phorum
OCTOBER 5, 2020
PRISYM ID provides regulated content and label management solutions designed specifically for life science companies and medical device manufacturers, improving patient safety and health outcomes whilst ensuring regulatory compliance.
The Pharma Data
OCTOBER 18, 2020
19, 2020 06:00 UTC. BOCA RATON, Fla.–(
The Pharma Data
SEPTEMBER 20, 2020
NHS Test and Trace will make regular contact with those isolating to check compliance. But compliance isn’t the only problem. Prosecutions could follow in “high-profile and egregious” cases of non-compliance. Image copyright. PA Media.
Pharma Phorum
SEPTEMBER 7, 2020
Note to Editors: PRISYM ID provides regulated content and label management solutions designed specifically for life science companies and medical device manufacturers, improving patient safety and health outcomes whilst ensuring regulatory compliance.
Drug Channels
OCTOBER 12, 2020
Join Informa Connect-CBI’s 6th Edition Drug Pricing Transparency Congress to discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Informa Connect-CBI’s 6th Edition Drug Pricing Transparency Congress. November 16-17, 2020 | Virtual Event www.informaconnect.com/drug-pricing-transparency. Drug Channels Readers: View the complete agenda and register today.
Camargo
OCTOBER 14, 2020
Senior Director of Regulatory Compliance and Submissions. Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program.
Pharma Phorum
AUGUST 10, 2020
This was followed by compliance and then speed and efficiency. This enables companies to manage risk in label production and ensure regulatory compliance.”. Many respondents experience frequent problems and blame human error. Wokingham, United Kingdom — 6 August 2020.
The Pharma Data
SEPTEMBER 30, 2020
Learn how to achieve immediate improvements in key quality performance areas such as document control efficiency, training management compliance, corrective and preventive action effectiveness and human error mitigation.
Pharma Phorum
SEPTEMBER 23, 2020
The theme of the event is ‘Exploring Agile Contamination Control Strategy’, where the two-day conference will be co-chaired by James Drinkwater, Head of Aseptic Processing Technologies & GMP Compliance, F Ziel GmbH and Jim Polarine, Senior Technical Service Manager, STERIS Corporation.
The Pharma Data
SEPTEMBER 9, 2020
Download this ebook in collaboration with OSTHUS to find out how to increase laboratory productivity and meet compliance standards while ensuring data quality.
The Pharma Data
OCTOBER 18, 2020
Richner is an experienced public health policy professional with over 30 years of experience in Medical Devices, Reimbursement Strategy and Health Care Policy. MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel and BERLIN, Oct. 19, 2020 (GLOBE NEWSWIRE) — ReWalk Robotics.
World of DTC Marketing
JULY 23, 2020
They have to talk about the possibility of better outcomes and better compliance.
The Pharma Data
OCTOBER 14, 2020
Led by founder and CEO, Dr. Connie Wan , SGC redefines a household staple into a drug delivery platform to significantly increase patient’s medication compliance with its convenient and easy to take gummy medications. SEATTLE , Oct.
VirTrial
APRIL 29, 2020
Serious consideration should be given to assure the safety of trial participants while maintaining compliance with good clinical practice (GCP) and minimizing risks to trial integrity. The FDA recently released new guidance on clinical trials in the face of COVID-19. In their published report, FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic , they acknowledged that challenges may arise in ongoing trials.
Pharma Phorum
AUGUST 21, 2020
He said: “If you can get a CE mark [indicating compliance with the relevant legislation] for a bad test as there is no scrutiny on whether it works, it is just a marketing claim that is registered and we are left in a Wild West of antibody testing.”.
ERT
JULY 22, 2020
These enhancements make it the industry’s first respiratory solution to achieve full compliance with standards issued by the American Thoracic Society and European Research Society (ATS / ERS) in 2019.
Pharma Phorum
OCTOBER 16, 2020
When a trial is completed, the valuable and extensive data it has produced must be archived – an exercise crucial both to regulatory compliance and to any future efforts at repurposing. This percentage rose to 65% amongst QA, compliance, legal and regulatory professionals.
XTalks
AUGUST 25, 2020
Having a good history of compliance with the FDA could help manufacturers avoid import delays.
VirTrial
DECEMBER 17, 2019
DCTs enable PIs to maintain patient engagement and conduct remote safety check-ins, electronic questionnaires, and medication compliance via video, text, and email. Clinical trials require a significant commitment from patients, particularly in regard to travel time to research sites for regular visits. Consider the additional patient burden involved in clinical trials for patients with paralysis, dementia, or other conditions that make travel difficult or impossible.
Una Com Pharma
FEBRUARY 23, 2020
3) Co-ordinated enforcement: Cooperation between those responsible for enforcing the rules locally, at Member state level or EU wide combined with ‘passporting’ (meaning compliance with the rules in one state covers the whole EU) thus increasing confidence for businesses and citizens that they can trade EU wide. And it reduces the costly need to establish compliance systems for multiple countries.
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