Quality Systems

Articles

The EMA has published a revision to its guideline on the environmental risk assessment of human medicines.

EMA Publishes Revision to Environmental Risk Assessment Guideline

NICE has recommended the use of regorafenib as a treatment for NHS patients with advanced liver cancer, following consideration of a new commercial arrangement.

NICE Recommends Regorafenib for Use on NHS

Novartis has announced that the European Commission has approved Gilenya (fingolimod) as a treatment for children and adolescents (10–17 years) with relapsing-remitting forms of multiple sclerosis (RRMS).

European Commission Approves First Oral Disease-Modifying Treatment for MS

Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.

Shire Gains EU Approval for its Preventive Treatment of Hereditary Angioedema

Melissa Hanna-Brown is external technology & collaborations lead at Pfizer.

Joachim Ermer is head of Analytical Lifecycle Management Chemistry Frankfurt at Sanofi.

Stephanie Katzenbach is senior scientist, New Biological Entities, Analytical R&D at AbbVie.

Andy Rignall is product technical director at AstraZeneca.

Annick Gervais is director, Analytical Sciences Biologicals at UCB.

JÃ¶rg Hoffmann is director, CMC Regulatory Compliance at Merck KGaA.

Jette Wypych is director, Attribute Sciences at Amgen.

Kieran McLaughlin is principal scientist at MSD.

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Oliver Grosche is director, Collaborative Solutions at Elanco.

Peter Hamilton is scientific leader at GSK.

Thomas Uhlich is laboratory head Analytical Development at Bayer.

Christof Finkler is Analytics Biochemistry site head at Roche.

Katrin Liebelt is analytical project leader at Novartis.

Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.


Analytical Procedure Lifecycle Management: Current Status and Opportunities

Sean Milmo is a freelance writer based in Essex, UK.

EMA’s relocation to Amsterdam and resulting staff losses could severely weaken the agency’s role as a leading medicines regulator.

Relocating EMA: A Far from Ideal Situation

Owner of Immuno Biotech, David Noakes, has been sentenced to 15 months in prison over charges of manufacturing, selling, and supplying an unlicensed medicine, as well as money laundering.

Immuno Biotech Owner Imprisoned for 15 Months

Five additional European Union member states have been confirmed by the US Food and Drug Administration (FDA) as capable of performing good manufacturing practice inspections at a level equivalent to that of the United Sates

Five Additional EU Member States Able to Perform GMP Inspections Equivalent to US Level

A coalition group from the UK's health sector has called on both the UK and EU to ensure the protection of patients and public health when considering the future relationship of the regions post-Brexit.

Coalition of UK’s Health Sector Request Protection for Public Health Post-Brexit

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

During CPhI Worldwide in Madrid, Lynne Byers, executive director of NSF International detailed the facts about how Brexit can impact the pharmaceutical industry.

Regulatory/GMP Compliance, Europe