pharmaphorum

JUNE 7, 2021

Researchers in the US have developed a wearable fabric that can sense, store and analyse data that could be used to measure physiological functions or detect illness. “This type of fabric could give quantity and quality open-source data for extracting out new body patterns that we did not know about before,” said Loke.

Communication 145

Communication 145

PQA

AUGUST 29, 2022

COPD is a high-burden and expensive condition, so ensuring effective, high-quality treatment is a priority for patients and those who care for them. Learn more about the TEP below. These include an equity, diversity, and inclusion statement to guide planning. Email us. Nominations will be accepted through September 9.

Communication 52

Communication 52

PQA

JUNE 7, 2023

Diverse Voices in Quality is a new PQA blog series that showcases the successful career paths and experiences of medication use quality professionals from diverse groups at PQA member organizations. Tell us about your work and role at Turner Healthcare Quality (THCQ) Consulting, Inc. My background is very eclectic.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Medical Schools 52

PQA

FEBRUARY 10, 2023

PQA’s 2023 calendar is shaping up to be full of opportunities for members to engage in our work and advance the quality of medication use. If you have not already, sign up to receive notifications about our Quality Forum Webinars and Quality Connections Newsletter. Register today!

Communication 40

Communication Patient Care 40

The FDA Law Blog

JANUARY 1, 2024

It’s why litigators concentrate on their opening statement to a jury, and their closing argument. Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Colonial Dames Company, Ltd. Colonial Dames Company, Ltd.

FDA 59

FDA Documentation Labelling 59

European Pharmaceutical Review

DECEMBER 21, 2022

In the earlier statement, the regulatory agency noted that clinical research “…is a critical step in the generation of good quality evidence needed to better understand the potential health benefits and harms associated with the therapeutic use of psilocybin.” What sponsors should know about psychedelic drug development.

Compounding 114

Compounding Controlled Substances FDA Patient Care 114

pharmaphorum

JUNE 14, 2021

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. The numbers are never going to tell the whole story about quality of life,” she says.

Communication 105

Communication 105

pharmaphorum

SEPTEMBER 29, 2022

Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review.

FDA 68

FDA Immunization Vaccines 68

pharmaphorum

DECEMBER 19, 2022

Colombo opened with the impactful statement that 40% of the differences in cancer cases can be attributed to preventable factors, such as lifestyle. Regularly, only about half of the data needed to inform policy and practice is measured. Rossi posited that for equitable and high-quality cancer care, measurables are needed.

Documentation 97

Documentation Hospitals Communication Vaccines 97

Hospital Pharmacy Europe

JUNE 14, 2023

With increasing evidence that cannabis use is associated with adverse cardiovascular effects, questions are undoubtedly being asked about the safety of the drug for medical uses. Rod Tucker investigates.

Compounding 98

Compounding Hospitals 98

pharmaphorum

DECEMBER 15, 2022

Social media has become an important way for HCPs to exchange ideas, information, and questions, and to learn about new products and emerging data. Back in 2015, the influencer-of-influencers, Kim Kardashian, was slammed for failing to mention the potential side effects of an anti-nausea drug, leading to the US FDA getting involved.

Communication 103

Communication Vaccines FDA 103

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. There are only two marketed treatments for ALS in the US.

FDA 98

FDA Hospitals 98

ISPE

NOVEMBER 9, 2022

Quality Manager & Quality Auditor. She was followed by Mugdha Apte and Leila Heiba, the Genentech Problem Statement sponsor company representatives who worked for hand in hand with the hackathon task team to develop the Hackathon problem statement. Yanet Flor. Previous Slide ?? Thank you to all the hackathon organizers.

52

52

Hospital Pharmacy Europe

DECEMBER 19, 2023

In a statement, the COP28 Presidency said these partners have collectively ‘committed to dedicate $1bn to address the growing needs of the climate-health crisis‘. The PDA also recognise that the sum of each local action, no matter how small, can add up to make a global difference.‘

Hospitals 52

Hospitals 52

pharmaphorum

OCTOBER 19, 2021

ME/CFS is a complex illness and the US Centers for Disease Control and Prevention describe how some people with ME/CFS can be confined to bed and that ME/CFS can get worse after any activity, physical or mental. Controversial issues with the NICE draft guideline reflect controversy about the evidence. Disagreement amongst stakeholders.

131

131

BuzzRx

OCTOBER 31, 2022

The recalled drugs (Chantix tablets) were distributed nationwide in the US and its territories between May 2019 and September 2021. Please continue reading to find out more about Pfizer's Chantix recall and the FDA’s most recent update on the manufacturing of varenicline products in the U.S. Is Chantix available in the US at present?

Adverse Reactions 52

Adverse Reactions FDA Compounding Pharmaceutical Companies 52

pharmaphorum

SEPTEMBER 8, 2020

Faced with constant and overwhelming information about the pandemic, including rapidly changing policy responses, there is also an alarming acceleration of a healthcare sustainability issue that needs more of our immediate attention. In the US, biologic medicines represent 2% of medicine budget volume yet represent 37% of net drug spending.

Chemotherapy 98

Chemotherapy Patient Care Vaccines FDA 98

pharmaphorum

OCTOBER 27, 2020

Both mechanisms cover review of safety and efficacy data, as well as ensuring the product meets manufacturing and quality assurance standards. There has however been some debate about the lack of data behind the shot, and concerns that Russia rushed development to claim a political victory in the race to get a COVID-19 vaccine approved.

Vaccines 102

Vaccines 102

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.

Dosage 104

Dosage FDA 104

pharmaphorum

MAY 26, 2022

On average, a specialist should spend about 40 hours per week monitoring 100 sources. . He says that they should analyze information about drug safety and make decisions about what to do further with this data. However, Artem says that pharmacovigilance “is very important because medication use hasn’t stopped.”

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

ISPE

JULY 19, 2023

Nearly 500 participants attended either in person or online to learn about the latest developments. ™ opens new opportunities for quality, safety, productivity, and patient benefit. This asks, “What amount of change can we absorb before it negatively impacts us?” The concept of Industry 4.0

Documentation 98

Documentation FDA Labelling Communication 98

The Thyroid Pharmacist

JULY 29, 2022

Most of the time, we don’t think twice about what might be in that air — but it could actually be making us sick. One of the reasons I moved to Colorado was because of the promise of healthy living… I was so excited about living in a culture of wellness, farm to table food and fresh air…. How We Are Exposed to Unhealthy Air.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

ISPE

JULY 10, 2023

However, their arrival requires reconsiderations on risks, quality assurance, and validation from a GxP perspective. ChatGPT 1 has taken the use of artificial intelligence (AI) to the next level, reaching a global user base beyond the established AI circles, and other large language models (LLMs) like LaMDA as in Bard 2 followed.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JUNE 21, 2023

These systems were designed specifically to support validation or quality objectives. While a very nuanced conversation, I see struggles occur most often across the organizations that disagree on what ‘documentation’ should exist, ‘who and what’ constitutes quality reviews, and, of course, the demand for resourcing in time, people, and money.

Documentation 52

Documentation Data Entry Compounding FDA 52

ISPE

OCTOBER 27, 2022

Driving the transition to the digital world through the quality and validation lenses. This blog is the first in a 4 part series intended to explore how we can rethink the way we support and inspire one another as we reimagine quality and validation in a digital world. Walker, CPIP. 27 October 2022.

Documentation 52

Documentation 52

Digital Pharmacist

DECEMBER 20, 2023

Branding helps you create a memorable identity for your pharmacy business, including a mission and vision statement and brand story. Here are a few tips to help your website convert… Think about your audience and how to create webpages that answer the questions that brought them to your website in the first place.

Communication 98

Communication Immunization 98

ISPE

JULY 6, 2023

Advanced technologies such as CM have the potential to greatly transform pharmaceutical production processes by improving drug quality and supply continuity for consumers worldwide while benefiting the company’s bottom line. 2 1 US Treasury, Office of the Comptroller of the Currency. This is where an SRM capability is required.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

FEBRUARY 14, 2023

2 Yet according to a 2022 report by GlobalData, it is difficult to achieve high quality and highly pure mRNA via scalable manufacturing. Sarah Bundra, Pharmaceutical Analyst at GlobalData also warned about patient safety: “introducing mRNA carries the risk of activating the immune system.”

Vaccines 97

Vaccines Immunization FDA 97

pharmaphorum

DECEMBER 14, 2022

As many strive to bring about transformation in healthcare, Angelini Ventures takes a new approach to investments in digital health and life sciences companies that drive healthcare innovation and improve patient experiences. The last few years have put a spotlight on mental health,” said Stupka in a statement. About the interviewees.

105

105

European Pharmaceutical Review

DECEMBER 23, 2022

Overall, raw material sourcing and testing, and the preparation, storage and use of the buffer solution, are estimated to cost approximately $20-50 million per facility. Implementing on-demand, automated delivery of buffer solutions provides oversight of quality and control but has some integration challenges. About the authors.

Documentation 93

Documentation 93

pharmaphorum

JULY 15, 2021

After more than a year of COVID-19 dominating health conversations, HCPs have been engaging in dialogue about continually evident disparities that many are facing in healthcare. CREATION.co’s Mary Kangley explores what HCPs think about health equity in cancer care. of the US population, only 3% of oncologists are black.

Insurance 115

Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 115

pharmaphorum

JANUARY 12, 2021

Project Orbis is coordinated by the US Food and Drug Administration and includes Canada, Australia, Switzerland, Singapore and Brazil and focuses upon review and approval of cancer treatments that offer promise. The UK joined two initiatives in October 2020 that should bear fruit in the future: Project Orbis and the Access Consortium.

Documentation 81

Documentation 81

European Pharmaceutical Review

OCTOBER 31, 2022

Understanding the formulation problem statement and deciding the best approach to meet the target drug product profile will help clarify effective technology selection as well as the optimal development processes.” This prevents them snowballing over the different stages and ensures a close eye on process performance and quality.

Compounding 111

Compounding Pharmaceutical Companies Pharmaceutical Companies FDA 111

The Thyroid Pharmacist

AUGUST 18, 2023

When asked about the specific benefits seen from the use of turmeric, 64 percent of people reported that it helped them with reducing pain symptoms. My recommendation is to add more turmeric to your cooking (remember to add some pepper to the mix), as well as a high-quality curcumin supplement. Here’s what Kristin L.

Dosage 98

Dosage Compounding Labelling Immunization 98

The Physician Pharmacist

SEPTEMBER 7, 2023

He discusses the challenges of managing the medical school application process while still in pharmacy school, including studying for the MCAT, completing prerequisite courses, and writing a standout personal statement. Thanks for joining us today on the show today. Enjoying the podcast and want to listen to more?

Medical Schools 52

Medical Schools Patient Care Independent Pharmacies Insurance 52

pharmaphorum

AUGUST 27, 2021

I’m proud of the spotless quality of my own work and that of my team. Not even superficially – which would pain me anyway, since not only did my nights become later and later, but the quality of work suffered, too. Until our head of portfolio management challenged us by stating: “If you make everything a priority, nothing will be.

Communication 52

Communication Compounding 52

The FDA Law Blog

OCTOBER 17, 2023

The new guidance does not surprise us as the scope of the changes is limited to the select updates, but it is certainly exciting that FDA expands product areas for the Breakthrough Devices Program.

Documentation 53

Documentation FDA Medication Dispensing Hospitals 53