ISPE

MARCH 20, 2023

The Challenge New approaches and technical possibilities are constantly being developed to enable systems to communicate with each other and exchange data. Checklist 1 offers detailed guidance by allocating and documenting the responsibilities in the affected processes and overall system context.

Documentation

The FDA Law Blog

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,

FDA

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Gilenya is an oral medication for multiple sclerosis. 10,633,344.

Documentation

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.

Community Pharmacies

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.

Communication

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.

Documentation

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.

Documentation

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

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.

Documentation

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.

Documentation

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?”

Packaging

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.

Specialty Pharmacies

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.

FDA

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.

Insurance Coverage

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.

FDA

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.

Medical Records

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.

FDA

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.”

Documentation

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.

Pharmaceutical Companies

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.

Communication

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

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).

Documentation

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.

Pharmaceutical Companies

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?

Documentation

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.

Chemotherapy

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

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

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.

FDA

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.”

Packaging

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

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.

Labelling

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.

Packaging

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.

Communication

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

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.

Communication

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.

Documentation

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.

Communication