Module 1 2021

28-6-2021

Aspects of a Regulatory Strategy

Design of a regulatory strategy requires the regulatory professional to have: *Scientific know-how • Essential technical and scientific aspects of the product to be registered AND *Soft skills: • Negotiation skills • Problem-solving • Creativity and flexibility • Understanding of and insight in interests of stakeholders

The Organisation for Professionals in Regulatory Affairs

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Trends in Pharmaceutical Industry

• Shift to emerging markets • Unmet medical need: Alzheimer’s disease, obesity, diabetes type II • Personalised medicine • Drug-Device combinations e.g. Companion diagnostics • Need for prevention of diseases versus treatment (vaccines for developing countries, e.g. malaria)

The Organisation for Professionals in Regulatory Affairs

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