Morning session - Risk Management Concepts

Dr David Hillson (The Risk Doctor)

The morning session is intended for senior healthcare research professionals who require an understanding of the purpose and value of risk management, in order to implement it effectively and to support its use by others. No prior knowledge or experience of risk is assumed or required.

On completion of this session attendees will:

• Understand Key risk concepts, including the relationship between uncertainty, risk, threat and opportunity
• Be aware of the key stages of the risk process, and the main techniques
• Understand how to use risk-based information when making decisions
• Recognise the main benefits to the organisation of managing risk effectively
• Be committed to supporting and implementing risk management in their areas of responsibility

Afternoon session - Risk Management in Pharmaceuticals and Biologics

Hedley Rees (Biotech PharmaFlow Ltd)

The afternoon session is intended for senior staff engaged in clinical and non-clinical activities across the spectrum of drug development right through to commercialisation. It aims to demystify the process of risk management and position it as an important cross-functional competency set required of professional and managerial staff in the sector.

On completion of this session attendees will:

• Understand the process of risk management as recommended by the International Conference on Harmonisation (ICH) guidance on Risk Management, ICH Q9, and the associated benefits of using such an approach
• Be able to link their own particular circumstances to the wider product development and business environment risks, so as to maximise their own personal contribution to the organisation and also the contributions of colleagues
• Have a clear understanding of the Regulatory expectations for risk management in the pharmaceutical industry of the 21st century
• Take back to their work setting new approaches towards risk and ways of operating that have been tested in a ‘low risk’ environment
• Feel far more confident that they understand risk management as an integral part of their regular operations, rather than an ad-hoc event