ALiEM - Pharm Pearls

JANUARY 26, 2024

An 88-year-old female presented to the ER with a chief complaint of cough, vague abdominal pain, and a rash. The patient stated that she was started on Cipro eyedrops 1 or 2 days prior to presentation for a possible eye infection. Ciprofloxacin has been documented as a cause of IgA vasculitis. It was not on her palms or soles.

Nursing Homes 183

Nursing Homes Documentation Hospitals 183

ALiEM - Pharm Pearls

MARCH 11, 2024

In July 2022, a 32-year-old male with a past medical history of HIV (on antiretroviral therapy, CD4 390, viral load undetectable) presented to the emergency department with constitutional symptoms and a rash for 4-5 days. Ocular lesions are a rare presentation of the monkeypox virus. 10^3/mcL, Hemoglobin: 15.2

Hospitals 141

Hospitals Documentation 141

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

Documentation 97

Documentation 97

European Pharmaceutical Review

JULY 1, 2022

A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. To overcome these concerns, Pluta presents the process and documentation activities undertaken by one company.

Documentation 105

Documentation Pharmaceutical Manufacturing 105

ALiEM - Pharm Pearls

MARCH 29, 2023

If LP is traumatic or pleocytosis is present, administer antibiotics and admit. Example: A 48-day-old infant presents with a fever of 100.6F, CRP of 22 mg/L, and otherwise normal procalcitonin, ANC, and UA. This requires a documented positive viral swab and not just a presentation consistent with a viral syndrome.

Hospitals 360

Hospitals Documentation Inpatient Immunity 360

European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

Documentation 98

Documentation Communication 98

Pharma Pathway

JANUARY 28, 2023

174, Progressive Industrial Society, IDA-Bollaram, Jinnaram (M), Sangareddy (D)-502325, Telangana, India Note: Candidates must carry the following documents to eligible for Interview. Present CTC/ Present Increment Letter/ Previous Appointment Letter. Ltd, (Unit-I), Plot No. Passport Size Photo.

Documentation 77

Documentation 77

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

These efforts included the adoption of a new review template for the assessment and documentation to be used in reviewing NDAs and BLAs with an overall goal of having a more collaborative inter-disciplinary approach to the process. Before FDA even asked, we had been considering an HPM FDA Law Blog post on this subject.

Documentation 57

Documentation Packaging 57

Pharma Pathway

FEBRUARY 2, 2023

174, Progressive Industrial Society, IDA-Bollaram, Jinnaram (M), Sangareddy (D)-502325, Telangana, India Note: Candidates must carry the following documents to eligible for Interview. Present CTC/ Present Increment Letter/ Previous Appointment Letter. Ltd, (Unit-I), Plot No. Passport Size Photo.

Documentation 73

Documentation 73

RX Note

JULY 15, 2023

Introduction Medical/case note entries are legal documentation of all contributions made by healthcare providers in a patient's care. Documentation Clinical note entries shall be non-judgemental, provide accurate information and practical recommendations regarding patient care and be politely written.

Documentation 52

Documentation Communication 52

ALiEM - Pharm Pearls

APRIL 5, 2023

Does this come at the expense of your documentation? What is your method for reviewing learners’ notes and how do you provide feedback on documentation? I usually text them if it’s after shift, or talk to them on shift about their documentation. Do you typically see patients before or after they are presented to you?

Documentation 130

Documentation Hospitals 130

ALiEM - Pharm Pearls

MARCH 8, 2023

Does this come at the expense of your documentation? It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. How do you balance your flow with on-shift teaching?

Documentation 147

Documentation Hospitals 147

Express Pharma

OCTOBER 6, 2024

Bhaskar Reddy Pabbatireddy, Plant Head at Hetero Drugs, presented on “Pharma 2023,” addressing challenges like 21 CFR Part 11 compliance and data integrity issues. Dr Laxman from Laurus Labs presented on the impact of AI and digital technologies on pharmaceutical R&D, emphasising their role in improving clinical trials and drug discovery.

Documentation 97

Documentation 97

Big Molecule Watch

APRIL 18, 2023

Regeneron further argued that if it is required to narrow the patents ahead of schedule, Mylan should be required to narrow the defenses it will present at trial. Separately, in March 2023, Mylan also filed a motion to compel Regeneron to produce documents from a lawsuit that the U.S. The post Regeneron v.

Documentation 73

Documentation Biosimilars 73

ALiEM - Pharm Pearls

JANUARY 22, 2024

Fever was documented to be 102°F and was not associated with any chills or rigors. Case Discussion Take-Home Points Consider Scrub Typhus in a patient presenting with eschars. A 40-year-old male, tailor by occupation, was brought to the Emergency Department with complaints of high-grade fever for the past 11 days. doi: 10.1016/j.idc.2007.08.002.

Documentation 161

Documentation Hospitals 161

Syner-G

SEPTEMBER 20, 2023

Results Syner-G reviewed a wide spectrum of documents to ensure compliance with respect to GMP requirements. The review of the documents included master and executed batch manufacturing records, batch related deviations, investigations, analytical data, validation reports and protocols. Significant improvement was observed.

Documentation 40

Documentation 40

GMPSOP

JULY 14, 2024

This article provides an in-depth look at how you, as a professional in a GMP business, can prepare quality planning documentation, especially from the perspective of a medical device manufacturing business. Additional documents included each month. Documentation control b. Additional documents included each month.

Documentation 59

Documentation Customer Service Health and Personal Care Stores Communication 59

Pharma Pathway

JANUARY 23, 2023

174, Progressive Industrial Society, IDA-Bollaram, Jinnaram (M), Sangareddy (D)-502325, Telangana, India Note: Candidates must carry the following documents to eligible for Interview. Present CTC/ Present Increment Letter/ Previous Appointment Letter. Ltd, (Unit-I), Plot No. Passport Size Photo.

Documentation 52

Documentation 52

Pharma Pathway

JANUARY 4, 2023

Note: Candidates must carry the following documents to eligible for Interview. Present CTC/ Present Increment Letter/ Previous Appointment Letter. Ltd, (Unit-I), Plot No. 174, Progressive Industrial Society, IDA-Bollaram, Jinnaram (M), Sangareddy (D)-502325, Telangana, India. Contact: 9154030154. Passport Size Photo.

Documentation 52

Documentation 52

European Pharmaceutical Review

SEPTEMBER 2, 2022

The call for transparency in the presentation of study sampling methodology should not be limited to RMM effectiveness studies. The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. Any additional comments?

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

GMPSOP

MAY 31, 2024

A validation master plan (VMP) is a strategic document that identifies the elements to validate, the approach to each element, organizational responsibilities, and a strategy for maintaining validation documentation. – General guidance for validation document format. Additional documents included each month.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

GMPSOP

AUGUST 11, 2024

To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Additional documents included each month. ensure traceability and compliance.

Packaging 52

Packaging Documentation Labelling Dosage 52

Viseven

JULY 10, 2024

As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences. As regulations evolve, medical writers must adapt quickly, updating documents and processes to maintain compliance.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Express Pharma

AUGUST 16, 2024

Dr Udaykumar Rakibe, Founder of PharmaMantra, presented on the practical applications of QRM, using real-world examples to explain risk assessment, control measures, and the importance of ongoing risk communication. He emphasised the role of detection in ensuring that substandard products do not reach patients.

Documentation 109

Documentation Communication 109

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

Along with the proposed order, FDA issued as a supporting document the “ Scientific Review Supporting Proposed Administrative Order ” in which it describes the scientific data on the efficacy, pharmacology, and safety of oral PE underlying its determination to issue the proposed order.

Pharmacy Management 108

Pharmacy Management Dosage Documentation 108

Pharma Pathway

SEPTEMBER 23, 2022

Note: Candidates must carry the following documents to eligible for Interview. Present CTC/ Present Increment Letter/ Previous Appointment Letter. .: 147, Progressive Industrial Society, IDA-Bollaram, Jinnaram (M), Sangareddy (D) -502325, Telangana. Contact: 9154030154. Passport Size Photo.

Documentation 52

Documentation 52

ALiEM - Pharm Pearls

MARCH 22, 2023

” What is your method for reviewing learners’ notes and how do you provide feedback on documentation? I like to open an email while I sign my charts and take notes to send to learners; particularly if I notice a pattern of difficulty with documentation. Do you typically see patients before or after they are presented to you?

Hospitals 130

Hospitals Documentation Medical Schools 130

European Pharmaceutical Review

JANUARY 17, 2023

The document was commissioned by the Advanced Therapy Treatment Centres network’s Industry Advisory Group. Catapult presents vision for UK’s cell and gene therapy future. In March 2022, the CGT Catapult published the ‘National Cell and Gene Therapy Vision for the UK’.

Documentation 119

Documentation 119

Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. The importance of using plain language in health communications is well-documented in literature.

Documentation 52

Documentation Communication Mayo Clinic Drug Development 52

FDA Law Blog: Biosimilars

MARCH 7, 2023

Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission. This may result in the need to create additional documents that you may not necessarily need under the quality system.

Documentation 57

Documentation Communication 57

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

12, 2012). “[W]hen the circumstances surrounding the presentation of a prescription would give rise to suspicion in a ‘reasonable professional,’ there is a duty to question the prescription.” Pharmacists and pharmacy management should pay heed to these prescribing red flags, resolve them when they appear and document their resolution.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

pharmaphorum

OCTOBER 12, 2022

Presentation of data is vital when regulators carry out formal inspections. 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.

Documentation 101

Documentation Pharmaceutical Companies Pharmaceutical Companies 101

Express Pharma

SEPTEMBER 19, 2024

The Software Technology Pavilion, designed to highlight the latest advancements in software technology, will present innovations in AI, ML, QMS, MES, IoT, LIMS, robotics, digitisation, and automation.  There will be case study presentations on CAPA, precision lighting, ergonomic seating in classrooms, and building operational excellence.

Packaging 96

Packaging Documentation 96

pharmaphorum

SEPTEMBER 28, 2022

A new final guidance document that dropped today updates a 2019 draft guidance and clarifies the categories of clinical decision support software that would not be regulated by FDA as a medical device. “I O’Leary said.

Documentation 135

Documentation 135

Viseven

JULY 25, 2024

This includes verifying the evidence presented, the research results, and even the factual information. Compliance documentation Compliance documentation, such as pharma regulatory guidelines for audits and reviews, standard operating procedures, reports, and records, should also be verified by an MLR team.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

RX Note

JULY 24, 2024

This perception is fueled by their potential to manage tasks such as spreadsheets, documents, and presentations. Moreover, the growing demand for larger screens, beyond the limitations of smartphones, presents an opportunity for tablets to cater to entertainment enthusiasts. However, the reality is more complex.

Documentation 40

Documentation 40

Big Molecule Watch

MAY 3, 2024

The guidance remains in draft form and, as with any FDA guidance document, it is not legally binding and, when final, will reflect FDA’s “current thinking” on this topic.

Biosimilars 62

Biosimilars Communication Labelling Documentation 62