pharmaphorum

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Having worked for CROs since graduating, Sophie joined Pfizer in 2011 and has had various roles within the UK and now global groups.

Documentation 116

Documentation Pharmaceutical Companies Pharmaceutical Companies Hospitals 116

Impact Pharmaceutical Services

AUGUST 9, 2022

In 2011, following referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a small development stage pharmaceutical company located in the United Kingdom to assist them with pre-IND activities for a new chemical entity for the treatment of asthma.

Documentation 40

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 40

European Pharmaceutical Review

FEBRUARY 1, 2024

Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.

Documentation 97

Documentation Pharmaceutical Companies Pharmaceutical Companies 97

Omnicell

JANUARY 10, 2023

There was bipartisan support for the program at the hearing and support for measures such as requiring pharmaceutical companies to publish their prices in a password protected site on HRSA's website. Also, in 2011, the U.S. 2006: Congress passed, and President George W. 340B providers expressed significant concern.

Hospitals 96

Hospitals Insurance Omnicell Documentation 96

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

FDA 103

FDA Documentation Compounding Pharmaceutical Companies 103

ISPE

JULY 6, 2023

1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed.

Documentation 52

Documentation FDA Dosage Pharmaceutical Companies 52

ISPE

JULY 6, 2023

NASA Risk Management Handbook NASA/SP-2011-3422, Version 1.0. NASA Headquarters, 2011. link] The SRM risk assessment process is only as strong as the underlying risk culture and governance practices of the company. One of the most important components of SRM is the company’s risk appetite statement. 17 (2011): 10083–92.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52