ISPE

AUGUST 15, 2023

This conference will host six tracks on two significant topics for the pharmaceutical industry: 1) Pharma 4.0™ The presentation will explain a step-by-step approach to CCS, including gathering detailed data about process-related risks and implementing appropriate risk control measures. ™ and Annex 1 Conference on 11-12 December 2023.

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European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

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ISPE

MAY 10, 2023

Developed by a multinational team of experts consisting of engineers, toxicologists, hygienists, and analysts from major pharmaceutical companies and suppliers, the guide aims to consolidate this widely dispersed knowledge base into one document.

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pharmaphorum

OCTOBER 20, 2022

Executing an effective commercial success strategy requires extensive planning and implementation within pharmaceutical companies that spans teams, functions, and geographies. How can we take an innovative approach to drive commercial success across the pharmaceutical industry? Commercial excellence requires thoughtful planning.

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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. Problem Identification. CAPA Effectiveness.

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ISPE

JULY 6, 2023

1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 Although CM technology has been around for decades, it does present some novel challenges to the pharmaceutical industry, especially when the goal is to supply therapeutics globally.

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European Pharmaceutical Review

FEBRUARY 1, 2024

Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.

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Viseven

JANUARY 13, 2023

So what do exactly HEOR experts do for the pharmaceutical companies and what HEOR-collected data is used for? HEOR collects all reports about health outcomes from patients and physicians and later provides detailed analytics to healthcare providers, clinical outcomes research institutions or pharmaceutical companies.

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ISPE

NOVEMBER 1, 2022

The opening presentations on 31 October made it clear that in-person conference attendance is back in a big way, with more than 2,000 attendees from over 30 countries and more than 200 exhibitors at the meeting in Orlando, Florida. Many of the presentations, including all keynote presentations, were also available for virtual attendees.

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Viseven

NOVEMBER 17, 2022

The role of medical affairs in pharmaceutical companies. Medical affairs experts represent pharmaceutical companies and facilitate them in maintaining the flow of information within the medical communities. New medical affairs employment opportunities are also rising, indicating a revolution in pharmaceutical industries.

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pharmaphorum

AUGUST 31, 2021

Christopher Boone, global head of health economics and outcomes research at AbbVie, advises: “Evidence generation in drug development is ripe for innovation in the digital era and the expanded use of real-world evidence presents a clear enabler to saving time and money. Furthermore, ECAs are well-documented in the post-approval setting.

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pharmaphorum

JANUARY 9, 2023

The battle between harmonisation and fragmentation is often finely balanced, but at present, it seems to be tipping more to fragmentation. The presumption that an increasingly globalised pharmaceutical industry is inevitable will be tested in 2023. More remains to be addressed, and not just by conventional pharmaceutical companies.

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European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. The responsibility of printing paper leaflets is currently a key regulatory obligation for pharmaceutical companies. They detail the medication’s intended use, proper administration, potential side effects and precautions.

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pharmaphorum

SEPTEMBER 28, 2022

” All of Us researchers tested participants’ blood samples donated between January and March of 2020 and found that COVID-19 was present in five US states – earlier than scientists initially thought. Martin is also the primary author of the pivotal FDA guidance document Collection of Race and Ethnicity Data in Clinical Trials.

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European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. ” Tony Cundell: Contract manufacturing organisations (CROs), start-up companies, established pharmaceutical companies and regulatory agencies are having difficulty recruiting and retaining technically-trained personnel.

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European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

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pharmaphorum

OCTOBER 5, 2021

Firstly, there is an ever-present need to reduce healthcare costs. On the patient-facing side, you can adopt wearable, connected devices or ePRO strategies for remote patient monitoring, to ensure the treatment team has well-documented patient information between visits, or you can delve into digital therapeutics. About the author.

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ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

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ISPE

JULY 6, 2023

One of the most important components of SRM is the company’s risk appetite statement. This document is approved by the firm’s board of directors and sets the tone for risk-taking at the company by key risks and setting risk tolerances for how much risk the board is willing to take across all business activities.

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Pharma Marketing Network

APRIL 30, 2021

In a separate panel, Jenn Horonjeff, PhD, who is founder and CEO of Savvy Cooperative, stressed the importance of pharmaceutical companies engaging with those communities in culturally-sensitive ways. Another underserved population is those living in rural communities.

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ISPE

JULY 10, 2023

We structure the rest of our article as follows: We provide an overview of how LLMs operate and how ChatGPT was constructed, describe use cases of ChatGPT as an example of generative AI that is optimized for chatting, and present use cases ranging from the original idea of chatting and text creation to software development.

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European Pharmaceutical Review

SEPTEMBER 22, 2022

Dr Maier has over 25 years of experience in drug development and commercialisation at pharmaceutical companies in Europe, Canada, the United States and Asia. FDA presentation. NICE DSU technical support document 18: methods for population-adjusted indirect comparisons in submissions to NICE. Pediatr Pulmonol.

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European Pharmaceutical Review

JULY 1, 2022

The last several years have presented employers in the pharmaceutical industry with a challenging, rapidly changing landscape. Although there are currently no set metrics or prescribed areas of focus, there are several key areas that pharmaceutical companies can pinpoint when measuring the S in ESG.

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ISPE

MARCH 7, 2023

A collaborative mindset must prevail between pharmaceutical companies, suppliers, and regulators and include strategic partnerships that go beyond the pharmaceutical sector so we can move together to a more sustainable future. The risks are equally applicable to both privately owned and publicly traded companies.

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pharmaphorum

MAY 14, 2021

Experts from ICON give us their views on the past, present and future of NICE’s standing on the world stage. Practically though, there are risks of additional processes and requirements (and expense) for pharmaceutical companies. This article appears in our digital magazine, Deep Dive: Market Access 2021.

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ISPE

MARCH 7, 2023

A pharmaceutical quality system (PQS) is a management system used to direct and control a pharmaceutical company with regard to quality. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Press Release.

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ISPE

JULY 6, 2023

Operational Flexibility/Capacity Decentralized manufacturing Presently, portable end-to-end CM plants are not a widespread reality, but have been proven possible. Ireland, Singapore, and Puerto Rico are key pharmaceutical manufacturing hubs where these incentives have had great impact. 19 , 26 , 27 1 a b c Lovells, H.,

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Pharmaceutical Technology

DECEMBER 15, 2022

In addition, several pieces of documentation will be required to support the API qualification, e.g. pharmacopeial compliance. It is also essential to evaluate the reliability of the company supplying the ingredient: do they provide sufficient communication and documentation? Is Benzalkonium Chloride a good choice?

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Pharmaceutical Technology

MAY 5, 2023

Today, software companies know there is a growing market to meet demand for supply chain visibility platforms. The question for pharmaceutical companies is how they can best deploy their data to make supply chains more efficient. Another important thing is that manual evaluations have been reduced to less than 0.5%

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ISPE

SEPTEMBER 10, 2023

Then the durations were compiled for analysis and presented in the table. In the dynamic global environment, the approval times for postapproval changes can be expected to change over time and may well differ between pharmaceutical companies based on different practices and approaches. The proposals are consistent with WHO GRP.

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