6th Annual International Regulatory Affairs Symposium “Risk Governance in Regulation”

3. 6th Annual International Regulatory Affairs Symposium“Risk Governance in Regulation” Historical review – how old are the conception of “risk”? “The origin of our species – Chris Stringer” • The easy answers is where and when, the difficult one is why? Nonetheless he is bringing aspects of: • Risk reduction • Modern humans spread risk for survival through better technology, provisioning and mutual support • Risk taking • “Necessity is the mother of invention” • Innovation or imitation

4. Basic knowledge about risk From a regulators perspective - How to govern risk? What does a risk based approach mean? • Any human activity implies a risk • Uncertainty about the consequences of an activity will always exist • There is always something we do not know • Zero risk can be achieved only by zero activity • Zero uncertainty can be achieved only by zero activity

5. From a regulators perspective – how to govern risk? Command and control Self regulation You need to balance a regulatory role which encompasses: And

6. From a regulators perspective – how to govern risk? Command and control Self regulation Risk taking and risk reduction is about the interrelationship between

7. Social system - individuals - groups - needs Risk and rationality in a Human – Technology - Organisation-perspective H T O O O Technological system Mutual influence • Systemic characteristics - • Rationality • Scientific approach to ensure rational and effective production • Specialisation • Clarified roles (who das what) • Standardisation • Automation • Human needs and behaviour • Career planning • Job satisfaction (content and variation in the job) • On the job training/learning • Empowerment and decision-making • Execution of power • Reputation/prestige (support, trust etc) • Integrity and autonomy

8. System perspectives 8

9. Activities in a high risk environment How to utilize tacit knowledge? Knowledge based management Large-scale operation O O O New intelligent and virtual tools • Development and utilisation of • knowledge and knowledge systems • Development of strategic • expertise platforms • with greater width and • depth • The empowered employee • autonomy • integrity • Management tool • - team (virtual) • - network • Adaptive to uncertainty in the • market Specialisation around similar work tasks - standardisation - common procedures Elimination of overlapping work Synergy of large-scale operations - Optimal investments - low unit costs Management tool - hierarchy - instructions and procedures Depended on internal and external stability

10. How to develop knowledge in a risk based regulatory context? Quality Care why? Know why? Know how? Know what? Experience/ competence

11. Care why – demands focus on values, people and leadership Guiding our behaviour and discuss what we expect from our fellow colleagues, our companies and our leaders