Life Sciences

White Papers

Keeping your Balance

How lessons from the factory can optimise capacity in PV operations
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Sourcing Pharmacovigilance Activities

Strategic or Tactical imperative?
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What can sourcing do for drug safety?

Achieving capability and capacity to operate an effective PV system
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Taking the risk out of managing change

Blending a change management framework with a risk management approach
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Good Risk Management Practice

The case for action
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Planning the un-plannable

All futures are unpredictable, but some are more unpredictable than others
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Industrial Alchemy for Chemists

What can be learnt from other sectors?
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Tide of change in drug safety?

A call for a huge cultural and technology shift in the world of drug development
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How to build Risk Management into Clinical Trials

To Err is Human, to De-Risk Divine...
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Manage Risk Manage the Regulator

How life science companies can both manage risk and manage the regulator
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Developing Holistic Safety Risk Management

How pharma companies can develop effective lifecycle-long safety risk management
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Lean Compliant Operations in Life Science

Increasingly beleaguered, pharma in general and biopharma in particular still shiver at the edge of the pool of lean operations, ...
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Drug Safety Grows Up

Increased regulations and worried consumers are just two of the factors driving trends in drug safety and risk management today
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What compels a company to change safety database systems

What are the factors that compel a PVO to make a decision of such significance?
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The Science of Regulated Manufacturing

Making fundamental change in a regulated manufacturing environment requires a holistic approach
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Good News Regulation Just Got Tougher

Just as we think we're sorted, the regulators shift the goalposts...
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Networking to reduce risk

While drug safety can be a source of competitive advantage, there is a greater mutual benefit in sharing experience and common ...
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Drug Safety in Biotech

Fewer potential new drugs, fewer mass market opportunities, candidate drop out, declining returns...just some of todays pressures ...
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The first rule of pharma is to do no harm

Periodic safety update reports can be seen as a time consuming exercise or as a positive step towards proactive pharmacovigilance
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Outsourcing Clinical Trials

Commercial pressures are driving pharma companies to look for new, smarter ways of working
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