EMWA Webinars Programme
EMWA webinars help members to develop skills and keep up to date with new or rapidly developing areas. Most of our webinars are live, online seminars with the opportunity for participants to ask questions. For live webinars, you only need to register – you will need your EMWA membership details.
Live webinars are recorded and uploaded to the Webinar Archive soon after the event. The Webinar Archive is only accessible to EMWA members.
Each year we run a few webinars that are publicly available.
Laura Collada Ali and Jules Kovacevic are the EPDC members responsible for webinars. With the support of the webinar team Laura and Jules lead, plan and promote the programme, help presenters to prepare for their webinars, provide quality assurance, and run the live webinars. The webinar team also provides analysis of the webinar metrics.
Meet the EMWA webinar team
We are happy to announce upcoming webinars below. Webinars may be either recorded and uploaded on the due date or live online seminars. For live webinars, you only need to register and then connect to our webinars platform on the due date. A recording will be available shortly after the event in the Archive section. Nevertheless, we advise you to participate, because this will enable you to ask questions and contribute to an active discussion. For the recorded webinars we encourage you to send us any questions you may have on the topic by the date indicated and they will be answered in the recording.
Please email the webinar team with any questions or accessibility concerns.
Note: We reserve the right to cancel a webinar if needed, although we will make all effort to avoid it. Also, we make every effort to ensure we have a stable internet connection to run EMWA webinars, but it is not possible to provide a 100% stable connection. If for any reason, the presentation has to be cancelled by the organiser, a notification email will be sent as soon as possible.
Thursday 15th September 2022, 14:00 CET
Assessing and Reporting Environmental Risk for Human Medicinal Products throughout Development
Diana Radovan PhD ELS, Head of Regulatory Affairs Europe at Plusultra pharma GmbH
Liron Sarid-Krebs PhD, Senior Consultant/Team Lead at Biopharama Excellence, a Pharmalex Company
Environmental risk assessment of medicinal products for human use is the process through which Health Authorities worldwide ensure that the potential effects of pharmaceuticals on the environment are studied and adequate precautions are taken if specific risks are identified. In this webinar, we’ll focus on European risk assessment requirements and how regulatory medical writers (of all experience levels, primarily those authoring/interested in authoring eCTD modules beyond Modules 2 and 5, as well as other non-eCTD key regulatory documents) can support risk reporting at different development stages:
• before initiating clinical trials, i.e. at Clinical Trial Application (CTA) stage
• at marketing authorisation application (MAA) stage (eCTD Module 1.6 preparation), including impact on product information
• when answering Day 80/120 EMA questions, i.e. what risk-related questions to expect.
Moreover, the recent and ongoing advancement of medicinal products into the advanced therapy medicinal product (ATMP) field and gene therapy medicinal product (GTMP) field dramatically increases the need for genetically modified organism (GMO) assessments at all development stages. Understanding GMO regulations, in particular at EU country level at CTA stage, can accelerate clinical trial initiation and overall development timelines. GMO and non-GMO European requirements will be critically discussed.
See Past Webinars
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Volunteering for EMWA webinars
If you think you have something interesting to communicate to other EMWA members and are eager to run a webinar of your own, contact the webinar team. Your proposal will be evaluated by the webinars team and the EPDC and we will provide our feedback as soon as possible.