ISPE

MARCH 8, 2023

To learn more about APQ Guides and other ISPE Guides, visit ISPE.org/publications/guidance-documents Learn More & Buy Meet the ISPE Staff: Tina Li In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. What do you love about your job?

Documentation 52

Documentation Communication 52

Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

ISPE

SEPTEMBER 1, 2023

In the event of inaccessibility, a business continuity plan should be in place including potential production risks and decision tree. Furthermore, there should be an evaluation of the cloud service provider to verify potential impact to product quality and/or data integrity in the event of inaccessibility.

Communication 98

Communication Documentation 98

PQA

FEBRUARY 23, 2023

From technical expert panels, stakeholder advisory meetings, the measure endorsement vote and convening events focused on future measure opportunities, PQA members have the opportunity to be involved each step of the way! Additional details about this PQA Convenes event will be shared in the coming months.

Specialty Pharmacies 40

Specialty Pharmacies Documentation Communication 40

DiversifyRx

OCTOBER 20, 2022

’ You want to ensure that you document the attestation every time you dispense the at-home COVID tests for a patient. Giving your community access to these tests will help reduce uncertainty about what may be causing their symptoms. People don’t want to needlessly isolate themselves and miss work and life events.

Insurance 98

Insurance Packaging Documentation Communication 98

ISPE

JULY 24, 2023

Data loss if local servers are damaged or destroyed in a system outage, natural disaster, ransomware attack, or other loss event. 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.

Communication 98

Communication Documentation 98

The Happy PharmD

JANUARY 18, 2023

By leveraging these events, you can get on the radar of employers early in the year. Apply the power of job crafting to create a new job after communicating your strategy for solving a problem in the firm. What does a successful job seeker do during the holidays? You lean into the holiday feel.

Documentation 52

Documentation Communication 52

pharmaphorum

SEPTEMBER 23, 2020

That’s according to the team at Sweden’s Sahlgrenska Science Park, who are getting ready to host a virtual event looking at how the specialisation of digital expertise is driving a trend of sector convergence that pharma is only just cottoning on to. Innovation versus regulation. For more information visit the Park’s website.

Documentation 140

Documentation Communication Hospitals 140

European Pharmaceutical Review

SEPTEMBER 26, 2023

Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon. In this role, Graeme is responsible for all pharmacovigilance (PV) systems that facilitate adverse event data collection and reporting.

Documentation 105

Documentation Data Entry Pharmaceutical Companies Pharmaceutical Companies 105

Pharmaceutical Technology

FEBRUARY 28, 2023

This document delves into the history of chromatography and clarification, addresses problems, proposes solutions, and offers a glimpse into what the future may look like after a revolution in biopharma production processing.

Documentation 94

Documentation Communication 94

ISPE

NOVEMBER 23, 2022

ISPE Represented at PIC/S 50th Anniversary Event. ISPE Represented at PIC/S 50th Anniversary Event. Continue active cooperation with strategic partners , encourage PIC/S membership and strengthen PIC/S communications and engagement. Trudy Patterson. Wed, 11/23/2022 - 06:50. iSpeak Blog. 23 November 2022.

Documentation 98

Documentation FDA Communication 98

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.”

Documentation 44

Documentation FDA Labelling Communication 44

Pharmaceutical Technology

MARCH 22, 2023

This document delves into the history of chromatography and clarification, addresses problems, proposes solutions, and offers a glimpse into what the future may look like after a revolution in biopharma production processing.

Documentation 52

Documentation Communication 52

DiversifyRx

SEPTEMBER 7, 2023

Provide answers to common queries such as appointment requirements, walk-in availability, duration, costs, required documentation, and operating hours. Email Marketing to Grow P OCT Email marketing enables direct communication with patients, fostering engagement and trust. Consistency is key.

Health and Personal Care Stores 40

Health and Personal Care Stores Independent Pharmacies Documentation Communication 40

ISPE

MARCH 16, 2023

The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. Some of these challenges include for example regulatory compliance, quality control and effective communication between the original manufacturer and the CMO.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation Compounding 98

ISPE

JULY 19, 2023

The framework conditions for this VUCA world have become more acute: Pandemics and geopolitical events are causing fragile and complex supply chains to collapse. and management communication strategy. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance? Information Systems DI Pharma 4.0™

Documentation 98

Documentation FDA Communication Labelling 98

ISPE

NOVEMBER 2, 2022

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. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong.

Documentation 52

Documentation Compounding Communication FDA 52

Viseven

JULY 11, 2023

Scale Member Management solution allows different types of managers to improve their cooperation, guide members through their journey, and improve health outcomes using a complete view of the customer, which provides relevant member information such as preferences, member plans, and health timelines showing clinical and customer service events.

Health and Personal Care Stores 40

Health and Personal Care Stores Scheduling Appointments Communication Documentation 40

Viseven

JULY 12, 2022

Generate leads by inviting professionals and non-experts to online events to discuss various topics and trends. Tell how your team participates in offline healthcare events such as conferences and presentations. In such an app, doctors can store documentation, track patient visits, provide instructions, and beyond.

Communication 52

Communication Documentation Hospitals 52

Pharmaceutical Technology

JUNE 15, 2023

For example, important information may be locked in knowledge silos or gained through experience, making it difficult to find or document. When R&D teams can easily share and access key information across the enterprise, such as recruitment data or trial results, they improve communication and collaboration while avoiding duplicate work.

Compounding 52

Compounding Adverse Reactions Documentation Data Entry 52

The Checkup by Singlecare

MAY 1, 2024

Untreated hearing loss impacts every area of life—from talking with relatives and attending social events to day-to-day interactions like paying bills. Necessary documentation and information Financial assistance programs may require proof of income. However, hearing aids may be pricey. Among the 28.8

Health and Personal Care Stores 85

Health and Personal Care Stores Insurance Insurance Coverage Communication 85

Pharmaceutical Technology

JANUARY 20, 2023

This document delves into the history of chromatography and clarification, addresses problems, proposes solutions, and offers a glimpse into what the future may look like after a revolution in biopharma production processing.

Documentation 52

Documentation Communication 52

Viseven

SEPTEMBER 14, 2023

Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. Regions which were once the sources of raw materials may be plagued by adverse weather events, hindering production and causing inflated costs.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmacy Procurement 52

Hospital Pharmacy Europe

JANUARY 11, 2024

In previous questionnaire-based analyses of clinicians responsible for fluid management – and with experience levels ranging from trainees to experienced clinicians – fluid management knowledge scores were low, and most participants reported having experienced unreported fluid-related serious adverse events.

Hospitals 105

Hospitals Patient Care Documentation Communication 105

Viseven

SEPTEMBER 13, 2024

For example, going “paperless” and moving all of the documentation to the cloud and keeping only electronic documents from now on can be considered a part of digital transformation. Communication platforms (e.g., This often means switching from usual solutions to new, more advanced ones. Digital Content Factory ).

Documentation 52

Documentation Communication 52

pharmaphorum

FEBRUARY 11, 2021

The online event also heard from Pfizer and patient advocate representatives and looked at how the NIHR’s collective approach allows life sciences firms to engage with patients while remaining aligned with ethics guidelines and codes of conduct – providing a UK solution to a global problem.

Communication 101

Communication Documentation Hospitals Vaccines 101

pharmaphorum

OCTOBER 4, 2022

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Software functions intended to display, analyse, or print medical information about a patient or other medical information (e.g.

FDA 105

FDA Documentation Communication Labelling 105

pharmaphorum

SEPTEMBER 15, 2020

The huge rise in the use of telemedicine services during lockdown has brought care directly to patients in their homes, while pharma’s communications with healthcare professionals (HCPs) has experienced a similar push to digital channels. About the interviewees. Joe Holmes – vice president of marketing services.

Communication 130

Communication Documentation Labelling Vaccines 130

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.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

The Infectious Pharmacist

AUGUST 1, 2021

All I have is news reports including one of an internal CDC document. Perhaps you’ve read about data from Israel documenting effectiveness of only approximately 30-60% of the Pfizer vaccine against the Delta variant? This town hosted multiple events with large public gatherings that attracted thousands of out-of-town visitors.

Vaccines 52

Vaccines Documentation Hospitals Communication 52

ISPE

JANUARY 8, 2023

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 52

Communication Documentation FDA 52

ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. Biotechnology Progress 36, no. 3 (2020):e2970. 34 Maschan, M., 1 (2021):7200. 35 Anguille, S., 36 Sterling, J. 22 March 2018.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 7, 2023

Interim targets for end goals should therefore be set to challenge conventional “straight-line” planning (as shown in Figure 1), which will miss the end goal if some unforeseen event disrupts progress unless a heroic effort is made to recover performance (the so-called “hockey-stick” performance profile). Leave this field blank

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

Hospital Pharmacy Europe

MAY 9, 2024

Opening his talk on LLMs, he noted that according to the World Economic Forum, misinformation and disinformation are currently the top short-term global risks , ahead of extreme weather events. In microbiologically documented HAIs, 32% of microorganisms were resistant to antimicrobials. The survey revealed that approximately 4.3

Hospitals 52

Hospitals Communication Clinic Management Documentation 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? Wireless medical devices. Is the action for the benefit of individual patients?

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

The FDA Law Blog

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. If FDA determines that a waiver will be issued, it may consider public communications about the decision.

FDA 57

FDA Communication Documentation Labelling 57

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? Wireless medical devices. Is the action for the benefit of individual patients?

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52