Express Pharma

JANUARY 10, 2025

.” She points out that, “Special attention is required when handling data related to children and minors, ensuring that verifiable consent is obtained from guardians and that consent management is robust and well-documented.

Documentation 105

Documentation Communication 105

RX Note

OCTOBER 9, 2023

Introduction Medical/health records form an essential part of a patient’s present and future health care. As a written collection of information about a patient's health and treatment, they are used essentially for the present and continuing care of the patient.

Documentation 52

Documentation Medical Records 52

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

GMPSOP

APRIL 3, 2023

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

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 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

ALiEM - Pharm Pearls

MARCH 3, 2023

Rarely should you do “nothing” for adults who present to the ED with or following epistaxis. Managing epistaxis is often challenging, time-consuming, and takes practice. Even under the best circumstances, epistaxis often results in return visits for rebleeding and poor outcomes.

Documentation 305

Documentation 305

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

Drug Patent Watch

DECEMBER 9, 2024

Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. ” – Dr. Vandana Shiva, Environmental Activist and Author Navigating the Patent Landscape for Natural Products Patenting natural products presents unique challenges. patent for the use of turmeric in wound healing.

Compounding 97

Compounding Drug Development Documentation Pharmaceutical Companies 97

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

pharmaphorum

MARCH 16, 2021

In a review of the documents, the BMJ said they showed concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. According to the BMJ EMA scientists ensuring the manufacturing quality of the product found “truncated and modified mRNA species present in the finished product”.

Vaccines 138

Vaccines Documentation 138

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

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

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

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

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

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

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

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

Putting Patients First Blog

APRIL 29, 2024

Recognizing both the potential benefits and challenges of the MPPP rollout, the NHC views the introduction of these documents as crucial for educating beneficiaries on their options, easing transitions, and possibly lessening the financial impact of prescription costs.

Documentation 40

Documentation Insurance Coverage and Processing Communication Pharmacy Technician 40

Express Pharma

MARCH 16, 2025

Indian companies will need to enhance their quality control mechanisms, data management systems, and documentation practices to comply with these demanding standards. Collaborative R&D models and partnerships also present an opportunity for Indian pharma companies to mitigate the risks and costs of innovation.

Biosimilars 98

Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 98

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

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 105

Documentation Pharmaceutical Companies Pharmaceutical Companies 105

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

DECEMBER 25, 2024

case presentation), be cautious about revealing names or other patient identifiers. Do not dispose of confidential documents and other media-containing sensitive information with regular waste. When discussing a patient with colleagues for patient care or training purposes (e.g. passwords for data stored electronically).

Community Pharmacies 40

Community Pharmacies Medical Records Documentation 40

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 75

Documentation Biosimilars 75

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 111

Documentation Communication 111

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 105

Documentation 105

FDA Law Blog: Biosimilars

DECEMBER 12, 2024

Judge Mulrooneys prehearing ruling establishes the schedule for the parties presentations and established hearing guidelines. Parties will have ninety minutes to present the testimony of their witness. Consolidated parties are allowed to present testimony of up to two witnesses during the hearing, a presentation up to 120 minutes.

Controlled Substances 52

Controlled Substances Documentation 52

pharmaphorum

JANUARY 15, 2021

Zejula competes with AstraZeneca/Merck & Co’s PARP inhibitor class rival Lynparza (olaparib) but in this case it has an advantage in this maintenance therapy use as it can be used regardless of whether the BRCA mutation is present. Zejula pills are taken three times daily.

Chemotherapy 105

Chemotherapy Documentation 105

pharmaphorum

SEPTEMBER 29, 2022

The FDA has issued multiple guidance documents over the past several years in an attempt to illustrate what is and what is not a medical device, what is subject to enforcement discretion, and what the FDA actively regulates. More information about this process may be found in FDA’s 513(g) Guidance Document. not a medical device, ii.

Documentation 104

Documentation 104

RX Note

DECEMBER 25, 2024

Data are presented to allow the practitioner to understand the nuances considered when developing the dosing recommendations. The Renal Drug Handbook, 2019 The Renal Drug Handbook is an invaluable guide in which the information has been compiled from a wide range of sources and from the clinical experience of the UK Renal Pharmacy Group.

Dosage 40

Dosage Documentation Hospitals 40

Eye on FDA

OCTOBER 19, 2022

That did not happen and in fact, it was many years before any draft guidance documents emerged and then there were principally two of them that addressed some of what was discussed in the 2009 framework – on Character Space Limitation and on Correcting Third Party Misinformation. It is a process that can often result in partial viewing.

Communication 89

Communication Documentation 89

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

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 105

Packaging Documentation 105

European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

Documentation 98

Documentation Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

JUNE 18, 2021

UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD). Sheena Macpherson.

Documentation 98

Documentation Packaging Diabetes 98