Risk rationale
To read the article on risk minimisation and communications
written by Dr Swapu Banerjee and
Dr Beverly Barr, click here.
Risk management and regulatory
Risk management is an emerging regulatory requirement and is increasingly
becoming part of responsible marketing.
Pope Woodhead is the leading European provider of risk management and appropriate use marketing programmes.
We can help you deliver acceptable risk management whilst maximising brand potential.
| Our areas of expertise include: | |
| • | understanding the risk/benefit ratio (initial risk assessment) |
| • | providing appropriate levels of physician and patient information, education and support regarding known risks to ensure appropriate product use (riskMAP and risk minimisation tools) |
| • | rapidly detecting changes in the risk/benefit profile that merit further investigation (evaluation including pharmacovigilance) |
| • | modifying both risk management and marketing
activities in line with new findings for positive reinforcement (re-assessment and continuous improvement). |
Evaluation of risk minimization plans
Pope Woodhead have produced original research on
novel methods of evaluation of risk minimization plans, which has been
published in pharmacoepidemiology and drug safety and presented at the
international society of pharmacoepidemiology in Copenhagen in 2008. View
pdf
Pharmacoepidemiology and Drug Safety,2008;17:S185
Risk Management Survey Results
In early 2006, Pope Woodhead conducted a survey
to understand how the industry is responding to the EMEA’s EU-RMP
legislation. The results were presented as a poster at the annual ISOP
meeting in Liege, Belgium (11–13 October 2006). View
poster
In a letter to Drug Safety the need for open
communication of benefit/risk issues between pharmaceutical companies
and their stakeholders (regulators, health authorities, doctors and patients)
and how the industry is tackling this was discussed.
View Letter