Agenda Links: Precons/Day 1 | Day 2
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
Compliance programs must evolve to keep current with new regulations, enforcements, and the changing business models. Auditing and monitoring are key to maintaining a robust program, and panelists will share insight as they address the following questions:
- 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
Introductions, Panel Discussion and Q&A
Antonio Cavallaro
Compilance & Data Protection Officer, Merck Serono SpA – Italy; Former Head of Compliance, Takeda Italy, Rome, Italy
Compilance & Data Protection Officer, Merck Serono SpA – Italy; Former Head of Compliance, Takeda Italy, Rome, Italy
Mr. Cavallaro has 35 years in the pharmaceutical sector; half in the finance & administrative department and half in the Compliance function. He is a Compliance Officer, Data Protection Officer and Member of the Supervisory Body for Merck Serono SpA (Italian subsidiary of Merck KGaA, Germany). Mr. Cavallaro is the former Head of Compliance, President of the Supervisory Body of Takeda Italia SpA (Italian subsidiary of Takeda Japan) and responsible for the Internal Auditing, and Registered Accountant, Registered Legal Auditor, Qualified Auditor for marketing, promotional and scientific information activities (ISO 19011 standard) and Anti-corruption (ISO 37001). He was the founder, Partner and Board Member of the Observatory on the Compliance in the Pharmaceutical Industries (www.231farmaceutiche.it)
Laura Nassar, PharmD
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
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
Laura Nassar is the Head of Compliance for Middle East at Roche Pharmaceuticals, based in Dubai. She is the Lead for PhRMAG (PhRMA Gulf) Compliance and Legal Working Group and Chair of the Middle East Ethics Review Board (LERB), governing body of the MEA Code of Promotional Practices. She has over 18 years’ experience in the healthcare industry, across a wide range of disciplines such as Pharmacy, Sales and Marketing, Skills Training and Compliance. She worked closely with management teams in Turkey, Middle East, West Asia and Africa to build a strong compliance culture and support sustainable business growth. Laura holds a Pharm.D degree from St Joseph University in Beirut, Lebanon.
Michael Bartke, PhD
Director Ethics and Compliance, Alexion; Former Director, Compliance Management, Daiichi Sankyo Europe GmbH; Strategic Committee, ETHICS, Munich, Germany (Moderator)
Director Ethics and Compliance, Alexion; Former Director, Compliance Management, Daiichi Sankyo Europe GmbH; Strategic Committee, ETHICS, Munich, Germany (Moderator)
Michael Bartke has more than 30 years’ experience at research-based companies e.g. Bristol Myers Squibb and Daiichi Sankyo – e.g. Head of Marketing involved in various national and international projects. 2008 Director Compliance Management at European Headquarter for Daiichi Sankyo Europe; experience in various areas of Compliance and risk management. Activities in associations re Compliance at FSA Berlin, Germany, EFPIA Brussels, Belgium ( Co-Chair Compliance Committee), and IFPMA Geneva, Switzerland ( Code Compliance Network); He is now the Director, Ethics and Compliance at Alexion Pharma Germany and since 2019 is a compliance consultant and a Member of Strategic Committee of ETHICS, Paris, France
Mini Summit 16: R&D and Clinical Trials Compliance Workgroup
8:30 am
Introductions, Panel Discussion and Q&A
This interactive workgroup will focus on R&D compliance risks in the EU, such as:
- 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.
Alexander Roussanov, LLM
Counsel, Life Sciences, Hogan Lovells, Former Legal Adviser, European Medicines Agency, Brussels, Belgium (Co-moderator)
Counsel, Life Sciences, Hogan Lovells, Former Legal Adviser, European Medicines Agency, Brussels, Belgium (Co-moderator)
Alexander Roussanov is a counsel of our Life Sciences practice and advises clients on a broad range of issues relating to the EU and national regulatory framework governing the marketing of medicinal products and medical devices. Through his work in private practice, pharmaceutical companies and the European Medicines Agency (EMA), Alexander acquired extensive first-hand experience in dealing with highly sensitive and complex regulatory matters, access to documents and clinical data disclosure. Alexander focuses on a broad range of issues relating the life-cycle of medicinal products and medical devicesproduct classification, clinical trials, marketing authorisation, CE marking, pharmacovigilance, post-marketing surveillance, marketing and promotion, interactions with healthcare professionals. In addition, he has been directly involved in internal investigations, audits and regulatory due-diligence projects. Before joining Hogan Lovells, Alexander served as Legal Adviser in EMA. He litigated successfully four access to documents cases in the General Court.
Elisabethann Wright, LLB
Partner, Hogan Lovells; Former Senior Legal Officer and Hearing Officer, EFTA Surveillance Authority, Brussels, Belgium (Co-moderator)
Partner, Hogan Lovells; Former Senior Legal Officer and Hearing Officer, EFTA Surveillance Authority, Brussels, Belgium (Co-moderator)
Elisabethann Wright has been practising in the Life Sciences sector for over 30 years in both private practice and international institutions. Her role includes assisting clients in the classification of their products, the establishment of a pathway to authorization and marketing of their products in the EU (including related regulatory obligations), pharmacovigilance obligations, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals, data privacy obligations, and conduct of compliance and anti-bribery investigations. Elisabethann also has experience in litigation before the European Court of Justice, the European Court of First Instance, and the European Free Trade Agreement (EFTA) Court, including challenges, on behalf of industry clients, to decisions of EU institutions and the validity of EU legislation. Elisabethann was a Référendaire (Law Clerk) at the Court of Justice of the European Communities for a number of years.
Mini Summit 17: Communications and Collaboration with in-company Business Partners Workgroup
Join this interactive learning session on interactions with internal business partners to:
- 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
Introductions, Panel Discussion and Q&A
Maike Bermüller
Senior Legal Counsel and Global Healthcare Compliance Officer, Boehringer Ingelheim, Frankfurt Am Main, Germany
Senior Legal Counsel and Global Healthcare Compliance Officer, Boehringer Ingelheim, Frankfurt Am Main, Germany
Maike Bermueller is the Head of Ethics & Compliance for Human Pharma for Boehringer Ingelheim. In this role she oversees the Global Healthcare Compliance Program for all Boehringer Ingelheim´s entities globally and for the implementation of the Ethics & Compliance Program for the Corporate Functions. Before joining BI in 2007 as a Legal Counsel, Maike worked in a law firm in Munich as a lawyer for anticompetition and IP Law.
Stephen Nguyen Duc
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
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
Stephen Nguyen-Duc joined Medday in November 2018 as VP, Global Head of Ethics & Compliance. As part of his career, he has held several senior positions in Clinical Operations, Human Resources and Compliance in multinational companies. In his last position before Medday, he was the Compliance Officer for Europe and Canada at Abbvie Pharmaceuticals. Stephen is an active member of various associations promoting Trust and Integrity in Healthcare. He is Board member and Co-Chair of the Strategic Committee of Ethics, the International association of Healthcare Compliance Officers
Tomasz Kruk, LLM, MBA
Head of Compliance, Vifor; Former Director International Compliance, Mallinckrodt; Former Director Global Ethics & Compliance, Actavis (now Allergan), Zurich, Switzerland
Head of Compliance, Vifor; Former Director International Compliance, Mallinckrodt; Former Director Global Ethics & Compliance, Actavis (now Allergan), Zurich, Switzerland
Thomasz Kruk is currently Head of Compliance at Vifor Pharma. He was previously in Mallinckrodt Pharmaceuticals, Actavis, Merck, Schering-Plough. He has comprehensive, cross-cultural experience as a compliance officer and lawyer in roles at the global, regional and local level in the pharmaceutical sector. His real-world compliance and anti-corruption expertise includes USA, LATAM, APAC (incl. China & Australia), Middle East, Africa, CIS (incl. Russia) as well as EU & Eastern Europe (incl. Balkans).
Ruth Sturm
Legal & Compliance, SHS LC CO, Siemens Healthcare GmbH, Erlangen, Germany
Legal & Compliance, SHS LC CO, Siemens Healthcare GmbH, Erlangen, Germany
Ms. Sturm is the Head of Compliance EMEA, Head of Global Business Partner Management, and Head of Compliance Direct and Export Business for Siemens Healthineers. She was previously the UK Senior Vice President, Chief Compliance Officer at Primetals Technologies Limited and Vice President Business Unit Compliance Officer Metals Technologies for Siemens VAI Metals Technologies GmbH, Linz, Siemens AG. Her career with Siemens began as Senior Manager Compliance, Siemens VDO Automotive AG (SV). Her previous experience was as Senior Manager IT Compliance, Infineon Technologies AG (IFX AG).
Sue Egan
Director and Principal Consultant, Sue Egan Associates, Great Missenden, Buckinghamshire, UK (Moderator)
Director and Principal Consultant, Sue Egan Associates, Great Missenden, Buckinghamshire, UK (Moderator)
Director, SEAL Compliance (a trading name of Sue Egan Associates Limited) Sue established her consultancy in January 2010 to provide practical assistance for small to medium sized companies trying to establish their compliance programs from nothing, improve on existing programs, and / or enable compliance team members to achieve their full potential. She has been a Compliance Officer at all levels from single marketing company and region for GlaxoSmithKline to international VP for AstraZeneca. As a founder member of the organizing committee of the International Pharmaceutical and Medical Device Compliance Congress, she has a high reputation as a speaker and presenter of case studies and practical guidance at conferences in the USA, Europe, Asia Pacific, and Latin America. Sue Egan Associates is also a member of the Thames Valley Chamber of Commerce Group. In addition to her consultancy work, Sue also provides membership assistance to ETHICS Society.
9:30 am
Transition Break
CLOSING PLENARY SESSION
9:45 am
Co-chair Welcome and Introductions
10:00 am
TI Annual Keynote Address
Rachel Cooper, LLB, MSc
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
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
Rachel Cooper joined Transparency International in November 2017 to lead and deliver the flagship project on Open Contracting in the Health Sector and to develop other areas of work, especially around Research and Development (and Clinical Trials Transparency), Procurement and Corruption in Health Service Delivery. Previously she served as a British diplomat in London, Copenhagen, Bratislava and Freetown, where she was Acting High Commissioner. Since leaving the Foreign Office she has specialised in global health and has worked with World Vision and a number of Medical Royal Colleges.
10:30 am
Ethics and Compliance Keynote Address
Guido Palazzo, PhD
Professor of Business Ethics, Department of Strategy, Globalization and Society, University of Lausanne, Lausanne, Switzerland
Professor of Business Ethics, Department of Strategy, Globalization and Society, University of Lausanne, Lausanne, Switzerland
Guido Palazzo is a professor of business ethics at the University of Lausanne. His research focuses on (un)ethical decision making in organizations. He has worked with numerous corporate boards and leadership teams on compliance and integrity, including Siemens, Airbus, Zimmer, Cook Medical, Medtronic, Johnson & Johnson, Audi, Volvo Cars, Statoil and many others. He also trains senior officials of the Chinese Communist Party. His online course “Unethical Decision Making in Organizations” on coursera.org has been taken by more than 35.000 people so far.
11:00 am
IFPMA Global Compliance Updates
Sofie Melis
Head of Ethics and Compliance, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland
Head of Ethics and Compliance, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland
After working for 10 years at the company side of the biopharmaceutical industry, Ms. Melis changed sides to the global trade organization (IFPMA) in 2016. A linguist and HR-professional by training, she enjoys the challenges Ethics and Compliance poses on people, behavior and communication.
11:30 am
Transforming Compliance into a Profession
Piergiorgio Pepe, MA EU Law
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
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
Piergiorgio Pepe is an independent compliance and ethics advisor, president of Quantum Ethics. He advises high profile companies and institutions on ethics and compliance matters in healthcare and beyond. Piergiorgio is also active in the academic field of compliance and ethics; he regularly teaches compliance-related courses at INSEAD and SciencesPo. He previously worked at AbbVie as Compliance Director, Western Europe & Canada and Compliance Director, Eastern-Europe, Middle-East and Africa, and as Business Program Director EMEA, Bristol-Myers Squibb. He was a senior lawyer in the EU, Competition and Regulatory department of the international law firm Simmons & Simmons, London, with a focus on healthcare clients. He is a Solicitor of the Supreme Court (Law Society of England and Wales) and an Avvocato at the Court of Bari, Italy. He regularly works in English, French, Spanish, Italian and has a basic knowledge of Greek.
12:00 pm
Adjournment
Agenda Links: Precons/Day 1 | Day 2