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    • News

      EDCTP Forum 2018

      26 september 2018

      At the EDCTP forum last week I presented for CARED foundation about the quality of investigational medicinal products (IMPs) used in non-commercial clinical studies in low- and middle-income countries (LMICs). Those are far too often of low quality (falsified, substandard or degraded). CARED promotes to add 'quality field' in all clinical trial registries (CTRs) for IMPs to have some easy check. At the moment most CTRs don't have those fields.

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      Vaccination coverage is declining in the EU. The European Commission has issued a proposal for Council Recommendation https://ec.europa.eu/health/sites/health/files/vaccination/docs/com2018_2442_en.pdf to help increase vaccination coverage, foster the alignment of vaccination schedules across the EU, promote vaccine acceptance, support vaccine research and strengthen vaccine supply, procurement and stock management, especially in cases of emergency. This recommendation strongly believes in that[...]

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      Seasonal influenza vaccination: complex and delicate

      Besides the usual pro- and anti-vaccine lobby arguments, there are more issues here. The included strains have to be decided on by the WHO long before the season starts. And like in this season (in The Netherlands and the UK at least), sometimes another strain proves to be involved (Influenza B/Yagamata strain) and causes a lot of confirmed influenza cases. Next to that – and perhaps even the first concern – is that the effectiveness of the flu vaccine is not like that of e.g. the polio [...]

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      Real World Evidence

      8 november 2017
      Real World Evidence

      In pharmacovigilance, the ‘real world evidence’ (RWE) has been used for a very long time. Post authorisation studies are a useful tool in getting to know a possible adverse event better, in terms of type, severity, and incidence. Since the late 00’s, more attention has been given to RWE. With the medicines that are investigated for use in orphan indications, or in high level cancer therapies, the concept ‘RCTs are the golden standard’ has to be modified. RCTs in large populations for [...]

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      Warm welcome!

      8 november 2017
      Warm welcome!

      A warm welcome to Dominicus Medicus Consultancy! We are very happy to work together with you on all your solutions for medical and regulatory related issues.  At the moment you will be dealing with Hanneke Dominicus mostly. With a Medical Doctor education, completed with epidemiology, and extensive experience in medicines regulation, pharmacovigilance (EMA), and as cherry on the cake public health (government), she is your perfect partner in handling all kinds of regulatory [...]

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