Profil #204732

As a Master Thesis student, I gained a broad and international experience with medicines clinical study design, regulation, submission, and approvals by E.U. European Medicine Agency (EMA) and U.S. Food & Drug Administration (FDA). As well as obtained deep knowledge and experience within the regulation of the clinical trials, study design, and real world evidence (RWE) measured by patient reported outcomes (PROs). During writing and managing independently the master thesis project within regulatory affairs on "Fixed Dose Combinations – Regulatory Aspects And Real World Measures On Xultophy Therapy: Part I – Differences Of EMA And FDA Label Indications For FDC Products Approved Jan 2000 – Apr 2017. Part II – A novel Approach To Collecting Real-World Patient Reported Outcome Applied To T2DM FDC Users".

Managing the master thesis project:
• Collaborating and communicating with different stakeholders: supervisors, regulatory affairs professionals, and pharmacists
• Analyzing and reporting the master thesis results
• Writing effectively and independently the master thesis
• Designing a novel second part of the master thesis project by developing patient questionnaire dispensed to community pharmacies
• Comparing and finding disparity or alignment between two major medicine agencies (EU-EMA vs. US-FDA)
• Collecting real-world evidence (RWE) using patient reported outcomes (PROs)

Key functions (objectives of occupation):
? Responsible for questions received from EMA, FDA and Switzerland during insulin faster aspart MAA, NDA assessment and for the phase 3a programme - in close collaboration with regulatory professional/associate
? Provides support to the team regarding preparation of label document for non-EU countries
? Participates in relevant team meetings and cross-functional teams meetings
? Provides support to regulatory professionals regarding search for information related to regulatory requirements and competitor products