European Pharmaceutical Review

SEPTEMBER 26, 2023

However, due to configuration differences between databases (such as code list definitions), cases may not always be an exact replica of the original case. Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon.

Documentation 105

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GMPSOP

MARCH 25, 2024

Additional documents included each month. Category 1 Standard hardware components Standard hardware components should be documented, including manufacturer or supplier details and version numbers. Any hardware configuration should be defined in the design documentation and verified in the installation qualification stage.

Documentation 59

Documentation Packaging Communication Pharmaceutical Companies 59

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

FDA provides definitions for the three datasets. The update procedures should include how the AI-DSF modifications will be implemented and communicated to end users. Impact Assessment The Impact Assessment documents the benefits and risks of implementing the AI-DSF and the mitigations for the identified risks.

Documentation 71

Documentation Labelling Method Validation Communication 71

Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 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. Additional documents included each month. Assessing validation failures/deviations 4.

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Documentation Communication Pharmaceutical Manufacturing Labelling 52

Syner-G

MAY 4, 2022

As highlighted in these guidance documents, the FDA offers five programs: fast track designation, breakthrough therapy designation, regenerative medicine advanced therapy (RMAT) designation, accelerated approval and priority review designation. Image courtesy of qimono at pixabay.com.

Documentation 52

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European Pharmaceutical Review

JANUARY 27, 2025

A clear and comprehensive definition of technology transfer is outlined in ICH Q10: The goal of Technology Transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realisation.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

FADIC

OCTOBER 20, 2023

■ All follow-up evaluations and interactions with the patient and his or her other healthcare professional should be included in MTM documentation. Simple random sampling: Definition, examples, and how to do it The post Medication Therapy Management in geriatric appeared first on FADIC. 2014;11(4):329-337. doi:10.11909/j.issn.1671-5411.2014.04.008

Health and Personal Care Stores 52

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

GMPSOP

MARCH 4, 2023

Additional documents included each month. Quality management system is primarily involved in ensuring good manufacturing practice (cGMP), good laboratory practice (GLP), good documentation practice (GDP), good automated manufacturing practice (GAMP) etc. The quality risk management framework is ingrained in its definition.

Documentation 52

Documentation Communication Method Validation Packaging 52

Putting Patients First Blog

APRIL 7, 2025

12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier. Finally, to support transparency, reproducibility, and traceability, the FDA should require thorough documentation of AI model validation and verification.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

GMPSOP

MARCH 17, 2023

Immediately communicate the incident to stakeholders and initiate an internal laboratory investigation. By definition, corrective actions are required to eliminate the causes of an existing nonconformity, defect, or other undesirable situation. Additional documents included each month. Additional documents included each month.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

GMPSOP

NOVEMBER 6, 2022

These standards can only be used if they are standardized against primary standards using definitive methods that are published in pharmacopoeias, and national and international standards. Additional documents included each month. Additional documents included each month. All written and updated by GMP experts.

Labelling 52

Labelling Documentation Packaging Communication 52

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

Packaging 59

Packaging Documentation Labelling Communication 59

Putting Patients First Blog

JULY 15, 2024

Engaging these communities in the policy development process ensures that their voices are heard and that their unique perspectives are incorporated into policy decisions. Federal surveys and administrative data collections use different definitions of disability and measure it in different ways depending upon the goal(s) of data collection.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Coverage and Processing Communication Documentation 52

Putting Patients First Blog

JULY 2, 2024

As noted in our previous communications, while the NHC would prefer a more traditional Notice and Comment rulemaking opportunity that would ensure the Agency directly responds to stakeholder feedback, we welcome this opportunity to express our reactions to CMS’ thinking on the negotiation program.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Putting Patients First Blog

JUNE 16, 2025

Health management and care navigation applications (apps) should provide a unified experience that allows users to track medications, manage appointments, communicate with care teams, and receive tailored health education. CMS can accelerate access by: Expanding Blue Button 2.0

Documentation 52

Documentation Communication Immunization Immunity 52

Putting Patients First Blog

APRIL 14, 2023

The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. Without appropriate guardrails, CMS’ broad definition of drugs eligible for negotiation may discourage these types of improvements.

Drug Pricing 40

Drug Pricing Drug Development Documentation Communication 40

Express Pharma

JUNE 20, 2025

Archive design basis documents for all facility, process, and utility decisions. Treat each deviation, complaint, or EM excursion as a rehearsal for an FDA discussion – document decisions, risk rationales, and CAPAs with inspection-grade clarity. Regularly conduct mock inspections using external or cross-site auditors.

Documentation 65

Documentation Compounding Compounding Pharmacies Pharmaceutical Manufacturing 65

ID Stewardship

MAY 12, 2023

Review your schedule, elective options, and documentation responsibilities We have to start with the basics in order to adequately orient to future expectations. Not too say it is as dramatic as the latter part of that statement, but it is a definite narrowing. Knowing how the RPD communicates is important.

Communication 52

Communication Documentation Vaccines 52

pharmaphorum

JANUARY 27, 2023

What I’ve seen with patient centricity over the last few years is really a broadening of the definition,” Dr Mullen explained. Clinical trials design and patient input The definition of patient centricity, in fact, and its benefits are now – finally – being defined by patients themselves. “We

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 111

Putting Patients First Blog

NOVEMBER 14, 2023

15 The NHC advocates for rigorous, transparent documentation of the medical rationale in such instances to prevent discriminatory practices. This change also reflects the person-first language that is a current best practice in respectful and dignified communication.

Communication 40

Communication Bioethics Hospitals Documentation 40

Putting Patients First Blog

SEPTEMBER 9, 2024

43 ,44 ,45 This change is crucial in ensuring that formerly incarcerated individuals do not face unnecessary barriers to accessing essential health care services upon reentry into the community. amazonaws.com/s3fs-public/documents/Update_HHS_Disparities_Dept-FY2020.pdf Implementation Science Communications, 11(1) , 165.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Hospitals Inpatient Documentation 40

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

Dosage 98

Dosage Documentation Diabetes Labelling 98

RX Note

FEBRUARY 23, 2023

Teaching - A selfless effort driven by passion Ideation - Dream big, start small Perspectives - How we viewed the world Work is Work - Do not take things too personal Knowledge is Not Free - The sad truth Communication - Food for thought Phone Addiction - Reflection on living Forget - Why I create notes?

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

Express Pharma

OCTOBER 31, 2024

People may not be dealing with patients, but somebody who is doing case processing of an adverse event, must not look at it only as a document to fill in data. So we also have programs focused on personal effectiveness, simple things like communication, planning prioritisation, presentation skills etc. The GCC and beyond GCCs?

Drug Development 105

Drug Development Hospitals Process Improvement Documentation 105

Putting Patients First Blog

SEPTEMBER 9, 2024

The continuation of audio-only communication options remains essential. Direct Supervision Flexibilities The NHC supports CMS’ proposal to extend the pandemic-era definition of direct supervision, which allows for a virtual presence via real-time, interactive audio-video technology. Psychiatric Services, 68(5), 427-429.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Documentation Vaccines Communication 40

FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

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