Clinical Trials with Drugs, Medical Devices and ATMP

Clinical Trials with Drugs, Medical Devices and ATMP
Clinical trials in Europe follow different rules and regulations, CTR, MDR, IVDR and combined studies have their challenges. We hear about COMBINE, experiences with clinical trials of drugs, medical devices, combination products, ATMP (cell and gene therapies) and some news about TOPRA. You get the opportunity to meet colleagues in a relaxed and pleasant environment. The meeting is open to anyone who works with and is interested in regulatory affairs.

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
 
When
20/11/2024
Where
KA Entree (Vega KA0 Venue) Pepparedsleden 1 MöLNDAL SWEDEN
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