Remove Definition Remove Documentation Remove Pharmaceutical Companies
article thumbnail

PDA revises report on glass container manufacturing

European Pharmaceutical Review

According the PDA, the standardised quality criteria in TR 43 are intended as a guidance overview for container manufacturers and for incoming container acceptance inspection at pharmaceutical companies.

article thumbnail

Considerations for safety data migration methods

European Pharmaceutical Review

Pharmaceutical companies regularly transfer databases as they shift to new systems or change service providers in pursuit of higher quality and increased efficiency. However, due to configuration differences between databases (such as code list definitions), cases may not always be an exact replica of the original case.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

It begs the question of why only two botanical drug products have obtained FDA approval and fulfilled the Botanical Guidance definition of a botanical product. Prior to joining Fieldfisher, Taly spent four years working as in-house counsel for a leading tech company helping launch products across multiple EU markets.

FDA 103
article thumbnail

The 20 Key Moments in the 340B Program's 30-Year History

Omnicell

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. Four of the five staffers originally involved in the investigation now work for or lobby for the pharmaceutical industry.

article thumbnail

Considerations for a successful tech transfer of a biologics upstream process

European Pharmaceutical Review

The emergence of huge pharmaceutical companies with discrete centres of excellence in geographically dispersed locations has upended the classic model of one-stop shopping for all development functions. Success requires close attention to the principles of tech transfer to ensure the smoothest path to market.

article thumbnail

Complete guide on pharmaceutical medical affairs

Viseven

A medical affair is a pharmaceutical or medical company department that communicates the correct information about the drug or medical device to doctors, other medical practitioners and healthcare providers. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

article thumbnail

ICH Q13 and What Is Next for Continuous Manufacturing

ISPE

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.