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: 17/09/2025
Time: 18:00 - 21:00
   

Agenda

18:00 – 18:30 The evening begins with light refreshments

18:30 – 18:35 Welcome
                                          Ruxandra Ionescu, TOPRA volunteer            

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

 19:30 - 19:45               Short break

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

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
                                         Margareth Jorvid, TOPRA volunteer

20:45 - 21:00 Q&A


PRICING
TOPRA Members: Free  
Non-member: £45

MPA/DMA Employees: [To register, please contact membership@topra.org]


 
When
17/09/2025 18:00 - 21:00
Where
Medicon Village (Room: Sharience), Scheeletorget 1 223 63 Lund SWEDEN
Sign in or create an account to register Registration ends 16/09/2025 16:00 (GMT Daylight Time)
My registration status: Not registered
Please complete your registration by adding any required items to your basket and proceeding to the checkout.
 
Your company name
Your VAT country
Your VAT number
NOTE
Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

Register now