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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ISPE

NOVEMBER 2, 2022

Jörg Zimmermann, International Board Chair for 2021–2022 and Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co., ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Past Chair.

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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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PQA

JUNE 27, 2024

The measure concept continued through PQA’s multistakeholder, consensus-based development process, and the Specialty Pharmacy Turnaround Time [Pharmacy] (SP-TAT-PH) pharmacy quality measure was endorsed through a PQA membership vote in 2021. Meeting patients where they are” can help to improve communications and ultimately reduce TAT.

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Viseven

JULY 26, 2022

billion in 2021. Mobile apps can help healthcare workers remember their daily tasks, browse the documentation, and optimize communication within their teams. It will streamline HCPs’ workflows, improve their productivity, and maintain communication agility with patients. Remote communications.

Health and Personal Care Stores 52

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published 15 November 2021. 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.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published 15 November 2021. 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.

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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 Eurostat (2022) “How many citizens had basic digital skills in 2021?”

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The Checkup by Singlecare

DECEMBER 26, 2023

It was first approved in December 2021. Some key elements pharmacists should be aware of when it comes to pharmacy laws and interchangeable biosimilars may include: Provider notification/permission: Communicating with prescribing healthcare providers may often be necessary when substituting a biologic medication for a biosimilar.

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The Checkup by Singlecare

SEPTEMBER 22, 2023

continues to impact BIPOC individuals and contribute to documented racial and ethnic disparities in health care. It’s worth considering how you can do so, such as through building trust and open communication. PLoS One (2021) The post How to take care of your BIPOC patients appeared first on The Checkup.

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The contents of the document are currently non-binding, but once finalised will represent the current thinking of the agency.

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Pharmaceutical Technology

JUNE 20, 2023

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. Can AI transform document translation? In clinical trials, the use of plain language for participants is essential.

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The FDA Law Blog

NOVEMBER 2, 2023

The absence of standards was a focal point of the Cellular, Tissue and Gene Therapies Advisory Committee Meeting in September 2021 that was convened to discuss the toxicity risks of AAV vector-based gene therapy products.

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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 Published March 2021. 2 Prager, C. GxP Systems on AWS.”

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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. But lack of investment in the right expertise and technology was the main hurdle cited by 37% of respondents in 2022, a significant rise from 25% in 2021.

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ISPE

JANUARY 8, 2023

21 April 2021. Furthermore, these outputs can support communicating the functioning of the algorithm and how it is embedded in operational procedures in an audit situation. In this process, documentation regarding the decisions made is important to justify the model and explainability mechanism selection in an audit context.

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

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ISPE

JANUARY 9, 2023

It was time for ISPE to update this key guidance document to reflect technological progress. 1 June 2021. North Bethesda, MD: International Society for Pharmaceutical Engineering, 2021. You may unsubscribe from these ISPE communications at any time. Facts About the Current Good Manufacturing Practices (CGMPS).

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Pharmaceutical Technology

MAY 23, 2023

In April, the pilot-level Nordic Pharmaceutical Forum (NPF) initiative, representing Finland, Iceland, Norway, Sweden, and Denmark, released an updated strategy document outlining the region’s plans to establish a joint procurement mechanism for medicines, with a declared focus on advanced therapy medicinal products (ATMPs) such as gene therapies.

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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. Free Report How is the Biopharmaceutical industry evolving?

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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. Big Data Research 24 (15 May 2021): 100172. González-Vélez, J. García-Gómez, et al.

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ISPE

MARCH 7, 2023

10 May 2021. Company standards for various aspects of environmental sustainability should be defined in technical documents and procedures that complement Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc. October 2021. Gerber, and K.

Health and Personal Care Stores 52

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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. 11 June 2021. 22 June 2023. EMA/321483/2020.

FDA 52

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ISPE

SEPTEMBER 12, 2022

And I'd like to make industry aware of a PIC/S document that's intended to guide inspectors on good data governance practices. Data integrity citations in fiscal year 2021 dropped significantly, and the lack of physical inspection is widely considered part of the reason. The draft was issued in December 2021. Alonza Cruse.

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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.,

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ISPE

MARCH 15, 2023

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. 14–25 (November–December 2021). 25 February 2021. 14 Whitford, W. AI’s Promise for ATMPs.”

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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.” However, it is important to critically reflect the decisions made so far, as more understanding of the use case will be gained once the first models are evaluated.

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ISPE

MARCH 7, 2023

9 December 2021. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” million Implementation Globally At product launch Up to 5 years from first stability set down 1 The IQVIA Institute. The Global Use of Medicines 2022.” Dahlbo, and P.

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Digital Pharmacist

NOVEMBER 21, 2022

b) Marketing and Communications Oversight. Medicare beneficiaries will be secured by CMS’s finalization of revisions to marketing and communications regulations that will guarantee they get accurate and understandable information about their coverage. Remind patient regarding preventive services and other communications.

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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.

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pharmaphorum

SEPTEMBER 15, 2021

That’s according to the European Federation of Pharmaceutical Industries and Associations (EFPIA), which has detailed the organisation’s 2021 Connecting Healthcare Awards winners in its fourth annual Health Collaboration Guide. Today’s healthcare challenges are complex and require the skills and perspectives of diverse stakeholders.

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The Happy PharmD

SEPTEMBER 15, 2024

Since 2021, pharmacy-related organizations have been addressing stress and burnout in the profession. The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue. Despite this report being from 2021, the issue still hasn’t been resolved.

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ISPE

OCTOBER 28, 2022

The writing of requirements, design documentation, and test scripts, and the configuration of hardware and software, can be conducted from home. Audio-visual communication. Text communication. Technology and communications requirements. Technology and communication requirements. Table 3: Codes. Advantages.

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pharmaphorum

OCTOBER 5, 2021

This was also one of the key messages from the recent Healthcare Automation and Digitalization Congress (AUTOMA+) 2021, at which I led a round-table discussion on the ‘prevention versus treatment’. They want to be involved, proactive contributors to their own health, with access to their own health information.

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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. Internet] WHO.

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Pharmaceutical Technology

MAY 31, 2023

The proposed “ Patient Medication Information ” guide would be an FDA-approved, one-page document that includes the necessary information for patients to understand the drug product and how to use it. The agency also aims to prevent misinformation and disinformation with this clearer form of patient communication.

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ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Is the software performing an action on data different from storage, archival, communication, or simple search?

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