TOPRA in Sweden: Regulatory News

TOPRA in Sweden: Regulatory News
This evening is an excellent opportunity to hear the latest regulatory news for pharmaceuticals and medical devices. We will discuss the ongoing work with the revision of pharmaceutical legislation in Europe, experiences with MDR and IVDR implementation as well as tips for working with EMA's electronic systems and forms, e.g. SPOR/IRIS. We also get to hear the latest about TOPRA. Open to anyone working with and interested in regulatory questions for pharmaceuticals and medical devices.

 Thursday 16 May 2024
Time: 17:00-20:00 (BST +1 GMT) / 18:00 – 21:00 CEST
Please note this is a face to face presentation, conducted in Swedish.
Venue: Medical Products Agency, Dag Hammarskjölds väg 42, Uppsala



 18.00 – 18.30 The evening begins with light refreshments 

18:30 – 18:35       Introduction
                                 Helena Ardebrant, AstraZeneca

18:35 – 18:40 Welcome - some thoughts on the evening's theme
Björn Eriksson, Medical Products Agency

18:40 – 19:05 Regulatory news – Medicines, for example
                               • Latest news from the EU Commission
                               • Revision of EU legislation for pharmaceuticals
                               • Management of drug shortages
                               Åsa Kumlin Howell, Medical Products Agency

19:05 – 19:30 Regulatory news – Medical devices, for example
                               • How does LV work with medical devices
                               • Experiences of MDR and IVDR, timelines
                               • Ongoing EU work (MDCG etc)
                               Ola Philipson/Sandra Brolin, Medical Products Agency

Short break

19:45 – 20:10 Companies' use of EMA's electronic systems, ex SPOR (substance, product, organization and referential) data and platforms, ex IRIS
                               • EMA Account Management /SPOR
                               • IRIS portal - scientific and regulatory procedures such as ODD, scientific advice, marketing status,
                                        inspections and Medicines Shortages Single Point of Contact (SPOC)
Helena Ardebrant, AstraZeneca

20:10 - 20:35 Use of some of EMA's IT support from an authority perspective
                               • How does LV use data from SPOR
                               • How does LV work in IRIS
                               • What is going on within the PLM portal (IRIS, eAF and ePI)
Karin Gröndahl, Medical Products Agency

20:35 – 20:45 TOPRA news 
Margareth Jorvid, TOPRA volonteer

20:45 - 21:00 Time for questions


TOPRA Members: Free [MPA employees - Free. Use code MPA200]  
Non-member: £45 (includes 2 months TOPRA membership)


Contact us

Contact or Margareth Jorvid at, if you want to become TOPRA member.



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16/05/2024 17:00 - 20:00
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