Author Archive

How Post-Market Feedback Can Influence Compliance when Using a Quality Management System

Guest blog by Tim Lozier.

In most industries, businesses run the same way. You can either stick your head in the sand and pretend that everything is going fine, or you can stand up and take the feedback—whether positive or negative—and react to it. This is especially true with Quality Management Systems (QMS).

In today’s dynamic and demand-driven world, businesses are challenged with speeding their product-to-market strategies to remain competitive. In the pharmaceutical industry, regulatory and compliance pressure add another dimension to the QMS. Organizations want to bring their products to market quickly, but need to ensure quality and compliance standards are met—it’s a paradox of “hurry up, but take your time doing so.” Read more »

Pharma’s First Facebook Game

Stephanie Sutton Pharm Tech EuropeThis morning I received a press invitation from Boehringer Ingelheim for the beta launch of its Facebook game, Syrum. The game is the first of its kind to be developed by a pharmaceutical company. Syrum’s website is already up for people to view but the game won’t be officially launched until September. Read more »

Three Reasons to Adopt Automated Validation in Quality Management Systems

Guest blog by Tim Lozier.

My daughter has been learning how to ride a bike for the past year.  She’s actually become quite adept at it, and for someone who loves to cycle, I am certainly proud.  But there were certain obstacles to overcome to get to this point.  We started simply with the tricycle – learning to pedal.  Then we switched to a “run-bike” to help learn balance.  Now we are on a two-wheeled bike with training wheels, and slowly beginning to take the training wheels off.  With each step forward, my daughter expressed a certain degree of fear – “will I be able to do this?,” she intimated. Once she made the leap to the next level, she realized how much easier biking can become.  Leaving the training wheels can be scary, but the freedom of two wheels is much better.

When I speak to customers and prospects about Quality Management Systems Validation, I get much of the same trepidation.  For many years, the concerns of software systems center around the validation of those systems.  After all, if the system fails to work properly, the company becomes liable and any repercussions will most likely not be pretty. Read more »

BRIC Retains Pharma Investments

Stephanie Sutton Pharm Tech EuropeEmerging markets continue to attract the attention of pharmaceutical companies thanks to their high growth and large patient populations. Back in 2011, the locations of focus were the so-called ‘BRIC’ countries (Brazil, Russia, India and China). But with more markets emerging and drawing the eyes of the pharmaceutical industry have the original BRIC countries lost some of pharma’s favour?

Not at all, judging by several developments this year. Read more »

UK Examines Earlier Access to Medicines

Stephanie Sutton Pharm Tech EuropeLast week, I looked at a consultation in the UK concerning access to unlicensed medicines. The 12-week consultation, launched by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), seeks opinions on giving physicians the option to prescribe seriously ill patients certain medicines that are still progressing through Phase II and Phase III clinical trials. The blog is available here.

The scheme forms a key part of the UK government’s Strategy for UK Life Sciences, which aims to support innovation and give the UK a leading role in life sciences globally. Included in this is a provision to provide patients with better access to innovative medicines. Read more »

UK Mulls Access to Unlicensed Medicines

Stephanie Sutton Pharm Tech EuropeThe UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently launched a 12-week public consultation for a national scheme that will look at the possibility of providing seriously ill patients with access to unlicensed medicines still in Phase III, or possibly even Phase II, clinical trials. Similar initiatives, mainly through extensions of clinical trials or managed-access programmes, are already in place in certain parts of the UK, as well as in the US and other countries, but these are often ad-hoc in nature and locally based. The proposed scheme would provide a national approach to providing early access to certain medicines in the UK.

Read more »

GSK’s Olympic Role

Stephanie Sutton Pharm Tech EuropeThere are many ways in which pharmaceutical companies can make a contribution to society beyond developing and manufacturing medicines. GlaxoSmithKline, based in the UK, has always been keen to position itself as a supporter of the British economy so it’s no surprise to see the pharma giant being patriotic once again as it touts its involvement in the Olympic Games, which will start in London in just under two-weeks time. Read more »

Deficiencies in Roche Safety Reporting

Stephanie Sutton Pharm Tech EuropeA coordinated European programme was recently carried out involving routine inspections of pharmaceutical companies’ safety reporting systems. Whether regulators suspected deficiencies or not is unknown, but they certainly found them when the UK’s Medicines and Healthcare products Regulatory Agency inspected one of Roche’s UK sites. During the inspection, the company identified around 80000 reports, including 15161 deaths, connected to Roche medicines marketed in the US that had not been evaluated to determine whether they should be reported as adverse drug reactions. The reports were collected through a Roche-sponsored patient programme. Read more »

Pricing Controversy in Germany

Stephanie Sutton Pharm Tech EuropeGermany used to be a golden market for the pharma industry in Europe because the country allowed global pharmaceutical companies to set their own prices for new medicines. However, all good things must come to an end…

In Germany, healthcare reform (known as AMNOG – Arzneimittelmarkt-Neuordnungsgesetz) that came into effect in January 2011 introduced stringent new pricing measures that linked the price of a medicine to its perceived therapeutic benefit. Eighteen months from the reform and the full effects have been realised. Although successful in cutting costs (a primary goal of the legislation), the change has resulted in a number of global companies delaying or refusing to market their drugs in Germany. It’s a testament to the fact that Germany has historically been one of the first markets in Europe to receive innovative new drugs. Read more »

Parallel Trade Fuels UK Drug Shortages

Stephanie Sutton Pharm Tech EuropeA bill has recently been in discussion in the US that contains measures to strengthen the ways in which drug shortages are dealt with. The US FDA is also taking action by asking companies to alert them as to possible drug shortages so that it can prepare back ups. But what about other parts of the world?

Drug shortages are not unique to the US. The UK is also currently struggling with severe shortages of prescription medicines. In the US, many shortages have been attributed to plant closures or manufacturing problems, but in the UK the shortages are being caused for a different reason: parallel trade.

Read more »

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