Pharmaceutical Technology

JUNE 5, 2023

Social engineering attacks will rise, in addition to phishing, smishing and deepfake attacks. Right now, it’s compliance by checkbox, in a static way. Pharmacies have also received EU General Data Protection Regulation (GDPR) fines for not being in compliance,” he adds.

Compliance 276

Compliance Regulation Pharmacy Genome 276

Pharmaceutical Technology

SEPTEMBER 7, 2022

Pharmaceutical companies are increasingly integrating data-driven and software-centric medical adherence products to improve patient compliance. The AI engine predicts and identifies patients who are at risk and optimises interventions for them by channel, messages and timing.

Pharmacy 130

Pharmacy Containment Manufacturing Compliance 130

XTalks

MAY 16, 2024

This data can be used for social engineering attacks or to hack into other organizations. Here’s a look at some of the biggest healthcare ransomware attacks in recent years, highlighting the critical importance of security and compliance fundamentals.

Compliance 52

Compliance Radiology Engineer 52

pharmaphorum

OCTOBER 12, 2022

Eleanor Kimber, Principal Device Engineer, GSK. Markus Hemminger, Principal Medical Device Engineer, Roche. Petra Renne, Senior Expert Engineering, Novartis. Nima Aghajari, Senior Simulation Engineer, Sanofi. Michael Becker, Packaging Engineer, Boehringer Ingelheim. Aaron Gowson, Public Affairs Manager, Chiesi.

Drugs 52

Drugs Packaging Packaging Drug Delivery 52

Cloudbyz

OCTOBER 25, 2023

SPAR Solutions provides agile, innovative solutions to help clients leverage the Salesforce platform as their primary business engine The joint partnership, powered by Cloudbyz ’s Clinical Research Management Platform and SPAR Solutions, holds immense promise for the healthcare and life sciences sectors.

Life Science 85

Life Science Clinical Trials Clinical Trials Compliance 85

WCG Clinical

NOVEMBER 17, 2023

Since then, however, certain genetic engineering technologies (e.g., For example, two trials testing genetically identical genome-edited cell therapies – one engineered with a viral vector, and one without – can differ in their IBC review requirements because of how the cells were modified rather than what they have become.

Genome 52

Genome Genomics Gene Editing Genetic Engineering 52

pharmaphorum

JANUARY 4, 2022

Working closely with Zebra engineering teams, we have tested the interoperability of PRISYM 360 with select products, including the ZT400, ZT600 and Xi4 printers that are extensively used by many of our customers,” said Chris Lentz, VP Cloud Platform, PRISYM ID. Media Contact: Andrew Baud, Distil,?

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

FDA Law Blog

FEBRUARY 7, 2023

It is common to refer to FDA regulations as either pre-market, meaning they are applied before the device may be marketed, or post-market, meaning that compliance is generally required only after the device is brought to market, with some exceptions. Part 803), and reporting corrections and removals (21 C.F.R.

Compliance 98

Compliance Marketing Regulation Development 98

Advarra

JANUARY 11, 2024

Some of these approaches involve directly isolating the patient’s immune cells and simply expanding their quantity, while other treatments involve genetically engineering their immune cells to enhance cancer-fighting capabilities. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

pharmaphorum

NOVEMBER 17, 2021

The two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more. Focus day chair: Els Ducheyne, Senior Manager Material Compliance & EPR, Environmental Product Compliance & Sustainability, Johnson & Johnson.

Drugs 52

Drugs Drug Delivery Engineer Production 52

Clinical Trial Podcast

AUGUST 24, 2023

Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases. There are no certification or degree requirements to work as a clinical research professional either.

Clinical Research 40

Clinical Research Research Gerontology Clinical Trials 40

FDA Law Blog

JANUARY 5, 2022

She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, and QSR compliance. Adrienne’s full bio can be found here.

Regulation 40

Regulation Compliance Engineer Manufacturing 40

Advarra

JULY 6, 2023

When conducting a trial involving engineered genetic materials, incidents involving occupational safety and environmental protection are also reportable to the IBC. Who Should I Report Unexpected Events to? The IBC will review the incident in a convened committee meeting to determine if any additional actions are required.

Genetics 52

Genetics Engineer Research Gene Therapy 52

Pharmaceutical Technology

JUNE 29, 2022

We also benefit from having cGMP manufacturing capabilities in compliance with global regulatory requirements, a strong heritage from our mother company’s brand, a proven track record of reliable and secure supply, and a new partner that is probably the best player in the market within enzyme diversity.

Drugs 295

Drugs Gene Therapy Manufacturing Production 295

Cloudbyz

OCTOBER 25, 2023

SPAR Solutions provides agile, innovative solutions to help clients leverage the Salesforce platform as their primary business engine. Together we aim to tackle the foremost challenges in the life sciences industry: timelines, productivity, and compliance.

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

FDA Law Blog

JANUARY 5, 2022

She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, and QSR compliance. Adrienne’s full bio can be found here.

Regulation 40

Regulation Compliance Engineer Manufacturing 40

FDA Law Blog

FEBRUARY 9, 2024

For these devices that do not have market authorization and are only used for remote data collection in a clinical investigation, if the sponsor conducts verification and validation activities consistent with the guidance to demonstrate the DHT is “fit-for-purpose,” FDA does not intend to assess sponsors’ compliance with design controls.

Compliance 105

Compliance Manufacturing Containment Regulation 105

Pharma Marketing Network

MAY 3, 2023

From search engine optimization (SEO) and social media marketing to email campaigns and targeted online advertisements, the digital space offers a wealth of opportunities for pharmaceutical companies to reach and influence their target audiences.

Marketing 52

Marketing Compliance Engineer Branding 52

pharmaphorum

DECEMBER 29, 2022

These capabilities also help accelerate process design and scale-up, as was necessary during the battle against COVID, and reduce risk of compliance delays, such as those encountered during this year’s outbreak of monkeypox. Its engineers employed these insights to design mechanical improvements.

Manufacturing 108

Manufacturing Medicine Pharma Companies Engineer 108

Cloudbyz

MARCH 6, 2024

Longer Lasting Effects: Many biologics have prolonged therapeutic effects, allowing for less frequent dosing regimens and improved patient compliance. These innovative approaches involve the delivery of genetic material or engineered cells to correct genetic defects, modulate cellular functions, or regenerate damaged tissues.

Gene 72

Gene Immune Response Manufacturing Gene Therapy 72

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. Companies should ensure key words are appropriate and do not constitute unauthorised promotion to the public.

Life Science 96

Life Science Compliance Regulation Cosmetics 96

pharmaphorum

NOVEMBER 13, 2020

The challenge of compliance. One of the main concerns the pharma industry faces is around the issue of compliance and what products they can and can’t advertise. Targeted advertising is crucial to ensure the messaging is tailored to the right audience – healthcare and medical professionals or customers and consumers”.

Branding 108

Branding Pharmacy Marketing Compliance 108

FDA Law Blog

DECEMBER 6, 2023

The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R. Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers.

Regulation 59

Regulation Genetics Cosmetics Compliance 59

pharmaphorum

NOVEMBER 17, 2021

Hear key regulatory updates from regulatory bodies including FDA and WHO on guidance for regulatory compliance. CHAIRS FOR 2022: Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University. BENEFITS OF ATTENDING: Gain insight into developments in microneedles for drug delivery and diagnostics. pharmaphorum .

Drug Delivery 52

Drug Delivery Drugs Vaccination Vaccine 52

XTalks

JUNE 12, 2023

The manufacturing process for cell therapies, like autologous T cell therapy, is complex and labor-intensive, involving numerous procedures that can affect regulatory compliance and consistency. Each batch of engineered T cells is manufactured individually and subsequently infused back into the original patient.

Manufacturing 95

Manufacturing Gene Therapy FDA Approval Gene 95

pharmaphorum

JANUARY 25, 2023

About the author Susan Hill joined IQVIA in 2018 as part of the acquisition of AHM and is responsible for the customer engagement and commercial compliance technology offerings. She holds a BS in Chemical Engineering from the University of Maryland, and an MS in Business Management from Johns Hopkins University.

Life Science 98

Life Science Sales Marketing Production 98

Pharma in Brief

OCTOBER 5, 2022

During the investigation, Board Staff rejected a proposed Voluntary Compliance Undertaking ( VCU ) from Horizon. It also rejected the proposed price tests, which it found were “reverse engineered” by Board Staff to require a greater price reduction than under the Guidelines. The Board rejected the proposed new category.

Drugs 52

Drugs Medicine Compliance Marketing 52

pharmaphorum

FEBRUARY 11, 2022

It’s our representation of tracking the deidentified, which is important from a privacy and compliance point of view,” Sun says. “It Sun says because of this, Komodo engineered solutions or apps that “do certain things for end-users applied against the Healthcare Map.”.

Life Science 101

Life Science Engineer Development Big Data 101

XTalks

JULY 15, 2021

However, as a needle-free test, the saliva test offers a painless and non-invasive way to monitor sugar levels, which could significantly help with compliance. This can be a painful process, which can lead to patients reducing the number of tests they take. Functional Printing.

Development 98

Development Research Containment Manufacturing 98

pharmaphorum

JUNE 10, 2022

The digital revolution has already reshaped the commercial engine of biopharma companies. The leaders knew that infrastructure could take years and would require deep investment in engineering. Pharma’s evolving role in patient care. Partner to deliver at speed.

Marketing 131

Marketing Engineer Bioinformatics Regulation 131

Camargo

MARCH 10, 2021

As an example, the manufacturing of a small-scale batch should be completed, with acceptable results, before an engineering batch at the intended manufacturing scale is produced. A technology transfer plan should be executed in stages as appropriate, with documented evidence that each stage is complete before the next stage starts.

Manufacturing 133

Manufacturing Production Development Compliance 133

pharmaphorum

MARCH 18, 2021

A way to ensure compliance is to make sure the voice is not recorded but analysed and the full text is purged in real-time, leaving only the summarised call notes. I am happy with that because I don’t want to imagine a world where healthcare is run by engineers like myself, their focus should remain specialised.

Sales 52

Sales Pharma Companies Engineer Life Science 52

Drug Discovery World

FEBRUARY 2, 2024

How do you increase compliance? ” What to expect from 2024 Looking forward, Tarselli says: “If you look at buzzwords in search engine optimisation, of course you will see AI. Everybody focuses on what more can be done, but we should also focus on what can be done better. For instance, how do you eliminate mistakes?

In-Vivo 52

In-Vivo Compliance Drugs Pharma Companies 52

Drug Discovery World

FEBRUARY 12, 2024

The emergence of low-code and no-code software engineering will start to make CGT application development easier, enabling more rapid, innovative solutions. Fiona Maini, Senior Director Global Compliance and Strategy at Medidata “AI is dominating conversations across the drug discovery process.

Genome 139

Genome Genomics Life Science Gene Therapy 139

Advarra

OCTOBER 26, 2023

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. Even if the environment is familiar, with or without hazards, the unknown or unlikely is a biosafety consideration.

Production 52

Production Containment Biohazard Biohazard 52

The Pharma Data

NOVEMBER 5, 2020

Marquis® now publishes many Who’s Who titles, including Who’s Who in America®, Who’s Who in the World®, Who’s Who in American Law®, Who’s Who in Medicine and Healthcare®, Who’s Who in Science and Engineering®, and Who’s Who in Asia®. Source link.

Research 52

Research Vaccination Vaccine Doctors 52

Intouch Solutions

AUGUST 10, 2021

Leverage search-engine data. Collaborate with your compliance team. Level-set on your disease indication and its affected populations. This might include patient and HCP demographics, behaviors, opinions, and cultural moments. Consider whether your media mix is representative of your affected populations.

Marketing 52

Marketing Branding Compliance Engineer 52