2019 eRegulatory Affairs (eRA) Conference
2019 eRegulatory Affairs (eRA) Conference
Munich Germany 2019.05.22~05.23
Summary
eRegulatory Affairs conference(eRA) designed for the regulatory affairs professionals from around the globe. eRA will invite some of the industry's leading roles to speech and join barcamps. They deliver unique view for the trend of full pharmaceutical product life-cycle, electronic submission, Pharmacovigilance, and clinical trial safety data management.
Topics
-1- Shape the way you work tomorrow. (SPOR, xEVMPD, TOM ,eAF, CESP and ePI)
-2- Regulatory update for the EAEU region (Russia)
-3- eCTD 4.0, new major version
-4- eCTDmanager 6.0 Demo
-5- Submission management in the cloud
-6- FDA Grouped submission
-7- ICH E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports.
GGA is the partner of EXTEDO. We were invited to have speech at eRA to share the trend of Asia electronic submission. We learnt the future of full pharmaceutical product life-cycle at Europe and America, and connect with experts all over the world. GGA will share the latest international trend and best practices at Taiwan and hope to leverage pharmaceutical industries to work more efficiently and gain new ideas with international regulation.
