Following a vote by member states in favour of Amsterdam as the agency's new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019. / read more /
A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities. / read more /
The acquisition adds to Catalent's capabilities in biologics development, analytical services, manufacturing, and finished product supply. / read more /
EMA recommends suspending the marketing of modified- or prolonged-released products containing paracetamol due to a difficulty in managing overdose. / read more /
The report emphasizes the publication of the 9th edition of the European Pharmacopoeia (Ph. Eur.) and the efforts made in global harmonization of standards and regulations throughout and beyond the European Union. / read more /
The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs. / read more /
This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved. / read more /
In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs. / read more /
The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts. / read more /
Industry experts discuss best practices for dissolution testing of poorly soluble, immediate-release, and controlled-release formulations and the different analytical approaches used. / read more /
Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified. / read more /
Date: 7 & 8 February 2018 Venue: Paris Expo, Porte de Versailles, Paris The event to showcase evolution and revolution in packaging and drug delivery
Pharmapack Europe is an essential event for industry insights and the latest industry innovations that are reimagining the capabilities of pharmaceutical packaging and drug delivery. Join 411 exhibitors and more than 5,290 attendees on 7 & 8 February at Paris Expo, Porte de Versailles! / Read more/
New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.
