Features
Proposed Guideline on LMWHs in Biosimilars
The European Medicines Agency (EMA) announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight heparins (LMWHs), a type of medical product often used... more »
Aug 5, 2013 in Regulatory Affairs Blog
Complete the Biocompatible Polymer Brands Survey for Your Chance to Win an iPad
Our sister publication Medical Plastics News needs your opinions on a range of biocompatible polymer brands. The independent research organisation DJS Research is working on behalf of MPN to perform a poll of the medical plastic processing community. more »
Jul 22, 2013 in Editor's Blog
Regulatory Affairs Vs Regulatory Sciences
Regulatory affairs is a comparatively new profession that developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical... more »
Jun 20, 2013 in Regulatory Affairs Blog
Achieving Fast and Economical Production of High Quality Tablets
The tablet remains the most popular dosage form and tabletting equipment has evolved significantly over the last decade to accommodate the ongoing demand for its advancement. Big pharma and their generic opponents increasingly seek to gain the... more »
Jun 20, 2013 in Editor's Blog
API GMP Requirements Update
In order to ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess, the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) was developed by the International... more »
Apr 29, 2013 in Regulatory Affairs Blog
EPM’s First Visit to TechnoPharm and POWTECH
The EPM team has just returned from the TechnoPharm and POWTECH show in Nuremberg. It was our first time at the event and in Bavaria’s second largest city, which dates back to the 11th century and is famous for the post-WWII Nuremberg trials. more »
Apr 26, 2013 in Editor's Blog
I Holland's R&D Manager Gives Lowdown on Anti-Sticking Project
In January 2012, I Holland and the University of Nottingham’s School of Pharmacy launched the two-year TSAR (Tabletting Science Anti-Stick Research) project to investigate and solve the most common tabletting issue of formulation ‘sticking’ to... more »
Apr 11, 2013 in Editor's Blog
Biosimilars Sector from EU and US Perspectives
Biosimilar medicines, one of the fastest growing sectors of the industry, constitute a major share of pharmaceutical expenditure in the EU, the US and globally. From a regulatory perspective, they are a new paradigm in drug development, similarly... more »
Mar 26, 2013 by Paolo Biffignandi in Regulatory Affairs Blog
Fancy Joining EPM's EAB?
I'm always keen to hear from individuals interested in joining the magazine's Editorial Advisory Board (EAB). more »
Mar 20, 2013 in Editor's Blog
Are You Involved in Tablet Production?
As you may be aware, we will be featuring a tabletting roundtable in the June issue of EPM, so I thought I would take this opportunity to ask you, our esteemed audience, whether there are any questions you would like put to our panel... more »
Feb 25, 2013 in Editor's Blog
Welcome to the New EPM Website
Hi everyone and welcome to our new and much improved website. The one-stop-shop for pretty much everything that makes up the pharmaceutical manufacturing supply chain. more »
Feb 5, 2013 in Editor's Blog
Asia's Changing Regulatory Environment and Pharma Outsourcing
Asia is the fastest growing pharmaceutical market in the world, providing significant opportunities for drug development and marketing. Consequently, pharmaceutical regulations in this region are fast gaining attention... more »
Jan 14, 2013 by Paolo Biffignandi in Regulatory Affairs Blog
Extractables, Leachables and QbD
Extractables and leachables are increasingly becoming a cause of major concern for both the pharmaceutical industry and regulatory bodies. The development of unique packaging, novel formulations and drug-coated medical devices has exacerbated... more »
Nov 20, 2012 by Paolo Biffignandi in Regulatory Affairs Blog
