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I Asphalion Open Doors: Latest Insights on Scientific & Regulatory Affairs

June 7

Asphalion Open Doors: Latest Insights on Scientific & Regulatory Affairs

What is the Asphalion Open Doors?

The Asphalion Open Doors is the unique event organized by Asphalion in collaboration with its partners Reguliance, Extedo, TDV, Cros NT, Dora Wirth Languages and Playbrand.

This annual event is free and will provide a structured introduction to all important aspects of Scientific & Regulatory Affairs world.

This year, the event will take place on 7th June in H10 Itaca, Barcelona.

The agenda will cover all important elements that you need to know about Regulatory Affairs for the success in development and registration of your product, whether this is a medicinal product and/or medical device.

During one day, you will be able to choose between two parallel sessions. You don’t have to choose a complete track, you can choose sessions from different tracks as long as they are not happening at the same time.

9:30 – 10:00 Registration and welcome coffee
9:30 – 10:00 TRACK 1 TRACK 2
10:00- 10:45 Session 1: Latest EU and US Regulatory and Scientific News & Statistics Session 1: Challenges of the new Medical Device Regulation: Latest News
10:45 – 11:30 Session 2: FDA basics and Overview of Regulatory Affairs in US Session 2: Digital media, a challenge in Pharmacovigilance?
11:30 – 12:00 Coffee Break
12:00 – 12:45 Session 3: Tools for faster access to medicines – How to make use of existing tools and incentives to expedite development and registration Session 3: Global status of electronic submission
13:00 – 15:00 Lunch
15:00 – 15:45 Session 4: How to survive Quality-by-Design (QbD) requirements? Session 4: IDMP and the impact of Regulatory Affairs
15:45 Coffee break & networking at Asphalion Offices
16:00 – 17:00 Demos of IT tools at Asphalion offices of: Safety Easy PV (Ab Cube – EXTEDO), RIManager (EXTEDO), eCTD  Manager (EXTEDO)

In the last session of this great event, we will run a live demonstration of 3 software’s:  Safety Easy PV, RImanager, eCTDmanager. This session will take place in Asphalion offices and you’ll be able to enjoy the excellent views we have of Barcelona and a very special coffee break prepared for you.

All our partners and Asphalion experts will be available for personal meetings before and after the event. In case you are interested please contact us [email protected]

Do not miss it! Free registrations: https://bit.ly/2UDUyEk

Here you can find the full agenda: https://bit.ly/2VzwrKz

You are invited to this first edition of the Asphalion Open Doors and we look forward to see you!


June 7




H10 Itaca
Av. de Roma, 22
Barcelona, Catalonia 08015 Spain
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