pharmaphorum

MAY 5, 2022

Assuring end-patient safety through holistic contamination control. This conference will explore the most pressing topics in this thriving field, from the movement toward process automation and minimisation of operator intervention, to the latest technologies in rapid microbiological testing methods and data integrity.

Documentation 52

Documentation 52

European Pharmaceutical Review

MARCH 13, 2024

In the paper, the author acknowledged that topical medicinal products require the absence of bacterial species such as P. In the control bottle, the colour stayed green,” Puscas explained. For example, the author shared that the procedure can be used in microbiological laboratories of various levels. aeruginosa.

Medication Labelling 90

Medication Labelling Pharmaceutical Manufacturing Compounding Labelling 90

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FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards This year has seen a flurry of activity by the U.S. Qualification threshold: 20 ppm “Use of in-vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms. Recommendations for stability studies.”

Documentation 52

Documentation Packaging Dosage 52

Pulses

MARCH 26, 2024

1 This is especially true for pharmacy learners, many of whom are learning new topics or applying concepts for the first time. Due to the nature of didactic learning, it is not possible to avoid switching topics or eliminate attention residue entirely. Executive Control of Cognitive Processes in Task Switching.

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Express Pharma

DECEMBER 18, 2023

Serialisation and track-and-trace systems in pharmaceutical packaging Quality control and assurance of pharmaceuticals Join PHARMAP 2024 by filling in the registration form at the official website of the Congress: [link] The post Guide the pharma world with PHARMAP 2024 appeared first on Express Pharma.

Packaging 101

Packaging Pharmaceutical Manufacturing 101

FDA Law Blog: Biosimilars

JANUARY 11, 2024

Given the significant growth and development opportunities available in Puerto Rico, Karla and Dara will discuss the FDA’s prescription drug approval process, and more importantly the “exportation” of prescription pharmaceuticals — including controlled substances — from Puerto Rico into the United States.

Controlled Substances 59

Controlled Substances 59

Express Pharma

DECEMBER 7, 2023

He emphasised that operational excellence is essential in the pharma industry to balance cost and product excellence through optimised processes and best practices. Building and nurturing a culture of quality and compliance is a must to make products and processes more robust, efficient and effective.

Generic Medicine 99

Generic Medicine Documentation 99

Express Pharma

DECEMBER 7, 2023

We need collaborative strategies that will fuel innovation and value-led growth The keynote speaker, K Raja Bhanu, Deputy Director & Joint Director (FAC), Drugs Control Administration, Visakhapatnam Region of Andhra Pradesh shared his insights for the progress of the pharma industry from a regulatory perspective.

Packaging 85

Packaging Biosimilars 85

pharmaphorum

DECEMBER 16, 2021

Exploring Robust Risk-Based Microbiological Control Strategy. The two-day conference will explore the most pressing topics in this thriving field, from the movement toward process automation and minimisation of operator intervention, to the latest technologies in rapid microbiological testing methods and data integrity.

Method Validation 52

Method Validation 52

European Pharmaceutical Review

OCTOBER 5, 2023

What are the key topics you plan to cover during your session at CPHI Barcelona? I firmly believe that manufacturing plays a pivotal role in this endeavour, and I will delve into topics such as production system optimisation and the standardisation of chemistry, manufacturing, and control (CMC) processes.”

Immunity 81

Immunity Immunization 81

Pharmaceutical Technology

AUGUST 17, 2022

The alliance will merge the cell and media products and process development services of RoosterBio with the worldwide cell and gene therapy manufacturing expertise of AGC. . To create strong and scalable processes for hMSC and exosome therapies, RoosterBio will leverage its broad-ranging cell and media product portfolio.

Vaccines 52

Vaccines Drug Development 52

Pharmaceutical Technology

MAY 22, 2023

Vyjuvek is a non-invasive, topical, re-dosable gene therapy that delivers functional human COL7A1 gene copies to offer wound healing. In the GEM-1/2 trial, repeat topical applications of Vyjuvek resulted in full-length cutaneous COL7 expression, durable wound closure and anchoring fibril assembly with minimal adverse events.

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Express Pharma

NOVEMBER 3, 2023

Touching on embedding technologies like intelligent process automation and AI within business processes and discussing the challenges and changes in the Indian pharma sector, Jain spoke about the importance of leveraging technology, sustainability, demand forecasting, and supply chain control towers is also emphasised.

Packaging 104

Packaging Dosage Communication 104

Quality Matters

NOVEMBER 11, 2022

FDA) workshop , my fellow panelist and I addressed the latest developments in the identification and control of nitrosamines in pharmaceutical products. To assess and control the presence of nitrosamine impurities in medicines, the U.S. With so many potential sources, it is critical that manufacturers evaluate their products for risks.

Packaging 52

Packaging Documentation Compounding Diabetes 52

GMPSOP

FEBRUARY 10, 2024

There should be a clear process to establish training needs, provide training, and evaluate, record, and reward archives as required by the local regulatory authorities. Gowning qualification training applies to all staff working in cleanroom processing areas on top of the training regime mentioned above.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Packaging Compounding 52

Digital Pharmacist

AUGUST 12, 2022

Pharmacies should prepare for higher volumes of controlled substance prescriptions used to treat ADHD like amphetamine salts, dextroamphetamine, lisdexamfetamine, methylphenidate, and dexmethylphenidate. Items for sports-related injuries, such as ACE bandages, topical anesthetics/counterirritants, would also be great to keep fully stocked.

Controlled Substances 90

Controlled Substances Immunity Immunization Vaccines 90

Pharmaceutical Technology

DECEMBER 14, 2022

This platform will aid Synplogen in boosting the speed of clinical manufacturing while lowering process development duration and expenses. As per the collaboration, Merck will provide technical support, training and process development and streamlining to Synplogen’s scientists at its M Lab Collaboration Center located in Tokyo, Japan.

Communication 52

Communication 52

Express Pharma

JULY 10, 2023

then led a session on “Change Control and Change Management,” to explain the transition from CSV to CSA. Additionally, Kalla designed a process activity for the delegates, promoting collaboration and emphasising the importance of unified systems. The latter half of the day concentrated on topics such as Industry 4.0

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Quality Matters

MAY 25, 2023

Establishing effective strategies to control and limit impurities in pharmaceutical products can help maximize manufacturing efficiency, manage costs, and reduce risks to end-users. FDA science policy advisor at the Center for Drug Evaluation and Research (CDER), addressed the topic of nitrosamine impurities from a regulatory perspective.

Communication 52

Communication 52

RX Note

JULY 15, 2023

Nonscarring alopecia Results from processes that reduce or slow hair growth without irreparably damaging the hair follicle. Trichotillomania Trichotillomania is an impulse control disorder in which individuals repeatedly pluck hairs from the scalp or other hair-bearing areas. The areas of alopecia may have irregular, bizarre shapes.

Chemotherapy 52

Chemotherapy 52

Pharmaceutical Technology

APRIL 4, 2023

Gennova Biopharmaceuticals has applied for an emergency use authorisation (EUA) from the Drug Controller General of India (DCGI) for its mRNA-based Omicron-specific Covid-19 booster vaccine. Topic sponsors are not involved in the creation of editorial content.

Vaccines 59

Vaccines 59

pharmaphorum

JANUARY 13, 2022

AstraZeneca has expanded its efforts to develop new therapies targeting transcription factors – proteins that regulate processes in the cell that have become a hot topic for drug discovery in cancer and other diseases.

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Pharmaceutical Technology

OCTOBER 14, 2022

Xcellbio said that the AVATAR AI technology uses the tight environmental control of the AVATAR product family. We believe our joint efforts will further accelerate the creation of automated, end-to-end cell therapy manufacturing and QC release platforms to streamline processing and optimise patient outcomes.”.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 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. The speed and efficiency of this process can make large amounts of mRNA in a short period of time. Quality testing is integral to the development and manufacturing processes. What is mRNA?

Vaccines 52

Vaccines Immunity Immunization Packaging 52

Safe Biologics

NOVEMBER 12, 2023

Participants will explore strategies in data management & signal detection, showcase how AI & machine learning have improved PV processes, and discuss the challenges creating a PV strategy for advanced therapies. Thanks to the IRA’s price controls, medical marvels like Keytruda will now be even more difficult to achieve.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

National Association of Boards of Pharmacy

SEPTEMBER 27, 2023

Most inspectors have similar experiences, often having worked in pharmacy, law enforcement, or regulatory law and are subject matter experts on diverse topics related to the drug supply chain. Temperature Control Temperature control is examined during a site visit, as many drugs must be stored at specific temperatures to remain effective.

Sterile Compounds 59

Sterile Compounds Controlled Substances Compounding Hospitals 59

PharmaState Academy

JANUARY 29, 2024

Various models of international pharmaceutical marketing and industry challenges, including price control and quality issues, were explored. Mr. Kapadia concluded by noting that companies are increasingly stringent in their selection process due to the investment involved.

Generic Medicine 52

Generic Medicine Packaging 52

pharmaphorum

NOVEMBER 25, 2022

German pharma Grünenthal has started the process of taking ownership of 13 ageing medicines developed by Japan’s Kyowa Kirin, which are currently sold by affiliate companies across Europe. Grünenthal’s own revenues were around €1.5 billion in 2021.

Diabetes 52

Diabetes 52

FDA Law Blog: Biosimilars

APRIL 25, 2023

We have recently blogged on this topic (“ Is my software a medical device? ”). Instead, FDA “intends to work collaboratively with sponsors of such premarket submissions as part of the interactive and/or deficiency review process.” Of course, if a product does not meet the definition of device, it is not subject to the FD&C Act.

Documentation 105

Documentation Labelling Communication 105

Express Pharma

APRIL 19, 2023

Planned topics for the first wave of training workshops include selecting excipients for controlled release dosage forms, enhancing bioavailability, and formulating effective orally dispersible and chewable tablets. Expert training, troubleshooting and scale-up advice will be priorities at the facility.

Dosage 52

Dosage Drug Development 52

ID Stewardship

JUNE 5, 2023

To shed light on this important topic, we had the privilege of interviewing an esteemed expert [ChatGPT by OpenAI] in the field of antimicrobial stewardship. Drug discovery and development: AI can accelerate the process of discovering and developing new antimicrobial drugs.

Vaccines 93

Vaccines Hospitals 93

Pharmaceutical Technology

DECEMBER 20, 2022

The randomised, controlled JCAR017-BCM003 trial is underway in 184 subjects with r/r aggressive B-cell non-Hodgkin lymphoma following first-line treatment. Topic sponsors are not involved in the creation of editorial content. Optimise your cell therapy process: a guide to cell thawing. Free Whitepaper.

Communication 59

Communication 59

Pharmaceutical Technology

APRIL 18, 2023

All three regulatory applications were based on the interim data obtained from a randomised, pivotal open-label, controlled, global Phase III KarMMa-3 trial, designed to assess Abecma against standard combination regimens. Topic sponsors are not involved in the creation of editorial content.

Labelling 52

Labelling 52

Find Your Script

MARCH 21, 2022

If you also want to improve study habits, see this post on the topic. It helps our body recognize that a physical space is designated for a particular activity – staying focused in the process. No Self-Control? An important part of successful studying is staying focused. Watch & Subscribe on our YouTube Channel !

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RX Note

AUGUST 4, 2023

Garis Panduan Kaunseling Ubat-ubatan, 2019 Compared to the previous edition, there are more topics being covered in Garis Panduan Kaunseling Ubat-ubatan 2019, such as Respimat and Breezhaler. what is the importance of sugar control). Try not to blink and do not rub. On page 11, gamma benzene hexachloride (GBH) 0.1%

Patient Counseling 52

Patient Counseling Communication Inpatient Diabetes 52

RX Note

MARCH 1, 2023

Coupled with Topical Preparations Counselling Guide for Pharmacist , these references provide a counselling checklist for pharmacists practicing in Malaysia. Garis Panduan Kaunseling Ubat-ubatan, 2019 In overall, compared to the 2nd edition, there are more topics being covered, such as Respimat and Breezhaler.

Patient Counseling 52

Patient Counseling Diabetes 52

Proxsys Rx

DECEMBER 8, 2022

That said, here are the critical factors you should consider when selecting a TPA to support your hospital’s 340B program: A well-supported TPA / 340B program onboarding process One of the most common technology-related problems occurs during the early phase of relationships between 340B program-eligible entities and TPAs.

Prescription Filling 52

Prescription Filling Hospitals Documentation 52