The FDA Law Blog

DECEMBER 12, 2022

It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop. or other similar or related article” which is “intended for use in the diagnosis of disease or other conditions.” General Wellness: Policy for Low Risk Devices.

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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.

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pharmaphorum

NOVEMBER 23, 2020

I saw a statistic in a Health Europe article, published in September this year, which reported that 81% of patients do not feel listened to by pharma companies. Through this outcomes measurement tool, patients keep comprehensive diaries of their condition, documenting what aspects of the disease affect them most. About the author.

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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 11 This requirement directly contradicts what is included in Article 63.

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European Pharmaceutical Review

OCTOBER 3, 2024

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety.

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Hospital Pharmacy Europe

JUNE 8, 2023

In the absence of transparency, he felt that both the pre-publication reviewers and those reading the final published article would not be aware of any retrospective protocol modifications and thus be unable judge the reliability of the final results. Nevertheless, it is incumbent on trialists to communicate such changes.

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Viseven

AUGUST 7, 2024

If you read this article, you probably dream of getting your foot in the door with medical writing. Medical writing refers to creating healthcare-related textual content that aims to improve doctor-patient communication and provide insights on industry topics. Or maybe you are an employer eager to add a medical writer to the crew.

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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. A version of this article was originally published by our sister publication The Pharmacist.

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Viseven

DECEMBER 4, 2024

This article will discuss pharmaceutical validation, its benefits, types, and basic recommendations. It also requires documenting the entire process, from raw material sourcing to product launch. Process design should be based on solid evidence and include thorough documentation. Keep on reading!

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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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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.

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Viseven

SEPTEMBER 6, 2024

In our new article, you will learn more about data integrity in the pharmaceutical and life sciences industry and why maintaining it matters so much. Key Principles of Data Integrity In the 1990s, the FDA developed a list of principles of data integrity, which still serve as a framework for working with data and documenting it.

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ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. It supports the analysis of Industry 4.0 initiatives.

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DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. The original article can be found HERE. The DSCSA Adventure continues. Identifiers All products received must contain a product identifier.

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Viseven

JULY 26, 2022

In this article, you’ll find more about mobile health app development, its enormous role in HCPs engagement, and the principal outcomes of including mHealth apps in your multichannel or omnichannel marketing strategy. It will streamline HCPs’ workflows, improve their productivity, and maintain communication agility with patients.

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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. Articles can be 400 to 1,000 words.

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Hospital Pharmacy Europe

NOVEMBER 27, 2024

Instead, they would be asked to support their trainee in ‘core foundational prescribing skills’, such as history taking, shared decision-making, basic physical examinations and documentation. Think about history taking, basic physical examination, documentation, communication… these things haven’t changed, really, for decades.

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The Digital Apothecary

APRIL 26, 2019

Most of the time they want to pick my brain on where pharmacy is going or what could be possible, so with that being the case, I thought it would be better to put this article together that may help potentially interested parties. Even some of the most recent pitches are very similar to each other I feel. So let's get started!

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Viseven

JULY 12, 2022

These categories can include short articles about news and updates in your company (its services and products), research-based long reads, infographics about industry trends, and beyond. It can be case studies about clinical research, articles that contain statistics, interviews with clients (or patients), and beyond. Post regularly.

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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. Sherwood Article of the Year Award.

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DiversifyRx

NOVEMBER 24, 2023

If you think that doesn’t happen nowadays, here’s an article about recent counterfeit HIV medications. This record-keeping includes detailed documentation of the product’s history and movement through the supply chain. Collaborate with Suppliers Establish clear communication and collaboration with your wholesalers.

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Independent Pharmacies Packaging Documentation FDA 40

The Checkup by Singlecare

OCTOBER 30, 2023

It’s important to note that this article doesn’t provide a complete list of all escitalopram interactions. Carefully read these documents as they contain important safety information, including information about interactions. This article does not provide a complete list of all escitalopram interactions.

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Viseven

SEPTEMBER 18, 2024

In this article, we will explore the main use cases for cloud computing in pharmaceutical industry, its benefits, and the challenges that still need to be addressed. Cloud computing facilitates effortless collaboration Cloud computing makes it easier for life sciences companies to communicate and collaborate globally.

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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. Prior to e-procurement, GlaxoSmithKline (GSK) , a global pharma brand, used old school paper cataloguing and communications over the phone.

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Viseven

JULY 11, 2023

In this article, we’ll explore typical cases of healthcare companies using Salesforce, review the functionality of Salesforce CRM and the solutions for different sectors within life sciences and healthcare, and discover how Salesforce supports healthcare companies and communities. Salesforce Healthcare Benefits – Are They Real?

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ISPE

JULY 10, 2023

For the sake of readability, we will use it interchangeably for both interpretations throughout the article. Our article concludes with an outlook on how the use of LLMs may evolve, beyond the current hype. ChatGPT is commonly used to refer to the chatbot web interface, and the underlying model.

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The Physician Pharmacist

JULY 30, 2022

In this article we will cover everything you need to know to not only excel during interview season, but build up personal confidence that you will carry throughout your medical career! Accepting Your Interviews : This probably goes without saying, but every single interaction/communication you have with a program can leave an impression.

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ISPE

MARCH 9, 2023

This article discusses the use of CFD for the purpose of predicting and optimizing the performance of a cleanroom facility in terms of steady-state airborne particulate levels and for estimating the recovery time to a particulate challenge per ISO 14644-3. To estimate the infiltrated door flows, design documentation can be used.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g., The authors propose using Module 2.3 Published 15 November 2021.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g., The authors propose using Module 2.3 Published 15 November 2021.

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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. This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America.

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ISPE

OCTOBER 26, 2022

This article outlines a broad framework to evaluate different types of modalities that may be accommodated concurrently in a new or existing facility and then uses a case study to explain how the approach may be applied to an existing facility. For the purposes of brevity, this article doesn’t discuss safety.

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ISPE

JANUARY 8, 2023

In this article, we elaborate on the benefits and requirements on xAI from a GxP point of view, along with the development and production process, with a focus on strategies to ensure that the intention of use is met and to manage risks for safety that arise from xAI itself.

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ISPE

SEPTEMBER 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities. Nature Communications 12, no. Biotechnology Progress 36, no.

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ISPE

NOVEMBER 3, 2022

Okudaira of PMDA agreed that communications may be a driving force of acceptance of new models, and also establishing international convergence documents may help. This was successful, he said, and EMA learned that communication is important between regulators. Communication is the key piece.”.

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ISPE

SEPTEMBER 11, 2023

This article provides background knowledge from literature and data from experiments to enhance the discussion. The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45

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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., Accessed 7 September 2021.

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