Regulatory Science

The information proposed in this section provides key elements on the regulation of medicines for Rare Diseases in human and provides support in the:
Health Technology Assessment,
Drug repurposing,
Preclinical suties,
Early access support,
Clinical Development,
Marketing Authorization,
Ethic and legal issues,
Regulatory Agencies.

  1. Showing 4 results for:
  2. Regulatory Science
All SubjectsClinical Trial

Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)

Published by EC

Clinical TrialMedicinal Productsinvestigational medicinal products

EU Regulation setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials

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Stakeholders interactions – Professional affairs and Community Engagement

Published by IRDiRC

Early Stage InteractionRegulatory AffairsEarly Access SupportPatient AdviceClinical TrialScientific AdviceRegulatory AdviceProfessional AffairsCommunity Engagement

Interaction of the stakeholders and multilateral education at an early stage of development will facilitate drug development (e.g. ensuring outcome measures for clinical trials are developed that are meaningful for patients, are acceptable to the regulators, and are acceptable to payers)

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Exploring the new horizons of Drug Repurposing: A vital tool for turning hard work into smart work

Published by European Journal of Medicinal Chemistry

Clinical TrialResearch and Drug DevelopmentDrug DiscoveryDrug RepurposingLead Molecule

This review provides different approaches for Drug Repurposing and addresses recent developments and future scope of drug repositioning strategies. In addition provides a list of repurposed drugs and repurposing resources.

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