Product complaints are a fact of life. However, the pharmaceutical industry is unique; with its levels of regulation, complex nature of complaints, heightened customer expectations, and the product ...
A focus on Quality, not just Compliance
Surely there is no industry where quality is seen as more important than it is in Life Sciences. Indeed, hundreds of thousands of people are employed by regulatory authorities to enforce quality thr ...
Are you confident when releasing an end product to market?
Over the last decade the pharmaceutical industry has changed dramatically. The need to continue to reduce costs has resulted in the outsourcing of manufacturing, and increasingly complex supply chai ...
The Challenges of Risk Management in Biopharmaceuticals
The Challenges of Risk Management in Biopharmaceuticals
Unlike traditional small molecule drugs, every part of the clinical development, manufacturing, and prescription process for biopharmaceuticals ...
How lessons from the factory can optimise capacity in PV operations
How lessons from the factory can optimise capacity in PV operations
Imagine that you are running a business-critical global process where the workload is steadily mounting, the pressure for improved ...
A WCI survey looking at sourcing in the life science industry
A WCI survey looking at sourcing in the life science industry
Almost everyone has a point of view about the pros and cons of sourcing pharmacovigilance (PV) activities, but what is the actual utilisa ...
Sourcing, when considered and approached correctly, can help to deliver the optimal solution
Sourcing, when considered and approached correctly, can help to deliver the optimal solution
At a time of unprecedented change and with safety's workload increasing in both volume and scope, the ques ...
Change is intended to strengthen companies, make them more competitive, and working more efficiently
Change is intended to strengthen companies, making them more competitive, and working more efficiently
Hardly a business day goes by without hearing the word 'change'. Change, apparently, is the onl ...
Maximising the benefits of risk management across the business
Maximising the benefits of risk management across the business
GRMP is WCI's approach to maximising the benefits of risk management across the business and ensuring satisfaction of the emergent requi ...
There is a tide of change in the pharmaceutical industry with a push for drug safety to have a stronger role within clinical development
There is a tide of change in the pharmaceutical industry with a push for drug safety to have a stronger role within clinical development. Taking drug safety operations from the reactive approach that ...
To err is human, to de-risk divine...
To err is human, to de-risk divine...
We live in an age where we wish to de-risk our investments. Today, in the highly competitive pharmaceutical sector, if you don't spot the risks before they beco ...
Risk Management is the smart route to safety and to well aimed investment
Risk Management is the smart route to safety and to well aimed investment
In the increasingly competitive Life Sciences sector, spotting potential risks before they become a danger to the patient is ...
Traditionally the approach to drug safety has been focused on the reactive. Recent events have shown that this is not enough to ensure visibility of safety risks during clinical development
Traditionally the approach to drug safety has been focused on the reactive. Recent events have shown that this is not enough to ensure visibility of safety risks during clinical development
Life Sci ...
Increased regulations and worried customers are just two of the factors driving trends in drug safety and risk management
Increased regulations and worried customers are just two of the factors driving trends in drug safety and risk management today. Examining the present situation, Deborah Gold at WCI Consulting Limite ...
WCI survey to gain better insight into the influencing factors
WCI survey to gain better insight into the influencing factors
At the core of all pharmacovigilance organisations (PVOs) is the Safety Database (SDB) system used to capture, assess, and report Advers ...
It's good for the customer, it's good for the industry, and it deserves to be embraced wholeheartedly
It's good for the customer, it's good for the industry, and it deserves to be embraced wholeheartedly
Regulation aims to keep the public safe and the playing field level. We used to marginalise it, ...
Whilst drug safety can be a source of competitive advantage, there is a greater mutual benefit in sharing experience and common challenges
Whilst drug safety can be a source of competitive advantage, there is a greater mutual benefit in sharing experience and common challenges.
Pharmaceutical and biotech organisations carry the responsi ...
Is there a way to solve the conundrum of maximising ROI as opportunities decline?
Fewer potential new drugs, fewer mass market opportunities, candidate drop out, declining returns...just some of today's pressures on life science companies. If only there was a way to solve the conu ...
PSURs can be seen as a time consuming exercise or as a positive step towards proactive PV
PSURs can be seen as a time consuming exercise or as a positive step towards proactive pharmacovigilance. Chris Holmes explains how to stay one step ahead...
No-one likes reporting bad news, especia ...