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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    15 December '22

    Healixia online conference: Medical Devices

    Online 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 '22

    Healixia workshop on RIP role and RIP legislation

    Affligem

    During 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 '22

    Introduction to Regulatory Affairs 2022

    Brussel

    The 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

    Online

    This 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 '22

    Healixia & UPIP-VAPI joint seminar on full GxP compliance

    Affligem

    During 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

    Online

    This 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 '22

    Advanced Course CTD module 3 - Quality section 2022

    Diegem

    This 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

    Online 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 '21

    Webinar - Gene Therapy Clinical Trial Applications: the proof is in the pudding

    Online 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 '21

    Introduction to Regulatory Affairs 2021

    Brussels

    The 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 '21

    Session on Food supplements

    Webinar

    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)

    Webinar

    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)

    On 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 '20

    Healixia webinar - Patient preference and engagement: reality or myth?

    Speakers:

    • 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

    Healixia's journey - let's connect: webinar 

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    22 October '20

    CTR Session (online)

    On 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

    We 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

    We 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)

    This 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)

    Brussel

    The 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.

  21. 03 December '19

    BRAS Session on Medical Devices 2019

  22. 28 November '19

    BRAS Advanced Course CTD module 3 - Quality section 2019

  23. 26 November '19

    Shortage of drugs (including unavailability's FAMHP platform)

  24. 14 October '19

    BRAS Symposium 2019

  25. 24 September '19

    BRAS Session Pharmacovigilance 2019

  26. 04 June '19

    Launch event ACRP.be/BeAPP/BRAS

  27. 04 June '19

    Joint Event ACRP.be, BeAPP and BRAS

  28. 21 May '19

    BRAS General Meeting 2019

  29. 13 May '19

    BRAS Introduction to Regulatory Affairs 2019

  30. 13 December '18

    BRAS Session on Medical Devices

  31. 04 December '18

    BRAS session on Market Access

  32. 22 October '18

    BRAS Symposium 2018

  33. 25 September '18

    BRAS Session on RMP / RMA

  34. 11 September '18

    Session 2018 on Clinical Trials

  35. 21 June '18

    Stay tuned with the latest developments within Regulatory Affairs: an overview of the latest legislation and guidelines

  36. 14 June '18

    Introduction to regulatory and legal framework for biobanks

  37. 28 May '18

    BRAS Introduction to Regulatory Affairs 2018

  38. 22 March '18

    Presentation on 'Journey of a Data Privacy Officer: industry perspectives and experience gained from the new EU GDPR'

  39. 14 December '17

    Session on clinical trials - NEW DATE

  40. 05 December '17

    Pharmacovigilance 2017

    Update on Pharmacovigilance topics

  41. 28 November '17

    Session on Medical Devices 2017

  42. 16 November '17

    BRAS Advanced Course CTD module 3 ? Quality section

  43. 24 October '17

    BRAS Symposium 2017

  44. 21 September '17

    Workshop on Market access in a hospital environment ? future challenges

  45. 13 June '17

    Session on Veterinary matters

  46. 16 May '17

    Session on borderline products (medicinal products/medical devices/food supplements/etc.)

  47. 08 May '17

    Introduction to Regulatory Affairs - 2017

  48. 28 March '17

    Presentation of the ?Trait? de droit pharmaceutique? + BRAS General Meeting

  49. 14 March '17

    BRAS Workshop on Art. 81 agreements with the authorities

  50. 31 January '17

    Session on Counterfeiting

  51. 01 December '16

    The evolving sickness funds - Final Programme

  52. 24 November '16

    BRAS Symposium 2016

    Annual BRAS Symposium 2016

  53. 06 October '16

    Clinical Trial session 2016

  54. 28 September '16

    How to integrate the Belgian price measures in ...

  55. 14 June '16

    Regulatory Data Management

  56. 17 May '16

    BRAS Introduction to Pricing & Reimbursement in Belgium

  57. 12 May '16

    Introduction to Regulatory Affairs

  58. 28 April '16

    Market Access - A practical advanced workshop on Health Economics

  59. 26 April '16

    Workshop from Auto-Control to Co-Responsibility

  60. 03 March '16

    Medical Devices session

  61. 26 January '16

    BRAS General Meeting + dinner

  62. 01 January '16

    Market Access Workshop on Generic Entry

  63. 26 November '15

    Pharmacovigilance session

  64. 19 November '15

    Advanced Course CTD Mod 3

  65. 13 October '15

    BRAS Symposium 2015 - Patient of the future: role of regulatory affairs

  66. 29 September '15

    Clinical trial session 2015

  67. 10 September '15

    Workshop on Budget Impact Calculation

  68. 07 May '15

    Introduction to Regulatory Affairs 2015

  69. 02 April '15

    BRAS Workshop on Biopharmaceuticals

  70. 26 March '15

    Social Media

    SOCIAL MEDIA IN THE PHARMACEUTICAL/MEDICAL DEVICES INDUSTRIES-SESSION 26 MARCH 2015

  71. 23 February '15

    Advanced Course CTD Mod 5

  72. 03 February '15

    BRAS General Meeting + Dinner

  73. 09 December '14

    Promotional Material

    BRAS session on Promotional Material

  74. 04 December '14

    BRAS Workshop on Registries, observational studies and ...

  75. 13 October '14

    TOPRA Annual Symposium

  76. 02 October '14

    Introduction to Pricing & Reimbursement in Belgium

  77. 23 September '14

    Market Access in a hospital environment

  78. 19 June '14

    Market Access - Workshop on Art. 81

  79. 17 June '14

    BRAS session on ASMF (Active Substance Master File)

  80. 22 May '14

    Introduction to Regulatory Affairs - 2014

  81. 13 May '14

    BRAS General Meeting & 25th Anniversary

  82. 24 April '14

    Advanced Therapies and Personalised Medicines

  83. 13 March '14

    Medical Devices session : new Belgian legislation and update on ...

  84. 03 December '13

    BRAS Workshop on Budget Impact Calculation

  85. 21 November '13

    Advanced Course CTD Module 3

  86. 14 November '13

    BRAS Symposium 2013

    BRAS European symposium 2013

  87. 24 October '13

    Pharmacovigilance

    Session on Pharmacovigilance 

  88. 24 September '13

    Clinical Trials - Practical aspects

  89. 25 June '13

    Variations

    Session on Variations with FAMHP

  90. 28 May '13

    Risk Management Plans And Risk Minimization Activities: An update!

  91. 23 May '13

    Introduction to Regulatory Affairs

  92. 30 April '13

    BRAS General Meeting

  93. 28 March '13

    The Sources of the Pharmaceutical Law

  94. 04 December '12

    Medical Devices

  95. 29 November '12

    Introduction to Pricing & Reimbursement

  96. 18 October '12

    BRAS National Symposium 2012

  97. 06 September '12

    Clinical Trials

  98. 26 June '12

    The Implementation of Transversal Inspections

  99. 07 June '12

    EDQM & Quality Guidelines

  100. 15 May '12

    Pharmacovigilance

  101. 03 May '12

    Introduction to Regulatory Affairs - 2012

  102. 15 March '12

    Challenges and opportunities in Paediatric development

  103. 16 February '12

    BRAS General Meeting + Workshop on LinkedIn

  104. 08 December '11

    Advanced Course: CTD Mod 3 - 2011

  105. 17 November '11

    Parallel Import & Counterfeiting

  106. 27 October '11

    BRAS Symposium 2011 on Reimbursement

  107. 06 October '11

    Advanced course: CTD Mod 4 (one day session)

  108. 27 September '11

    Variations

  109. 26 May '11

    Risk Management

  110. 12 May '11

    2 days Introduction to Regulatory Affairs - May 2011

  111. 03 May '11

    Clinical Trials

  112. 28 April '11

    ?Advertisement to health care professionals and the general public ...?

  113. 01 March '11

    Belgian Healthcare System

  114. 11 January '11

    BRAS General Meeting + ?The Belgian EU Presidency in a nutshell?

  115. 14 December '10

    Mastering eCTD?s

  116. 29 November '10

    2 days Advanced Course: CTD Module 3 - 2010

  117. 23 November '10

    The mixed commission: activities and assessment

  118. 14 October '10

    BRAS Symposium 2010

  119. 07 June '10

    2 days Introduction to Pricing & Reimbursement

  120. 03 May '10

    2 days Introduction to Regulatory Affairs

  121. 30 March '10

    Publicity & Mdeon

  122. 16 March '10

    Changes within the Herbals regulatory environment

  123. 02 March '10

    BRAS General Meeting and Conference dinner

  124. 28 January '10

    Introduction to Medical Devices

  125. 03 December '09

    Advanced Course: CTD Module 3

  126. 17 November '09

    Biotechnology and Advanced Therapies

  127. 22 October '09

    BRAS Symposium 2009 with all AFMPS/FAGG speakers

  128. 28 September '09

    Introduction to Pricing & Reimbursement in Belgium

  129. 24 September '09

    Clinical Trials: R&D within the Federal Agency of Medicines and Health Care products in Belgium.

  130. 19 May '09

    Session on GENERICS

  131. 14 May '09

    Introduction to Regulatory Affairs - Edition 5

  132. 31 March '09

    Regulatory impact of GXP-inspections

  133. 30 January '09

    BRAS 20 Years - Invitation

  134. 30 January '09

    BRAS General Meeting - 30 January 2009 at 11 a.m.

  135. 09 December '08

    OTC Medicines

  136. 02 December '08

    Veterinary Session

  137. 20 November '08

    Advanced Course: CTD Module 3

  138. 06 November '08

    Session on Counterfeiting

  139. 02 October '08

    Symposium 2008 - Facing New Challenges

  140. 25 September '08

    edition 4 - BRAS course Introduction to Regulatory Affairs

  141. 24 September '08

    edition 3 - BRAS course Introduction to Regulatory Affairs

  142. 02 September '08

    PSUR's Planning & Writing - New Date

  143. 24 April '08

    Session on PIL user Testing

  144. 18 March '08

    Session on Cosmetics

  145. 11 March '08

    BRAS General Meeting and Conference lunch

  146. 06 March '08

    BRAS course Introduction to Regulatory Affairs

  147. 06 December '07

    Paediatrics

  148. 25 October '07

    BRAS Symposium 2007 - Reimbursement; status & future

  149. 27 September '07

    BRAS first

  150. 18 September '07

    Clinical Trials