Express Pharma

JULY 29, 2023

They have main and interaction effects on drug quality and process performance with process buffers. The post WonHyun (James) Hwang, Head of Application, Asia and Middle East of Africa Biopharma, Avantor Performance Materials Korea | FDD Conclave 2023 appeared first on Express Pharma.

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Quality Matters

NOVEMBER 27, 2023

FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards This year has seen a flurry of activity by the U.S. Ophthalmic drug products with names recognized in the USP are generally required to also meet the particulate matter requirements in USP General Chapter Ophthalmic Products—Quality Tests.

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Documentation Packaging Dosage 52

Board Vitals - Pharmacist

FEBRUARY 9, 2024

By taking the time to study some often overlooked topics, you will be ready to do your best come test day. What topics are on the Radiology Core Exam? basis for quality control of the various nuclear medicine agents. The post 5 of the Most Overlooked Topics on the Radiology Core Exam appeared first on BoardVitals Blog.

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Express Pharma

DECEMBER 7, 2023

India Pharma Inc, hailed for its prowess in the production of high-quality generic medicines, now needs to shift from a conventional, volume-based business strategy to a value-based approach to keep it up its growth momentum. He explained about the role of performance management, leadership, people, culture, risk and quality management etc.

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Generic Medicine Documentation 104

Pharmaceutical Technology

APRIL 25, 2023

The audit was focused on the quality management systems and platform AAV manufacturing process of the facility. It received orphan drug, fast track and rare paediatric disease designations from the US Food and Drug Administration. Topic sponsors are not involved in the creation of editorial content.

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The Luxe Pharmacist

AUGUST 8, 2023

With that being said, I’d like to place a disclaimer that I know anything surrounding money can be a sensitive topic and this post is in no way meant to brag or boast about my ring. He does truly appreciate all the comments on Instagram telling him he did such a great job and having that much faith in his design eye.

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pharmaphorum

JANUARY 4, 2021

Join us virtually, on the LHN virtual event platform to improve your medical writing strategies by understanding evolving regulatory protocols and submission guidelines, and learn how to improve quality and content optimizations. TOPICS TO BE ADDRESSED: Project Management Best Practices for Compliant and Timely project completion.

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Communication 64

Pulses

APRIL 25, 2024

Intentionally design class materials for social connection: Incorporate a Backchannel (TodaysMeet, Padlet, etc) Design resources that build connection with remote learners Twitter as an In-Class Backchannel Tool in a Large Required Pharmacy Course. Perceived stress and quality of life among doctor of pharmacy students.

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Doctor of Pharmacy Community Pharmacies 52

Express Pharma

JULY 10, 2023

The day continued with a session delivered by Deepa Pangaonkar from Wockhardt, on “Quality Testing and Evidence” within CSA and CSV. Additionally, Kalla designed a process activity for the delegates, promoting collaboration and emphasising the importance of unified systems. Vivek Bansal from Biological E.

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Pharmaceutical Technology

APRIL 5, 2023

Caribou Biosciences has secured fast track designation from the US Food and Drug Administration (FDA) for its CAR-T cell therapy, CB-011. The newly granted designation helps the firm accelerate the development and evaluation of CB-011. Topic sponsors are not involved in the creation of editorial content.

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Communication 59

Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals has received fast track and orphan drug designations for RP-A601 from the US Food and Drug Administration (FDA) to treat plakophilin-2-related arrhythmogenic cardiomyopathy (PKP2-ACM). Topic sponsors are not involved in the creation of editorial content.

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Communication 59

Express Pharma

DECEMBER 7, 2023

He also advocated the need to embrace positive change, cultivate a growth mindset, encourage a culture of quality and compliance, and sustaining an environment of trust amongst all stakeholders for future progress. At the outset of his presentation, Katta outlined the differences between quality assurance and regulatory compliance.

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Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has given orphan drug designation to SiSaf’s siRNA [a double-stranded RNA molecule that is non-coding] therapeutic, SIS-101-ADO, for the treatment of autosomal dominant osteopetrosis type 2 (ADO2), a rare and serious skeletal disorder in children.

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Pharmaceutical Technology

MAY 19, 2023

MT-302 is a TROP2-targeting in vivo chimeric antigen receptor (CAR) that has been designed to express in the myeloid compartment. We are pleased that such high-quality investors have joined with us to accelerate this effort.” Topic sponsors are not involved in the creation of editorial content.

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Labelling 98

Express Pharma

JUNE 15, 2023

The agenda of that day included the session dedicated to up-to-date topics of the pharma industry, including the sustainable future of the pharma packaging model, supply chain optimisation, cost-optimisation, agile pharma manufacturing, and innovative packaging solutions. Hoffmann-La Roche during the session.

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Packaging Pharmaceutical Manufacturing 93

pharmaphorum

JULY 22, 2022

This one-of-a-kind meeting will facilitate networking opportunities with key opinion leaders from all areas of pharmaceuticals, biologicals, and cleanroom industry experts to explore hot topics within cleanroom design and engineering, best practices and regulation, environmental and contamination control, and pharmaceutical microbiology.

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Compounding Pharmacies Compounding 52

FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

See our prior blog post on the topic here. Total Product Lifecycle (TPLC) This guiding principle reminds manufacturers that PCCPs and MLMD changes should be integrated into the lifecycle management of the device and be part of their existing quality system processes including but not limited to risk management and post market monitoring.

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Express Pharma

MARCH 4, 2024

Our infrastructure is designed to foster a congeniality in which new thoughts, the comfort of discussion, and openness can be actualised. I was impressed by the quality of the speakers, the diversity of the topics, and the relevance of the discussions to the real-life problems faced.

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GMPSOP

FEBRUARY 10, 2024

GMP/GLP and PPE training are applied to all employees, contractors and casual staff working in a GMP environment, including manufacturing, packaging, labelling, distribution, QA, QC, development, validation, engineering, IT staff and anyone whose activities could affect product quality. – What are the training topics or subject matter?

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Health and Personal Care Stores Documentation Packaging Compounding 52

pharmaphorum

JANUARY 24, 2022

Ensuring Risk-Based, Safety-Driven, High-Quality Operation. The conference will encompass the critical topics including risk assessment, occupational toxicology, engineering controls for containment, facility design, and the impact of pharmaceutical manufacture on the environment. SMi’s 6th Annual. 9th and 10th May 2022.

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Pharmaceutical Manufacturing 52

pharmaphorum

OCTOBER 16, 2020

The trial – run by Boehringer Ingelheim and Yale University – will test a smart bathroom scale device that has cardiac monitoring built in, as well as an app to help patients improve their diet and lose weight and a digital assistant designed to motivate them to actively manage their health.

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Communication Hospitals 114

pharmaphorum

OCTOBER 12, 2022

Explore updates to drug device combination product design approaches considering patient preference at the forefront with case studies from big pharma representatives. Theresa Scheuble, Head of Design and Innovation, Johnson & Johnson. Sustainability for Injectable Delivery Devices. Primary Packaging Development.

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Packaging 52

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand. Voluntary consensus standards will not design the measuring tools, but they will help companies validate these tools and define acceptable results.

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Packaging Documentation Labelling Communication 59

FDA Law Blog: Biosimilars

SEPTEMBER 10, 2023

An interesting addition in the final guidance is that it explains that the topics discussed “apply to any type of RWD, including data on products used in clinical practice under an emergency use authorization (EUA).” For obvious reasons, EUAs have been more prominent in recent years than they had been previously. Will it ever happen?

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Documentation Vaccines Drug Development 108

Pharma and Life Sciences Blog

MAY 5, 2023

Complicating the task, direct materials sourcing faces many challenges such as price and demand volatility, supply disruptions, quality issues, compliance risks, and lack of visibility. These obstacles require the ability to forecast demand, understand costs and respond effectively to commodity fluctuations — what can you do to get there?

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Pharmaceutical Technology

OCTOBER 13, 2022

The process aims to increase the engineered T cells’ quality as well as their durability in the tumour microenvironment. Topic sponsors are not involved in the creation of editorial content. This non-viral technology is well suited to the CAR-T cell process of Inceptor Bio.

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Board Vitals - Pharmacist

MAY 10, 2023

Educational videos may not cover all the necessary topics in sufficient detail, while question banks are designed to test students on a wide range of topics and provide detailed explanations for correct and incorrect answers.

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Packaging Medical Schools 52

FDA Law Blog: Biosimilars

AUGUST 7, 2023

Through ELP, CDRH staff visit sites that provide formal training and enhance understanding on topics such as how products are developed and how they fit into the larger healthcare system.

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Documentation 40

Pharmaceutical Technology

OCTOBER 13, 2022

VTA-100 has been designed to be an autologous therapy which combines gene correction as well as induced iPSC technology for repairing and replacing muscle cells for LGMD2A patients. Topic sponsors are not involved in the creation of editorial content. It is now undergoing investigational IND-enabling studies.

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FDA Law Blog: Biosimilars

AUGUST 28, 2023

Verification and validation of DHTs for use in clinical trials were topics on the minds of many, based on the questions raised by participants during the public meeting. A systematic approach similar to that used in development of SaMD (including, for example, design controls) is recommended.

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Drug Development 59

Board Vitals - Pharmacist

AUGUST 11, 2023

For general surgeons, the Continuous Certification Assessment (CCA) plays a vital role in maintaining their certification and providing high-quality patient care. Taking the Assessment According to the ABS, the assessment process is designed so that diplomates can “demonstrate their surgical knowledge on a continual basis”.

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Hospitals 52

Quality Matters

MARCH 8, 2022

But thanks to the vaccines developed to fight the pandemic, mRNA, specifically mRNA vaccines, has become a topic of public interest. All vaccines, including mRNA vaccines, undergo rigorous quality control and quality assurance protocols to ensure their safety and efficacy. What is mRNA? Are mRNA vaccines safe?

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Syner-G

MAY 4, 2022

As highlighted in these guidance documents, the FDA offers five programs: fast track designation, breakthrough therapy designation, regenerative medicine advanced therapy (RMAT) designation, accelerated approval and priority review designation. Image courtesy of qimono at pixabay.com.

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Documentation Drug Development Communication 52

Quality Matters

MAY 25, 2023

Impurities in the medicines supply chain: Global cooperation essential to safeguarding patients Continued global cooperation to strengthen supply chain resilience and assure medicines quality was a recurring theme at the Asia-Pacific Economic Cooperation ( APEC ) forum’s Medical Product Supply Chain Dialogue April 25-26, co-hosted by the U.S.

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Communication 52

Pharmaceutical Technology

APRIL 13, 2023

However, Vertex and CRISPR’s exa-cel is designed to remove a part of the patient’s BC11A gene to increase foetal haemoglobin levels in red blood cells, using CRISPR editing. ICER uses quality-adjusted life year (QALY), a cost effectiveness metric to measure the value of a healthcare intervention.

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Fusion Pharmacy

APRIL 29, 2022

The Advantages of Holistic Treatments Topical and transdermal creams and gels are potential alternatives to traditional oral pain medications. Topical medications are effective and avoid the side effects associated with oral administration. These can be formulated to provide high local concentrations at the site of your chronic pain.

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PharmaShots

MAY 5, 2023

There will be around 3,000 senior healthcare managers and clinicians striving to transform care and improve quality against the backdrop of Covid-19 and the challenges ahead. The key topics of the event will be: Federated Learning: What Hospitals and other Healthcare Providers can learn from each other with Data Science projects.

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Hospitals 40