![]() | ||||||||||||||
![]() |
|
|
![]() | |||||||||||
![]() |
![]() |
|
![]() | |
![]() |
![]() |
DAY I: LATIN AMERICAN PHARMA/DEVICE CONGRESS Tuesday, July 29, 2014 |
![]() | |||
![]() | |||||
![]() |
OPENING PLENARY SESSION |
![]() |
![]() |
1:00 p.m. ![]() |
![]() |
Welcome Carlos Campillo Serrano, MD President, Council of Ethics and Transparency of the Pharmaceutical Industry (CETIFARMA), Mexico City, Mexico |
![]() | |
![]() |
![]() |
![]() |
Imelda Álvarez Integrity and Compliance Head for Latin America and Canada, Novartis Corporativo, S.A. de C.V., Mexico City, Mexico (Co-chair)
She is the head of Integrity and Compliance for Latin America and Canada at Novartis Formerly she was general counsel and compliance officer for Sandoz Mexico; she has more than 12 years of experience in legal and compliance field within the Pharmaceutical Industry. Previously she worked for a Public Notary and accredited the initiation course at the Colegio de Notarios del Distrito Federal in Mexico BA in Law, graduated from the Universidad Intercontinental in Mexico, she studied an executive MBA at the IPADE. She is the Chair of the Latin American Compliance Network (Pharma Regional Compliance Officers) |
![]() | |
![]() |
1:10 p.m. ![]() |
![]() |
Latin American Pharma Congress Vision, Overview and Issues to be Addressed Imelda Álvarez Integrity and Compliance Head for Latin America and Canada, Novartis Corporativo, S.A. de C.V., Mexico City, Mexico (Co-chair)
She is the head of Integrity and Compliance for Latin America and Canada at Novartis
Presentation Material (Acrobat)Formerly she was general counsel and compliance officer for Sandoz Mexico; she has more than 12 years of experience in legal and compliance field within the Pharmaceutical Industry. Previously she worked for a Public Notary and accredited the initiation course at the Colegio de Notarios del Distrito Federal in Mexico BA in Law, graduated from the Universidad Intercontinental in Mexico, she studied an executive MBA at the IPADE. She is the Chair of the Latin American Compliance Network (Pharma Regional Compliance Officers) |
![]() | |
![]() |
![]() |
![]() |
Felipe Coronel, Esq. Chief Compliance Officer, Regional Head Office, Grünenthal Latin America, Panama City, Panama (Co-chair)
Mr. Coronel is the General Counsel, Risk Manager and Chief Compliance Officer for Latin America, Regional Head Office for Grunenthal (German pharmaceutical multinational company) As General Counsel, Mr. Felipe is Head of the Legal Department, in charge of 13 legal entities in Latin America. He has served in this capacity since 2009 and has had among his responsibilities to define a Legal & Compliance regional strategy in alignment with company strategic business direction (mainly in corporate, civil, commercial, labor and Intellectual Property matters), establishing, promoting and reinforcing the Corporate Compliance Program as well as compliance standards, aligned with local laws and company compliance regulations in different areas relevant to the business. Prior to joining Grunenthal, Mr. Coronel was the Founder and Partner of Coronel & Moraga, Law Firm in Quito, Ecuador. While with Coronel and Moraga Law Firm, Mr. Felipe litigated dozens of cases before hearing officers and argued appeals in front of the Ecuadorian Supreme Court. Mr. Coronel participated in the creation of Grünenthal´s Code of Conduct (2012) and is the creator and Developer of the Regional Legal Department for Grunenthal in Latin America. |
![]() | |
![]() |
![]() |
![]() |
Karla Guillén Regional Lead Officer - Pharma Latin America, Health Care Compliance & Privacy, Johnson & Johnson, Mexico City, Mexico (Co-chair) |
![]() | |
![]() |
![]() |
![]() |
SanDee Priser, JD, CPA Partner, EY, New York, NY (Moderator)
SanDee Priser has 20 years of experience performing forensic accounting, bribery/corruption and other internal investigations for global corporations. With a focus on life sciences companies, she helps companies develop effective regulatory compliance programs integrated into business processes and leveraging monitoring techniques. She has performed numerous reviews of those programs for life science companies and third parties with particular emphasis promotional activities and related global corruption issues. Prior to relocating to the United States, Ms. Priser spent nearly four years in Europe during which she led Ernst & Young’s Fraud Investigation & Dispute Services in Frankfurt, Germany and the Russia/CIS region. |
![]() | |
![]() |
1:40 p.m. ![]() |
![]() |
LATAM Compliance and Ethics - Perspectives from the C-suite Oscar Ferenczi Senior Vice President, Latin America, Grünenthal; Former Head Latin America, Sandoz; Former Vice President and General Manager Brazil and Former General Manager Chile, Peru, and Ecuador, Merck Sharp & Dohme, Miami, FL, USA
Oscar Ferenczi began his career in the pharmaceutical industry as a Corporate Internal Auditor at Merck & Co. In the 25 years that have followed, Ferenczi developed his career in an array of diverse cultures and areas of the business. He managed operations for Merck & Co. in the Caribbean, Mexico, Ecuador, Peru, Chile, and Brazil before moving to Sandoz where he managed the generics business in Latam. More recently he has been leading Grunenthal Latam were the company has seen explosive growth after the acquisition of a few products lines and companies in the region. Given his extensive knowledge on Latin America and the time he has spent in the Region, he has generated value and helped growth our industry. |
![]() | |
![]() |
![]() |
![]() |
Antonio Ferreira International Vice President, Janssen Latin America, part of Janssen Pharmaceutical Companies of Johnson & Johnson; Chairman, Johnson & Johnson Latin American Contribution Committee (LACC); Board Member, Council of the Americas, Miami, FL, USA
Antonio Ferreira is International Vice President of Janssen Latin America, part of Janssen Pharmaceutical Companies of Johnson & Johnson. Antonio also serves as Chairman of the Johnson & Johnson Latin American Contribution Committee (LACC), and is a board member of the Council of the Americas and a member of the Portuguese Economic Association. Antonio holds a bachelor's degree in Management from ISCTE-Lisbon University Institute in Portugal and an Advanced Executive Program certificate in Management from the Kellogg Graduate School of Business at Northwestern University. |
![]() | |
![]() |
![]() |
![]() |
Gavin French Vice President and General Manager, Latin America, Edwards Lifesciences, Sao Paulo, Brazil
Gavin has worked for Edwards Lifesciences since 1996 where he originally joined the Cardiovascular Group when Edwards was part of Baxter Healthcare. He left the UK in 2000 and has worked internationally as Country Director for the Nordic and Baltic region for 5 years from 2004 to 2009. This was followed by Senior Director Europe for the Cardiac Surgery Systems and Vascular Divisions between 2009 and 2011. For the last three years he has held his current position of Vice President / General Manager for Latin America. Gavin lives in Sao Paulo, Brazil taking the role without ever having visited Latin America previously nor having flown past the Ecuator. |
![]() | |
![]() |
![]() |
![]() |
Carlos D. Garcia, MBA President, Latin America and Canada, Novartis, Miami, FL
Twenty six years of pharmaceutical industry experience, with major accomplishments in regional and general management, sales, marketing and financial management in Europe, Latin America, Asia and United States. Throughout his career, he has established a track record in Sales, Marketing and Finance, in Europe, Latin America, Asia and the United States. In 1980 he got his degree in Industrial Engineering from Universidad del Norte, in Colombia, and has also Master’s in Business Administration Degrees in International Business from the Katholieke Universiteit te Leuven, Belgium and in Finance from Cornell University, USA. Carlos joined Novartis in September 2002 from Eli Lilly & Co. where he spent 19 years, in many role ending as Area Director for Central and Eastern Europe. He began his career in financial analysis in the US Headquarters, then became CFO of Lilly Colombia and in 1989, moved into Commercial operations and has built an impressive career growing businesses as Managing Director of Lilly units in the Philippines, Argentina and Mexico. Since 2002, Carlos is the President of Novartis Pharma for Latin America & Canada Region and is based in Miami, Florida. He is married and has two teen-aged children. |
![]() | |
![]() |
![]() |
![]() |
Miguel Salazar Hernandez President and Country Manager, Mexico, Central America and Dominican Republic, Boehringer Ingelheim Mexico S.A. de C.V., Mexico City, Mexico |
![]() | |
![]() |
![]() |
![]() |
Martin Mercer Vice President, Latin America, Astellas Pharma; Former President, International Region, Valeant Pharmaceuticals International, Inc.; Former Vice President North Andes Zone, GlaxoSmithKline, Northbrook, IL, USA
Martin N. Mercer is Vice-President, Latin America, Astellas Pharma US, Inc, Martin leads the company's comercial pharmaceutical operation in Latin America across over 20 countries with a diverse and growing porfolio in the Oncology, Urology and Transplant markets. Martin has over 30 years of experience in the pharmaceutical industry mainly in commercial roles across Latin America.
Presentation Material (Acrobat)Prior to joining Astellas, Martin was the Executive Vice President at Valeant Pharmaceuticals responsible for Latin America and South East Asia. In his earlier career, he has been Managing Director for Glaxo, GaxoWellcome and GlaxoSmithKline in Ecuador, Colombia and Venezuela. Martin is a native of Buenos Aires, Argentina and currently lives in Chicago, Illinois and works out of Astellas America's Headquarters in Northbrook Illinois. |
![]() | |
![]() |
![]() |
![]() |
Imelda Álvarez Integrity and Compliance Head for Latin America and Canada, Novartis Corporativo, S.A. de C.V., Mexico City, Mexico (Co-chair)
She is the head of Integrity and Compliance for Latin America and Canada at Novartis Formerly she was general counsel and compliance officer for Sandoz Mexico; she has more than 12 years of experience in legal and compliance field within the Pharmaceutical Industry. Previously she worked for a Public Notary and accredited the initiation course at the Colegio de Notarios del Distrito Federal in Mexico BA in Law, graduated from the Universidad Intercontinental in Mexico, she studied an executive MBA at the IPADE. She is the Chair of the Latin American Compliance Network (Pharma Regional Compliance Officers) |
![]() | |
![]() |
3:00 p.m. |
![]() |
Break |
![]() | |
![]() |
3:30 p.m. ![]() |
![]() |
Establishing the Consensus Framework for Ethical Collaboration: Patients, HCPs and Industry Joanna Groves Chief Executive Officer, International Alliance of Patients' Organizations (IAPO), London, UK
Joanna is the Chief Executive Officer of the International Alliance of Patients' Organizations (IAPO). IAPO is the global group representing patients from all disease areas and all regions of the world. Joanna is responsible for managing and implementing the overall strategy of the organization as defined by IAPO's Governing Board. Driven by its membership, IAPO focuses on issues that are of importance to patients' organizations regardless of their disease area or geographical location.
Presentation Material (Acrobat)Joanna holds a Master's degree in Science and Technology Policy Studies. She joined IAPO in 2004 as Policy & External Affairs Director before becoming Chief Executive Officer in 2007. Prior to joining IAPO, she worked in other nonprofit health organizations including in a policy and research capacity building role for The Wellcome Trust's Biomedical Ethics Section. She has particular interest in how policy is formulated, supporting a stronger role for patient engagement and social and ethical considerations in health policy-making. |
![]() | |
![]() |
![]() |
![]() |
Otmar Kloiber, MD, PhD Secretary General, World Medical Association, Ferney-Voltaire, France
After studying medicine at the University of Cologne Otmar Kloiber joined the Department of Biochemistry at the University of Minnesota, Duluth in 1985. He continued as a research fellow at the Max-Planck-Institute for Neurological Research in Cologne until 1991 when he joined the German Medical Association. There he worked in various functions and finally left as Deputy Secretary General. Since 2005 he serves as Secretary General of the World Medical Association (WMA). He is interested in the development of deontology under the influence of health system organization and its relation to the provision of medical care. Otmar is fellow at the at the Center for Global Health and Medical Diplomacy, University of North Florida where he is also served as Clinical Professor in health administration from 2009 to 2013.
Presentation Material (Acrobat) |
![]() | |
![]() |
![]() |
![]() |
Russell Williams President, Rx&D Canada; Chair, IFPMA Code Compliance Network; Former Member, National Assembly of Quebec, Ottawa, Canada (Moderator)
President, Rx&D Russell Williams is a passionate advocate for innovation in health care and in economic development. Since joining Rx&D in March 2004, Mr. Williams has promoted policies that improve patient outcomes by expanding patient choice and access to new medicines and vaccines. He works tirelessly to ensure that Canada is a world leader in attracting biopharmaceutical investments, which are key components of the knowledge-based economy. Under Mr. Williams' leadership, the association's Code of Ethical Practices has been significantly enhanced to ensure that all member companies adhere to the highest standards of ethics. He has participated actively in numerous provincial working groups and task forces aimed at improving the partnership between industry, governments and stakeholders. Prior to joining Rx&D, Mr. Williams had a successful career in provincial politics and community service. |
![]() | |
![]() |
4:30 p.m. ![]() |
![]() |
Transparency International Keynote Latin American Transparency Concerns and Expectations from the Pharmaceutical Industry Alma Rocio Balcazar Romero, Esq. Representative, Transparency International; Independent Consultant on Governance, Compliance and Corruption Risks, Bogota, Colombia
As Director of the Private Sector Area of Transparency International - Colombia Chapter, she led research studies and publications such as "Index of Transparency for Public Utility Services Companies" and "National Entrepreneurial Survey on Bribery Prevention" and the design and implementation strategy of the "Ethics and Anti-corruption in the Value Chain of Small and Medium Size Companies" which has called the attention of international organizations for application in other Latin American countries. She does currently cooperate with Transparency International on a voluntary basis, as one of the thirty two worldwide individual members credited by this organization. She also headed Corporate Integrity Management at Millicom/Tigo Colombia Movil, with local and regional responsibilities, consulting role on governance and anti-corruption matters with a focus on Central and South America.
Presentation Material (Acrobat)Alma has experience in the design of strategies to facilitate collective actions and of anticorruption sector agreements in a variety of sectors including pharmaceuticals. Her work in leadership and facilitation of the Anti-corruption Agreement of Pipe Manufacturing Companies in Colombia received the World Bank award "Collective Action Practitioners Competition". She is a speaker and panel member in domestic and international forums. |
![]() | |
![]() |
![]() |
![]() |
Sharing a Local Experience in a Latin American Country - Transparency International, Mexican Chapter Eduardo Bohorquez Executive Director, Transparencia Mexicana, Mexico Chapter of Transparency International; Executive Director, Este Pais, Mexico City, Mexico
Mr. Bohórquez has been the Executive Director of Transparencia Mexicana, the Mexican chapter of Transparency International, since 1999
Presentation Material (Acrobat)In 2001, he additionally accepted the executive direction of Este País, A.C. foundation, which specializes in applied investigation and strategic communication for development. Mr. Bohórquez graduated from the National Autonomous University of Mexico, with an undergraduate degree in Political Science and Public Policy. He continued his studies at Cambridge University receiving a master?s degree in Development Studies. In addition, Mr. Bohórquez is a member of the Consumption Council of the National Government?s and of the Directive Board of the National Institute of Evaluation of Education. He has taught at Centro de Investigación y Docencia Económicas (CIDE), Instituto Tecnológico y de Estudios Superiores de Monterrey, and the Universidad Iberoamericana, among other academic institutions. Furthermore, he collaborates with the World Bank providing consulting in matters of political transparency, specifically in the provision of public service and the administration of natural resources such as water. |
![]() | |
![]() |
5:15 p.m. ![]() |
![]() |
Global Code Update Roundtable Latin American Codes Felipe N. Ferenzini Public Law, Life Sciences, Compliance and Regulatory, Trench Rossi e Watanabe Advogados, Brasil
Felipe Noronha Ferenzini is graduated from the Catholic University of Sao Paulo with a degree in Law in 2005. LL.M in Regulatory Law at Fundação Getúlio Vargas - GVLaw FGV in 2009. His area of expertise is Public Law, Life Sciences, Compliance and Regulatory, with focus on adisory matters. He is a speaker in events related to Compliance in Contracts with the Government and Life Sciences. Related Legal Services Dispute Resolution Energy, Mining & Infrastructure Information Technology & Communications Mergers & Acquisitions Pharmaceuticals & Healthcare Related Areas of Practice Administrative & Public Law Biotech Corporate Compliance & Governance Financial Services & Regulation Health Care Hotels & Resorts Infrastructure Life Science Marketing & Regulatory Medical Devices Oil & Gas, Petrochemicals Privacy & Information Management Public M&A Reorganizations Telecommunications Related Local Practices Banking, Finance Law & Project Finance Dispute Resolution Energy, Mining, Petrochemicals & Infrastructure IT & Communications Mergers & Acquisitions Pharmaceuticals, Food & Cosmetics Languages Portuguese, English and Spanish |
![]() | |
![]() |
![]() |
![]() |
ABPI Code Heather Simmonds Director, Prescription Medicines Code of Practice Authority; Vice-Chair, IFPMA Code Compliance Network, London, UK
Heather Simmonds is the Director of the Prescription Medicines Code of Practice Authority (PMCPA). Heather chairs the Code of Practice Panel, which considers complaints submitted under the Code in the first instance, and is responsible for the overall running of the organisation. Heather also works with IFPMA and EFPIA in relation to their codes of practice.
Presentation Material (Acrobat)Heather has a degree in pharmacology and joined the ABPI in 1984. Heather has been working full time on the Code of Practice since 1989 and has been Director of the Authority since 1997. |
![]() | |
![]() |
![]() |
![]() |
IFPMA Code Tamara Music Manager, Influenza Vaccines and Code Compliance, IFPMA, Geneva, Switzerland
Manager, Influenza Vaccines & Code Compliance, IFPMA Tamara Music joined the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in 2007 and is a Manager leading the Influenza Vaccines Supply (IVS) International Task Force as well as the transparency and ethics initiatives which include the IFPMA Code of Practice and the Code Compliance Network (CCN). Previously, Tamara has also worked on global health policy topics related to healthcare systems and market access. Tamara received her B.A. in Political Science from University of California, Berkeley, her Masters in International Affairs from the Graduate Institute in Geneva, and Certificate of Advanced Studies (CAS) in Pharmaceutical Economics and Policy from University of Lausanne, School of Business (HEC). |
![]() | |
![]() |
![]() |
![]() |
EFPIA Code Jose F. Zamarriego Izquierdo Director Unidad de Supervision Deontologica, FARMAINDUSTRIA, Madrid, Spain
José Zamarriego has been the Director of the Code of Practice Surveillance Unit of the National Association of the Pharmaceutical Industry in Spain (Farmaindustria) since the establishment of this Compliance Control Body in 2004. Together with his team he oversees implementation and compliance with the self-regulation system of the pharmaceutical industry, adapting and anticipating to the growing demands of a society in constant evolution. At a European level, José is Chair of the EFPIA (European Federation of Pharmaceutical Industries and Associations) Code Compliance Committee and Vice-Chair of the Compliance Committee. He is also Chairman of the IFPMA (International Federation of Pharmaceutical Manufacturers & Associations) Code Complaint Procedure Adjudication Group. He has actively participated in several modifications of national, European and worldwide codes of practice for the pharmaceutical industry. José completed his PhD. on Economics & Business Studies in the Universidad Complutense de Madrid, expanding his education with an MBA on Business Administration by the University of Wales and a General Management Program by the IESE Business School. Before joining the innovative pharma association, he was General Secretary and General Director of the Spanish Generic Pharmaceutical Manufacturers Association (AESEG). José also has a background as an educator in the Universidad Europea de Madrid (UEM), where he was Dean of the Faculty of Economics and Business Administration and Executive Director of the UEM General Foundation.
Presentation Material (Acrobat)Presentation Material Spanish (Acrobat) |
![]() | |
![]() |
![]() |
![]() |
PhRMA Code Keith M. Korenchuk, JD, MPH Partner, Arnold & Porter LLP, Washington, DC, USA
Keith Korenchuk is a partner in the FDA and Healthcare practice of Arnold & Porter, LLP in Washington D.C. He counsels and advises pharmaceutical, life sciences, medical device, biotechnology, and specialty pharmacy companies in the United States and worldwide on regulatory and compliance matters, including on the following matters: |
![]() | |
![]() |
![]() |
![]() |
AdvaMed/EUCOMED Codes Rodrigo Salles Medina, JD, LLM Legal Director, Latin America, Medtronic Inc, Miami, FL, USA |
![]() | |
![]() |
![]() |
![]() |
Moderator Russell Williams President, Rx&D Canada; Chair, IFPMA Code Compliance Network; Former Member, National Assembly of Quebec, Ottawa, Canada
President, Rx&D Russell Williams is a passionate advocate for innovation in health care and in economic development. Since joining Rx&D in March 2004, Mr. Williams has promoted policies that improve patient outcomes by expanding patient choice and access to new medicines and vaccines. He works tirelessly to ensure that Canada is a world leader in attracting biopharmaceutical investments, which are key components of the knowledge-based economy. Under Mr. Williams' leadership, the association's Code of Ethical Practices has been significantly enhanced to ensure that all member companies adhere to the highest standards of ethics. He has participated actively in numerous provincial working groups and task forces aimed at improving the partnership between industry, governments and stakeholders. Prior to joining Rx&D, Mr. Williams had a successful career in provincial politics and community service. |
![]() | |
![]() |
6:30 p.m. |
![]() |
Adjournment and Networking Reception |
![]() |
![]() | |||
![]() |
|
![]() | |
![]() |