18.00 – 18.30
Light refreshments (sandwiches and drinks)
18:30 – 18:35
Introduction
Anna Mäkinen Salmi, Medical Products Agency
18:35 – 18:40
Welcome - some thoughts on the evening's theme
Björn Eriksson, Medical Products Agency
18:35 – 19:05
Lifecycle Management strategy – Medicines
•
Lifecycle management strategy
•
Patents, new indications, new formulations
•
Important to think about
Eva Barkstedt, AstraZeneca
19:05 - 19:30
Periodic Safety Update Reports (PSUR)
•
Purpose and content
•
Regional/Global PSUR
•
Planning for submission
•
PSUR assessment procedure
•
Experiences
Josephine Ingemarsson, Arex Advisor
Short break
19:45 - 20:10
Repurposing - authority perspective
•
What is repurposing
•
New legislation
•
How are applications handled at the MPA
•
The pilot project
•
Experiences
Katarina Lönnquist, Medical Products Agency
20:10 – 20:40
Variation regulation for human/veterinary medicinal products
•
What has changed
•
Experiences
•
Lessons learned that can be used for the revision of the regulation for medicinal products
for human use
Rotana Al-Shammari, Medical Products Agency
20:40 - 21:00
Time for questions and networking
Pricing
TOPRA Members: Free [MPA employees - Free. Use code MPA200]
Non-member: £45 (includes 2 months TOPRA membership)
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