Controlled AI in Regulatory Strategy
AI use in regulatory strategy.
RAPS Euro Convergence 2025, 13 – 16 May, Brussels, with focus on AI in regulatory
The RAPS Euro Convergence 2025, 13 – 16 May, 2025 at the Square Congress Center in Brussels is the place to be to learn about the current state of regulatory science. It offers an unique change to interact with regulatory experts in different fields from pharmaceuticals, to medical devices and invitro diagnostic devices.
Dr. Luc Van Hove of MARACA International is looking forward to an exciting RAPS Euro Convergence in Brussels, to meet old friends and to make new friends. I’ve selected to participate in the PMS workshop since this field is evolving quickly. It is important to find agreement with your Notified Body on the PSUR format to be presented. AI help with the PMS activities is hot and interesting.
During the main congress many interesting sessions are planned. Of notice are the many presentations on the use of AI in the regulatory activities. AI applications in regulatory activities dominated the congress. AI is here to stay in regulatory. All stakeholders are trying to improve their processes with AI. It is impressive. When you are active in Regulatory Affairs you should start using AI!
The MedTech EU Forum 2024, 22 -24 May Vienna
The MedTech EU Forum Meeting starts now in Vienna. Dr. Luc Van Hove of MARACA International is excited to participate for Silimed at The MedTech EU Forum Meeting in Vienna on 22 – 24 May. This is the largest European gathering of European Medical Technology companies to discuss the current innovations in the field of medical devices and in-vitro diagnostics devices. It is a terrific opportunity to network with key people in the medical technology industry, the European Commission, Competent Authorities and Notified Bodies. All European key players will be there. The European Commission and several Competent Authorities and Notified Bodies will present their views on the current status of the MDR and IVDR implementation and what the stuck points are. How they plan to keep medical technology innovation at the forefront in Europe. A weld of topics will be discussed in parallel sessions. There is also a very interesting ask the expert track running through the meeting. This one I enjoy the most. The new HTA regulation will be discussed, as well as the new EU product liability rules. The European Innovation in Health Initiative (IHI) will be presented with case studies. The European Green Deal with its challenges and opportunities for the medtech sector will be discussed. Global clinical evidence challenges and opportunities of Real World Evidence (RWE) will be reviewed. Is real world data a game changer for the medtech industry? A very interesting topic is the transformation of postmarket surveillance with GenAI and automations.
So this is a very exciting meeting to participate in. I hope to see you there also.
EAAR RMD Conference 2024 on regulations of medical devices, Brussels 26 – 27 February
Dr. Luc Van Hove participates, as representative of the European Authorized Representative (EAR) Silimed BV NL at the European Association of Authorized Representatives (EAAR) in the RMD Conference in Brussels, 26 – 27 February. The conference is focused on industrial challenges and key regulatory developments for medical devices that are important for Authorized Representatives to know. Of particular interest are the sessions on the latest developments on the MDR and IVDR regulations and the EMA role in the MDR/IVDR framework for combination products. Additional national requirements beyond the MDR and IVDR will also be highlighted. Positive and negative experiences with the Notified Bodies will be discussed. Legal aspects of the MDR and IVDR will be reviewed and the potential impact of AI will be assessed. Of particular interest to MARACA International are the sessions on Clinical evaluations and scientific validity as their pain points will be reviewed. Also of interest are the discussion of a practical approach to postmarket surveillance and vigilance requirements. Last but not least, the status of the EUDAMED database will be presented.
MARACA International at Berlin Marathon 2023 and 24th IMDRF Stakeholder Workshop
It is great to start our visit to Berlin with the Berlin Marathon 2023. It reminded me of the marathons I’ve run in the past and all the excitement around such an event. Due to the Marathon I had to do a walking marathon to see the Berlin monuments. The Brandenburg Gate and the Reichstag building were located within the Marathon zone, which is super for the runners, but difficult for tourists. The weather was great so the long walk back and forwards though the Tiergarten was very enjoyable.
Next, MARACA International and Silimed participate in the IMDRF-Stakeholder Workshop and Stakeholder forum on 25 – 26 September. We’ll follow the regulatory developments around breast implants. What is expected for performance of breast implants and what level of side effects are acceptable. Also, patients will participate as stakeholders to express their own views. It will be a great meeting with all these regulatory experts from around the world to talk about the regulatory progress they have made. I’m looking forwards to the sessions.
Safe-n-Medtech 54th month Management Committee meeting in Bilbao, Spain to start the OITB Pathway
Safe-n-Medtech calls its 54th month management committee meeting in Bilbao on 20 – 21 September 2023 to start the OITB Pathway.
All nine work package leaders of safenmt will present the final progress of their work packages.
Dr. Luc Van Hove of MARACA International , as WP7 Leader, Regulatory and Ethics, will present the final update of the medical device and IVD harmonized standards to be used for the development of nanotechnology-based medical devices. He will also present the report on applying ethical behavior in the development of nanotechnology-based medical devices.
Moreover, Luc reviewed the Quality Management Systems (QMS) and Technical Documentation (TD) of several test case partners, identified gaps and proposed resolutions to bring their QMS and Technical Documentation into compliance with the MDR, the IVDR or ISO 13485:2016. He developed regulatory strategy plans for several partners and improved the risk documentation of several nanotechnology-based devices to be in compliance with ISO 14971:2019. Luc also developed scientific validity reports with systematic literature searches to support the clinical evaluation of some medical devices and IVDs and he was a medical member of the NoCanther clincial trial Safety Board.
MARACA International is also heavily involved in the creation of the OITB Pathway portal.
The OITB Pathway company is created as a single-entry commercial enterprise portal to link medical device and IVD clients with partners who offer different specialized services to research and develop medical devices and IVD to a successful registration in Europe.
MARACA developed the Quality Management System for the OITB Pathway company in compliance with ISO 9001:2015.
MARACA International will offer its regulatory, quality, and clinical services through the OITB Pathway to the many clients in need of such services.
Workshop on Hyperthermia in Oncology
MARACA International and Safe-N-Medtech participate in the workshop on Hyperthermia in cancer treatment, organized by Vall d’Hebron Hospitals, Barcelona, Spain.
Dr. Luc Van Hove presents the European regulation of medical devices and in vitro diagnostics from a rare disease’s perspective.
Pancreatic cancer is a rare disease. It is therefore difficult to include sufficient study subjects for a rare disease clinical investigation. At the European chaired IMDRF congress in Brussels 27 March 2023, real world data collection was discussed as an option for clinical studies of rare diseases. During this Hyperthermia workshop we’ll examine this possibility for pancreatic cancer as a rare disease. Specifications for post-market clinical follow-up studies will be considered. Interaction with notified bodies and the Spanish Competent Authority will be part of this discussion. It is exciting to be in the forefront of this new hyperthermia treatment for rare cancers.
Klimaatdag – Rotselaar
Kom je ook naar de Klimaatdag-Rotselaar, 23 April 2023, in de Sportoase Den Toren?
You are invited to the Climate Day of Rotselaar, 23 April 2023, Sportoase Den Toren.
Organized by the MAR – Milieuadviesraad van Rotselaar
including Dr. Luc Van Hove of MARACA International
Met:
- Infomarkt met slimme oplossingen voor energiebesparing
- Lezing van Pieter Bousemaere over de 10 klimaatacties die werken
- Voorstelling Klimaatplan van Rotselaar met interview door student van het Montfort college
With:
- Infomart on smart solutions for energy savings
- Presentation by Pieter Bousemaere on the ten climate actions that work
- Presentation of the Climate Plan of Rotselaar with an interview by a student at the Montfort college
The ten climate actions that work for you are:
- Inform yourself
- Influence your environment
- Influence your government
- Select green electricity
- Use electricity wisely
- Select the right heating
- Select the right mobility
- Limit flying and compensate
De tien klimaatacties die werken zijn:
- Informeer jezelf
- Beïnvloed je omgeving
- Beïnvloed je overheid
- Kies de juiste elektriciteit
- Spring verstanding om met elektriciteit
- Kies de juiste verwarmingsbron
- Kies de juiste motor
- Beperk vliegreizen en compenseer
Tijdslijn:
12 u infomarkt met o.a:
- Workshop veggie zero waste Koken
- Zonnepanelen, thuisbatterijen en laadpalen
- Warmtepompen en isoleren
- Repair café
- Energieloket en premies
- Deelwagens en mobiliteit
14 u: ECoOB productie hernieuwbare energie door burgers
14.20 u: Lezing Pieter Bousemaere
16.30 u: Interview Klimaatplan Rotselaar
Time Line
12 hr.: Infomart with
- Workshop veggie zero waste cooking
- Solar panels, home batteries, charging stations
- Heat pumps and isolation
- Repair Cafe
- Energy counter and premiums
- Share cars and mobility
14 hr.: ECoOB production of renewable energy by citizens
14.20 hr.: Lecture by Pieter Bousemaere
16.30 hr.: Interview Climate Plan Rotselaar
We need to reduce Carbon emission by 55% within the next 7 years (2030) per the European Green Deal regulation.
The MARACA International office is already carbon neutral with its solar panels, heat pumps, home batteries and led lights. What are you doing to preserve a livable world for your grandchildren and to become carbon neutral?
Het MARACA bedrijf is reeds koolstofneutraal met zijn zonnepanelen, warmte pompen, thuis batterijen en led verlichting. Wat doe jij om een leefbare wereld na te laten voor je kleinkinderen en om koolstofvrij te zijn tegen 2050?
MARACA at Safe-N-Medtech meeting in Barcelona
MARACA International participated in the annual Safe-N-Medtech OITB consortium meeting in Barcelona. Dr. Luc Van Hove presented the work package
NoCanther study moves magnetic nanoparticle device towards the clinic
Dr. Luc Van Hove from MARACA International participated in the IMDEA meeting in Madrid on Magnetic nanoparticle-based medical devices towards the clinic. This scientific and clinical meeting transitioned the NoCanther clinical study from REFINE to the Safe-N-Medtech consortium for further development. At the meeting the status of the development of paramagnetic iron nanoparticles was reviewed. Details were presented on how to produce stable iron nanoparticles of the right size and the right properties. The establishment and validation of the clean room manufacturing of the iron nanoparticles was discussed. The status of the preclinical testing in vitro and in vivo in different animal models was reviewed. The first in-human pancreatic adenocarcinoma patients of the NoCanther clinical study which are treated with the Resonant Circuits Limited (RCL) hyperthermia therapy were reviewed. The treatment was found to be safe and possible. The NoCanther clinical investigation is transitioning from REFINE, which comes to an end, to Safenmt for further study progression. MARACA presented at the meeting the regulatory and clinical investigation requirements for a Pre-CE conformity study to establish the safety and performance of the RCL NTT hyperthermia device. Moving this new treatment from the development phase to the clinic is an exciting achievement. Everyone involved deserves congratulations for their hard work!