Pharmaceutical Commerce

JULY 16, 2025

Navigating the legal and reputational minefield for startups Navigating the burgeoning market for compounded GLP-1 alternatives presents a complex and perilous landscape for startups, laden with significant legal and reputational risks. Implement and meticulously document robust quality control and assurance processes internally.

Compounding

Pharma Marketing Network

MAY 9, 2025

These dossiers must combine: Clinical efficacy and safety data Pharmacoeconomic models Budget impact analyses Comparative effectiveness studies Health economics and outcomes research (HEOR) plays a pivotal role in generating and presenting these data. Teams that wait until launch to assemble this data often fall short in access negotiations.

Packaging

European Pharmaceutical Review

JULY 9, 2025

This collaborative approach enabled us to implement customised aseptic processing simulations and establish comprehensive documentation for API traceability before production began. Consider their communication approach, project management capabilities, and how they handle unexpected challenges—because there will be challenges.

Documentation

Pharmaceutical Technology

JULY 2, 2025

In addition, documentation of the material is required, along with clearly defined next steps for modification and expansion. Nevertheless, both present logistical challenges when operating across different regulatory environments. Sign up for our daily news round-up!

Packaging

Drug Topics

JUNE 11, 2025

1 With a complex interplay between patients’ skin and the diseases that impact it, PsD is a debilitating disease that presents physical, psychological, social, and economic burdens, leading to significant decreases in quality of life (QOL). of the population across the region,” wrote authors of the study.

Immunization

IDStewardship

DECEMBER 13, 2024

It may be derived from work completed inthe microbiology lab, unitsdispensed from the pharmacy, administrations performed by nurses, expenditures produced from drug purchases, documentation within any area of the electronic medical record, extraction from supplemental tools or data warehouses, and so much more.

Communication

STAT

FEBRUARY 23, 2023

attorney general is specifically looking at “communications with AKF, documents relating to donations to the AKF, and communications with patients, providers, and insurers regarding the AKF.” ” The probe covers everything from January 2016 to the present day.

Communication

Viseven

JULY 10, 2024

It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication. As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences.

Communication

European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

Documentation

IDStewardship

OCTOBER 14, 2024

brief report, concise communication) will provide structure guidance (number of words, figures/tables, references allowed). Some AI websites to check out include Dall-E for images, ChatGPT or Google Gemini for text, Suno for music generation, Microsoft Copilot for document analysis, and Plus for presentations. Gauthier, Pharm.D.,

Documentation

ISPE

NOVEMBER 23, 2022

The Symposium program comprised a wide range of presentations and panel discussions on GMP-related topics, which included participation from Heads of Medicines Agencies, Heads of GMP Inspectorates, official PIC/S representatives and ISPE. He indicated that PIC/S participates in the ICH Q12 implementation Working Group.

Documentation

pharmaphorum

NOVEMBER 15, 2021

That’s why the GLSP document, which has been included in EudraLex Volume 10, is just as applicable in other markets, including the UK and US, as they are in the EU. “We The text, the structure of the text, and the presentation of data needs to account for a limited understanding.”.

Documentation

Pharmacy Is Right For Me

APRIL 4, 2023

Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC). It also improves care coordination and eliminates communication gaps. It involves the training of community paramedics in performing some aspects of medication reconciliation.

Hospitals

Pharma Marketing Network

OCTOBER 13, 2021

Senior Director and Head, Scientific Communications and Operations at Biohaven Pharmaceuticals, shared advice with conference attendees on how to Navigate Getting Noticed, Hired and Promoted in a Virtual World. “Do Over-Communicate. Senior Director and Head, Scientific Communications and Operations at Biohaven Pharmaceuticals.

Communication

The FDA Law Blog

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. Table 1 below shows the 510(k) submission process based on the MDUFA III Performance Goals.

FDA

The FDA Law Blog

MARCH 7, 2023

If multiple people are reviewing and need to communicate changes it may be challenging to ensure all updates are incorporated. Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission.

Documentation

European Pharmaceutical Review

JULY 4, 2023

There are also numerous industry guidance documents for products manufactured for use in clinical trials and guidelines, some which are specific to advanced therapeutic drug products that must be consulted. Teams must also accept the variety of analytical procedures these regulatory agencies prefer.

Communication

The Checkup by Singlecare

DECEMBER 1, 2022

Assessing and communicating the regulatory guidelines for medication approval. Compiling the documents needed to obtain authorization for a new drug or designate a new indication or formulation for a previously approved drug. Presenting documents to the appropriate regulatory agency and making changes as necessary .

Pharmaceutical Companies

ISPE

FEBRUARY 14, 2023

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Know the key topics.

Documentation

The FDA Law Blog

OCTOBER 31, 2022

FDA proposes that “modern mechanisms that support clear and consistent communication of device information could facilitate efficient device review activities” and notes that they “consistently observed the need for structured data.” Despite the limitations in testing, some of the findings were noteworthy. Key Performance Indicators.

Documentation

pharmaphorum

FEBRUARY 22, 2022

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. Listen deeply, stay present and pay attention to the discussion – not an electronic device. As a participant, arrive on time, too.

Communication

Viseven

JULY 25, 2024

This includes verifying the evidence presented, the research results, and even the factual information. Compliance documentation Compliance documentation, such as pharma regulatory guidelines for audits and reviews, standard operating procedures, reports, and records, should also be verified by an MLR team.

Documentation

pharmaphorum

OCTOBER 4, 2022

4) intended for the purpose of enabling such HCPs to independently review the basis for such recommendations that such software presents, so that it is not the intent that such HCPs rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient (Criterion 4). Criterion 3.

FDA

DiversifyRx

AUGUST 23, 2024

By accurately accounting for add-backs, you can present a clearer financial picture to potential buyers or investors, thereby increasing your pharmacy’s value and cash flow. – Owner Expenses: Owner expenses charged to the business, such as personal travel or entertainment, should be excluded to present a true financial picture.

Independent Pharmacies

The FDA Law Blog

JUNE 27, 2023

FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission. There are drawbacks to the current communication channels: 1.)

FDA

pharmaphorum

NOVEMBER 20, 2020

Behind the Mask is a global research initiative to document health experiences during the COVID-19 pandemic and beyond. Havas Health & You (HH&Y) has launched the details of a long-term global research project, Behind the Mask, a longitudinal, multi-armed study that focuses on documenting the ongoing evolution of health and wellness.

Documentation

The FDA Law Blog

JUNE 8, 2023

The pandemic had changed the way people live, work and communicate. A teleconference will be conducted by voice only with no projection of presentations or use of video/camera; a videoconference would involve sharing a screen so that a presentation can be viewed by all participants and/or involve the use of video.

FDA

The FDA Law Blog

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Two licensed pharmacists must directly communicate the transfer. By Larry K. The content and prescription information elements required by 21 C.F.R.

Controlled Substances

DiversifyRx

MARCH 16, 2023

Be Present : Give your full attention and effort to the meeting or topic at hand. Provide them with the Parking Lot document HERE to supercharge your action! You can get more from your team and help them feel fulfilled by increasing communication with them as a group and one-on-one.

Customer Service

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. Each member organization has one vote.

Community Pharmacies

Roots Analysis

AUGUST 9, 2023

Integrating advance tools and technologies with manufacturing execution system (MES) ensure smooth communication within different production process, enhance decision making capability of MES and also enhance risk prediction capabilities.

Documentation

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

European Pharmaceutical Review

MARCH 12, 2024

Good documentation practices. Following good documentation practices (GDP) throughout all stages of data generation, collection, analysis and reporting is vital. This involves keeping accurate and up-to-date records, documenting any deviations and corrective actions, and providing sufficient training to employees on GDP standards.

Documentation

The deprescribing.org Blog

APRIL 14, 2021

Providing good clinical care can be challenging as community pharmacists often don’t have access to useful resources, such as electronic health records. Communicating with prescribers, typically located offsite, can also have its challenges. Document, document, document. Discharge medication reviews. v=0Gb7Zs4ndXU.

Community Pharmacies

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.

Documentation

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 green guides, which have been developed through multi-stakeholder feedback, set out actions that pharmacy staff and settings can achieve to help the NHS meet its net zero targets.

Hospitals

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.

Documentation