Join Medfiles’ free live webinar on Thursday 25th of March from 1 pm to 2:30 pm (UTC+2)! Our second webinar of the 2021 webinar series is aimed at EU pharma business operators.
Medfiles will organise a webinar series this spring for those working in pharmaceutical, medical device, IVD or food and feed sectors. The webinars will be organised with Teams live-event tool, so you can participate from your own computer – wherever you are. Registration for the second webinar is now open, so sign up right away and let your colleagues know as well! When signing up, you will be able to ask questions from our experts beforehand to get them answered during the event.
Webinar time table:
13:00 – 13:05 Welcome and introduction (Business Development Manager Tuuli Marvola)
13:05 – 13:25 GMP Responsibilities of marketing authorisation holder (Regulatory Affairs Manager Anna Alonen)
13:25 – 14:05 Navigating through marketing authorisation quality section (Mod 3/Part II) considering recent guideline updates in the EU (Senior Pharmaceutical Chemical Expert Eeva-Maija Walin, Senior Pharmaceutical Chemical Expert Heta Karvinen, Pharmaceutical Chemical Expert Ulla Orava)
- EU GMP Annex 1 Manufacture of sterile products revision 2020
- Nitrosamine impurities in human medicinal products, EMA Guidance for marketing authorisation holders
- Elemental impurities in veterinary medicinal products
- Draft guideline on quality and equivalence of topical products
- Draft guideline on the quality requirements for drug-device combinations
14:05 – 14:25 EMA SPOR data management system and EDQM submissions (Support Operations Expert Maija Linnakangas)
- EDQM Submissions
- EMA SPOR data management system
- UK Submission portals
14:25 – 14: 30 Closure (Tuuli Marvola)
To stay up to date on the time table, topics and registration for the individual events, follow us on LinkedIn or subscribe our webinar newsletter!