Safety Monitoring in the Market - Pharmaceuticals and MDs

Safety Monitoring in the Market - Pharmaceuticals and MDs
Safety monitoring in the pharmaceutical and medical device market means that authorities and manufacturers monitor and evaluate the safety and performance of products after they have been released on the market. This is to detect and address any problems that may arise in practical use, and to ensure that the products continue to meet the requirements of the regulations. This evening is an excellent opportunity to hear what rules apply and what it is like to work with safety monitoring in the pharmaceutical and medical device market.

Language: Swedish


Date: 7 October 2025 
Time: 18.00-21.00 
 
This in-person event is open to everyone who works with and is interested in regulatory questions for pharmaceuticals and medical devices. 


Agenda 

18.00 – 18.30 The evening begins with light refreshments  

18:30 – 18:35 Introduction
Charlotte Lewerth, TOPRA volunteer 
 
18:35 – 18:40 Welcome – some thoughts about the topic of this evening 
Ann Lindberg, Director General, Swedish MPA
 
18:40 – 19:05 Pharmacovigilance from the agency's perspective Pharmacovigilance EU cooperation 
Oscar Ljungberg, Medical Products Agency 
 
19:05 – 19:30 Pharmacovigilance (PV) work in companies MAH responsibilities Local PV and QA Quality
                                        system and PV system 
Azadeh Foumani, Scandinavian Regulatory Services

19:30 - 19:45 Short break
 
19:45 – 20:10 Medical Device Vigilance from the agency's perspective Safety Monitoring Experiences 
Ellenor Winquist, Medical Products Agency  
 
20:10 - 20:35 Vigilance work in companies for MDR and IVDR Systematic follow-up Experience 
Karin Rye and Viktoria Hammarstedt, Scandinavian Regulatory Services 

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

20:40 - 21:00 Q&A's  


PRICING
TOPRA Members: Free  
Non-member: £45
MPA/DMA Employees: [To register, please contact membership@topra.org] 
When
07/10/2025 18:00 - 21:00
Where
MPA, Dag Hammarskjölds Väg 42 Uppsala SWEDEN
Sign in or create an account to register Registration ends 06/10/2025 16:00 (GMT Daylight Time)
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