Phorum

Drug Substance

Deliverables

Jan 2020

Drug Substance Papers

Industry reflection on the registration of raw materials entering the composition or presentation of biopharmaceuticals in China January 2020

Read article

Jan 2020

Drug Substance

Biopharmaceutical industry position on European Medicines Agency (EMA) guidance and expectations at product changeover (PCO) December 2019

Read article

Sep 2019

Drug Substance

Creating a lean approach to qualification and validation

The Lean Qualification and Validation (LQV) workstream has published the first in a proposed series of practical guides to support the wider[..]

Read article

Sep 2019

Drug Substance

Proactive prioritization: a new tool for assessing raw material risk

The Raw Material Risk Management workstream has launched a new, raw material risk assessment tool aimed at helping industry identify and prioritize[..]

Read article

Jul 2019

Drug Substance

Best practice on transport qualification: good distribution practice

Transport validations “were like building a new Eiffel Tower every time,” said Kim Bang Salling, Transport Validation Expert at Novo Nordisk. “The documentation[..]

Read article

Jun 2019

Change Notification

Decision tree to support alignment of risk assessment for changes to single-use biomanufacturing systems

The BioPhorum single use change notification team has been working on developing and standardizing best practice for single use change notification since[..]

Read article

Mar 2019

Drug Substance Papers

General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example of Brazil

This concept paper outlines BioPhorum’s considerations regarding Anvisa’s intention to adopt WHO guidelines while meeting the related ICH ones. The paper demonstrates[..]

Read article

Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

Newsletter subscribe

You can unsubscribe at any time by clicking the link in the footer of our emails. For information about our privacy practices, please visit our website.



© 2019 Biophorum Operations Group · All Rights Reserved

Registered Address: 5 Westbrook Court · 2 Sharrow Vale Road · Sheffield · S11 8YZ

Company Number 06794795 · VAT Number GB298617544