European Pharmaceutical Review

AUGUST 25, 2022

In a recent paper, published in the International Journal of Pharmaceutics , researchers identified nitrocellulose blister packaging as a potential source of N -nitrosodimethylamine (NDMA) and N -nitrosodiethylamine (NDEA) impurities.

Packaging 142

Packaging Dosage 142

European Pharmaceutical Review

FEBRUARY 2, 2023

The winners of Pharmapack Europe’s 2023 awards have been announced, presented across a range of innovative recyclable packaging, drug delivery solutions, and reusable connected devices. The winner in the Eco-Design category was a high grade, 100 percent PET blister packaging.

Packaging 80

Packaging Medication Delivery 80

STAT

MAY 10, 2023

Parents of kids who have peanut allergies have to practice constant vigilance, whether that means carefully skimming the ingredients on food packaging or warning teachers about the dangers of unexpected treats at school. Europe, Australia, and Canada discuss the results of a Phase 3 trial of the Viaskin Peanut skin patch.

Packaging 98

Packaging Pharmaceutical Companies Pharmaceutical Companies 98

Pharma Times

JULY 8, 2022

Preclinical data package details pharmacology and safety of VMX-C001

Packaging 39

Packaging 39

Roots Analysis

FEBRUARY 28, 2022

One of the stages that require quality assurance is packaging of the drug product, as compromised packaging could have serious consequences. The defects in the packaging of container closure system could adversely affect the sterility and stability of the drug through contamination via reactive gases, humidity and microbial ingress.

Packaging 52

Packaging Immunization 52

STAT

JANUARY 24, 2024

Investigators from all five of the studies will be presenting their data on Feb. 3 at a meeting of the Association for Research in Otolaryngology. The therapy was developed by Akouos, which Lilly recently purchased for about $487 million.

Packaging 90

Packaging Vaccines 90

Pharma Mirror

OCTOBER 1, 2020

Since the in-person PACK EXPO International and Healthcare Packaging EXPO have been cancelled, the process and packaging technology specialist Syntegon is presenting its latest solutions at the virtually-hosted PACK EXPO Connects from November 9 to 13, 2020.

Packaging 52

Packaging 52

STAT

AUGUST 21, 2023

These studies demonstrate “that there’s no evidence of vertical germline transmission of those edits,” Jonathan Phillips, head of pharmacology and toxicology at Intellia, said during a presentation Saturday. Intellia is one of the leading companies working to advance in vivo gene editing therapies.

Packaging 98

Packaging 98

European Pharmaceutical Review

DECEMBER 19, 2022

The other half will be given a very low dose of ketamine and a seven-session education package about the harmful effects of alcohol, to determine whether the ketamine and therapy package reduces harmful drinking. Half will be given ketamine at the dose used in the first clinical trial with psychological therapy.

Packaging 105

Packaging 105

pharmaphorum

MAY 4, 2022

Leading experts from big pharma will be presenting case studies on recent advances in platform approaches in drug delivery devices and smart devices, while a panel discussion will explore the emerging opportunities of platforms for injectable devices. Assess developments in primary packaging and CMC considerations for injectable devices.

Packaging 52

Packaging FDA 52

Pharma Marketing Network

AUGUST 9, 2023

Maintain a balanced approach by presenting both the benefits and potential risks of the medication or treatment. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

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Packaging Labelling Communication Pharmaceutical Companies 52

European Pharmaceutical Review

SEPTEMBER 15, 2023

A modern identity for Janssen The new logo, colors, and font for J&J Innovative Medicine will be rolled out steadily across all company materials, product packaging, and branding assets over time.

Chemotherapy 92

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies Packaging 92

Viseven

SEPTEMBER 7, 2023

The events cover every step of the pharma supply chain: ingredients, machinery, equipment, technology, package and contract service suppliers, distributors, and buyers from the pharmaceutical industry. At the event, the Viseven team showcased its services using portfolio presentation and medical animation videos.

Packaging 52

Packaging Dosage 52

Pharma Mirror

SEPTEMBER 27, 2021

New York/USA, At Interphex 2021 in New York, Syntegon (formerly Bosch Packaging Technology) presents new solutions for lab-scale and small batch filling of solid and liquid pharmaceuticals. The need for smaller quantities of highly potent drugs is rising continuously.

Packaging 52

Packaging 52

European Pharmaceutical Review

MARCH 14, 2023

This concerns the quantity of the medicinal product in the packaging, ie, the increase or decrease in the number of units of the product in the outer packaging according to local demands and its labelling, including the leaflet, which should be in the language of the country into which the product is imported.

Packaging 83

Packaging Generic Medicine Labelling Pharmaceutical Companies 83

Pharma Marketing Network

AUGUST 9, 2023

Maintain a balanced approach by presenting both the benefits and potential risks of the medication or treatment. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

Packaging 40

Packaging Labelling Communication Pharmaceutical Companies 40

European Pharmaceutical Review

AUGUST 30, 2023

The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. After this date: Under the framework, medicines can have the same packaging and labelling across the UK. UK packaging must carry a clearly legible ‘UK only’ label to be allowed onto the UK market.

Packaging 96

Packaging Labelling 96

pharmaphorum

JANUARY 28, 2021

For PRISYM ID client RxSource , a Global Clinical Trial Supplies Specialist, it means being ready to partner with sponsor companies to get everything set up for a clinical trial within a week, including packaging and labeling. This was an incredibly fast turnaround for what could easily have been a long and arduous onboarding process.

Labelling 52

Labelling Packaging Vaccines 52

European Pharmaceutical Review

AUGUST 25, 2023

Contaminants in pharmaceutical packaging For clarity, the authors described that the aim of extractable studies are to: “identify the freely available substances present in a given material.” In the case of leachable species profiling studies, these focus on “investigating contaminants in the actual product formulation.”

Compounding 94

Compounding Packaging 94

Roots Analysis

APRIL 15, 2024

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Packaging Labelling 40

ISPE

NOVEMBER 22, 2022

I presented on planning and executing and designing fill lines, RABS, Isolators, and transfers – along with the differences between processing potent compounds versus non- potent compounds. Along the way – one of the things that we noticed across the industry was that most presenters at most conferences were men. Vetter Pharma.

Compounding 98

Compounding Packaging Dosage Vaccines 98

European Pharmaceutical Review

JULY 27, 2023

So the solid-state storage of biologics presents the next advance in the field. With this innovation, researchers can package biological materials into tablets that can be stored on a shelf at room temperature.

Packaging 89

Packaging 89

ISPE

SEPTEMBER 8, 2022

Each session will include ample time for the audience to engage with the presenters and pose additional questions. Presentations will share the specifics of facility design considerations and modular approaches to meet the increasing viral vector manufacturing demand. In another presentation, Amgen Inc.

Packaging 93

Packaging FDA 93

pharmaphorum

OCTOBER 12, 2022

BENEFITS OF ATTENDING: Engage with senior industry opinion leaders presenting their experiences and case studies in innovative device design and advanced drug product formulation. Primary Packaging Material Designers. Secondary Packagers. Visit the website to find out more: [link]. Microneedle Device Developers. Drug Developers.

Packaging 40

Packaging Vaccines 40

The FDA Law Blog

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. Table 1 below shows the 510(k) submission process based on the MDUFA III Performance Goals.

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FDA Documentation Packaging Communication 75

European Pharmaceutical Review

AUGUST 18, 2022

Newly synthesised oRNA molecules are more compactly packaged into custom LNPs, which Orna has engineered to target key tissues in the body. Orna’s proprietary oRNA technology creates circular RNAs from linear RNAs by self-circularisation.

Vaccines 88

Vaccines Research Laboratories Packaging 88

Pharmaceutical Technology

JULY 29, 2022

Injectables and their packaging requirements have never been more important to marketed treatments, given the volume of vaccines being packaged that are required to tackle the Covid-19 pandemic, as well as the rising presence of biologics in pipelines and their marketed approvals.

Vaccines 52

Vaccines Packaging Immunization FDA 52

The FDA Law Blog

FEBRUARY 16, 2023

Essentially, FDA already prepared a sample DFL and made the preliminary determination that there are sufficient safety and efficacy data to support an Rx-to-OTC switch, but still needed product-specific data on the nonprescription user interface design, including packaging and labeling, to make a conclusive determination.

Labelling 64

Labelling Packaging FDA 64

pharmaphorum

AUGUST 24, 2020

In the run up to the conference, Alan Franklin, CEO, ForwardVue Pharma is interviewed by SMi Group to discuss his presentation details, insights of the Ophthalmic market and his thoughts on the biggest growth area and key developments that have taken place in the last year. Ophthalmic Drugs Conference. 23 rd -24 th November 2020.

Packaging 52

Packaging FDA 52

pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines.

Packaging 80

Packaging Generic Medicine Communication Hospitals 80

Hospital Pharmacy Europe

OCTOBER 30, 2023

The Federal Institute for Drugs and Medical Devices also highlighted that Ozempic counterfeits had been identified at wholesale level in Germany and couldn’t rule out that they were also present in the country‘s distribution chain. The issue is currently being investigated by EU medicines regulatory authorities and the police.

Labelling 52

Labelling Packaging Hospitals 52

The Checkup by Singlecare

MARCH 19, 2024

Checking ingredient lists, reviewing the package insert information, and getting the professional medical advice of your pharmacist is critical. While amoxicillin dosing may need to be adjusted if kidney disease is present, Tylenol dosing may need to be reduced or avoided in people with liver disease.

Adverse Reactions 78

Adverse Reactions Packaging Dosage FDA 78

pharmaphorum

JANUARY 17, 2022

SMi presents its 16th annual Parallel Trade conference on the 21st and the 22nd March 2022. SMi Group offer direct access to key decision makers through tailored sponsorship and exhibitor packages. There will be highlights of Professor Stefan Enchelmaier’s work and case studies, focusing on re-packaging and intellectual property.

Packaging 52

Packaging Vaccines 52

The FDA Law Blog

MARCH 3, 2024

The legislation may be revised, and the below is not an exhaustive list of our questions and concerns, but at present we have several observations and questions about how the Act may be implemented and potential consequences.

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Packaging FDA 102

European Pharmaceutical Review

MARCH 28, 2024

Measuring treatment effect in rare disease populations presents many methodological challenges due to small sample sizes and heterogeneity of the study population. How does the qualification package support more meaningful endpoints and rare disease research as a result?

FDA 52

FDA Packaging Insurance Communication 52

ISPE

FEBRUARY 14, 2023

This blogpost will summarize inspection topics for presenting digital CQV content and provide a list of common questions encountered during inspection events. During paper-based inspection events, a CQV package is requested and a printed report with a physical binder are brought in to support the request.

Documentation 52

Documentation Packaging 52

Omnicell

JANUARY 10, 2023

XR2 offered two key advantages – flexibility to support multiple distribution models including centralized, decentralized, or hybrid, and the ability to store and dispense many different form factors in their native manufacturer packaging. One of the most exciting features of XR2 is the dispensing accuracy.

Inventory Control 52

Inventory Control Medication Dispensing Omnicell Patient Care 52