Compliance, Life Science and Packaging - Clinical Research Informer

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. They provide specific guidance on packaging requirements for closed closure integrity (CCI) and general integrity testing. Container Closure Systems. Container closure systems are highly regulated by health agencies.

Packaging

Packaging Packaging Containment Production

PCI Pharma Services Invests Over $365 Million in EU, US Facilities to Drive Clinical and Commercial Supply of Advanced Drug Delivery and Drug Device Combination Products

XTalks

JANUARY 29, 2025

This initiative focuses on enhancing infrastructure to support the clinical and commercial-scale final assembly and packaging of drug-device combination products, emphasizing advanced drug delivery systems, particularly injectable formats.

Drug Delivery

Drug Delivery Production Packaging Packaging

Employee Retention and Motivation Strategies for Life Science Companies — Free Onboarding Checklist Included

XTalks

JULY 5, 2022

Employee retention and motivation is a challenge that all life science companies face. A corporate compliance training program is a part of many onboarding programs to ensure employees are up to date with the latest rules and regulations they must adhere to while working for the company. Training and Development Opportunities.

Life Science

Life Science Compliance Packaging Packaging

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Protecting the supply chain: Why biopharma needs integrated workflows

Pharmaceutical Technology

AUGUST 31, 2022

“As we continue to grow and meet demand, we will remain focused on providing broader and more integrated workflow solutions within the biopharma, cell & gene therapy, and related life sciences end markets.”. and Japanese Pharmacopoeia (JP).

Packaging

Packaging Packaging Production Containment

PRISYM ID Achieves Zebra Technologies Validation

pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork.

Life Science

Life Science Clinical Trials Clinical Trials Compliance

New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. About the authors.

Life Science

Life Science Medicine Regulation Compliance

Cleanrooms-on-demand: a more efficient future for pharma?

pharmaphorum

NOVEMBER 24, 2022

And even once the facility is fit for purpose, specialised staff are required to maintain compliance with strict regulations. The pharmaceutical and life sciences services provider recently revealed its latest partnership with Moderna, collaborating for renting of COD services across the US. Enter cleanrooms-on-demand….

Manufacturing

Manufacturing Pharma Packaging Production Packaging

Can technology help diversify clinical trials?

pharmaphorum

MAY 27, 2022

The possibilities are endless, and in the context of trial participation and access to medicine technologies could assist: Reduced assessment times and hence increased patient compliance. Underrepresentation is multifactorial, so concerted efforts from life science companies are required to address inequitable healthcare.

Clinical Trials

Clinical Trials Clinical Trials Trials Packaging

From start to finish – digitising clinical trials

pharmaphorum

AUGUST 16, 2021

Compliance is key. These are now used by several regulatory bodies, including the Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for submission packages. Metadata can also be uploaded into ryze and validated against relevant CDISC standards to ensure compliance.”.

Clinical Trials

Clinical Trials Clinical Trials Trials Compliance

Setting up a virtual clinical trial: Things to consider

Cloudbyz

JANUARY 27, 2021

Package Installation. Package Installation - Sandbox. Chayanika is a content writer and guest contributor to Cloudbyz, specializing in well-researched content for the healthcare and life sciences industries. Package Installation. Package Installation - Sandbox. Compliance. ICH Good Clinical Process.

Clinical Trials

Clinical Trials Clinical Trials Trials Packaging

Clinical Trial Manager Jobs: What You Should Know

XTalks

MAY 9, 2023

As the demand for clinical trials continues to grow, so does the need for skilled professionals who can manage complex trial operations and ensure that studies are conducted in compliance with regulatory requirements. Ensuring compliance with applicable regulations, guidelines and ethical principles.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Technology advancement to ease patient recruitment and engagement

Cloudbyz

FEBRUARY 3, 2021

Package Installation. Package Installation - Sandbox. Chayanika is a content writer and guest contributor to Cloudbyz, specializing in well-researched content for the healthcare and life sciences industries. Package Installation. Package Installation - Sandbox. Global Site Solutions Summit. Internal Seminar.

Clinical Trials

Clinical Trials Clinical Trials Trials Packaging

Health Canada consults on transition of interim order drugs, vaccines, and medical devices to permanent approval pathways

Pharma in Brief

DECEMBER 3, 2020

The proposed amendments to the FDR will allow COVID-19 products that were previously approved under the Interim Order for Drugs and Vaccines to apply for a notice of compliance ( NOC ) using a similar streamlined regulatory process. require market authorization holders to meet post-marketing regulatory requirements; and.

Vaccine

Vaccine Vaccination Drugs Manufacturing

PRIYSM ID boosts customer service offer with new customer experience team

pharmaphorum

JULY 13, 2021

PRISYM ID provides industry-specific labeling and packaging solutions designed for life science companies and medical devices manufacturers, improving patient safety and health outcomes by ensuring compliance with global regulations.

Clinical Trials

Clinical Trials Clinical Trials Compliance Trials

New public Clinical Trials database leads to increased tax & regulatory transparency – risk of supply chain disruption / recall

Pharma Business Blog

MARCH 15, 2023

Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material. Based on the increased transparency, compliance in that regard has become crucial in order to ensure the risk of a supply chain disruption and recall of the IMP. Pharma regulatory point of view.

Clinical Trials

Clinical Trials Clinical Trials Trials Regulation

Keeping tabs on Covid-19: Cell and gene clinical trials advance despite Covid-19…

The Pharma Data

AUGUST 7, 2020

We are committed to bringing these life-changing therapies to patients in need,” Lambert added. CluePoints provides clinical studies with risk management support package during Covid-19. Download the e-book here. Source link.

Clinical Trials

Clinical Trials Clinical Trials Gene Trials

The need for a centralized platform for clinical research study

Cloudbyz

JANUARY 20, 2021

Assure compliance A centralized platform helps in achieving better compliance by identifying missing data or data outliers. Package Installation. Package Installation - Sandbox. Package Installation. Package Installation - Sandbox. Compliance. This ensures a better outcome of the study. Newsletter.

Clinical Research

Clinical Research Research Clinical Trials Clinical Trials

Empatica’s EpiMonitor and EmbracePlus: A New Era in Epilepsy Monitoring Technology

XTalks

MAY 31, 2024

Key Features of the EpiMonitor The EpiMonitor package includes two main components: the EmbracePlus wearable device and the EpiMonitor app, a dedicated smartphone application for seizure monitoring. The EpiMonitor earned US Food and Drug Administration (FDA) clearance for use in adults and children aged six and above.

Life Science

Life Science FDA Approval Packaging Packaging

Decentralized Trials will dominate Clinical Research space in 2021

Cloudbyz

JANUARY 13, 2021

Decentralized clinical trials or DCT have become the new norm for the life sciences industry. Package Installation. Package Installation - Sandbox. Package Installation. Package Installation - Sandbox. Compliance. Jan 13, 2021. 8 min read. Share on linkedin. Share on twitter. Share on facebook.

Clinical Research

Clinical Research Trials Research Clinical Trials

How to choose a reliable CTMS

Cloudbyz

DECEMBER 30, 2020

Compliance: A reliable CTMS should be compliant. Package Installation. Package Installation - Sandbox. Chayanika is a content writer and guest contributor to Cloudbyz, specializing in well-researched content for the healthcare and life sciences industries. Package Installation. Compliance. Newsletter.

Clinical Trials

Clinical Trials Clinical Trials Trials Packaging

Pharma in Brief: The 2021 Year in Review

Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. The courts also had a busy year in 2021.

Regulation

Regulation Manufacturing Drugs Medicine

Emergent BioSolutions Announces 2021 Financial Guidance, Provides Preliminary 2020 Results

The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers. FOOTNOTES. (1)

Production

Production Manufacturing Vaccination Vaccine

Maximizing Efficiency and Sustainability in Pharmaceutical Packaging Design and Artwork Development

XTalks

JANUARY 31, 2025

Packaging design and artwork development are often seen as minor, last-minute hurdles in the journey to commercialization. A well-executed packaging design must integrate manufacturability, regulatory compliance, and branding requirements to support successful commercialization.

Packaging

Packaging Packaging Development Manufacturing

The High Potent Pathway: Keys to Successful Development and Manufacturing

XTalks

JANUARY 28, 2025

It outlines the main touchpoints, including the earliest stages of technical transfer and new product introduction, through formulation development and scalable manufacture, and finally ensuring that these potent products are packaged in a safe environment before global distribution to clinic or market.

Manufacturing

Manufacturing Development Contamination Production

Subcutaneous Biologics Market Analysis: Current Trends and Future Outlook

Roots Analysis

JANUARY 27, 2025

Moreover, such therapies have been shown to have a profound impact on patient compliance as well as therapy adherence, where the patients can self-administer the drugs. She holds a bachelors degree in Pharmaceutical Sciences which has provided her with a solid foundation in the ever-growing domain of life-sciences.

Marketing

Marketing Drug Delivery Development Protein

Clinical Research Informer

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

PCI Pharma Services Invests Over $365 Million in EU, US Facilities to Drive Clinical and Commercial Supply of Advanced Drug Delivery and Drug Device Combination Products

Webinars

Trending Sources

Employee Retention and Motivation Strategies for Life Science Companies — Free Onboarding Checklist Included

Webinars

Protecting the supply chain: Why biopharma needs integrated workflows

PRISYM ID Achieves Zebra Technologies Validation

New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

Cleanrooms-on-demand: a more efficient future for pharma?

Can technology help diversify clinical trials?

From start to finish – digitising clinical trials

Setting up a virtual clinical trial: Things to consider

Clinical Trial Manager Jobs: What You Should Know

Technology advancement to ease patient recruitment and engagement

Health Canada consults on transition of interim order drugs, vaccines, and medical devices to permanent approval pathways

PRIYSM ID boosts customer service offer with new customer experience team

New public Clinical Trials database leads to increased tax & regulatory transparency – risk of supply chain disruption / recall

Keeping tabs on Covid-19: Cell and gene clinical trials advance despite Covid-19…

The need for a centralized platform for clinical research study

Empatica’s EpiMonitor and EmbracePlus: A New Era in Epilepsy Monitoring Technology

Decentralized Trials will dominate Clinical Research space in 2021

How to choose a reliable CTMS

Pharma in Brief: The 2021 Year in Review

Emergent BioSolutions Announces 2021 Financial Guidance, Provides Preliminary 2020 Results

Maximizing Efficiency and Sustainability in Pharmaceutical Packaging Design and Artwork Development

The High Potent Pathway: Keys to Successful Development and Manufacturing

Subcutaneous Biologics Market Analysis: Current Trends and Future Outlook

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