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. However, there is still some use of remote patient monitoring technologies.

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ISPE

FEBRUARY 14, 2023

ISPE’s Regulatory Commenting Process Trudy Patterson Tue, 02/14/2023 - 16:19 iSpeak Blog iSpeak ISPE’s Regulatory Commenting Process Wendy McGhee 14 February 2023 What is Commenting? After a thorough internal review, health authorities sometime release a document for public comment. Give specific examples to illustrate concerns.

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The FDA Law Blog

APRIL 25, 2023

This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Timeline Section 524B became effective on March 29, 2023.

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The FDA Law Blog

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic had changed the way people live, work and communicate. CDER and CBER CDER and CBER announced they would resume in-person face-to-face (FTF) industry meetings on February 13, 2023.

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PQA

DECEMBER 1, 2023

In support of this goal, PQA has performed a review of its bylaws and proposes revisions which modernize and streamline this important governing document. If community pharmacists can easily collect these data, they can be an effective resource to promote clinical trial diversity. This webinar is supported by PQS. Learn more.

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PQA

SEPTEMBER 30, 2024

Today, we published the 2024 PQA Annual Report, which documents our progress towards our strategic goals. It is a collection of accomplishments from September 2023 to August 2024 and captures the efforts of our members and staff over the past year. Members can join our email list to receive updates from PQA! 

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Specialty Pharmacies Documentation Communication 52

The FDA Law Blog

JUNE 27, 2023

On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH. Any comments to the public notice must be submitted by August 11, 2023. There are drawbacks to the current communication channels: 1.)

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ISPE

APRIL 19, 2023

An effective project manager understands the associated processes of the critical systems/equipment under test and is able to identify any issues/misalignments with expectations that may compromise the qualification performance of another system or equipment and communicate/correct them accordingly. For example: 1.

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The FDA Law Blog

AUGUST 9, 2023

48365, 48369 (July 27, 2023). Two licensed pharmacists must directly communicate the transfer. As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies.

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The Checkup by Singlecare

APRIL 5, 2024

“Commonly, BCBS requires proof of a diagnosis of Type 2 diabetes and documentation that the patient has not adequately responded to other diabetes medications before approving Ozempic,” he says. When BCBS covers Ozempic, the out-of-pocket costs will vary based on the drug tier it falls in.

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The FDA Law Blog

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

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Hospital Pharmacy Europe

NOVEMBER 2, 2023

To support the documents, in spring 2024 the RPS will launch a Greener Pharmacy Toolkit, allowing pharmacies to self-accredit their sustainability status. The online consultation will run until 8 November 2023.

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ISPE

NOVEMBER 28, 2022

The Advancing Pharmaceutical Quality, Quality Management Maturity Program includes five guidance documents: Corrective Action and Preventive Action (CAPA) : ICH Q10 demonstrates defined requirements for a robust corrective action and preventive action system throughout the product lifecycle. Internal Communication. CAPA Effectiveness.

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The FDA Law Blog

FEBRUARY 28, 2023

The general structure of our submissions, and of many others that we have seen, is to have a document for each of the twenty sections and then to refer to other files, such as labeling and test reports, as attachments. Several sections of the eSTAR templates have questions that walk through related guidance documents.

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Documentation Labelling Communication FDA 52

IDStewardship

APRIL 13, 2023

BCPS, BCIDP Article Posted 14 April 2023 In 2014 CDC released the Core Elements of Hospital Antibiotic Stewardship Programs (Core Elements) to help hospitals increase infection cure rates while reducing treatment failures, C. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023.

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pharmaphorum

FEBRUARY 28, 2022

UK Health Secretary Sajid Javid has said he wants to accelerate the rollout of electronic patient records (EPR) in the NHS, with 90% of NHS trusts using them by the end of 2023. Other digital initiatives will include greater use of remote monitoring of patients to allow them to be cared for in their own homes.

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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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IDStewardship

SEPTEMBER 2, 2022

These updates go into effect January 2023 and can be found here. CMS also mentions guidelines several times in their 22-page document on new antimicrobial stewardship requirements for hospitals. We need to stop thinking of guidelines as flat, text documents resembling journal articles.

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PQA

JUNE 27, 2024

Measure rates were calculated at baseline (October 2021 – September 2022), midpoint (October 2022 – March 2023) and endpoint (October 2022 – September 2023) for each specialty pharmacy organization’s participating pharmacies. Meeting patients where they are” can help to improve communications and ultimately reduce TAT.

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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 References European Commission, (26 April 2023). Euractiv (6 October 2023).

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ISPE

MARCH 16, 2023

During the 2023 ISPE Europe Annual Conference , you will have the opportunity to explore all these topics in details. The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination.

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ISPE

NOVEMBER 2, 2022

The gavel passed to a new International Board Chair and ISPE leaders shared 2022 achievements and plans for 2023 at the 2022 ISPE Membership Meeting and Awards Lunch. Highlights were presented about what to expect in 2023 from ISPE leadership and Board members, and recipients of the 2022 ISPE International Honor Awards were announced.

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Documentation Compounding Communication FDA 52

ISPE

MARCH 8, 2023

ISPE Briefs: New Guide Promotes Cultural Excellence Trudy Patterson Wed, 03/08/2023 - 10:07 InTouch March / April 2023 ISPE Briefs: New Guide Promotes Cultural Excellence Marcy Sanford 1 March 2023 Cultural excellence is the expressed and implied ways in which an organization operates. What do you love about your job?

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The FDA Law Blog

FEBRUARY 27, 2023

That emergency declaration is set to expire on May 11, 2023. 180 days past May 11, 2023) for those telemedicine relationships established during the COVID-19 emergency. Helpful practitioner prescribing guidance is set forth in a simplified document here. 21 U.S.C. § 802(54)(D)(i). Stay tuned.

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European Pharmaceutical Review

NOVEMBER 9, 2022

Another factor in this enhanced adaptability is development of in-house expertise that enables more efficient interaction by simplifying communication channels. Technology transfer of the process from development to manufacturing involves generating a wide variety of documentation, data and training.

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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.

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ISPE

SEPTEMBER 28, 2023

Navigating Life Sciences Construction in California Trudy Patterson Thu, 09/28/2023 - 11:40 iSpeak Blog iSpeak Navigating Life Sciences Construction in California Gul Dusi 28 September 2023 Few industries have as deep a footprint in California, USA as life sciences. billion a year.

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The FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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ISPE

JULY 24, 2023

For example, HTTPS should be used for encrypted communication between the web browser and the cloud application, and the system should be designed with multi-tenant architecture to isolate each customer’s data.

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The FDA Law Blog

NOVEMBER 15, 2022

The small business fees for FY 2023 can be found here. If you would like to request for FY 2023 status, you can submit an application through September 30, 2023. To submit a small business certification request: Collect tax documentation. Send documents to FDA. Submitting a Small Business Certification Request.

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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. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Nat Biotechnol. Injection Safety Fact Sheet. Internet] WHO.

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ISPE

MAY 11, 2023

™ Roadmap Trudy Patterson Thu, 05/11/2023 - 13:25 Technical May / June 2023 Methodology to Define a Pharma 4.0™ ™ Roadmap Emmie Heeren AREND JAN WASSINK Venkateshwar Rao Nalluri, PhD Sebastian NIEDERHAUSER 1 May 2023 In the context of data integrity, data flows are essential. Methodology to Define a Pharma 4.0™ initiatives.

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ISPE

SEPTEMBER 1, 2023

For example, HTTPS should be used for encrypted communication between the web browser and the cloud application, and the system should be designed with multi-tenant architecture to isolate each customer’s data.

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Communication Documentation 98

ISPE

JULY 19, 2023

™ Is Gaining Momentum and Driving Innovation Trudy Patterson Wed, 07/19/2023 - 08:17 Online Exclusives July / August 2023 Pharma 4.0™ ™ Is Gaining Momentum and Driving Innovation Thomas ZIMMER, PhD 19 July 2023 The fifth Pharma 4.0™ and management communication strategy. ISPE Pharma 4.0™ Information Systems DI Pharma 4.0™

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The Checkup by Singlecare

OCTOBER 30, 2023

Carefully read these documents as they contain important safety information, including information about interactions. Additionally, communicate with your providers about any side effects you’re experiencing, even if you aren’t sure if they are related to escitalopram. In some cases, side effects may be related to a drug interaction.

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The FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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Hospital Pharmacy Europe

JANUARY 11, 2024

A systems approach recognises the roles that all specialties play in patient care and encourages open communication that avoids practices that unnecessarily separate different aspects of the fluid management team into independent parts. Ann Intensive Care 2023 Sep 25;13(1):89 Miller TE, Myles PS.

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