AGENDA: DAY III
WEDNESDAY, APRIL 10, 2019
7:30 am
Registration Commences
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?
8:30 am

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
8:30 am
- 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
8:30 am

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)
9:30 am
Transition Break
CLOSING PLENARY SESSION
9:45 am
Co-chair Welcome and Introductions
10:00 am
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
10:30 am
Ethics and Compliance Keynote Address

Professor of Business Ethics, Department of Strategy, Globalization and Society, University of Lausanne, Lausanne, Switzerland
11:00 am
IFPMA Global Compliance Updates

Head of Ethics and Compliance, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland
11:30 am
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
12:00 pm
Adjournment