Language Swedish
Agenda
18:00 – 18:30 The evening begins with light refreshments
18:30 – 18:35 Welcome
Speaker Helena Ardebrant, TOPRA volunteer
18:35 – 19:00 COMBINE - project
- Combined trials of drugs, medical devices and IVD
- Challenges and way forward
Speaker Elin Karlberg, Medical Products Agency, Uppsala
19:00 – 19:20 Clinical trials of medical devices
- Trials for CE marking
- Clinical evaluation
Speaker Christina Kultje, Mölnlycke Health Care
19:20 – 19:40 Medical device with medicinal substance
- Regulatory challenges
- Experience of clinical trials
Speakers Katrin Gisselfält/Petra Rosén, XVIVO
19:40 - 19:55 Break
19:55 – 20:15 Clinical trials of medicinal products
- To work with CTIS
- Experiences
Speakers Johan Jeppsson/Ann Novotny, AstraZeneca
20:15 - 20:35 Preparing for clinical trials and ATMPs
- To work with cell and gene therapies
- ATMP manufacturing
Speakers Jim Lund/Juliana Kovacka, CCRM
20:35 – 20:45 TOPRA news
Speaker Margareth Jorvid, TOPRA volunteer
20:45 - 21:00 Q&A & Networking
Pricing
TOPRA Members: Free [MPA employees - Free. Use code MPA200] Non-member: £45:00