European Pharmaceutical Review

APRIL 4, 2024

million initiative announced on 21 March is set to accelerate advanced therapy development in the UK. The scheme aims to support UK advanced therapy medicinal product (ATMP) clinical trials. What key solutions will the investment in the Advanced Therapy Treatment Centre Network provide?

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PQA

APRIL 26, 2024

The PQA Postdoctoral Executive Fellowship helps produce the next generation of leaders in health care quality through a full-time, 12-month program. Executive Fellows collaborate with PQA staff, members and other stakeholders on a variety of initiatives to improve medication use quality. Learn more about her in this Q&A.

Patient Care 52

Patient Care 52

European Pharmaceutical Review

APRIL 3, 2024

Research by Roots Analysis predicts the pharmaceutical contract manufacturing market will value $140 billion by 2030. The report noted that there has been “considerable” merger and acquisition activity in recent years within the pharmaceutical contract manufacturing market. percent between 2022-2030. percent between 2022-2030.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Compounding 52

European Pharmaceutical Review

MAY 17, 2024

Everything in the pharmaceutical industry now seems to rely increasingly heavily on effective organisation and handling of data. But what needs to happen so that users/process owners can fully trust data’s quality, integrity, reliability, etc? But actually, it is more important that work starts now.

Communication 52

Communication 52

European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. Use of advanced technologies. By enforcing GDP, we can ensure the quality and integrity of our data. Implement quality management systems.

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Documentation Data Entry Communication Compounding 88

Roots Analysis

MARCH 26, 2024

In fact, the initial stage of lockdown featured the fragile nature of pharmaceutical supply chain as a result of plant shutdowns and subsequent drug shortages. However, in order to deal with this situation, the medical agencies came up with the option of advanced technologies, such as continuous manufacturing technology.

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Pharmaceutical Companies Pharmaceutical Companies FDA 52

European Pharmaceutical Review

FEBRUARY 8, 2024

Another driving factor shared in the research was technology advancement and the integration of digital technologies in the market. These tests help to ensure the quality and safety of pharmaceuticals. Higher initial costs of incorporating rapid microbiology testing technologies could be a hinderance too.

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ISPE

NOVEMBER 1, 2022

2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. 2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. Quality and Stability. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. iSpeak Blog.

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FDA Insurance Chemotherapy Documentation 98

PQA

AUGUST 29, 2023

PQA released today an important report that we believe is a key step towards improving the quality of care for individuals using oral anticancer medications (OAM). PQA will begin research in 2024 to advance the health plan measure concept for adherence or persistence to OAMs.

Specialty Pharmacies 52

Specialty Pharmacies 52

Hospital Pharmacy Europe

OCTOBER 26, 2023

An advanced specialist curriculum and credentialing framework for clinical specialities falling under the UK Clinical Pharmacy Association (UKCPA) umbrella has been jointly established by the Royal Pharmaceutical Society (RPS) and UKCPA. Credentialing assessments and the underpinning professional curricula fill this gap.

Patient Care 52

Patient Care Hospitals Specialty Pharmacies 52

ISPE

SEPTEMBER 8, 2023

This article outlines ISPE task teams created reports and a model to examine the challenges surrounding drug shortages, emergency preparedness, and the supply chain of active pharmaceutical ingredients (APIs). This article outlines these initiatives. This article outlines these initiatives.

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Documentation 91

European Pharmaceutical Review

SEPTEMBER 7, 2022

The 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU ( ACT EU ) has been published by the European Commission (EC), Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA). implementing the CTR – focus on CTIS and CTR training activities and trouble-shooting any issues encountered by trial sponsors.

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PQA

SEPTEMBER 8, 2023

Last week, PQA released an important report, Recommendations to Improve the Quality of Oral Anticancer Medication Use, which we believe is a key step towards improving the quality of care of individuals using oral anticancer medications (OAM).The Questions about the initiative can be sent to QuIRC@PQAalliance.org.

Community Pharmacies 52

Community Pharmacies 52

ISPE

MARCH 16, 2023

We will also address the ways in which these approaches can help to improve adherence to new Annex 1 and the overall quality and safety of pharmaceutical products. One of the key changes in the latest revision of Annex 1 is a focus on Contamination Control Strategy (CCS) and Quality Risk Management (QRM).

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Pharmaceutical Companies Pharmaceutical Companies Documentation Dosage 98

European Pharmaceutical Review

MARCH 24, 2023

Initially published in March 2020, the strategy provides a plan for advancing regulatory science over a five-year period. Regulatory science refers to the scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products.

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European Pharmaceutical Review

APRIL 11, 2024

The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. Globally, the pharmaceutical sector emitted around 52 megatonnes of CO 2 in 2015, the most recent period for which detailed numbers are available. appeared first on European Pharmaceutical Review.

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European Pharmaceutical Review

AUGUST 22, 2023

Digitalisation and automation Microndesign plans to develop new methods for optimising pharmaceutical freeze-drying processes for the manufacture of injectable drug products. Autolomous is initiating a project to improve cell and gene therapy (CGT) manufacturing through automation or digitalisation.

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Vaccines Packaging 86

European Pharmaceutical Review

MARCH 5, 2024

The biotech’s new appointment underlines its commitment to advancing clinical development initiatives in the European region. Beigene also noted that during her last seven years at Novartis, de la Rocha led the Operational Excellence team in Translational Clinical Oncology, contributing to streamlined processes and high-quality trials.

Medical Schools 91

Medical Schools 91

ISPE

AUGUST 30, 2023

™, Quality Risk Management (QRM), Contamination Control Strategy (CCS) and Annex 1, Facility Design and Operations, Artificial Intelligence and Machine Learning, and Professional Development. The QRM principles outlined in ICH Q9 are intricate and vital for the advancements of drug development and therapies seen today.

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Documentation Vaccines 98

ISPE

NOVEMBER 23, 2022

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin, Ireland on 4 October 2022. Theresa Mullin, US FDA/CDER discussed ICMRA’s strategic initiative on “ Global Pharmaceutical Knowledge Management Systems ” to enable the enhancement of regulatory reliance and agility.

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Documentation FDA Communication 98

PQA

AUGUST 21, 2023

The PQA Postdoctoral Executive Fellowship helps produce the next generation of leaders in health care quality through a full-time, 12-month program. Executive Fellows collaborate with PQA staff, members and other stakeholders on a variety of initiatives to improve medication use quality.

Patient Care 40

Patient Care FDA 40

Pharmaceutical Technology

AUGUST 2, 2022

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Vaccines 104

ISPE

JULY 21, 2023

ICH Q9 (R1): The Next Frontier Trudy Patterson Fri, 07/21/2023 - 11:53 iSpeak Blog iSpeak ICH Q9 (R1): The Next Frontier Christopher John Potter, PhD 21 July 2023 A one-day seminar titled ICH Q9(R1): The Next Frontier was hosted by the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (TU Dublin) on 1 June 2023.

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Documentation 98

ISPE

NOVEMBER 23, 2022

ISPE’s regulatory volunteer groups are charged with bringing visibility and solutions to major challenges faced by the industry with regard to regulatory/quality matters, and facilitating the flow of information between ISPE members and global Health Authorities. A presentation on ISPE’s Pharma 4.0®

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FDA Documentation 52

ISPE

MAY 2, 2023

Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing Trudy Patterson Tue, 05/02/2023 - 13:42 iSpeak Blog iSpeak Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing Lisa J. Resources, Organization, Culture, and Information Systems. To make it real.

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Pharmaceutical Technology

JUNE 13, 2023

Spanish Prime Minister Pedro Sánchez has called a snap general election for 23 July, throwing several significant health reform initiatives into doubt. Two broad health reform initiatives are affected by the election. However, even if the PP did pass such measures, the reforms would be unlikely to materialise in 2023.

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PQA

FEBRUARY 29, 2024

Ensuring the quality of medication use is critically important for rare disease patients, payers, clinicians, specialty pharmacies and everyone with a role in the care process. PQA is the national quality organization dedicated to improving medication safety, adherence, appropriate use and medication management services.

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Specialty Pharmacies Communication Patient Care 45

PQA

OCTOBER 3, 2023

PQA offers a competitive Advanced Pharmacy Practice Experiential (APPE) Rotation for pharmacy students, which provides experiential learning opportunities in non-profit association management, medication use quality education, communications, research and performance measurement. What are your goals for your time at PQA?

Communication 52

Communication Patient Care Hospitals FDA 52

European Pharmaceutical Review

JUNE 29, 2023

Quality control testing can help manufacturers in monitoring their processes and reduce the risks of potential formation of those impurities, thus minimising disruptive and costly drug recalls. First detection of nitrosamine impurities in pharmaceuticals The first reports of nitrosamines as a known animal carcinogens date back to 1956.

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FDA Compounding 85

Roots Analysis

AUGUST 8, 2023

Recently, in the biopharmaceutical industry an increasing demand for quality biologics has been observed, where Single-Use-Systems (SUSs) Bioreactors have emerged as one of the most prominent and reliable solution for biomanufacturing. The biomass or the culture is totally dependent on the initial substrate.

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PQA

OCTOBER 10, 2022

PQA, the Pharmacy Quality Alliance, is launching a national initiative to prioritize research and measurement strategies to improve the quality of care for individuals using oral anticancer medications (OAM). We are hopeful that our initiative will yield specific measure concepts that can advance quickly.

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pharmaphorum

JULY 22, 2022

Advances in Pharma 4.0 SAE Media Group are pleased to announce the 2nd Annual Next Generation Pharmaceutical Cleanroom Conference. An event that focuses on cleanroom technology in the pharmaceutical industry, the conference will serve to bridge that gap between the two areas while simultaneously providing a unique selling point.

Compounding Pharmacies 52

Compounding Pharmacies Compounding 52

ISPE

JUNE 27, 2023

Korakianiti started by referring to the EMA Quality Innovation Group (QIG), which contains EMA assessors and some academics. Question: How do individual agency regulatory initiatives and flexibilities align to ensure that MRA agreements are not undermined? As Rosa commented “be prepared to teach us”.

Communication 52

Communication FDA Vaccines 52

European Pharmaceutical Review

OCTOBER 25, 2023

These recognise outstanding achievements and contributions from the global pharmaceutical industry and supply chain across 12 broad categories. Lambda’s software suite enables real-time, accurate data capture through advanced functionalities like barcode scanning and retina-based verification, helping to transform clinical research.

Packaging 90

Packaging 90

European Pharmaceutical Review

JANUARY 26, 2023

Helen Knight, Director of Medicines Evaluation at NICE noted: “The evidence from [use of Yescarta ® ] in the CDF and clinical trials shows it can offer an effective treatment, helping people live longer and with a better quality of life.” Could CAR T therapies be manufactured in one day?

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Chemotherapy Immunization 118

Pharmaceutical Technology

FEBRUARY 23, 2023

It continues to offer GMP materials, including plasmid DNA and the ancillary materials development for supporting the mRNA manufacturing process, as RVAC advances its mRNA candidates’ development. The GenScript ProBio team also offers consultative and expert guidance concerning the regulatory and quality expectations of agencies globally.

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Vaccines Communication 115

ISPE

APRIL 13, 2023

Whether for risk assessment or optimization, process simulation aims to represent a chemical or biochemical process by modeling the governing mechanisms that affect quality, yield, throughput, environmental impact, and related outcomes under a variety of scenarios. Sustainability by design for pharmaceutical products.” Register Now!

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Compounding FDA 98