Continuing the series of webcasts on the XEVMPD regulation, industry expert Andrew Marr, PhD joined Wim Cypers, VP Regulatory Affairs, for a one-hour, free-wheeling question and answer session with Regulatory Affairs professionals from many large, medium and small pharmaceutical companies.
Andrew began the session with a brief overview of the latest set of XEVMPD guidelines published by the EMA on March 05, 2012. He gave a glimpse of the changes such as structured substance information (SSI) submission made optional and language related regulations clarified and expanded. After this Wim facilitated a 35-minute Q&A session open to the audience. We got almost all of the audience questions answered.