In recent weeks, the European Medicines Agency (EMA) published a report to support the implementation of a new international standard for the safety monitoring of medicines in the European Union (EU). The new standard (ISO ICSR) improves the reporting of suspected side effects of medicines in Individual Case Safety Reports (ICSRs) and will take effect from 1 July 2016.*
Hear more from the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), who will be delivering an exclusive keynote address at SMi's 4th annual Pharmacovigilance, Drug Safety & Risk Management conference when it returns to London on the 11th - 12th May 2015.
The address presented by PRAC member Doris Irene Stenver, Chief Medical Officer from the Danish Health & Medicines Agency, will provide the latest PRAC updates and discuss optimising the outcome of risk assessments and risk minimisation measures. Other key features of her presentation will include insights into the Integration of stakeholders and signal management processes in the EU.
Confirmed attendees include: Bluefish pharmaceuticals, Daiichi Sankyo UK Ltd, Danish Medicines Agency, Drug Safety Research Unit, EudraVigilance Consultants, MedDRA Maintenance and Support Services Organisation (MSSO), NDA Regulatory Science Ltd, Novartis International AG, Novonordisk, Pfizer Ltd, pharsafer associates, Quintiles, Roche Products Limited, Royal College of Physicians London, Solvay Pharmaceuticals, Takeda Chemical Industries Ltd, TEVA Pharmaceuticals, Vifor Pharma
For those who are interested in attending, there is currently a £300 discount available which expires on the 27th February.
For more information or to download a brochure visit http://www.smi-online.co.uk/goto/2015pharmacovigilance41.asp