European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house.

Manufacturing 104

Manufacturing Food and Drug Administration Patients Pharma 104

pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.

Food and Drug Administration 105

Food and Drug Administration FDA Medical Food 105

European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. Training and education. This involves providing continuous training and education to all employees at every level. How can this be mitigated?

Government 98

Government Pharma Training Ethics 98

European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 98

Manufacturing Pharma Food and Drug Administration Safety 98

Medico Reach

OCTOBER 17, 2022

From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 52

Marketing Pharma Food and Drug Administration Media 52

Nixon Gwilt Law

APRIL 22, 2024

If a Covered Entity or Business Associate is using PHI in model development (training data for example), deployment, or maintenance of a healthcare AI system, then HIPAA obligations likely apply. Implementation of risk management practices for all predictive DSIs, ensuring their validity, reliability, safety, security, and effectiveness.

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

Nixon Gwilt Law

APRIL 22, 2024

If a Covered Entity or Business Associate is using PHI in model development (training data for example), deployment, or maintenance of a healthcare AI system, then HIPAA obligations likely apply. Implementation of risk management practices for all predictive DSIs, ensuring their validity, reliability, safety, security, and effectiveness.

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

Food and Drug Administration 95

Food and Drug Administration Pharmaceutical Pharmaceutical manufacturing Pharma 95

Legacy MEDSearch

OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States.

FDA 52

FDA Food and Drug Administration Physicians Safety 52

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 40

Marketing Pharma Food and Drug Administration Media 40

Rep-Lite

SEPTEMBER 21, 2024

It’s like having a playbook—everyone knows their position, boosting performance and making sales training more effective. Training and Onboarding New Sales Representatives A comprehensive medical sales training program is key to equipping new hires with the right product knowledge and sales tactics.

Medical sales 52

Medical sales Sales Medical Medical sales reps 52

Salesforce

JUNE 28, 2024

Clinical data management (CDM) manages the data protocols for clinical trials, including establishing the right systems, processes, procedures, and training to extract meaningful results and comply with local and federal regulations around the world.

Management 59

Management Electronics Food and Drug Administration Recruitment 59

pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

Food and Drug Administration 105

Food and Drug Administration Prescription Media Patients 105

European Pharmaceutical Review

MARCH 28, 2024

The discourse will enable us to differentiate what we have developed from these anecdotal methods, with its end-to-end audit trail, video quality control, rater training and certification programme, and validated quantification methodology.

Food and Drug Administration 52

Food and Drug Administration FDA Patients Insurance 52

Medico Reach

OCTOBER 17, 2022

From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Legacy MEDSearch

JULY 11, 2022

based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. In addition, candidates cannot have had previous cataract surgery in the study eye and must agree to post-operative comprehensive visual rehabilitation and training.

Food and Drug Administration 52

Food and Drug Administration Recruitment FDA Patients 52

Pharmaceutical Technology

APRIL 25, 2023

Storage in other conditions can cause damage to the antigen or adjuvant and reduce the vaccine’s safety or efficacy. This requires cold chain infrastructure investments, workforce training and, very importantly, last mile coordination.” The majority of this rise came from the African region.

Food and Drug Administration 69

Food and Drug Administration Government Prospecting Food 69

Pharma Marketing Network

OCTOBER 3, 2024

A strong brand message conveys the unique value proposition of the pharmaceutical product, highlighting its benefits, efficacy, and safety. The pharmaceutical industry is highly regulated, with strict guidelines governing the promotion of products to ensure patient safety and ethical standards.

Marketing 52

Marketing Pharmaceutical Healthcare Healthcare 52

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Food and Drug Administration 115

Food and Drug Administration Side effects Pharmaceutical Leads 115

Pharmaceutical Representative Training

JUNE 22, 2024

They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. Regulatory Compliance: Compliance with regulations must be fully understood by representatives.

Sales 52

Sales Pharmaceutical Ethics Pharmaceutical Sales 52

European Pharmaceutical Review

FEBRUARY 5, 2025

This guidance aims to streamline access pathways for patients, without compromising on the safety of these personalised immunotherapies. The recommendations cover product design and manufacture, evidence needed show safety and effectiveness, and post-approval safety monitoring, according to the MHRA.

Food and Drug Administration 52

Food and Drug Administration Government Safety Medicine 52

Evolve Your Success

MAY 17, 2022

You know when they are trying to push a drug and white-knuckling it. You ask the hospital administrators to figure out the financial aspects of that side of it. What drugs are we using? This office or rep prescribed this drug and this is what I want you to know about this drug.”. You do not even have to say it.

Medical sales 130

Medical sales Medical Sales Patients 130

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.

Pharmaceutical 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

Clarify Health

NOVEMBER 9, 2022

However, some communities have historically been underrepresented in clinical research due to barriers like a lack of access, awareness, and trust in drug development processes. Patient-centric approach: Seeking patient input throughout drug development processes can be critical to the success of pharma.

Pharma 40

Pharma Food and Drug Administration Patients Medicine 40

Clarify Health

NOVEMBER 9, 2022

However, some communities have historically been underrepresented in clinical research due to barriers like a lack of access, awareness, and trust in drug development processes. Patient-centric approach: Seeking patient input throughout drug development processes can be critical to the success of pharma. Current FDA guidance.

Pharma 40

Pharma Food and Drug Administration Medicine Patients 40

European Pharmaceutical Review

APRIL 2, 2025

3 High attrition rates in early clinical trials have bedevilled the industry in recent years, and the average likelihood of approval (LOA) for a new Phase I drug is now just 6.7 7,8 Some of the challenges arise from the data quality/data sharing/proprietary data that are available as training sets for AI systems. Drug Discov.

Pharmaceutical 52

Pharmaceutical Food and Drug Administration Manufacturing FDA 52

European Pharmaceutical Review

APRIL 8, 2025

Next, budgeting is an important factor to estimate values of purchases, maintenance, hardware, software, training, contingency budgets and overall, any work package referenced in Figure 1. Training programmes must be tailored based on the technology itself, the operator level and responsibility. European Commission, 2015.

Manufacturing 52

Manufacturing Food and Drug Administration Management Pharmaceutical 52

Nixon Gwilt Law

JANUARY 14, 2025

Venture investment skyrocketed, partnerships between leading AI startups and health systems took shape, and policymakers across the globe grappled with AIs implications for consumer safety and algorithmic transparency. Want to stay up to date on the latest changes in statewide regulatory changes? Federal healthcare privacy laws (e.g.,

Healthcare 52

Healthcare Healthcare Food and Drug Administration Government 52