RR DRA 2019 Jan/Feb Regional Roundtable DrugRegulatory Affairs

RR DRA took place at 3 alternative dates on 11 January (de), 18 January (de), 12 February (fr) 2019

47 regulatory professionals from 35 companies participated.  For the first time we had over 10 participants from 6 companies in the French group.

The participants had a lively and fruitful exchange of information how to handle the new guidances regarding the TPA Rev2 and its ordinances, which entered into force on 1 January 2019. Tips were given how to work pragmatically with the new forms. Questions about practical issues were submitted to Swissmedic, who were answered quickly.

Thanks to Katharina Oehler-Tomamichel, Doris Penna, Katja Starke and Stefanie Zaugg for their dedicated moderation and reporting.