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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
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create an account
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Registration ends 16/09/2025 16:00 (GMT Daylight Time)
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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
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