Piribo: Reporting Adverse Events, new publication announcement

Report Summary
These are challenging times for drug safety professionals. Much is to be done within the profession to gain and maintain public trust by improving drug safety, pharmacovigilance and risk management practices. In the USA, drug-related adverse reactions (ADRs) result in an estimated 100,000 deaths per year, and up to 5% of all hospitalisations involve some of the most widely prescribed drugs. Less than 10% of ADRs are currently reported back to the manufacturer or the regulatory authorities.

Mandatory legislation changes have altered the landscape on both sides of the Atlantic. Product safety is a key element, and the clinical trial process is now more highly regulated. These changes cover applications to ethics committees, clinical trial study monitoring, adverse event reporting during trials, clinical practice audits and inspections, and preparing for marketing authorisation of products. The European Union (EU) Clinical Trials Directive has had a great impact on post-marketing surveillance. It introduced two new terms to the pharmacovigilance vocabulary: SUSAR (a suspected unexpected serious adverse reaction) and SAR (a serious adverse reaction). The pharmacovigilance requirements of the Food and Drug Administration are also evolving, especially in the areas of electronic submissions, pre-marketing safety assessment plans and risk management.

The SMi Reporting Adverse Events conference discussed various tactical and transactional aspects of safety, providing an overview of strategic aspects of risk assessment and risk management. This KeywordPharma Conference Insights review from NetworkPharma Ltd provides analysis of the most salient issues raised in selected presentations at the event. These included electronic reporting, signal detection, high-profile drug withdrawals, drug risk-benefit assessments, the implementation of risk management and a glimpse into future developments.
Industry professionals are currently being forced to react to changing regulatory requirements, internal company integration and public/political pressures. This report highlights how the industry is addressing these evolving needs. It concludes that drug safety groups should play a more prominent role not only in the procedures mentioned above but also in strategic aspects of risk-benefit optimisation.

“Reporting Adverse Events” is available from Piribo. For more information go to: http://www.piribo.com/publications/research_development/clinical_trials/reporting_adverse_events.html

Piribo Product ID: NWP007

About Piribo.
Piribo (http://www.piribo.com) is a UK-based independent online store supplying business information on the pharmaceutical and biotechnology industries. The website now carries over 3,800 English language titles including, market reports, studies and books and is the UK’s largest online biopharma information store. Subscribers receive a free monthly newsletter and email alerts on new titles in their areas of interest. The company was established in 2004.