Quality Systems

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Articles

Under the revised NIS-2 Directive in Europe, pharma companies will need to be proactive in safeguarding their digital assets.

Securing Europe’s Critical Entities from Cyber Attacks

Alasdair Leckie is operations director at Rephine Ltd, a firm of deeply experienced GMP auditors which proactively help pharmaceutical companies around the world with their supply-chain quality assurance. Alasdair has been with Rephine for nine years and has a Bachelor’s Degree in Chinese and Economics from SOAS University of London.

A new survey has demonstrated that remote audits, brought to the fore thanks to COVID-19, are not necessarily a preferred option for clients. 

Will Remote Pharma GMP Auditing Endure Post-Pandemic?

Julie Lippke, analytical research and development at Pfizer Inc., Groton, CT

Joseph Mongillo, analytical research and development at Pfizer Inc., Groton, CT

Thomas Cullen, analytical research and development, AbbVie Inc., North Chicago, IL

Christian Metz works in Analytical Research and Development at AbbVie Inc., Ludwigshafen, Germany.

Katria Harasewych, quality, Merck & Co., Inc., Kenilworth, NJ

Fouad Benamira works in Analytical Development Sciences for Biologicals at UCB S.A. Belgium.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

A Harmonized Approach to Performing a Risk-Based Audit Trail Review

Amy Williams is director at Iperion—a Deloitte business.

EMA has announced a change of plan for the IDMP.

A Change of Tack for IDMP

Cheryl Barton is director of PharmaVision, 

A new unitary patent system is due to come into effect in Europe later on this year.

What Impact Will the New Unitary Patent System Have in Europe

NICE has recommended the use of Tavneos (avacopan) in combination with rituximab or cyclophosphamide regimen.

Tavneos Gains Nod from NICE as Treatment for Two Main Forms of AAV

Kapruvia (difelikefalin) has been granted approval by Swissmedic as a treatment for moderate-to-severe pruritis associated with CKD.

Treatment for Moderate-to-Severe CKD-Associated Pruritus Gains Swiss Approval

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

European Commission Approves Bevacizumab Biosimilar from Celltrion Healthcare

EMA has accepted the marketing authorization application for an oral fixed-dose combination treatment as an initial treatment for adults with AML.

EMA Starts Review of Oral Fixed-Dose Combination Treatment for AML

Séverine Allard is Head of Global Regulatory Affairs at RegCMC Vaccines.

Thierry Gastineau is Global Head of Quality Advocacy, Culture, & Innovation at Sanofi Vaccines.

A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect. 

Regulatory/GMP Compliance, Europe