pharmaphorum

JANUARY 27, 2023

Then, at the end of the study, [making sure] that all of the study documentation, [the] study report, matches up with everything that has happened during the study. Having the ability of these groups to be able to communicate directly with patients is tremendous.” It really enables the smooth running of studies.”

Pharmaceutical Companies 105

Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 105

Hospital Pharmacy Europe

JANUARY 19, 2023

In 2016, the country’s first National Strategic Plan in Antimicrobial Resistance 2017–2021 was published. Accompanying leaflets for patients have been developed and also digital versions of the documentation. was a remarkably effective way to establish good communication, he said. By 2021, reductions of 15.2%

Community Pharmacies 98

Community Pharmacies Hospitals Communication Medical Schools 98

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Wireless medical devices. Is the action for the benefit of individual patients? MDCG 2019-11.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

The FDA Law Blog

JANUARY 4, 2023

Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. By Dara Katcher Levy — A win for patient access!

Communication 64

Communication FDA Labelling Documentation 64

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Wireless medical devices. Is the action for the benefit of individual patients? MDCG 2019-11.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

NOVEMBER 28, 2022

The Advancing Pharmaceutical Quality, Quality Management Maturity Program includes five guidance documents: Corrective Action and Preventive Action (CAPA) : ICH Q10 demonstrates defined requirements for a robust corrective action and preventive action system throughout the product lifecycle. Internal Communication. CAPA Effectiveness.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

FDA 105

FDA Documentation Communication 105

pharmaphorum

OCTOBER 20, 2020

While remote communication with HCPs rose in all countries in the same time period, not all remote engagement was the type likely to be described as meaningful – much of the volume was in emails, with WhatsApp, and other remote messaging, also important during the peak infection period. In the US, the trend had already started pre-COVID-19.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Procedia CIRP 60 (2017): 86–91. initiatives.

Packaging 52

Packaging Documentation Communication Data Entry 52

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 5, 2023

Due to the expanding workload of the ETP, CDER has begun implementing ETP program enhancements to improve strategy and operation and to enhance communication with those adopting new technologies. September 2017. Eventually all CM technologies will graduate from the ETP. Guidance for Industry. link] 8 Allison, G., Garcia, T.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 2 (2017): 44–46. link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 You may unsubscribe from these ISPE communications at any time. October 2004.

Documentation 52

Documentation FDA Packaging Communication 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., Macheras, and K.

Documentation 52

Documentation FDA Communication Packaging 52

The Thyroid Pharmacist

JUNE 14, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! Nov 20, 2017. Physiol Rev.

Health and Personal Care Stores 104

Health and Personal Care Stores Immunization Documentation Compounding 104

pharmaphorum

DECEMBER 6, 2022

Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past. In most cases, the EHRs and EDCs don’t communicate, so in order to share that data with trial organisers, staff members at medical centres must manually copy data between the EHR and an EDC.

Data Entry 98

Data Entry Communication Hospitals Documentation 98

ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. The second edition of the ISPE guide received regulatory input from the FDA and other agencies and was published in 2017. Published 2017. 5 European Commission.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Published 19 January 2017. You may unsubscribe from these ISPE communications at any time.

Dosage 52

Dosage Chemotherapy Documentation Labelling 52

ISPE

MARCH 7, 2023

Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” EMA/CHMP/QWP/545525/2017 Rev. Committee for Medicinal Products for Human Use. 27 January 2022.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

MARCH 15, 2023

7 December 2017. 1 December 2017. There is an increase in those issuing a path to net zero design strategy document, which sets out design parameters covering all aspects of a project from initial concept through the commissioning, post-occupancy surveys, and audits. [link] 4 World Economic Forum. “3 7 November 2022.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

SEPTEMBER 10, 2023

PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?” 5 (2017):421–27. en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf 9 European Commission. Edwards, K.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98

The Thyroid Pharmacist

JANUARY 20, 2023

In one small study published in 2017 in the Journal of Complementary Medicine , after eight weeks of treatment, ashwagandha was found to improve serum TSH, T3 and T4 levels, normalizing serum levels. [14] doi:10.1155/2017/9217567; Cohen MM. Published 2017 Dec 1. doi:10.1155/2017/8024857 [48] Lee Y, Jung JC, Jang S, et al.

HIV Treatment and Prevention Agents 90

HIV Treatment and Prevention Agents Immunization Compounding Dosage 90

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

Documentation 97

Documentation FDA Hospitals Dosage 97

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 83

Dosage Documentation FDA Labelling 83

Pharmaceutical Technology

JUNE 22, 2023

According to the document, this scheme would instead harm patient access to drugs, which will take longer to turn generic. The EU previously focused on AMR through the One Health Action Plan, which was released in 2017. The voucher system marks another one of the EU’s steps against the rising threat of AMR announced in recent years.

Documentation 52

Documentation Communication 52

Pharmaceutical Technology

APRIL 16, 2023

mL autoinjector debuted in 2017. To learn more, download the document below. The NIT thus simplifies the injection process by eliminating the need for patients to attach the needle to the cartridge, making for a simplified and safe end-user experience – and freeing autoinjectors to carry larger doses than existing PFS-based devices.

Documentation 52

Documentation Communication Hospitals 52