Pharmaceutical Regulatory Affairs Summit

• How is Novartis Ethics Risks and Compliance (ERC) organised • What are the Novartis ERC priorities • Examples of how Novartis brings ERC to .. Read more life, code of ethics, integrated risk management, 3rd party risk, management and human rights. The overall objective of the European Commission “EU Pharmaceutical Strategy” is to help ensure EU’s supply of safe and affordable medicines to meet patients’ needs and support EU industry to remain world leader and innovator. This presentation will provide a regulatory affairs perspective on the challenges & opportunities lying ahead of us as the Commission legislative and non-legislative proposals materialise. • The regulatory affairs elements within the 10 points of action put forward by the Commission • The industry perspective on the non-legislative and legislative proposals • The parallel impact assessment and revision of the Orphan Regulation (141/2000) and Paediatrics Regulation (1901/2006). • How did the pharmaceutical industry and drug regulations develop in EU? • What are the challenges of a regulatory affairs profession? • Organisational structure of regulatory affairs • Regulatory strategy: The process • The importance of regulatory affairs in the pharma industry • Regulatory affairs agencies: What are their responsibilities?.