AGENDA: DAY III
WEDNESDAY, APRIL 10, 2019
DAY III: MINI SUMMITS AND CLOSING PLENARY SESSION
MINI SUMMITS ROUND IV: 8:30 am – 9:30 am
Mini Summit 15: Auditing and Monitoring Workgroup
- Why auditing and monitoring and update on recent changes?
- Who is responsible, including collaboration with Internal Audit?
- What are best practices in operationalizing and executing?
- With whom should summary report be shared and how to best communicate?
- What will change in the future as the environment in pharmaceutical & medical device industries change?
Compilance & Data Protection Officer, Merck Serono SpA – Italy; Former Head of Compliance, Takeda Italy, Rome, Italy
Head of Compliance Middle East, Roche Pharmaceuticals; Chair, Compliance Committee, Pharmaceutical Research and Manufacturers Association, Gulf (PhRMAG); Former Regional Pharma HCC Officer Emerging Markets, Johnson & Johnson, Beirut, Lebanon
Director Ethics and Compliance, Alexion; Former Director, Compliance Management, Daiichi Sankyo Europe GmbH; Strategic Committee, ETHICS, Munich, Germany (Moderator)
Mini Summit 16: R&D and Clinical Trials Compliance Workgroup
- Clinical trial recruitment
- Financial relationships with sites/CROs/treating physicians/patients
- Interactions with HCPs
- Access to the investigational medicinal product
- Interactions with patients
- Data privacy issues
- FCPA/antibribery controls
Participants will work through a case study to identify the risks related to conduct of clinical research in the EU and appropriate related approaches in your R&D compliance program.
Counsel, Life Sciences, Hogan Lovells, Former Legal Adviser, European Medicines Agency, Brussels, Belgium (Co-moderator)
Partner, Hogan Lovells; Former Senior Legal Officer and Hearing Officer, EFTA Surveillance Authority, Brussels, Belgium (Co-moderator)
Mini Summit 17: Communications and Collaboration with in-company Business Partners Workgroup
- Build trust with both informal and formal personal interactions
- Manage the dual role of being a business partner / service provider with follow up on infringements
- Discuss Critical Success factors in building those relationships
- Invest quality time to understand the eco system in each company / part of a company
- Influence without authority / positional power
Senior Legal Counsel and Global Healthcare Compliance Officer, Boehringer Ingelheim, Frankfurt Am Main, Germany
Vice-President, Global Head of Human Resources and Ethics & Compliance, Medday Pharmaceuticals; Board Member, Strategic Committee International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Head of Compliance, Vifor; Former Director International Compliance, Mallinckrodt; Former Director Global Ethics & Compliance, Actavis (now Allergan), Zurich, Switzerland
Legal & Compliance, SHS LC CO, Siemens Healthcare GmbH, Erlangen, Germany
Director and Principal Consultant, Sue Egan Associates, Great Missenden, Buckinghamshire, UK (Moderator)
CLOSING PLENARY SESSION
Co-chair Welcome and Introductions
TI Annual Keynote Address
Director, Pharmaceuticals & Healthcare Programme, Transparency International UK; Former Director, Global Health, Royal College of Obstetricians and Gynaecologists; Former Head, Government Relations, World Vision UK; Former Vice Consul, British Embassy, Copenhagen; Deputy Head of Mission, British Embassy, Bratislava, Deputy High Commissioner, Freetown, London, UK
Ethics and Compliance Keynote Address
Professor of Business Ethics, Department of Strategy, Globalization and Society, University of Lausanne, Lausanne, Switzerland
IFPMA Global Compliance Updates
Head of Ethics and Compliance, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland
Transforming Compliance into a Profession
President, Quantum Ethics, Ethics and Compliance Lecturer, SciencesPo; Former Compliance Director Western Europe & Canada, AbbVie; Former Director, Compliance & Ethics EMEA, Bristol-Myers Squibb, Paris, France