Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

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Documentation FDA Hospitals Dosage 97

The deprescribing.org Blog

APRIL 14, 2021

Over the past 10 years, Amy has been working as a community pharmacist. From October 2020 to January 2021, Amy worked with Dr. Barbara Farrell in the Bruyère Continuing Care Geriatric Day Hospital and with her Deprescribing Research Team as part of her postgraduate PharmD training. Document, document, document.

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Community Pharmacies Documentation Hospitals Communication 52

Omnicell

JANUARY 10, 2023

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. 2020: After being sued once again by 340B providers, HRSA established the Administrative Dispute Resolution program.

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Hospitals Omnicell Insurance Documentation 96

pharmaphorum

OCTOBER 20, 2020

As Graphic 1 shows, during the height of the pandemic, March-May 2020, face to face discussions between pharmaceutical companies and HCPs reduced to close to zero in all major countries. As Graphic 2 shows, 2020 has indeed brought some trend-breaking changes in HCP channel preference.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

Pharma Marketing Network

OCTOBER 13, 2021

Just a few weeks ago, August 3 rd marked Black Women’s Equal Pay Day, or the day Black women had to work into 2021 to catch up to what white, non-Hispanic men earned in 2020. Dr. Abbott suggests that you start a new weekly ritual: every Friday, take time to create an outline documenting all that you’ve accomplished that week.

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Communication Documentation 52

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

DECEMBER 13, 2022

In 2020, the pharmaceutical supply chain faced one of its biggest global challenges. Integrated logistics and quality data is documented automatically, and operators can spend less time chasing status, progress and performance data from multiple sources. Challenge 3: Minimising waste. Please check your email to download the Report.

Vaccines 52

Vaccines Communication Documentation 52

Hospital Pharmacy Europe

JUNE 8, 2023

They examined possible changes using three different methods: the history of tracked changes on ClinicalTrials.gov ; self-reported changes noted in the article; and changes reported within the protocol, including all available protocol documents. Nevertheless, it is incumbent on trialists to communicate such changes.

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Documentation Communication Patient Care Hospitals 52

The Checkup by Singlecare

DECEMBER 26, 2023

Yes, as of March 2020 , insulin is considered a biologic product by the FDA. It was first approved in June 2020. Patient communication: Informing patients about the substitution and discussing its safety and efficacy can help them understand and be comfortable with the change. Is insulin a biologic medication?

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FDA Communication Documentation 52

Viseven

JULY 26, 2022

Digital health app providers added over 90,000 new apps to app stores in 2020. Mobile apps can help healthcare workers remember their daily tasks, browse the documentation, and optimize communication within their teams. Remote communications. Apps for Clinical Communications. billion in 2021. Patient Loyalty.

Health and Personal Care Stores 52

Health and Personal Care Stores Dosage Communication Medical Records 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

Documentation 52

Documentation Dosage Packaging Communication 52

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 Article 63 EMA (29 January 2020).

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Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 98

PQA

JUNE 27, 2024

In parallel with measure development, PQA initiated a research project in 2020 to identify facilitators and barriers impacting specialty pharmacy prescription turnaround time. For example, some patients are more technology-averse and can have longer TAT compared to populations that have embraced electronic communications.

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Specialty Pharmacies Communication Packaging Documentation 40

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. It supports the analysis of Industry 4.0 initiatives.

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Packaging Documentation Communication Data Entry 52

ISPE

JANUARY 9, 2023

The regulated company is responsible for including its use of the cloud in its quality management system (QMS) and other quality documentation. Data must always be attributable, stored in a legible format, have timestamps for each life cycle step, be documented by a X.509 Managing the Digital Transformation of Companies–Update 2020.”

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Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

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Documentation Communication FDA 52

Pharmaceutical Technology

JUNE 22, 2023

According to the document, this scheme would instead harm patient access to drugs, which will take longer to turn generic. This could be done through revenue guarantees, which were mentioned in the EC’s Council recommendation document, and other approaches, says Årdal. Please check your email to download the Report.

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Documentation Communication 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 This was followed in September 2022 by the publication of the PIC/S’s identical Annex 1. m/s up to 0.54

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Documentation FDA Packaging Communication 52

ISPE

JANUARY 9, 2023

It was time for ISPE to update this key guidance document to reflect technological progress. 15 September 2020. You may unsubscribe from these ISPE communications at any time. The concepts of CSA related to US FDA CDRH Case for Quality program are also explored and applied where relevant. 1 US Food and Drug Administration.

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Documentation FDA Communication 52

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. IEEE Transactions on Signal Processing 68 (2020): 4069-82. Published 19 January 2017.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

ISPE

SEPTEMBER 8, 2023

In addition, this article provides an explanation of the purpose and expected outcomes from the survey, subsequent plans for communicating the results from the survey across ISPE, and development of concrete proposals to address the sources of challenges and barriers to innovation. EMA/321483/2020. 3 July 2020. 22 June 2023.

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FDA Documentation Dosage Communication 52

ISPE

JULY 10, 2023

In this constructive process, documentation regarding the decisions made are important to justify the model and explain-ability mechanism selection in an audit context.” Advances in Neural Information Processing Systems 33 (2020): 1877–901. ChatGPT : “The solution should be made to meet its desired quality standards. Subbiah, J.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 7, 2023

Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Journal of Validation Technology (26 January 2020). Press Release. 30 November 2022. link] 6 European Medicines Agency. Committee for Medicinal Products for Human Use.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

Documentation 52

Documentation FDA Communication Packaging 52

IDStewardship

APRIL 13, 2023

The most recent CARB addresses the years 2020-2025, building upon the initial one released in 2015. An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here.

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Hospitals Documentation Communication Patient Care 246

European Pharmaceutical Review

NOVEMBER 24, 2022

Indeed, a 2020 operation coordinated by Europol across 27 countries led to the seizure of more than 25 million units of counterfeit anticancer drugs and erectile dysfunction medicines among other fake drugs worth nearly €73 million. Several branded medicines are available that feature holograms on the packaging or in the blister pack.”

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Packaging Labelling Documentation Dosage 111

ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

Documentation 52

Documentation FDA Packaging Communication 52

The Checkup by Singlecare

OCTOBER 16, 2023

Below, we detail the 14 categories of conditions that qualify for SSA disability in adults and what you may be expected to provide for documentation for each. The SSA also requires persuasive medical documentation from a healthcare provider. (This is not to be confused with Medicare Part A and Part B.)

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Documentation Immunization Mayo Clinic Insurance 105

European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Internet] WHO. cited 2023July]. Internet] WHO. cited 2023July].

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Vaccines Communication Immunization Documentation 111

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Published 2 October 2020. Updated October 2020. Published March 2020.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Published 19 October 2020. Published 22 September 2020. Digital Health.”

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

pharmaphorum

OCTOBER 28, 2020

A 2020 survey from DrugsDisclosed.com of 3,346 users of prescription and over the counter (OTC) medicines from the UK and the Nordics revealed that: more than three-quarters of patients do not trust advice from pharmaceutical companies about their medication; 81% feel the pharmaceutical industry influences prescription decisions; and.

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pharmaphorum

FEBRUARY 2, 2022

As the COVID-19 pandemic ricocheted around the world at the start of 2020, researchers were faced with a stark choice – go remote or go home. Through a series of workshops and surveys, which collected the views of research professionals, patients and carers, the group has developed a new guidance document. A practical consensus.

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Documentation Packaging Communication 52

The Thyroid Pharmacist

APRIL 12, 2023

The adrenals may be totally healthy and capable, but there’s a breakdown of communication in the hypothalamic-pituitary-adrenal (HPA) axis, and desensitization of certain receptors, that can lead to the symptoms associated with adrenal fatigue. In fact, HPA axis dysfunction is well documented in scientific literature.

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Communication Documentation 85

ISPE

JULY 5, 2023

Due to the expanding workload of the ETP, CDER has begun implementing ETP program enhancements to improve strategy and operation and to enhance communication with those adopting new technologies. International Journal of Pharmaceutics 581 (2020). Biotechnology Progress 2020, 36 (3). 5 (2020): 14–15. doi:10.1016/j.ijpharm.2020.119297

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

pharmaphorum

SEPTEMBER 14, 2022

So, it is critical that sponsors better promote DCT models and communicate the ease of the trial experience at every touchpoint when recruiting. It is encouraging to see hybrid trials weaving in DCT solutions since and becoming the norm. However, a notable survey finding showed nearly 75% of respondents as being unaware of DCT options.

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Vaccines Medical Records Documentation Communication 98