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
Pricing
TOPRA Members: Free [MPA employees - Free. Use code MPA200]
Non-member: £45 (includes 2 months TOPRA membership)
Contact us
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Questions: toprainsweden@topra.org
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