2021-11-23T14:00:00+00:00By Laure Bidois
This session looked at one of the main elements of the practical implementation of Regulation 2019/6, which is the creation of a Union Product Database (UPD).
2021-11-23T13:45:00+00:00By Rhona Banks
Opening the session, Ivo Claassen spoke about the unprecedented situation of the COVID-19 pandemic and the effects it has had on regulatory adaptation and emergency response preparedness. It was remarkable that novel mRNA vaccines for humans were developed and licensed in such a short period. He believes that there will be a considerable impact on the regulatory landscape in the long term.
Session 2 co-chaired by Beate Lohr and Emily Drury looked into specific opportunities opened up by the Veterinary Medicines Regulation intended for limited markets (Article 23) and for gaining additional data protection through defined post-authorisation product developments (Article 40(5)).
2021-11-23T13:55:00+00:00By Anja Holm
During the session, the speakers presented an overview of the new and revised rules and guidance, explored the major hurdles for new AMs, and discussed how we can protect existing AMs on the market through measures such as harmonisation of summaries of product characteristics (SPC) and flexible dosing labels.
The peer-reviewed journal, published 11 times per year and available free to TOPRA members.
The Organisation for Professionals in Regulatory Affairs
TOPRA Publishing, 6th Floor, 3 Harbour Exchange, South Quay, London E14 9GE, UK
Tel: +44 (0) 20 7510 2560
Blvd du Souverain 280, 1160 Brussels, Belgium
Tel: +32 (0) 2 808 72 70