10th DIA Asia New Drug Conference in Japan

Risk management should be conducted throughout a product’s lifecycle. Pharmaceutical companies should apply risk management methodologies to detect, assess, communicate and minimize risks throughout a medicine’s lifecycle to optimize its benefit/risk balance. This includes learning about and interpreting a product’s benefits and risks, designing and implementing interventions to minimize a product’s risks, evaluating interventions in light of new knowledge that is acquired over time, and revising interventions, when appropriate. EMA published Module V Risk Management Systems as part of the important regulatory guidance in conjunction with the EU Good Pharmacovigilance Practices (GVP) or PV legislation that went into effect in July, 2012. US FDA provided Risk Minimization Action Plans in 2005 and it was included in FDAAA which was finally effective March 2008. Japan has been leading the implementation of RMP in Asia area and set up the legislation on risk management plan in 2013. Early approval and launch of new drugs based on the best benefit-risk balance and controllable risk, RMP can help to verify the safety profile in a larger population, ensure sustained monitoring of the approved drug and implement risk minimization actions, to make up for the limitations of pre-approval clinical trial data and protect patient safety. How is risk management performed in the US and Europe? Are there any experiences from which Asian countries can learn? We will share in this session view points from pharma companies, academic institutions and regulatory agencies on the role of the RMP in drug R&D. Updates on the latest status of RMP implementation worldwide will also be presented.