ISPE

SEPTEMBER 8, 2023

A highlight of the session was the mutual praise from industry and regulators on how well the two parties worked together during the pandemic to bring vaccines and drugs to the patients in record time. During inspections, I find beautifully written reports that are delightful to read. We hear people discuss the concept of second air.

FDA 52

FDA Vaccines Documentation 52

pharmaphorum

NOVEMBER 24, 2021

The pandemic has propelled issues for the pharmaceutical industry to the top of the political and public agenda, from clinical trial recruitment to the journey required for medicines or vaccines to reach patients. Getting the UK’s COVID vaccine and treatments programme ahead of schedule. Why is this important for the UK?

Vaccines 95

Vaccines Documentation 95

DiversifyRx

MAY 26, 2023

Pharmacy Owner Overwhelm Is Everywhere I recently received an email from a Pharmacy Badass Member that I suspect is what many independent pharmacy owners face: overwhelm. So basically, I have 5 hours per day to smash 20 hours of work into and I end up just doing nothing but snacking and making coffee.”

Independent Pharmacies 52

Independent Pharmacies Documentation Labelling Vaccines 52

pharmaphorum

NOVEMBER 23, 2020

I saw a statistic in a Health Europe article, published in September this year, which reported that 81% of patients do not feel listened to by pharma companies. Patient-centricity has, I fear, turned into a buzzword. As I said at the start, we thrive when we are united behind one common purpose.

Communication 128

Communication Documentation Vaccines 128

Colors Make me Happy

MAY 29, 2022

When I was the CEO for the SC Pharmacy Association, I would visit about 20 pharmacies a week. I watched them work selflessly to meet the needs of their patients. The impact of the pandemic on the mental health of healthcare workers, including pharmacists, has been well documented. It is designed for survival.

Community Pharmacies 40

Community Pharmacies Documentation Hospitals Vaccines 40

pharmaphorum

FEBRUARY 24, 2022

I feel that, in the developed world, we sleepwalked into the current pandemic. Unlike many of its predecessors, then, this document is not merely an exercise in raising awareness. Unlike many of its predecessors, then, this document is not merely an exercise in raising awareness. Clear objectives. High hopes for future action.

Documentation 52

Documentation Vaccines 52

pharmaphorum

APRIL 8, 2021

COVID-19 has been a trial-by-fire showing just how quickly drugs and vaccines can be developed under the right circumstances – but there is much to do to ensure this progress is not lost, said speakers at WIRED Health 2021, including the CEOs of BioNTech and BenevolentAI. . Remember, in 2020 much more people died from cancer than COVID-19.

Vaccines 82

Vaccines Documentation Communication 82

pharmaphorum

NOVEMBER 23, 2022

Within EY, I work a lot more on our innovative offerings around market access, so we are really striving to move the industry and healthcare system forward – payment for performance, outcome performance.”. I help our clients think about strategy and designing those new types of contracts, and very much about implementation.

Dosage 98

Dosage Documentation Hospitals Vaccines 98

The Checkup by Singlecare

OCTOBER 10, 2023

Required documents for application When applying for Medicaid in Texas, you should have all relevant information readily available and be prepared to provide documentation if requested. Texas Medicaid FAQ How do I find a doctor who accepts Medicaid? How do I renew Medicaid coverage? How do I appeal a denied claim?

Insurance 52

Insurance Insurance Coverage Documentation Hospitals 52

The Digital Apothecary

APRIL 26, 2019

I get calls frequently from investors and entrepreneurs looking to get into the pharmacy space, and let me be honest: They ask pretty much the same things. Even some of the most recent pitches are very similar to each other I feel. What are the main areas of interest in pharmacy I am seeing? I don't know, but it's not now.

Communication 52

Communication Packaging Patient Care Hospitals 52

PharmaShots

JUNE 1, 2023

PDC*line is much more potent than conventional dendritic cell-based vaccines in priming and boosting antitumor antigen-specific cytotoxic T-cells, including the T-cells specific for neoantigens, and is synergistic with checkpoint inhibitors. Smriti: Elaborate on the trial design of the PDC-LUNG-101 P-I/II clinical study.

Immunization 40

Immunization Vaccines Health and Personal Care Stores Labelling 40

Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). For example, the Covid-19 pandemic brought messenger ribonucleic acid (mRNA) vaccines into international prominence.

Vaccines 52

Vaccines Documentation FDA 52

pharmaphorum

JANUARY 18, 2022

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience.

Packaging 52

Packaging FDA Documentation Vaccines 52

pharmaphorum

FEBRUARY 11, 2021

She told the webinar: “Speaking to patients early on when the protocol’s in the early stages of development means that protocols and other documents can be revised from the feedback.”. During the course of my treatments and my trials, and afterwards, I was the expert in how I wanted to manage my life.”. Designing better trials.

Communication 91

Communication Documentation Hospitals Vaccines 91

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. The safety and efficacy of mRNA vaccines should be a game changer and is the likely solution to antibiotic-resistant microorganisms and emerging viral pathogens.” Perhaps we will see a universal flu vaccine in the near future.

Vaccines 127

Vaccines FDA Research Laboratories Documentation 127

Hospital Pharmacy Europe

JANUARY 19, 2023

Accompanying leaflets for patients have been developed and also digital versions of the documentation. Another simple measure is to change the way you introduce yourself – “Hi I am your pharmacist – I’m looking after your medicines …. The next stage of the project involves a roll out to 11,000 pharmacies for one year.

Community Pharmacies 98

Community Pharmacies Hospitals Communication Medical Schools 98

European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

Packaging 98

Packaging Vaccines Documentation FDA 98

DiversifyRx

OCTOBER 20, 2022

I ran into many pharmacy owners at the NCPA conference who were unaware that you could dispense up to eight at-home COVID tests in a single dispensing every 30 days for patients covered by most insurances. ’ You want to ensure that you document the attestation every time you dispense the at-home COVID tests for a patient.

Insurance 98

Insurance Packaging Documentation Communication 98

The Infectious Pharmacist

AUGUST 1, 2021

I feel a bit like Michael Corleone in Godfather Part 3 (yes, it’s the worst of the three, but it’s good for this line): Just when I thought I was out they pull me back in! And my favorite (this is a family blog so I can’t use profanity): Well that’s great. I was wrong… and right. I was wrong.

Vaccines 52

Vaccines Documentation Hospitals Communication 52

ISPE

OCTOBER 27, 2022

You will get answers to the following questions: How were the fill-finish processes for the SARS CoV-2 vaccines developed and qualified, and how did the manufacturers manage to provide vaccine doses in such large quantities in such a short time? SARS CoV-2 vaccines have been formulated in lipid nanoparticles.

Dosage 98

Dosage Vaccines FDA Documentation 98

pharmaphorum

AUGUST 16, 2021

Nearly every element of the clinical trial design, data collection, analysis and approvals has been shortened and this helped ensure the swift rollout of safe and effective vaccines.”. Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials.

Documentation 98

Documentation Vaccines Packaging Pharmaceutical Companies 98

ISPE

SEPTEMBER 11, 2023

Initial Clinical Results of Atalanta-1, a Phase I/II Trial of Point-of-Care Manufactured GLPG5102 (19CP02) in RR NHL.” Regional Manufacturing Hubs Make Sense for Autologous Therapies.” “Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” New Project: Evolutive Vaccines Facility for Sanofi.”

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Frazier, I.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Complete Data Gathering. Outline Guiding and Segregation Principles.

Vaccines 97

Vaccines Compounding Documentation FDA 97

PharmaShots

JUNE 19, 2023

During this period, while on placebo, patients were asked to dose daily and provide daily diary entries documenting data such as average daily pain score, use of daily rescue pain medication (acetaminophen), and interference of sleep from pain. I believe this positions LX9211 as an exciting potential future treatment option.

Documentation 40

Documentation Vaccines 40

pharmaphorum

OCTOBER 7, 2020

The FDA may have been blocked from issuing stricter guidelines for emergency approval of COVID-19 vaccines by the Trump administration, but it has still managed to make its new approach public. Industry is also concerned.

Vaccines 59

Vaccines FDA Documentation Communication 59

Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022.

Vaccines 52

Vaccines Documentation Communication 52