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

European Pharmaceutical Review

SEPTEMBER 22, 2022

11 have recently conducted an analysis of international HTA submissions from 2011-2019 to determine the acceptability of single arm clinical studies and ECs as part of the drug reimbursement process. 2011 May; 46(3): 399–424. Patel et al. Multivariate Behav Res. doi: 1080/00273171.2011.568786. Available at: [link].

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 122

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 Omnicell Insurance 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

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

ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

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