Global Pharmaceutical Regulatory Affairs Summit, Berlin 2016

Achieve fast and compliant global product approval through direct regulatory authority access and real time updates. Meet with the pharmaceutical regulatory community for improved knowledge, networking and experience exchange. Regulatory Affairs in Emerging Markets: Get your burning questions answered in our; Russian GMP requirements interactive troubleshooting session; Q&A session on registration in Ukraine; Brazil and China Q&A sessions; and Collaboration Zone round tables on Russia & CIS, Turkey & MENA, Latin America. and Asia-Pacific. Global eSubmissions: Join our; interactive round tables to share experiences with EU eCTD Module 1 Specification v3.0; Global Collaboration Zone to overcome challenges with global eCTD requirements; and our IDMP experience exchange as part of the IDMP Focus Day Pharmaceutical Labelling: Join your peers in an interactive discussion forum examining strategies to improve communication between pharmacovigilance, labelling, regulatory affairs and risk management; overcome labelling challenges resulting from increasing serialisation and coding requirements by attending the in-depth serialisation workshop; and understand best practice for creating a CCDS suitable for global implementation with a dedicated CCDS workshop.