TOPRA IN Sweden: Different Forms of Advice Procedures

TOPRA IN Sweden: Different Forms of Advice Procedures
During the development of new medicines or medical devices, a dialogue with various authorities is an important factor for success. There are many forms of advice both nationally and centrally. This evening is an excellent opportunity to hear experiences of different forms of advice. We will hear about the processes that exist for medicines nationally in Sweden and other EU countries, centrally with the EMA and FDA, as well as the opportunities that exist for medical devices and combination products. We also get to hear some news about TOPRA. You get the opportunity to meet colleagues in a relaxed and pleasant environment. The meeting is open to anyone who works with and is interested in regulatory affairs.


 
Language Swedish

Date: 03/03/2026
Time: 18:00 - 21:00
 
Agenda
 
18:00 – 18:30 The evening begins with light refreshments
  
18:30 – 18:35 Welcome
                                Alenoosh Abedi, Medical Products Agency            

18:35 – 19:05 National advice at the Swedish Medical Products Agency
                                       • Different forms of advice
                                       • Scientific advice
                                       • Simultaneous National Scientific Advice (SNSA)
                                       • Experiences
Speaker Jonas Tallkvist, Medical Products Agency

19:05 – 19:30 EMA Scientific Advice
                                       • Procedure and timelines
                                       •  Preparations
                                       • Experiences
Speaker Ruxandra Ionsecu,ProPharma group
  
19:00 - 19:15       Short break

19:45 – 20:10 Different interactions with FDA
                                       • Different type of meetings and timelines
                                       • Pre-IND
                                       • Experiences
Speaker Margareth Jorvid, Methra Uppsala


20:10 – 20:35        Advice for Medical Devices and Combination Products
                                       • What kind of advice and feedback is available for Medical Devices and Combination Products?
                                       • Experiences
                                 Speaker Callum Kitson-Parker, ArexAdvisor


20:35 – 20:45 TOPRA news
                                Speaker Margareth Jorvid, Chair TOPRA IN Sweden

20:45 - 21:00 Q&A

PRICING
TOPRA Members: Free
MPA employee: Free
Non-member: £60
 

 
When
03/03/2026 18:00 - 21:00
Where
Hotell Uplandia (Lokal: Tranan) Dragarbrunnsgatan 753 20 UPPSALA SWEDEN
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