A medicine can be marketed in the European Union (EU) until the company has obtained a Marketing Authorisation (MA) for that medicine from the relevant regulatory authority. MAs are...
The processes of patient involvement in industry medicines research and development have evolved, but the evolution of frameworks, mechanisms, metrics and processes happens individually without much alignment and sharing.
A case report on Phase II patient involvement into Proof of Concept study design, to improve probability of success generating patient-relevant data and meeting current regulatory needs.
Involvement of the foundation ‘Children with SMA’ (spinal muscular atrophy) with an academic institution in Ukraine to design a pilot clinical trial addressing issues in SMA clinical trials.
The starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day...
