Regulatory News - Pharmaceuticals / Medical Devices

Regulatory News - Pharmaceuticals / Medical Devices
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, information on update of the variation regulation and experiences with MDR and IVDR implementation. We also get to hear the latest about TOPRA. Open to anyone working with and interested in regulatory questions for pharmaceuticals and medical devices


Language Swedish


Agenda
 
18.00 – 18.30          The evening begins with light refreshments 

18:30 – 18:35          Introduction
                                    Rolf Eriksson, ArexAdvisor     

18:35 – 19:05          Regulatory news – Pharmaceuticals
                                      -  Latest news from the EU Commission
                                      -  Revision of EU legislation for pharmaceuticals
                                      -  Management of drug shortages
                                      Speaker Asa Kumlin Howell, Medical Products Agency

19:05 – 19:35         Regulatory news – Medical devices   
                                     -   How does LV work with medical devices
                                     -   Experiences of MDR and IVDR
                                     -   Ongoing EU work (MDCG etc)

                                    Speaker Ola Philipson, Medical Products Agency

19:35 – 19:50         Short break

19:50 - 20:10         New updates of the regulation on examination of variations from the agency's perspective
                                     -  News
                                     -  Experience
                                     Speaker Adam Andersson, Medical Products Agency

 20:10 - 20:30        From the industry perspective
                                     -  How does it change the work
                                     -  Tips to consider
                                     Speaker Ruxandra Ionescu, ProPharma group
 

20:30 – 20:40         TOPRA News
                                    Speaker Margareth Jorvid, Chair TOPRA In Sweden

20:40 - 21:00           Q&A
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PRICING
TOPRA Members: Free [MPA employees - Free. Use code MPA200]   Non-member: £45
Student: £35 with code STU100.      
When
22/05/2025 18:00 - 21:00
Where
MPA, Dag Hammarskjölds Väg 42 Uppsala SWEDEN
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