Past events - Healixia

Join us for our fourth session on the “Sources of life sciences regulation”.

15 June '23

Healixia online session: Regulatory update on Luxembourg

Online

During this 90 minutes online session, we will give you an update on Regulatory Affairs topics in Luxembourg.

08 June '23

Healixia Spring Barbecue and Networking Event

Grimbergen

Join us at the end of spring for an inspirational talk by Sabine Appelmans, former Belgian WTA-top 20 tennis player, followed by an informal get-together, where you can meet long-known and new peers over some good food and drinks.

08 June '23

Healixia General Assembly 2023 (members only)

Grimbergen

Cross-domains, Medical Affairs

Program:

16h45: Registration
17h00: General Assembly
- Approval activity report and financials Healixia 2022
- Approval action plan and budget Healixia 2023
- Mandates Board Members: ‘discharge

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23 May '23

Healixia Conference: Deep Dive into BeNeLuxA

Grimbergen

Come and benchmark your current knowledge with actual insights and developments and receive practical advice, gain insight and discuss with peers about the challenges and opportunities.

27 April '23

Healixia Annual Conference 2023

Grimbergen

With:

PETER PEUMANS (Imec)
TOM BRAEKELEIRS (BlueHealth Innovation Center)
Prof. SARAH LEBEER (UAntwerpen)
Prof. Dr. SYLVIE ROTTEY (UZ Gent)
Prof. KAI DALLMEIER (KU Leuven)
SOPHIE VANDERVENNET (Janssen)

16 March '23

Webinar: The sources of life sciences regulations - Pharmacovigilance

Online

This 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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03 March '23

Healixia lunchmeeting: Value Based Healthcare

Grimbergen

In this session, we will explore how value-based healthcare (VBHC) provides a philosophy and instrument to redirect our healthcare system.

Prof. Brecht Cardoen, Vlerick business school & KU Leuven, will sketch the theoretical framework on VBHC and its implementation. Prof. Dr. Jo Lambert, UZ Gent, illustrates this with real life examples from her own practice.

16 February '23

Webinar: Clinical Research in emerging markets

Online

In recent years an increasing share of clinical research is being conducted outside of the traditional markets such as US and Europe. With this webinar we would like to better understand these shifting dynamics by focusing on two countries in particular. The aim is to look at capacity building, to assess strengths and weaknesses of emerging markets for research and how this relates to what makes Belgium attractive today.

02 February '23

Healixia New Year's Event

Antwerpen (Wilrijk)

Join us for an inspirational talk and a networking drink to kick off 2023!

Keynote: Wellbeing is key for business succes, by Gert Braeken, author of 'Het burn-outvaccin'.

27 January '23

Healixia seminar: From CTD to CTR - How to keep Belgium attractive for early phase development in EU

Diegem

Early Development

From January 2023 onwards all clinical trial applications, including phase 1 trials, need to be submitted according to the new Clinical Trial Regulation (CTR). 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.

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.

01 December '22

Healixia Essentials: How does pharma.be defend the interests of the innovative pharma industry in Belgium?

Brussels

Face-to-face lunchmeeting.

pharma.be is the voice of the innovative Belgian - human and veterinary medicine - pharmaceutical industry. As interest group it represents 130 both small and large innovative pharmaceutical and biotech companies and is the centre of excellence for the industry.

Come and learn more on how exactly pharma.be works to defend the interests of the pharma industry in Belgium and take the opportunity to meet your peers.

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.

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.

08 November '22

Webinar: Patient experts: an innovative partner to improve patient related outcomes in Belgium

Online

The patient has a unique expertise: “being a patient.” But how can they put this expertise to good use, for their peers as well as in contributing to integrated participation in research, education and advice?

27 October '22

Healixia Essentials: the role and impact of the MSL (Medical Science Liaison) explained.

Online

The how, the why and the who: all you would like to know about the MSL (Medical Science Liaison). This webinar is aimed at life science professionals who are not very familiar with this role or who would like to learn more on it.

20 October '22

Healixia Clinical Conference - formerly known as the ACRP EUROPEAN CONFERENCE

Diegem

We are very excited to welcome you this fall to our CLINICAL CONFERENCE - formerly known as the ACRP EUROPEAN CONFERENCE - on October 20, 2022 at the Park Inn by Radisson Brussels Airport.

Closed for registration.

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.

14 October '22

Webinar: How to use the Investigator's Brochure in de-risking a First-in-Human study

Online

Early Development

During this webinar, we will focus on how to use the Investigator's Brochure to de-risk a First-in-Human (FIH) trial.

Speakers: Prof. Dr. Jan de Hoon and Dr. Thomas Lodeweyckx (UZ Leuven)

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.

13 September '22

Webinar: The sources of life sciences regulations - part I: Medical devices

Online

Cross-domains, Medical Affairs

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.

27 June '22

Webinar: Healixia essentials: what you should know about the RIP (Responsible person for Information and Publicity)

Online

The how, the why and the who: all you would like to know about the RIP (Responsible for Information and Publicity) when working outside regulatory affairs. This webinar is aimed at life science professionals who are not necessarily familiar with the term or who would like to learn more on it.

Healixia Essentials: during several short sessions throughout the year, we tackle different terms, concepts or processes to keep all professionals up to speed with the essentials of the life sciences industry.

14 June '22

Eufemed General Assembly 2022 (members only)

On behalf of the EUFEMED Board, you are kindly invited to the EUFEMED General Assembly 2022. It will be a virtual event; you will receive the dial-in information shortly.

As EUFEMED needs to register the attendees, we kindly ask you to confirm your presence by registering, if you are planning to attend (Healixia members only - login first to register).

09 June '22

Healixia Spring Barbecue and Networking Event

Grimbergen

Join us at the end of spring for an informal get-together, where you can meet long-known and new peers over some good food and drinks.

Don't miss the keynote by Thierry Geerts, Country Director at Google Belgium, on his book 'Homo Digitalis' and his view on the impact of digital revolution on healthcare! Every participant receives a copy of his book.

09 June '22

Healixia General Assembly 2022 (members only)

Grimbergen

On the agenda:

Approval activity report and financials Healixia 2021
Approval action plan and budget Healixia 2022
Mandates Board Members: ‘discharge’, election Board 2023-2025

Program:

16h45: Registration
17h00: General Assembly

03 June '22

Webinar: IB for an early phase/FIH trial: more than just a regulatory document

Early Development

This online workshop will discuss the IB (Investigator's Brochure) structure, content and quality as important topics for all parties involved in planning, set-up, conduct and interpretation of a clinical study. Some practical highlights will be shared on challenges on writing a “good” IB for a FIH/Early Phase trial on the one hand, and on how to use it for an optimal benefit-risk assessment on the other hand.

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.

28 April '22

Webinar: the impact of Covid-19 on clinical trial execution at investigational sites and sponsors

Online meeting

In this webinar, the results of conducted research on the impact of Covid-19 on clinical trial execution will be discussed by Prof. Yves Geysels (Dept of Biomedical Sciences, University of Namur) and Florent Piraux.

24 March '22

Healixia Annual Conference: Current and future trends in patient centric solutions for healthcare

Diegem

Healixia Annual Conference 2022: Current and future trends in patient centric solutions for healthcare.

22 February '22

Webinar - Innovation in Healthcare: Current and future trends

Online meeting

In this webinar, Giovanni Briganti will introduce the field of AI in healthcare, starting from a scientific standpoint to clinical applications, as well as the promise and challenges that it entails for the Belgian Landscape.

01 February '22

Healixia New Year's Event WILL NOT TAKE PLACE

Due to COVID, our planned New Year's Event will not take place.

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.

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.

23 November '21

Healixia session - Learnings from the current pandemic: can these benefit patients?

Free online session.

In June 2021, Noël Wathion retired as Deputy Executive Director EMA. Over the past two years, he has been able to fully utilize his expertise and management skills to master the consequences of the Covid-19 storm. On November 23, he will share his learnings from the current pandemic with us.

07 October '21

Expected trends in the CRO industry

Online meeting

Speakers:

Prof. Yves Geysels, Dept of Biomedical Sciences, University of Namur
Omer Saka - Partner - Life Sciences and Health Care at PricewaterhouseCoopers Advisory, Capital Projects & Infrastructure

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.

16 September '21

Healixia webinar: Pharmacovigilance

Online

Online meeting about

Methods for safety assessment of Covid-19 vaccines at the European level (Xavier Kurz, EMA) incl. Q&A
Best practices regarding inspections of the Belgian authorities and remote inspections (Evelien GERITS, Infarama) incl. Q&A

14 September '21

Recognition of Pharmaceutical Medicine/Clinical Pharmacology as a specialty for MDs in Belgium: a status update.

Online

Online meeting

During this webinar, a status update will be provided on the recognition of Pharmaceutical Medicine/Clinical Pharmacology as a specialty for Medical Doctors in Belgium.

18 June '21

Does price transparency for innovative medicines lead to lower prices?

Webinar

Speaker: Prof. Dr. Walter Van Dyck

15 June '21

Understanding biomarkers in immune therapy

Webinar

Speaker:

Yannick Waumans - Global Head Pathology, Imaging and Quantification at CellCarta

27 May '21

Session on Food supplements

Webinar

Confirmed speakers:

Leen Rasschaert - FAVV-AFSCA
Valerie Vercammen - be-sup

21 May '21

Healixia General Assembly (members only)

Online

On the agenda:

activity report and financials Healixia 2020
approval action plan and budget 2021

20 May '21

From EMA authorization to market access in Luxembourg

Webinar

Speakers:

Anna Chioti - Head of Division Pharmacy and Medicines at Luxembourg Health Directorate
Sonia Franck - Secretary-General at APL

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

23 April '21

Digitization within Medicine, the Belgian eHealth case

Speaker:

Frank Robben, general manager of the Crossroads Bank for Social Security.

23 March '21

The evolving role of MSLs

Speaker: Samuel Dyer - CEO and Chairman of the Medical Science Liaison Society and author of several publications, articles, and an Amazon #1 Best Selling book on the subject of the MSL career.

16 March '21

Towards a global implementation of eConsent in clinical trials

Speakers:

Lou Guffroy, Dept of Biomedical Sciences, University of Namur
Prof. Yves Geysels, Dept of Biomedical Sciences, University of Namur

11 February '21

Public Affairs & Medical Affairs, pharma’s perfect couple

Speaker:

Stefaan Fiers - Head Corporate Communications, Public Affairs and Patient Advocacy at Takeda Belgium

21 January '21

The Sustainable Development Goals: impact on our business and your job

Sustainable Development Goals are ubiquitous, also in the pharmaceutical industry. But how do organisations incorporate the SDGs? And what influence does this have on the individual employee?

08 December '20

Impact of Covid-19 on clinical trial execution

Speakers:

Muriel Lins
Teresa Lamantia

03 December '20

Session Medical Devices (online)

Cross-domains, Medical Affairs, Regulatory Affairs, Clinical Research, Early Development

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

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.

27 November '20

The evolving role in Medical affairs: our increasing role in market access (online)

Cross-domains, Medical Affairs

With Patricia van Dijck - Market Access & Public Affairs Director at GSK Belux

24 November '20

Healixia webinar - Value based pricing: are outcome-based market entry agreements the future?

Healixia's journey - let's connect: webinar

16 November '20

Healixia webinar - The scientific approach to a virus epidemic

Cross-domains, Clinical Research

Healixia's journey - let's connect: webinar

13 November '20

Healixia webinar - Advanced therapies: the demise of alchemy and rise of pharmacology

Cross-domains, Early Development

Healixia's journey - let's connect: webinar

10 November '20

Healixia webinar - Pioneering malaria challenge trials in Belgium: from theory to practice in a Phase I unit

Healixia's journey - let's connect: webinar

22 October '20

CTR Session (online)

Cross-domains, Regulatory Affairs, Clinical Research

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

14 October '20

Healixia's journey - Let's connect

Cross-domains, Medical Affairs, Regulatory Affairs, Clinical Research, Early Development

We invite you to our Healixia's journey - let's connect: multiple webinars from our 4 domains: whenever and wherever you want!

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.

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

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.

25 September '20

The Anticancer Fund – starts where others stop (online)

This will be an online session.

Speakers:

Dr. Guy Buyens, Medical Director
Dr. Gabry Kuijten, Coordinating Physician, My Cancer Navigator

22 September '20

Digitization of research sites for clinical research: challenges and opportunities (online)

This will be an online session.

Digital transformation of a research site is a complex, resource-intensive, and lengthy undertaking with many challenges, that can cover the entire process of clinical research allowing data to be used much more effectively and efficiently for patient-centered research.

29 April '20

Healixia online meetup: the impact of COVID 19 on the FAMHP

During this online meetup, we will look into the impact of COVID 19 on the FAMHP and FAMHP related topics.
You can ask your work-related questions concerning the COVID 19-crisis to Greet Musch, General-director at FAMHP.

02 March '20

BeAPP Professional Development Meeting

07 February '20

Lunchmeeting: Medical Affairs Competence Profile, developed by NVFG

Brussel