pharmaphorum

MAY 25, 2022

When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Here, we take a look at the top five takeaways from the document: 1. The same cannot be said for online events.

Documentation 104

Documentation Communication Pharmaceutical Manufacturing Labelling 104

European Pharmaceutical Review

APRIL 10, 2024

The regimen may be applied as a quality indicator fulfilling certain ISO quality control criteria, and offers “documented, systematic feedback”. Additionally, a laboratory could assume that a partially degraded nucleic acid “is a consequence of upstream preanalytical events rather than contamination in their laboratory”.

Documentation 77

Documentation 77

European Pharmaceutical Review

AUGUST 3, 2023

Rather than focusing on documentation with the aim to achieve compliance, the initial proposed framework shined a light on problem-solving and therefore the initiation of preventative action as a key part of the process. These results are included in most recent paper.

Documentation 52

Documentation Process Improvement 52

GMPSOP

AUGUST 10, 2023

Scope : This procedure applies to the training and development of all personnel within a GMP site including the documentation and retention of training records. Procedure Originator is responsible for determining who requires training on Document Change Notification (DCN). Annual refresher training shall be documented.

Documentation 74

Documentation Communication 74

Express Pharma

JUNE 13, 2023

The theme for this year’s annual flagship event is ‘Patient Centricity: New Paradigm of Manufacturing and Quality’. This will be followed by the release of IPA’s Best Practices document.

Documentation 98

Documentation 98

Express Pharma

JANUARY 16, 2024

The ADR i.e. DRESS syndrome, mentioned in the IPC alert, is a very rare event that is previously documented in medical literature, both in India and globally. The company said mefenamic acid, apart from India (as meftal and meftal-spas) is being prescribed in countries like the USA, the UK, Japan etc.

Adverse Reactions 105

Adverse Reactions Documentation 105

pharmaphorum

DECEMBER 10, 2020

FDA reviewers have already concluded that the vaccine is safe and effective in a briefing document ahead of the Vaccines and Related Biological Products Advisory Committee’s meeting.

Vaccines 101

Vaccines Documentation 101

FDA Law Blog: Biosimilars

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

Documentation 108

Documentation Vaccines Drug Development 108

Drug Channels

DECEMBER 2, 2021

Dr. Gottlieb documents—with great specificity—how and why our government’s public health infrastructure failed us during the pandemic. Click here to learn more and register for this event. I suggest Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic , by Scott Gottlieb, M.D. Amazon link). to 1:30 p.m.

Documentation 58

Documentation 58

Express Pharma

SEPTEMBER 26, 2023

Speakers in this video: Upendra Singh Bisht, Manager-Business Development, Ami Polymer Topic: Critical product solutions for the pharma industry Key Takeaway: Ami Polymer, apart from offering a wide range of new age polymeric solutions, also provides quick customisation, technical documentation support, quick delivery support The post Upendra Singh (..)

Documentation 52

Documentation 52

pharmaphorum

MAY 5, 2022

Following on the success of the previous West Coast events, we are delighted to announce 5th Annual Pharmaceutical Microbiology West Coast conference taking place in San Diego on June 20th and 21st,2022. Event Hashtag: #PharmaMicroWC. Sponsored by: Associates of Cape Cod, Bioscience International and Ecolab. Key Reasons to Attend: 1.

Documentation 52

Documentation 52

FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M.

Documentation 105

Documentation 105

Express Pharma

SEPTEMBER 26, 2023

In this video: Keynote Address by Dr Rajesh Gupta, All India Head-Pharma, Laghu Udyog Bharati, President – Himachal Drugs Manufacturers Association Topic: The regulatory perspective Key Takeaway: India Pharma Inc needs to document our data better, balance quality and cost, as well as improve continously to enable regulatory compliance and maintain (..)

Documentation 52

Documentation 52

pharmaphorum

OCTOBER 12, 2022

Facilities can be asked to provide documented records of environmental monitoring, as well as personnel interaction with systems of record and the order in which events occurred. Presentation of data is vital when regulators carry out formal inspections.

Documentation 103

Documentation Pharmaceutical Companies Pharmaceutical Companies 103

RX Note

JULY 30, 2023

Adverse Drug Reactions The World Health Organization (WHO) defines an adverse drug reaction (ADR) as 'a drug-related event that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function'. Is it safe?

Adverse Reactions 52

Adverse Reactions Patient Counseling Medical Records Documentation 52

Putting Patients First Blog

FEBRUARY 5, 2024

In addition, the NHC hosts ad-hoc meetings, events, webinars, and briefings on relevant and timely topics. The NHC strives to share relevant policy work such as comment letters, working documents on policy positions, and white papers with its members well ahead of deadlines. To view our 2024 policy priorities, click here.

Documentation 59

Documentation Communication 59

pharmaphorum

JULY 15, 2022

The just-published final technology appraisal document recommends that Vazkepa (icosapent ethyl) can be prescribed to people in England and Wales for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides (1.7 mmol/litre or above) in their blood who are already taking statins.

Documentation 98

Documentation Diabetes 98

pharmaphorum

JANUARY 13, 2023

At the moment the threshold for prescribing these drugs to a patient is a 10% or greater risk over 10 years of a cardiovascular event such as a heart attack or stroke. A daily 20 mg does of atorvastatin – available as a low-cost generic – is the statin of choice for primary prevention, according to the document.

Documentation 52

Documentation 52

GMPSOP

DECEMBER 24, 2023

Additional documents included each month. The points below outline some areas in the codes where G(C)LP regulations are embedded in the GMP regulations and guidance documents. Additional documents included each month. All sampling procedures and plans must be documented. All written and updated by GMP experts.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

AUGUST 23, 2022

Assessing the impact of changes to a process/system The use of quality risk management and the methodology to be used should be documented in the relevant validation plan or change management procedure. Additional documents included each month. Assessing validation failures/deviations 4. All written and updated by GMP experts.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

European Pharmaceutical Review

JANUARY 19, 2023

The final appraisal document (FAD) recommended the triple regimen as an option for adult patients who have received two or three lines of therapy. Adverse events (AEs) observed in the ixazomib arm were consistent with reported safety profiles for the individual agents.

Hospitals 78

Hospitals Documentation 78

pharmaphorum

OCTOBER 7, 2022

As we enter October and the Frontiers Health 2022 conference in Milan, we’re shining a spotlight on some of the Steering Committee members who have helped make the event what it is. And check out DTx and National Health Systems from last year’s event below. A cooling off in digital health investment. “Yet,

Documentation 98

Documentation Diabetes 98

Express Pharma

JUNE 2, 2023

By accurately documenting the movement of drugs, manufacturers can identify any quality issues that may arise during production, storage, or transportation. Quality control and regulatory compliance: Traceability is crucial for maintaining quality control and ensuring compliance with stringent regulations in the medicine space.

Adverse Reactions 103

Adverse Reactions Packaging Documentation Dosage 103

pharmaphorum

NOVEMBER 11, 2022

According to court documents, Cohen reached out in 2015 to Moshe Alafi, former general partner at Alafi Capital who he had known for decades – and his son Christopher Alafi, who is the firm’s capital director – to seek investment in Nuredis. .

Documentation 111

Documentation 111

GMPSOP

NOVEMBER 19, 2023

Additional documents included each month. If significant trends are identified, they should be documented, and changes should be made to avoid out-of-specification results. The number of batches manufactured, released and rejected should be documented. Additional documents included each month. Checkout sample preview s.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

pharmaphorum

DECEMBER 14, 2022

.” The experts reviewed data from the GALACTIC-HF trial, conducted when Cytokinetics was partnering the drug with Amgen, in which the drug met its primary objective of reducing cardiovascular death or heart failure events compared with placebo in HFrEF patients, cutting the combined rate by 8%. with omecamtiv mecarbil from 39.1%

Documentation 52

Documentation Labelling 52

pharmaphorum

JANUARY 30, 2023

Network with the industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insights.

Documentation 52

Documentation Drug Development 52

GMPSOP

MARCH 17, 2023

Additional documents included each month. – Market action: conduct mock recalls and other contingency planning activities to ensure the organization is prepared to respond effectively in the event of a product recall or other crisis. Additional documents included each month. All written and updated by GMP experts.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

European Pharmaceutical Review

JULY 21, 2023

The document is part of the joint Heads of Medicines Agencies (HMA)-EMA Big Data Steering Group (BDSG) initiatives to develop the European Medicines Regulatory Network’s capability in data-driven regulation. How can AI be best harnessed for pharmacovigilance data?

Drug Development 86

Drug Development Documentation 86

National Association of Boards of Pharmacy

JUNE 14, 2023

The idea is to create a workplace culture that encourages transparency and learning from mistakes, rather than taking disciplinary action in the event of errors or near misses. Understanding “Just Culture” A just culture approach is often presented as an alternative to a “blame culture.” OPSC currently performs this duty through 2 channels.

Pharmacy Technician 40

Pharmacy Technician Documentation 40

Pharma in Brief

OCTOBER 29, 2020

The FC Guidelines differ from previous FC Notices to the Profession in a number of notable respects, including the following changes and additions: Electronic documents: Electronic production of documents is encouraged. Digital documents submitted via a USB key, with hyperlinks to case law, are encouraged.

Documentation 52

Documentation 52

pharmaphorum

JULY 16, 2021

Advisory committee members were mainly concerned about the safety profile of roxadustat, an oral HIF-PHI drug, including its potential to cause serious thromboembolic events which were flagged by the FDA in a briefing document published ahead of the meeting.

Documentation 52

Documentation 52

RX Note

MARCH 29, 2024

In the event of the cancellation of any license, the date of such cancellation shall be noted in the register. Section 27 Register of Licences: Every licence issued shall be numbered consecutively in respect of each type and of the year in which it was issued, commencing each year with the number one.

Documentation 40

Documentation Compounding 40

Board Vitals - Pharmacist

APRIL 22, 2022

Events sponsored by an accredited CME provider include national, regional, or local conferences, workshops, seminars, journal clubs, simulation labs, and live webinars. Live CME activities typically require physicians to arrange travel and lodging for the event(s). Here are some of the top ways to earn CME quickly and easily. .

Documentation 52

Documentation 52

FADIC

OCTOBER 20, 2023

Aim The role of MTM provider to geriatric patient to reduce the rate of adverse drug event caused by medication errors, drug interactions. ■ All follow-up evaluations and interactions with the patient and his or her other healthcare professional should be included in MTM documentation. ■ How to handle missed doses.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Medication Therapy Management (MTM) Medical Records 52

pharmaphorum

OCTOBER 5, 2022

He’s been involved with the event from the early days, and he says he sees different ways in which pharma could integrate digital therapeutics. So, in France, if I’m under an oncology medication, I have an app, and there’s an improved survival documented in the RCP. What will the market dynamics of DtX look like?

Documentation 98

Documentation Pharmaceutical Companies Pharmaceutical Companies 98

Pharmacy Joe

JUNE 5, 2022

No patient in the study cohort required treatment for extravasation, and the bedside team taking care of each patient never documented an extravasation event. The study reviewers did however note 3 possible cases of extravasation when looking back at the care team’s notes.

Documentation 40

Documentation Hospitals Inpatient 40