advisory groups
Regulatory Science is a topic that is gaining increasing
attention within the MEB. In order to safeguard the quality of our
work, initiatives are being deployed to ensure knowledge exchange
between employees and (external) experts.
For example, expert and sounding board groups have been initiated
in the fields of
Paediatric Medicines,
Pharmacovigilance,
Advanced Therapies and
Medical Practice.
Due to the importance the MEB ascribes to the development of new
medicines for children, more research into the use of existing
medicinal products and the development of new pharmaceutical forms
of existing medicines for children, cooperation was sought with a
number of leading paediatricians/pharmacists in the Netherlands in
the field of pharmacotherapy in children.
What does the paediatric medicines sounding board group do?
- Inform each other about important developments in the field
of
paediatric medicines
- Monitor the MEB with a critical eye regarding marketing
authorisations and advisory activities in the field of medicines
for children
- Peer review of MEB reports on paediatric medicines for
Europe
- Providing expert advice if the MEB requires expertise or wishes
to consult an expert
- Participation in national and international expert meetings on
behalf of the MEB
In addition to evaluating medicines, the MEB is also tasked with
monitoring the risk-benefit balance after granting marketing
authorisation by tracking, continuously evaluating and preventing
undesired adverse events and interactions. The latter is known as
Pharmacovigilance, and is one of our strategic objectives.
What does the Pharmacovigilance expert group do?
- Monitor MEB’s activities with a critical eye, and provide
requested and unrequested commentary
- Monitor MEB’s activities in the field of pharmacovigilance with
a critical eye, and forward signals from the field to the MEB
- Contribute practical experience and above all clinical
expertise in the assessment of MEB employee reports
- Additionally, individual members may be consulted for
individual expert advice or for peer review of assessment
reports
On 1 January 2009, the European regulation came into effect,
creating a separately defined group of medicinal products, the
Advanced Therapy Medicinal Products (ATMPs). The ATMPs encompass
products for gene and cell therapy, in which manipulated genes or
cells are used to heal a patient.
What does the Advanced Therapies expert group do?
- Inform each other about important developments in the field of
ATMPs
- Monitor the MEB with a critical eye regarding marketing
authorisations and advisory activities in the field ATMPs
- Peer review of MEB reports on paediatric ATMPs for Europe
- Providing expert advice if the MEB requires expertise or wishes
to consult an expert
- Participation in national and international expert meetings on
behalf of the MEB
The
Committee for Advanced Therapies (CAT) is a
multidisciplinary committee in which experts from all over Europe
come together to evaluate the quality, risks and efficacy of the
ATMPs. The Netherlands is represented (on behalf of the Medicines
Evaluation Board) by Dr Hans Ovelgönne (also a member of this
expert group) in the CAT.
The MEB likes to keep informed of
knowledge and experience from medical practice. Doctors,
pharmacists, pharmacy assistants and nurses jointly form this
medical practice group.
What does the medical practice expert group do?
- Receive and provide feedback on medicine use aspects in daily
practice, in terms of both the information provided and the
medicine itself.
- Identify problems in the field, such as product withdrawals,
abuse or incorrect use of medicines, product availability,
packaging and administration issues.
- Identify problems with information in the SmPC (Summary of
Product Characteristics), package leaflet and labelling.
- Identify problems in the field with substitution and
biosimilars.
- Discuss medication errors where MEB could take action, e.g. by
improved user instructions or label modifications.
- Act as a sounding board for medicine problems in the field,
identified by medical professionals.
