Ethics and Compliance: Healthcare and Pharmaceuticals

Graphic: Ethics, Complaince, and Best Practices shown in a circular graph.

The focus of this workshop is on the key challenges facing E&C Officers and staff members in the pharmaceutical, healthcare, and bio-medical science companies operating in global contexts. A critical aspect of this workshop looks at how a company responds to global ethical challenges, such as conflicts of interest, privacy, safety, bribery and corruption in medical science and pharmaceutical business practices.

E&C programs support business objectives, compliance with applicable laws and regulations, as well as creating a company culture that fosters the passion for ethical decision-making in business practice.

Kaiser Permanente Logo

This complimentary one-day workshop is practitioner-directed by industry and academic ethics and compliance experts, and sponsored by Kaiser Permanente.

Registration

Ethics & Compliance: Healthcare & Pharmaceuticals

November 2014 Ethics & Compliance Workshop Agenda (pdf)

The Workshop Series

The workshop includes a morning reception and opening roundtable discussions, followed by three afternoon topic sessions with E&C professionals, and a closing panel on E&C careers with select graduate and undergraduate students of SF State. Workshops are facilitated by and for chief E&C officers, CFOs, COOs, CIOs, HR directors, senior operations managers and their staff, as well as university students interested in E&C careers.

  • SF State Downtown Campus, 835 Market Street (near Powell St.), San Francisco

For more info, contact Denise Kleinrichert, associate professor of management and ethics, at dk@sfsu.edu

Moderators

Denise Kleinrichert, Ph.D., College of Business, SF State

Sally Baack, Ph.D., College of Business, SF State

November 2014 Speakers

  • Mia Okinaga, VP Compliance, Fraud Control & Data Analytics, Kaiser Permanente
  • Rani Radhakrishnan, Director, Health Industries Advisory, PricewaterhouseCoopers
  • Tania Adams-Webb, Director, Cyber Risk Services, Deloitte & Touche LLP
  • Abhiroop Gandhi, Compliance Officer, Questcor Pharmaceuticals, Inc.
  • K.C. Turan, Chief Risk Officer & Chief Compliance Officer, Blue Shield of California
  • Fabiana Lacerca-Allen, Ethiprax Associates, LLC
  • David Pulido, Principal, Deloitte & Touche LLP Health Care Risk Analytics Services
  • Veronica Lim, Life Science Senior Manager, Deloitte & Touche LLP
  • Russell L. Jones, Partner, Deloitte & Touche LLP Health Sciences & Public Sector Cyber Risk Services

Workshop Bios

Denise Kleinrichert, Ph.D.
Associate Professor, Management/Ethics

Denise Kleninrichert

Expertise in business ethics and corporate social responsibility (CSR) includes research and teaching at San Francisco State University and University of South Florida, as well as corporate executive experience. Personal mission: “conducting a thorough examination of what is known and unknown in a given field.” Specific research areas include corporate social responsibility, business ethics, social entrepreneurship and women, and supply chain analysis of start-up social entrepreneur endeavors. Earlier corporate endeavors in risk management and human resources management in the banking, health care and property/casualty insurance industries. PhD in Philosophy/Ethics and two Master’s degrees at University of South Florida, and a BA in Economics at Indiana University.

Teaching: management and leadership of ethical business practices, corporate social responsibility, and sustainable, triple bottom line (people, planet and profit) business endeavors in society. Faculty member of the Sustainable Business faculty sub-group in the Management Department of the College of Business. Founding colleague of the Center for Ethical and Sustainable Business (CESB) at SF State University. The Center integrates ethics and sustainable business research with teaching and service to the community and the university.

Sally Baack, Ph.D.
Professor, Management

Sally Baack

Sally Baack is a professor in the management department. She is a repeat winner of the Professor of the Year Award for the College of Business, for her outstanding achievements in teaching, research and service. In 2007, Sally Baack was named an "Ascendant Scholar" by the Western Academy of Management—an honor awarded to scholars who have shown outstanding potential in their early careers and who are on track to becoming leaders in their fields.

Professor Baack joined San Francisco State University in the Fall of 2000. She earned her Ph.D. in International Strategic Management from the University of Southern California, and is an honors graduate in Political Science and German Literature from the University of California, Berkeley, and the Georg-August Universitaet, Goettingen, Germany. She is fluent in German.

Professor Baack’s research focuses on strategic management, ethical leadership and international competition. Her work has been published in the Journal of International Business Studies, the Case Research Journal, the Academy of Management Best Paper Proceedings, the Academy of Management Journal of Learning and Education, the International Journal of Cross-Cultural Management, the International Trade and Finance Journal, and the International Association for Human Resource Information Management Journal.

Mia S. Okinaga
Vice President, Compliance, Kasier Permanente

Mia S. Okinaga

Mia Okinaga is the vice president of reimbursement compliance, fraud control and compliance information and analytics at Kaiser Permanente.

She is responsible for enhancing national and regional programs that:

  • facilitate accurate and complete government reimbursement.
  • minimize losses to fraud, waste and abuse.
  • assure appropriate response to allegations of misconduct.

Mia’s team proactively uses data and analyses to prioritize compliance risks. Analytical studies are deployed to focus compliance resources and initiatives. Tools are developed to facilitate integrated risk management such as risk assessment, work plans, investigations, and corrective action plans across risk management units. Mia also serves as the compliance officer for Program Offices, functions and departments that do not have a dedicated compliance officer. Mia joined Kaiser Permanente in 1997. Prior to this role, Mia served in director roles for Compliance Operations and Compliance Audit in NCO. She also served as a manager in the Internal Audit department and directed operational reviews of health plan and care delivery functions. Mia has also participated in systems implementations (data migration, user acceptance testing, internal controls) for Membership Accounting, Retirement Plans, Payroll and E-Commerce. Prior to joining Kaiser Permanente, Mia worked at Coopers and Lybrand (now known as PricewaterhouseCoopers or PwC). She facilitated implementation of a corporate compliance program for an integrated health care system and performed due diligence procedures on a durable medical equipment vendor. She also performed financial statement audits and prepared corporate tax returns. Mia holds a Master of Business Administration from the Wharton School at the University of Pennsylvania and a Bachelor of Business Administration in accounting from the University of Hawaii. Mia is a certified public accountant in California. She has taught finance and accounting courses at the University of Hawaii and University of Phoenix.

David Pulido
Principal, Deloitte & Touche LLP, Health Care Risk Analytics Services

David Pulido

David Pulido is a principal in Deloitte & Touche LLP’s Health Care Risk Analytics Services practice—a data analytics service that focuses on providing solutions to help organizations capture, sustain, transform, analyze, visualize and ensure the quality of their diverse data assets. David has over 25 years of professional experience and is responsible for developing and driving Deloitte’s Risk Analytic capabilities. David focused on designing and deploying business intelligence solutions to improve companies’ profitability and optimize their risk position. He leverages his expertise to harness data in a meaningful manner to drive business strategy, improve performance, and deliver analytic insights using a range of approaches including forward-looking scenario planning and predictive modeling. The solutions he delivers improve value in health care that is driven by advancements in technology, healthcare reform, regulatory mandates, and the emergence of value-based payment models turning everyday information into useful and actionable insights.

Veronica Lim
Life Science Senior Manager, Deloitte & Touche LLP

Veronica Lim

Veronica Lim is a life science senior manager in Deloitte & Touche’s Advisory practice. She has over 24 years of experience in life sciences with planning and implementation of information management systems that support critical business processes. Veronica is one of Deloitte’s leaders for the MeDSS offering and has led various initiatives in the medical technology industry. Prior to joining Deloitte, Veronica led several global Quality and IT initiatives in the pharmaceutical industry. The life science companies she has served include St. Jude Medical, Genzyme/Sanofi, Alcon/Novartis, Genentech Inc, Roche Pharmaceuticals, Agilent Technologies, Elan Pharmaceuticals, Varian Medical Systems, and Onyx Pharmaceuticals.

Russell L. Jones
Partner, Deloitte & Touche LLP, Health Sciences & Public Sector Cyber Risk Services

Russell L. Jones

Russell L. Jones has over 22 years of experience working with health care provider, biopharma, medical device manufacturer and public sector clients addressing a wide variety of information security, cybersecurity, data privacy and IT risk management issues. The projects that Russell has led have addressed multiple regulations/standards such as the HIPAA security and privacy rules, EHR Incentive Program Readiness (Core Measure 14 & 15), FISMA, the EU Data Protection Directive (down to the EU member state level), FDA 21 CFR Part 11 and Part 820, U.S. state beach notification laws (e.g. California SB1386), ISO 27001/27002, ISO 14971 and NIST 800-53. Russell is the leader of Deloitte’s Medical Device Safety and Security (MeDSS) offering for health care providers, medical device manufacturers and related technology companies. Russell has been published numerous times in periodicals such as the ISACA Journal, Information Security Magazine, and ISC2Information Systems Security Journal. Russell also has been quoted in publications such as the Wall Street Journal, InformationWeek, and Healthcare IT News. Russell is a Certified Information Privacy Professional (CIPP), Certified Information Systems Security Professional (CISSP), Certified Information Systems Auditor (CISA), and Certified Public Accountant (CPA) licensed in California and Maryland.

Rani Radhakrishnan
Director, Health Industries Advisory, PricewaterhouseCoopers

Rani RadhakrishnanRani Radhakrishnan is a director in PwC's Health Industries Advisory Management Consulting Practice based in San Francisco, Calif. She focuses on governance, risk and compliance in the payer and provider sectors, and has over 16 years of experience assisting clients with large scale transformations in the areas of risk management, operations and technology. Specifically within GRC, she focuses on working with compliance programs within clients to standardize processes to gain operational efficiencies. She also assists clients make GRC product selections, establish governance structures for large scale GRC transformations and assists with program management activities for GRC technology implementations. Rani holds an M.B.A. from the Haas School of Business, University of California, Berkeley and a Bachelor of Technology in Computer Engineering from India. She is also a certified project management professional and a certified scrum master.

K.C. Turan
Chief Risk Officer & Chief Compliance Officer, Blue Shield of California

K.C. Turan

K.C. Turan is Blue Shield of California’s chief risk officer and chief compliance officer. In this role, he is responsible for building and leading Blue Shield’s Compliance & Ethics, Privacy, Medicare Compliance, Special Investigations (Fraud) and Enterprise Risk Management (ERM) programs across the enterprise. This encompasses regulatory compliance, corporate risk management, Code of Conduct, corporate ethics, corporate investigations, privacy, fraud, anti-corruption, records management and Medicare regulatory matters, among others. Prior to joining Blue Shield, K.C. was Dun & Bradstreet’s chief compliance officer and chief privacy officer. K.C. previously worked for Countrywide Financial Corporation (now Bank of America), Ford Motor Company and Graham & James. K.C. has been recognized by the Ethisphere Institute as one of the world’s “Top Compliance & Ethics Officers” and he has been named to Computerworld’s “Best Privacy Advisers” list. Blue Shield of California and Dun & Bradstreet have been named to Ethisphere’s “World’s Most Ethical Companies” list in each of K.C.’s years with both companies. K.C. received a B.A. from the University of Pennsylvania, a J.D. from Loyola Marymount University and an M.B.A. from UCLA. K.C. lives in the San Francisco Bay Area with his wife, daughter, son and two dogs.

Abhiroop Gandhi
Compliance Officer, Questcor Pharmaceuticals, Inc.

Abhiroop Gandhi

Abhiroop Gandhi is executive director, compliance at Mallinckrodt Pharmaceuticals. He is responsible for implementing and managing the company’s healthcare compliance program and is based in the San Francisco Bay Area. This program includes development, implementation and oversight of compliance policies and procedures, employee training, audits, monitoring, incident management & investigations, transparency initiatives and providing day-to-day advice to business partners. Mr. Gandhi is also responsible for keeping the Executive Committee and the Board of Directors abreast of the changing compliance landscape and the company’s initiatives. Mr. Gandhi was playing a similar role at Questcor Pharmaceuticals until it was acquired earlier this year by Mallinckrodt. Prior to joining Questcor, Mr. Gandhi was director of commercial compliance at Actelion Pharmaceuticals, Inc., where he established and managed the healthcare compliance program. Previously, he was at Genentech in the Commercial Business Practices group, where he was involved with initiating and managing various cross-functional compliance and commercialization initiatives. Mr. Gandhi has spent 15 years in the area of pharmaceuticals/biotechnology and healthcare compliance. Prior to Genentech, Mr. Gandhi was a management consultant with Razorfish and advised clients in the life sciences and high-tech industries. Mr. Gandhi has served as a panel member for the U.S.-India Science & Technology Endowment Fund, which awards grants to promising joint US-India entrepreneurial initiatives to generate public good through commercialization of technology. He holds a master’s degree from Carnegie Mellon University, an M.B.A. from FMS, Delhi University, India and a Bachelor of Engineering (Mechanical) from Birla Institute of Technology, India.

College of Business Enterprises

Please contact Orlando Harris for more information about corporate benefits of executive education at the College of Business.

Photograph of Orlando HarrisOrlando Harris
Executive Director for Business Development and Marketing
San Francisco State University Downtown Campus
835 Market Street, Suite 600
San Francisco, CA 94103
Phone:(415) 817-4321
E-mail: oharris@sfsu.edu

Ethics & Compliance: Medical Health & Pharmaceutical Practices is a College of Business Enterprises (COBE) program offered in partnership with the College of Extended Learning at San Francisco State University.

Location: 
San Francisco State University Downtown Campus, 835 Market Street, San Francisco, Suite 6
Event Date: 
Wednesday, November 05, 2014