Title: DIA Eurasia Workshop – Implementing eCTD and ICH in the Region
Date: 8 AM – 6 PM, 23 October, 2019
Venue:Conference venue: Marriott Moscow Grand Hotel, Tverskaya St., 26/1, Moscow, Russia
Duration: 1 day
The Eurasian Union is working to improve the submission process by implementing eCTD and also other ICH guidelines to support the aspiration to increase local manufacturing capacity. As the only public workshop in the region with international experts bringing their knowledge and experience, this is a must-attend for anyone who wants to stay abreast and implement the new requirements smoothly. Get first hand information about the hottest topics concerning pharmaceutical industry and regulatory reviewers in Russia, Kazakhstan and Ukraine.
Our PharmaL.expert Karl Heinz Loebel will be at the workshop as a speaker. His topic will be: Comparison of eCTD and CTD and Preparing your company for electronic submission – required business process changes.
Karl Heinz’ experience in positions of responsibility within regulatory operations spans a period of 6 years with particular focus on e-documentation and the associated systems that support the ability to manage and be compliant with the connected regulations. Highlights include his involvement in a global capacity providing counselling and support on optimisation of eCTD compilation and his current position which has seen him involved in working groups on current ISO issues faced by Eudravigilance and Regulatory professionals.