European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. 25 In 2021 an estimated 25 million children under the age of one year did not receive basic vaccines, and the number of completely unvaccinated children increased by five million since 2019. 2019; 9:11409.

Vaccines 99

Vaccines Communication Immunization Documentation 99

ISPE

SEPTEMBER 28, 2023

billion in 2019 to $17.3 The sub-standard heights were discovered during the initial document review and site assessment. This issue was resolved using communication methods and reprogramming strategies from the TI and core and shell sides. billion in 2022.

Hospitals 98

Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 98

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published November 2019. Currently, it takes time and/or communications (e.g., The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published November 2019. Currently, it takes time and/or communications (e.g., The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. However, for certain DHTs classified as devices or SaMD, ISO 14971:2019 specifies the terminology, principles, and process for application of risk management. Is the software MDSW according to MDCG 2019-11?

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

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. Pharmaceutical Engineering (May/June 2019).

Packaging 52

Packaging Documentation Communication Data Entry 52

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. However, for certain DHTs classified as devices or SaMD, ISO 14971:2019 specifies the terminology, principles, and process for application of risk management. Is the software MDSW according to MDCG 2019-11?

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

pharmaphorum

JANUARY 27, 2023

She knows only too well how understanding the importance of patient centricity is crucial to the success of any modern life sciences company – but how has the landscape changed since 2019? “I Having the ability of these groups to be able to communicate directly with patients is tremendous.”

Pharmaceutical Companies 105

Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 105

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. For DCTs, even a small virtual component can make the trial somewhat decentralised.

Documentation 52

Documentation Communication FDA 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. Senator Chuck Grassley, along with three other senior GOP lawmakers, begins a two-year investigation of the 340B program. However, the U.S

Hospitals 96

Hospitals Insurance Omnicell Documentation 96

ISPE

SEPTEMBER 11, 2023

2 October 2019. Nature Communications 12, no. Meet Eli Lilly and Company - 2019 Facility of the Year Process Innovation Category Winner.” 11 September 2019. 6 November 2019. 12 July 2019. 3 (2019):285. BioPharm International. Benefits of Prefabricated Modular/Podular BioPharma Facility Construction.”

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

JULY 5, 2023

Two of the most significant policy developments since 2014 have been the release of the Quality Considerations for Continuous Manufacturing draft guidance in 2019 and the International Council for Harmonisation (ICH) Q13 guidance on CM of drug substances and drug products in 2023. 3 (2019): 253–67. Lee, and S. doi:10.1016/j.tibtech.2018.08.008

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

SEPTEMBER 10, 2023

Existing regulatory frameworks In the 1950s and 1960s, the WHO published documents outlining how countries should set up a regulatory framework to control pharmaceuticals and ensure the safety of their subjects. You may unsubscribe from these ISPE communications at any time. The proposals are consistent with WHO GRP. www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98

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 6 (November–December 2019). ISA 88: Batch Control.

Documentation 52

Documentation Communication 52

ISPE

JANUARY 8, 2023

Lecture Notes in Computer Science 11700 (2019) Springer, Cham. 8 April 2019. Furthermore, these outputs can support communicating the functioning of the algorithm and how it is embedded in operational procedures in an audit situation. In: Samek, W., Montavon, A. Vedaldi, L. Hansen, and K. Müller (eds.). 12 November 2018.

Communication 52

Communication Documentation FDA 52

ISPE

MAY 10, 2023

1 May 2023 Funded by the European Commission from 2019, the Smart Pharmaceutical Manufacturing Project (SPuMoNI) 1 harnesses the potential of state-of-the-art technologies for the pharmaceutical industry. You may unsubscribe from these ISPE communications at any time. Juan Miguel García-Gómez, Ph.D. Chis, Ph.D.

Dosage 52

Dosage Chemotherapy Documentation Labelling 52

The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Medical information about a patient. Other medical information.

FDA 52

FDA Labelling 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 ASHRAE Journal (2019): 38–54. Cleanrooms and Associated Controlled Environments—Part 3: Test Methods” 2019. You may unsubscribe from these ISPE communications at any time. m/s up to 0.54 link] 5 Naughton, P.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Published 2019. You may unsubscribe from these ISPE communications at any time. The assessment may also identify perception concerns. Technical Report No.

Vaccines 97

Vaccines Compounding Documentation FDA 97

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

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. Published November 2019. 22 June 2023. 3 July 2020.

FDA 52

FDA Dosage Documentation Communication 52

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

FDA 105

FDA Documentation Communication 105

European Pharmaceutical Review

NOVEMBER 9, 2022

An analysis performed at the end of 2019 concluded that demand for viral vectors would have surpassed CDMO capacity during 2020. Another factor in this enhanced adaptability is development of in-house expertise that enables more efficient interaction by simplifying communication channels.

Vaccines 95

Vaccines Documentation Communication Hospitals 95

European Pharmaceutical Review

SEPTEMBER 13, 2023

As small and medium-sized enterprises (SMEs) often face unfair competition when doing business in Europe, through the (SME) Relief Communication, the European Commission (EC) has proposed new measures to provide short-term relief, boost long-term competitiveness, and improve equality in the business environment across the Single Market in Europe.

Communication 74

Communication Documentation 74

pharmaphorum

OCTOBER 20, 2020

While remote communication with HCPs rose in all countries in the same time period, not all remote engagement was the type likely to be described as meaningful – much of the volume was in emails, with WhatsApp, and other remote messaging, also important during the peak infection period. In the US, the trend had already started pre-COVID-19.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

ISPE

MARCH 7, 2023

Published November 2019. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” 5 (2019): 517–521. [link] 4 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Press Release.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

MARCH 9, 2023

To estimate the infiltrated door flows, design documentation can be used. Air communication between rooms was only allowed via a 0.5-inch 1 1 ISO Standard 14644-3. Cleanrooms and Associated Controlled Environments—Part 3: Test Methods.” link] An equation is derived to predict the recovery time for a cleanroom that is challenged with 0.5-micron

Documentation 52

Documentation Communication 52

ISPE

MARCH 15, 2023

24 September 2019. There is an increase in those issuing a path to net zero design strategy document, which sets out design parameters covering all aspects of a project from initial concept through the commissioning, post-occupancy surveys, and audits. Wiley (2019). New Biotechnology 49 (2019): 37–42. 1 July 2019.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

pharmaphorum

MARCH 5, 2021

The Commission will also examine whether Teva may have launched a communication campaign to create a “false perception” about the health risks of prescribing generic competitors, aimed at healthcare professionals and hospitals.

Documentation 98

Documentation Communication Hospitals 98

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.” April 2019. Prototyping strategies for early feedback and alignment reduce the acceptance risks further down the development process stream. Blumenthal, I.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

OCTOBER 4, 2022

The final guidance follows the draft CDS software guidance issued on the same date in 2019. Software functions intended to display, analyse, or print medical information about a patient or other medical information (e.g.

FDA 101

FDA Documentation Labelling Communication 101

The Thyroid Pharmacist

JUNE 14, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! May 22, 2019. May 16, 2019.

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Health and Personal Care Stores Immunization Documentation Compounding 104

Pharmaceutical Technology

MARCH 30, 2023

One route to more engaged patients is clear, accessible information – but clinical trial documentation is often highly technical and full of jargon. Plain language summaries simplify clinical trial documentation, using language that any non-expert could understand. So why are so many clinical trials falling short of enrolment targets?

Documentation 99

Documentation Communication 99

The Thyroid Pharmacist

JANUARY 20, 2023

The first case is outlined in a 2019 report by Roberto Vita and his research team, and published in Revista da Associação Médica Brasileira. Markomanolaki and published in a 2019 issue of Journal of Molecular Biochemistry. Published 2019 Jul 22. Published 2019 Dec 9. Published 2019 Aug 15. vs. 398 U/mL). [1]

HIV Treatment and Prevention Agents 90

HIV Treatment and Prevention Agents Immunization Compounding Dosage 90

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition. 2019;10:864.

Dosage 83

Dosage Documentation FDA Labelling 83

Pharmaceutical Technology

JUNE 20, 2023

GlobalData forecasts that the market for AI platforms for the entire healthcare industry will reach $4.3bn by 2024, up from $1.5bn in 2019 [i]. Consent documents often describe technical medical conditions and regulatory bodies are increasing pressure on sponsors to ensure that patient-facing information can be easily understood by patients.

Medical Records 52

Medical Records Documentation Communication Dosage 52

Pharmaceutical Technology

JUNE 8, 2023

The onset of the Covid-19 pandemic was one catalyst; GlobalData social media analytics suggest supply chains received 1,908 mentions in 2019, compared with 25,636 in 2021. Supply chains are increasingly in the spotlight. Controlant’s validation of a science-based target demonstrates a clear commitment towards sustainability leadership.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 52