Healixia saw the light of day early 2020. Below you find all the past events of Healixia, and - for the sake of completeness - also of the former associations (ACRP, BAPU, BeAPP and BRAS) that joined forces within Healixia.
Past events
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16 March '23Webinar: The sources of life sciences regulations - Pharmacovigilance
OnlineRead moreThis third session on the “Sources of life sciences regulation” is intended to provide the participants with a high-level overview of the pharmacovigilance legislation in the European Union and will include a specific part on the Belgian legislation.
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15 December '22Healixia online conference: Medical Devices
Read moreOnline conference.
This training course is intended for both manufacturers and distributors of medical devices/ in vitro medical devices and will address various questions/issues under the MDR/IVDR.
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22 November '22Healixia workshop on RIP role and RIP legislation
AffligemRead moreDuring this workshop, we will work in small groups, where you can discuss different cases, challenges, bumps in the road, best practices,... with peers. Each group will have a lead who is experienced in the RIP role and RIP legislation.
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17 November '22Introduction to Regulatory Affairs 2022
BrusselRead moreThe course is addressed to people new to regulatory affairs who want to acquire a comprehensive foundation; to regulatory professionals wishing to update their knowledge, and to all collaborators working in close relationship with regulatory affairs and wishing to understand the role of the department.
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18 October '22
Webinar: The sources of life sciences regulations - part II: Medicinal products
OnlineRead moreThis session is the second part of a two-part training course on the “Sources of life sciences regulation”. It serves to provide participants with a high-level overview of the rules and regulations applicable to medicinal products for human use in the European Union. The session will include a specific part on the Belgian legislation. It will also provide the audience with practical tips on researching applicable laws.
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20 September '22Healixia & UPIP-VAPI joint seminar on full GxP compliance
AffligemRead moreDuring this session, we will tackle the required departmental (inter)actions for ensuring full GxP compliance. The Marketing Authorization Holder’s responsibilities will be highlighted within the legal framework of the different good practice guidelines (GMP, GDP, GVP…).
In collaboration with UPIP-VAPI.
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13 September '22
Webinar: The sources of life sciences regulations - part I: Medical devices
OnlineRead moreThis first session on the “Sources of life sciences regulation” is intended to provide an overview of the main body of the legislation applicable to the placing on the market or making available of medical devices in the European Union. The session will include a specific part on the Belgian legislation. It will also provide the audience with practical tips on researching applicable laws.
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12 May '22Advanced Course CTD module 3 - Quality section 2022
DiegemRead moreThis two-day course is intended to provide an in depth knowledge and understanding of the main principles and concepts of the Quality part of the Common Technical Document.
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07 December '21
Healixia conference: Medical Devices
Read moreOnline conference.
This training course is intended for both manufacturers and distributors of medical devices/ in vitro medical devices and will address various questions/issues under the MDR/IVDR.
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30 November '21Webinar - Gene Therapy Clinical Trial Applications: the proof is in the pudding
Read moreOnline meeting
During this session, an overview will be provided of both the overarching European GMO legislation as well as the GMO regulatory framework and procedures in Belgium and how this impacts the Clinical Trial Application process for gene therapy clinical trials in Belgium.
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04 October '21Introduction to Regulatory Affairs 2021
BrusselsRead moreThe course is addressed to people new to regulatory affairs who want to acquire a comprehensive foundation; to regulatory professionals wishing to update their knowledge, and to all collaborators working in close relationship with regulatory affairs and wishing to understand the role of the department.
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27 May '21Session on Food supplements
Read moreWebinar
Confirmed speakers:
- Leen Rasschaert - FAVV-AFSCA
- Valerie Vercammen - be-sup
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04 May '21
Falsified Medicines Directive (FMD) – 2 years later (online)
Read moreWebinar
Speakers:
- Jean-Pierre Engels - General Manager of the Belgian Verification Organisation
- Jan Depoorter - Expert FMD - Europe at APB
- Morgane franck - Quality Manager/QP/RP - Movianto
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03 December '20
Session Medical Devices (online)
Read moreOn the agenda:
- State of play on MDR and IVDR implementation
- Medical Devices Regulations: Should the pharma industry be concerned?
- Lessons learned from the first MDR and IVDR projects
- Evaluation old pact and elements new pact: Industry perspective
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30 November '20Healixia webinar - Patient preference and engagement: reality or myth?
Read moreSpeakers:
- Isabelle Huys and Rosanne Janssens (KU Leuven)
- Danielle Derijcke (MSD Belgium). She will speak on behalf of EUPATI Belgium.
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13 November '20
Healixia webinar - Advanced therapies: the demise of alchemy and rise of pharmacology
Read moreHealixia's journey - let's connect: webinar
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22 October '20CTR Session (online)
Read moreOn the agenda:
- Implementation CTR EU and national
- EU PD Portal: status update
- Future training
- Role of the College and ethics committee
- Pilot projects with reflections from:
- FAMHP
- Academic sponsors
- Industry
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14 October '20
Healixia's journey - Let's connect
Read moreWe invite you to our Healixia's journey - let's connect: multiple webinars from our 4 domains: whenever and wherever you want!
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05 October '20
Video on demand Pharmacovigilance
Read moreWe offer you the opportunity to follow the session Pharmacovigilance on demand. Be careful: once you have registered, you will have to pay for this session.
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29 September '20
Session Pharmacovigilance (online)
Read moreThis session has been organized for years by the domain 'Regulatory affairs' and is highly rated by participants of previous editions. This year the following themes will be discussed:
- Pharmacovigilance Signals
- Pharmacovigilance inspections: preparation and inspection
- Business continuity planning
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28 September '20
Introduction to Regulatory Affairs 2020 (complete)
BrusselRead moreThe course is addressed to people new to regulatory affairs who want to acquire a comprehensive foundation; to regulatory professionals wishing to update their knowledge, and to all collaborators working in close relationship with regulatory affairs and wishing to understand the role of the department.
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21 June '18
Stay tuned with the latest developments within Regulatory Affairs: an overview of the latest legislation and guidelines
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22 March '18
Presentation on 'Journey of a Data Privacy Officer: industry perspectives and experience gained from the new EU GDPR'
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16 May '17
Session on borderline products (medicinal products/medical devices/food supplements/etc.)
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26 March '15
Social Media
Read moreSOCIAL MEDIA IN THE PHARMACEUTICAL/MEDICAL DEVICES INDUSTRIES-SESSION 26 MARCH 2015
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24 September '09
Clinical Trials: R&D within the Federal Agency of Medicines and Health Care products in Belgium.
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