Quality Systems

Articles

Pharma industry welcomes announcement of a draft withdrawal agreement, stating it is an important step towards securing a Brexit deal.

Pharmaceutical Industry Welcomes an Important Step Toward Securing a Brexit Deal, Says ABPI

The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.

EMA Recommends Four Medicines for Approval

After a review of serious side effects, the agency decided to suspend marketing authorizations for quinolone and fluoroquinolone antibiotics and restrict use of remaining fluoroquinolone antibiotics.

EMA Suspends Authorizations of Quinolone and Fluoroquinolone Antibiotics

The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.

EMA Gives Update on Brexit Plans

The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.

EMA Publishes Guidance on Pediatric Drug Safety

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

Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.

Guidelines on Integral Drug-Device Combinations

Investigatory work arranged by Swissmedic has revealed that sartan-containing medicines on the Swiss market are safe in respect of NDMA.

Medicines Containing Sartan Currently Available in Switzerland are Free of NDMA, Says Swissmedic

Permission from the United Kingdom's Supreme Court has been granted to the UK BioIndustry Association, allowing it to intervene in a dosage regimen patent case.

UK Supreme Court Grants Permission to UK BioIndustry Association to Intervene in Case

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL. 

User Requirements Specifications–How Difficult Can It Be?

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

… Brexit may be a bumpy ride. Here, the new European editor of the PharmTech Group, Felicity Thomas, discusses Brexit and its implications for the pharma industry.

Regulatory/GMP Compliance, Europe