Month: November 2018

Conferences

Speaker’s Corner: DIA European eDM Conference

Peter Lassoff, Vice President and Head, Global Regulatory Affairs, and Joel Finkle, Associate Director Offering Management for Regulatory Innovation will both be speaking at the Drug Information Association’s eDM 2018 – Clinical and Regulatory Operational Excellence Forum 29-30 November in Barcelona, Spain. They will coincidentally be presenting in the same session, Process Automation, chaired by …

ACUTA, ARIM, eCTD, Switzerland

SwissMedic Updated eCTD Guidance November 2018

On November 1, SwissMedic, the regulatory agency for Switzerland, updated their guidance for eCTD, including a new version 1.4 of the Data Type Definition (DTD), and validation rules. This corresponds to the recent Revision 4 of the Therapeutic Product Ordinances (HMV4). These rules area available starting January 1, to become mandatory in June. If you …

ARIM, ARIM Publisher, Australia, eCTD, RIM+

Australia Proposing Mandatory eCTD starting 2019

In late October 2018, Australia’s Therapeutic Goods Administration (TGA) opened consultation regarding their proposed schedule to make eCTD mandatory for prescription drug dossier submissions. The full proposal document can be found at the link above.