Download one of the World Drug Safety 2011's most successful presentations- Ronald Leong, Executive Director, Patient Safety USA, AstraZeneca, gave an Update of US Drug Safety Regulatory Environment which covers:
â€¢ FDAAA update (including REMS, Sentinel), risk communication, transparency
â€¢ Risk communication and transparency
â€¢ Case study: simultaneous announcement by FDA and EMA of their decision on Avandia
Download the presentation here
Ronald Leong is also presenting at this year’s event and will be involved with both a panel session entitled “Is there a lack of regulatory transparency in the pharma industry?” which looks at ensuring pharma understand the regulations and the resulting requirements AND a presentation on “Sentinel: perspective of a non-epidemiologist” which covers updates on Sentinel and Mini-sentinel and implications for overall safety profile and labelling.
Download Update of US Drug Safety Regulatory Environment here!
For more information on the 2012 World Drug Safety Congress Americas please visit our website.