With the accelerating pace of innovation, speed in which regulation is changing and the shift in societal norms, we need to transform ourselves to manage the increasing complexity of organisational risks and return more to society.

• How is Novartis Ethics Risks and Compliance (ERC) organised
• What are the Novartis ERC priorities
• Examples of how Novartis brings ERC to life, code of ethics, integrated risk management, 3^rd party risk, management and human rights

This presentation will give an overview over EU regulatory landscape, legal framework, and how to accelerate product development in order to get promising medicines to patients faster. There are a few approaches from regulatory agencies, i.e. the PRIME scheme in the centralised approval process at the EMA, but most of the acceleration efforts need to come from companies. An adequate, state of the art regulatory strategy is essential to gain a competitive advantage and get medicines to patients faster.

• The EU regulatory landscape / why regulate medicines?
• Novel ways for drug development and the regulatory strategy behind them – How to get medicines to patients faster?
• Artificial intelligence to aid in product development – The use for regulatory strategy and acceleration
• Early Collaboration with Market Access – How to work hand in hand to overcome access and reimbursement hurdles already during the drug development process
• Regulatory affairs as a driver for competitive advantage and fast-to-market strategies

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. The strategy will profoundly change the legal, economic and scientific landscape in which we currently operate. 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)

An overview on drug regulations in EU and on regulatory affairs profession including different roles and positions, responsibilities and career paths. This presentation will also provide an introduction on regulatory affairs agencies with corresponding registration process and the importance of regulatory strategy for the pharmaceutical industry.

• How did the pharmaceutical industry and drug regulations develop in EU?
• Why do we need to regulate?
• 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?