Policy & regulation

LEGISLATIVE, REGULATORY AND RESEARCH RESOURCES WORLDWIDE

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ACCELERATE actively engages with policy makers & other stakeholders in the community of pediatric oncology. As a unique multi-stakeholder Platform, we make sure the voice of all our stakeholders is heard! We represent following stakeholders, who are all equal members of ACCELERATE:

Patients and parents’ organisations

Academic paediatric oncologists and haematologists and academic researchers

Representatives from biopharma companies

Regulatory networks (FDA, EMA, TGA, Health-Canada, PMDA) and health technology assessment authorities

ACCELERATE engages, where possible, in policy initiatives which apply to the field of childhood cancer policy. We make sure our voice is heard by prioritising for the following goals:

1.

Accelerating science-driven development of pediatric oncology drugs based on mechanism-of-action rather than adult indication.

2.

Facilitating international cooperation and collaboration among stakeholders.

3.

Improving early-access to new anti-cancer drugs in development for children and adolescents.

4.

Setting-up long-term follow-up of children and adolescents exposed to new drugs.

Europe

Initiatives in which ACCELERATE has contributed:

  • Provided feedback to the Roadmap inception impact assessment of the orphan and pediatric medicines regulation – in the scope of the Pharmaceutical Strategy.
  • Provided feedback to the Roadmap inception impact assessment of the general pharmaceutical legislation – in the scope of the Pharmaceutical Strategy.