Healixia seminar: From CTD to CTR - How to keep Belgium attractive for early phase development in EU
From January 2023 onwards all clinical trial applications, including phase 1 trials, need to be submitted according to the new Clinical Trial Regulation (CTR). As is often the case, a change in procedures and regulations is a cause for concern.
Therefore, in this meeting, all stakeholders are brought together and given the opportunity to express their perceived challenges and opportunities as we move into this new legislative framework.
Ample time will be available for a panel discussion in which all participants are invited to participate.
NEW as from 2023: during registration, you can now indicate to be mentioned on the online attendees list that is published on this event page.
Program:
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13:00-13:30 |
Registration & welcome coffee |
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13:30-13:40 |
Welcome and introduction |
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13:40-14:00 |
From CTD to CTR: where are we? - Ingrid Theeuwes, Managing Director PhaRA |
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14:00-14:20 |
Federal Agency for Medicines and Health Products (FAMHP): threats and opportunities for early clinical drug development in Belgium - Hugues Malonne, Director General FAMHP Pre-authorization |
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14:20-14:40 |
CT-collège: the new kid in town - Katelijne Anciaux, Clinical Trial College - Project Lead Quality at FPS Health, Food chain safety and Environment |
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14:40-15:00 |
Belgian Association of Research Ethics Committees (BAREC): the new challenges ahead for (early) clinical research - Christel Vansteenkiste, BAREC President |
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15:00-15:20 |
Coffee break |
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15:20-15:40 |
Pharma.be: how to consolidate Belgium as pharma valley? - Nathalie Lambot, Public Health and Clinical Trials Advisor |
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15:40-16:00 |
Implementing the CTR: sponsors' challenges perceived - Klaartje Boodts, Senior Clinical Operations Lead (Roche) |
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16:00-16:45 |
Panel discussion: How to consolidate and accelerate Early Clinical Trials in Belgium? Moderators: J. de Hoon and S. Rottey - Participants: H. Malonne (FAMHP), K. Anciaux (CT-collège), C. Vansteenkiste (BAREC) |
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16:45-17:00 |
Closing remarks |
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17:00-18:00 |
Networking drink |
We offer a 'group advantage 5+1': every sixth participant from the same organisation, participates for free. This advantage will be settled by us at the moment of invoicing, so all members can easily register individually.