Master
Strategiske og transparente medicinsk-regulatoriske beslutningsprocesser
Få kompetencerne til at vejlede andre til en mere robust beslutningsproces baseret på videnskabelig evidens samt de administrative og juridiske aspekter inden for regulativer.
Regulatory science bruger videnskabelig evidens, når det kommer til beslutningsprocesser. Det faciliterer velfunderede og transparente regulatoriske beslutningsprocesser og gør dig i stand til at udfordre specialister og argumentere for klinisk relevans og videnskabelig legitimitet for at tilsikre et solidt, pålideligt og kvalitetsbaseret handlingsforløb.
For at opnå et stærkt regulatorisk handlingsforløb for et produkt er der behov for kompetencer inden for kemisk driftskontrol, klinisk og præ-klinisk sikkerhed, godkendelsesprocedurer, forståelser af regulativer og sundhedssystemets tilgange, identificering af konkurrenter og kriterier for markedsadgang.
Regulatory science og critical thinking
Regulatory affairs giver dig mulighed for at tilgå regulatoriske processer på tværs af kliniske sikkerheds- og kvalitetsorienterede discipliner for at opnå en sikker og hurtig markedsføringstilladelse og undgå forsinkelser i kriterierne for markedsadgang.
Regulatory science lærer dig at forstå og undersøge lovgivning omkring lægemiddelregulativer og -direktiver samt forskellene i globale regulatoriske behov.
I definitely recommend the Master of Medicines Regulatory Affairs to others. The lecturers have a high standard and broad knowledge, and the other students are very experienced. This combination creates a wide perspective, interesting discussions, and a great network.
| Kursus | Niveau | Startdato | Varighed |
|---|---|---|---|
| Citizen Science This MSc course offers an in-depth introduction to citizen science: the involvement of the public in all levels of the scientific process. Citizen Science is an innovative method with the potential to collect large amounts of data over short time periods and is increasingly recognized for its enormous potential to make research relevant to the public by their involvement in the research process. Part of UCPH International Summer Programme. |
Kandidat | Juli | 2 uger |
| Science as a cultural human right This course will take a multidisciplinary approach to the right to science and to cultural rights in general, exposing students to fields outside their respective core disciplines of study. Among the topics focused on are scientific freedom and dissemination, the importance of international scientific collaboration, and the relationship between intellectual property and authors’ rights. Part of UCPH International Summer Programme. |
Kandidat | Juli | 2 uger |
| Science Communication in Theory and Practice Students will work together to produce high quality science communication products such as short films, podcasts, articles and complementary social media. Project groups will be interdisciplinary, giving students the chance to gain hands-on experience of research and development across disciplinary boundaries. Part of UCPH International Summer Programme. |
Kandidat | August | 2 uger |
Søger du efter et kursus om regolatory science and affairs, der matcher netop jeres virksomheds eller organisations behov?
Med et skræddersyet kursus har du mulighed for at få tilrettelagt et kursusforløb, der giver dine medarbejdere et kompetenceløft inden for præcis det fagspecifikke emne, der interesserer jer, og som matcher netop jeres virkelighed.
I chose this master’s programme because I want to be able to help advise government and regulatory bodies in Rwanda on how to optimize regulatory affairs without compromising the outcome on access to medicines. For that, I needed a specialized education, and I found that at University of Copenhagen.