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DIA, Europe, Middle East, and Africa office

Jun 05, 2019 8:00 AM - Jun 05, 2019 4:30 PM

Kuechengasse 16, 4051 Basel, Switzerland

EU and US Health Authorities Scientific and Regulatory Advice

The course is built up as a dialogue between industry and regulator perspective and will teach you what authorities pay attention to, what inquiries they make and what they expect to hear from sponsors.

Faculty

Eva  Boge, MPharm

Eva Boge, MPharm

Senior Regulatory Project Manager, Zealand Pharma A/S, Denmark

Eva Bøge has a MScPharm and a Master in Industrial Drug Development from University of Copenhagen and more than 13 years of pharma industry experience from Lundbeck and Leo Pharma with solid knowledge about the entire product life cycle and value chain. Eva has several years’ experience as Global Regulatory Strategy Leader responsible for global regulatory strategies and operational company deliverables for early and late-stage development projects, as well as US NDA activities incl. FDA Advisory Committee preparation and execution. Eva is currently the Regulatory Lead for a late stage development project within a paediatric orphan indication at Zealand Pharma.

Trine B. Moulvad, MSc

Trine B. Moulvad, MSc

Global RA, Medical Documentation and R&D QA, Lundbeck, Denmark

Trine Moulvad has an MSc from University of Copenhagen, Denmark. She is an all-round experienced drug developer and leader with more than 25 years of experience within the pharmaceutical industry. She previously worked at Eli Lilly, Ferring and Novo Nordisk in global Regulatory leadership capacities, and have most recently gained experience from the 'small business' world of biotech at Zealand Pharma heading up Regulatory, Pharmacovigilance and Medical Writing accountable for successful Agency negotiations and taking projects from early development through to regulatory submission and approval in both US and EU. Engaged in trade associations as well as teaching and course leadership for DIA and other training organizations.

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