|
|
|
Press Release: Join Over 400 Attendees from 175 Organizations at the PCF Pharma Compliance Congress XIX
|
- Sponsored by the Pharmaceutical Compliance Forum
- November 7 - 9, 2018
- Onsite at the Mandarin Oriental, Washington, DC
- Online in Your Own Office or Home Live via the Internet with 24/7 Access for Six Months
- Media Partners: Harvard Health Policy Review, Health Affairs and Life Sciences Compliance Update
- www.PharmaCongress.com
PRESS RELEASE
Phone: 800-503-7419
Email: registration@hcconferences.com
Website: www.PharmaCongress.com |
|
|
OVER 50 CCOS SCHEDULED TO ATTEND THE INVIATION-ONLY CCO ROUNDTABLE
|
|
JOIN OVER 400 ATTENDEES FROM THE FOLLOWING ORGANIZATIONS
|
- AbbVie
- Acella Pharmaceuticals
- Aclaris Therapeutics, Inc
- ADvaMed
- Aegerion Pharmaceuticals
- Akebia Therapeutics
- Alexion Pharmaceuticals
- AlixPartners
- Alkermes
- Allergan
- Alnylam Pharmaceuticals
- Amgen
- Ankura Consulting Group, LLC
- Apellis Pharmaceuticals
- Apotex
- Arnold & Porter Kaye Scholer LLP
- Assertio Therapeutics
- Astellas Pharma
- Astrazeneca
- Avanir Pharmaceuticals
- Baker & McKenzie LLP
- Bayer
- Berkeley Research Group (BRG)
- Biogen
- BioMarin
- Bloomberg BNA
- Boehringer Ingelheim
- Bradley Arant Boult Cummings LLP
- Bristol-Myers Squibb
- BTG International
- Celgene
- Chiesi USA, Inc.
- "Chiesi"
- Clovis Oncology
- Collegium Pharmaceutical
- ComplianceStat, LLC
- Cooley, LLP
- Covington & Burling, LLP
- CTI BioPharma Corp.
- Cutting Edge Information
- Davis Wright Tremaine LLP
- Debevoise & Plimpton LLP
- Deloitte & Touche LLP
- Department of Commerce
- Dermira
- DLA Piper
- Dovetail Consulting Group
- Drexel University
- ECI (Ethics and Compliance Initiative)
- Eli Lilly and Company
- Endo Pharamceuticals
- Epizyme
- Ernst & Young LLP
- Exiger
- Federal Bureau of Investigation (FBI)
- Ferring Pharmaceuticals
- Flexion Therapeutics
- Front-Line Anti-Bribery, LLC
- FTI Consulting
- G&M Health, LLC
- GE Healthcare
- Genentech
|
- Gilead Sciences
- GlaxoSmithKline
- Global Research Management, Inc.
- Globus Medical, Inc.
- Grant Thornton LLP
- Greenwich Biosciences
- Grifols
- Grunenthal USA Inc.
- Harvard Business School
- HC Ethics LLC
- Helio Health Group
- Hogan Lovells LLP
- Horizon Pharma
- Independent Commercial Compliance™ (ICC)
- Incyte
- Indivior
- Insightec
- Insmed
- Insulet Corporation
- INSYS Therapeutics Inc.
- Ipsen
- IQVIA
- Janssen
- Jazz Pharmaceuticals
- Johnson & Johnson
- Kadmon
- kaleo, Inc.
- Kellogg Hansen Todd, Figel & Frederick
- King & Spalding LLP
- KPMG LLP
- Lexicon Pharmaceuticals, Inc
- Loxo Oncology
- Lundbeck Pharmaceuticals LLC
- Mallinckrodt Pharmaceuticals
- MATRIX Healthcare Strategists Inc., Bayer
- Mayne Pharma
- MedForce
- Medison Pharma Ltd.
- MediSpend
- Medtronic
- Merck & Co., Inc.
- Moderna Therapeutics
- Morgan Lewis & Bockius
- MorphoSys AG
- Mylan
- Nalpropion Pharmaceuticals Inc.
- Navigant Consulting
- Neos Therapeutics
- Neurocrine Biosciences
- Newlink Genetics
- Novartis
- Novo Nordisk
- Novocure
- NXLevel Solutions
- Olympus Corporation of the Americas
- Optinose
- Otsuka Pharmaceutical Companies
- Paul Hastings LLP
|
- PCF
- Pfizer
- Philips Electronics
- Phillips & Cohen, LLP
- PhRMA
- Polaris, an IQVIA company
- Porzio Life Sciences, LLC
- Potomac River Partners
- Precision Spine
- PTC Therapeutics, Inc.
- Purdue Pharma LP
- PwC
- qordata
- Quinn Emanuel Urquhart & Sullivan
- Regeneron Pharmaceuticals
- Ropes & Gray LLP
- Sage Therapeutics
- SAI Global
- Sanofi
- Sarepta Therapeutics
- SCILEX Pharmaceuticals
- Seton Hall Law School
- Shionogi Inc.
- Shire
- Sidley Austin LLP
- Simpson Thacher & Bartlett
- Skadden Arps LLP
- Smith & Nephew
- Spark Therapeutics
- Spectrum Pharmaceuticals
- Strongbridge BioPharma plc
- Syneos Health
- Takeda Pharmaceuticals
- Temple Law School
- Terumo BCT, Inc.
- TESARO, Inc.
- Teva Pharmaceuticals
- TherapeuticsMD
- TrialCard
- Tthe Network for Excellence in Health Innovation (NEHI)
- "U.S. Department of Health and Human Services Office of Inspector General"
- UCB Pharma
- Ultragenyx Pharmaceutical
- United States Attorney's Office, Eastern District of Pennsylvania
- Upsher-Smith Laboratories
- US Attorney's Office for the District of New Jersey
- US Attorney's Office, Southern District of New York
- US Department of Justice
- US Food and Drug Administration
- Validu
- Verisys Corporation
- Vertex Pharmaceuticals
- VMS Biomarketing
- Whistleblower Law Collaborative, LLC
- "Whitelaw Compliance Group, LLC"
- Yuhan Corporation
|
|
|
WASHINGTON, DC USA -- PHARMA UPDATE NEWS SERVICE™ -- OCTOBER 24, 2018: The Pharmaceutical Compliance Forum's Nineteenth Pharmaceutical and Medical Device Compliance Congress, www.PharmaCongress.com, will be held November 7 - 9, 2018 at the Mandarin Oriental in Washington, DC. Registrants may attend the event in person or online (live webcast and archived for 6 months).
|
|
KEYNOTE SPEAKERS
|
Thomas W. Abrams, RPh, MBA
Director, Office of Prescription Drug Promotion, US Food and Drug Administration, Silver Spring, MD |
Leslie Backschies, MA
Supervisor Special Agent and Unit Chief, International Corruption Unit, Federal Bureau of Investigation, Los Angeles, CA |
Richard Bistrong, MA
Chief Executive Officer, Front-Line Anti-Bribery LLC, Contributing Editor, FCPA Blog, Former Confidential Human Source (CHS) and Cooperating Witness, FBI and US DOJ, Former Cooperating Witness, City of London Police, HMRC and CPS, UK, New York, NY, USA
|
Hui Chen, JD
Ethics and Compliance Advocate and Consultant, HC Ethics LLC; Former Compliance Counsel Expert (Consultant), US Department of Justice; Former Assistant General Counsel, Pfizer, New York, NY |
Zachary A. Cunha, JD
Assistant US Attorney and Chief, Civil Division, US Attorney's Office, District of Rhode Island, US Department of Justice, Former AUSA, District of Massachusetts and Eastern District of New York, Providence, RI |
Susan Dentzer
President and Chief Executive Officer, NEHI, (The Network for Excellence in Health Innovation), Analyst on Health Policy, The NewsHour, Former Editor, Health Affairs, Washington, DC
|
Jacob Elberg, JD
Assistant US Attorney, US Attorney's Office, District of New Jersey, US Department of Justice, Newark, NJ |
Christopher B. Harwood, JD
Assistant US Attorney and Chief of the Civil Health Care Fraud Unit, US Attorney's Office, Southern District of New York, Former Assistant US. Attorney, US Attorney's Office for the District of Columbia, US Department of Justice, New York, NY |
Tarek Helou, Esq.
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC
|
Rachael Honig, JD
First Assistant US Attorney, US Attorney's Office for the District of New Jersey, Former Corporate Counsel, Litigation, Celgene, New York, NY |
Mary E. Riordan, Esq.
Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, US Department of Health and Human Services, Washington, DC
|
Gregg Shapiro, JD
Assistant US Attorney, US Attorney's Office, District of Massachusetts, US Department of Justice, Boston, MA |
Sally Q. Yates, JD
Partner, King and Spalding, Former Acting Attorney General, Former Deputy Attorney General, Former Assistant US Attorney, US Attorney's Office, Northern District of Georgia, US Department of Justice, Washington, DC
|
|
|
AGENDA-AT-A-GLANCE
|
|
WEDNESDAY, NOVEMBER 7
|
|
|
|
FEATURING AN INVITATION-ONLY CCO ROUNDTABLE
|
- Hosted by PCF and PhRMA CCO Working Group; Featuring Hui Chen, JD, HC Ethics LLC
|
|
PRECONFERENCE SESSIONS
|
- Patient Support Programs: Risk and Risk Management Best Practices
- Practical Approaches to Handling Investigations
- Advanced Strategies in Auditing and Monitoring
- Asking the Right Risk Questions to Power your Advanced Analytics Strategy
|
|
PLENARY SESSIONS
|
- OIG Keynote Address
- FDA Keynote Address
- Risks Your Risk Assessment Might Miss
- Chief Compliance Officer Roundtable
|
|
THURSDAY, NOVEMBER 8
|
|
|
|
PLENARY SESSIONS
|
- Sally Yates Keynote Address
- Annual AUSA Roundtable
- Annual Qui Tam Roundtable
- DOJ, FBI and SEC FCPA Enforcement Update
- Patient Support Programs Roundtable
- Pharma and Device Pricing and Cost Containment
|
|
MINI SUMMITS
|
- Fostering a Culture of Ethics and Compliance
- Global Compliance Function Harmonization
- Third Party Lifecycle Management
- Annual Medical Device Compliance Roundtable
|
|
|
|
MINI SUMMITS, CONTINUED...
|
- Dissecting Recent CIAs and Review of Draft Model CIA
- Strategies to Measure Effectiveness, Monitor and Report
- Managing Promotional Programs and Patient Advocacy Groups
- Open Payments: Where Does the Sun Shine Now?
- Interactions with Specialty Pharmacy
- Is your Board Bored of your Compliance Dashboards?
- Next Generation Data Analytics Promotion with Medical Professionals: Avoiding White Coat Marketing
- Market Access Compliance Considerations
- Global Documentation Framework
- R&D: Hidden Risks beyond Clinical Trail Recruitment
- Compliance for Small to Mid-size Pharma and Device Companies
- Compliance Issues Associated with PBM Relationships
- Risk Assessments and Mitigation Plans
- "All in Compliance" -- Aligning with Your Business Partners
- Navigating the Murky Waters of Patient Programs
- Compliance for "Evolved" Products, including Aesthetics and Gene Therapy
- Best Practice in HCP/HCO Management
- Compliance Considerations in Value-based Contracting
- Risks and Opportunities related to Medical Affairs
- An Interactive Case Study in Effective Crisis Management
- Privacy and Cybersecurity Compliance Update, including GDPR
- The Compliance Training Revolution
|
|
FRIDAY, NOVEMBER 9
|
|
|
|
INDUSTRY-ONLY BEST PRACTICES ROUNDTABLE
|
- Featuring AUSA Gregg Shapiro, JD
|
|
|
FEATURED SESSION: ANNUAL CCO ROUNDTABLE WITH
|
Jill Fallows-Macaluso, JD
Chief Compliance Officer and Vice President, Novo-Nordisk, Princeton, NJ |
Jonathon Kellerman
Executive Vice President, Global Chief Compliance Officer, Allergan PLC, Former Partner, PwC, Parsippany, NJ |
Robert A. Ladd, JD
Vice President, Global Head Integrity & Compliance, Oncology, Novartis; Former, General Counsel, GE Healthcare Partners; East Hanover, NJ
|
Puja Leekha, JD
Vice President, Chief Compliance Officer and Corporate Counsel, Corporate Compliance, Lundbeck Pharmaceuticals LLC, Former Division Legal Counsel & Compliance Officer, Stryker Corporation, Deerfield, IL |
Lori Queisser
Sr VP and Global CCO, Teva, Former Sr. VP Global Compliance & Business Practices, Schering-Plough, Former VP & CCO, Eli Lilly, Former Co-chair, PCF, Horsham, PA |
Paul Silver
Principal, Regulatory & Compliance Life Sciences Leader, Deloitte Advisory, Deloitte, Atlanta, GA (Moderator)
|
|
|
FEATURED FACULTY
|
James Accumanno, JD
Director Risk, Monitoring and Auditing, Novo Nordisk, Former Associate Counsel, Bayer, Philadelphia, PA |
Anthony Alvizu, CPA, EnCE, CFE
Managing Director, Global Risk & Investigations Practice (GRIP), FTI Consulting, Chicago, IL |
Eliza L. Andonova, JD
Counsel, Hogan Lovells, Washington, DC |
Timothy Ayers, JD, MPH
Vice President, Chief Compliance Officer, Horizon Pharma PLC, Former VP, Chief Compliance Officer, Dendreon, Chicago, IL
|
Eric Baim, JD
Managing Director, Dovetail Consulting Group, LLC, Former VP, Head of US Compliance, Shire, Boston, MA |
Yogesh Bahl, CPA, MBA
Managing Director, Alix Partners, New York, NY |
Minna Bak, MBA
Senior Manager, Helio Health Group, New York, NY |
Jennifer Barbre, MA
Executive Director, Compliance, Spectrum Pharmaceuticals, Inc., Former Director, Compliance and Ethics Program, Avanir, Irvine, CA
|
Dennis K. Barnes, JD, MBA, CPA
Vice President, Global Governance, Risk and Compliance, Mayne Pharma, Raleigh-Durham, NC |
Scott Bass, JD
Partner and Head, Global Life Sciences Team, Sidley Austin LLP, New York, NY |
Ann E. Beasley, JD
Director, Life Sciences, Governance, Risk & Compliance, Navigant, Former Senior Vice President, Chief Compliance Officer, Biogen, Boston, MA |
Thomas Beimers, JD
Partner, Hogan Lovells, Former Senior Counsel, Office of Counsel to the Inspector General, US DHHS, Minneapolis, MN and Washington, DC
|
John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud, and Chief Privacy Officer, US Department of Justice; Washington, DC |
Andrew Blasi
Director, C&M International, Crowell & Moring, Former Pamela Harriman Foreign Service Fellow, US Embassy in London, Former Congressional Liaison, Australian Embassy and Foreign Affairs Subcommittee on Europe, US House of Representatives, Washington, DC |
Brian A. Bohnenkamp, MHA, JD
Partner, FDA & Life Sciences Practice, King & Spalding LLP, Washington, DC |
Christine N. Bradshaw, JD
Vice President, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman PC, Morristown, NJ
|
Julianne Brierley
Director, Head of Compliance Learning, Novartis, New York, NY |
Katherine Buckley, MBA
Partner, Pharmaceutical and Life Sciences Advisory Practice, PwC, Philadelphia, PA |
Terra Buckley, JD
Executive Director, US HCC Business Advisory Center of Excellence, Celgene, Former Head, US Compliance, Helsinn, Summit, NJ |
Ed Buthusiem, JD
Managing Director, Berkeley Research Group, Adjunct Professor Of Law, Temple University, Former SVP, R&D Legal Operations & Vaccines, GSK, Devon, PA
|
Joseph Calarco
Chief Compliance Officer at Neos Therapeutics, Inc., Philadelphia, PA |
Christie Camelio
Vice President and US Healthcare Compliance Officer, Celgene, Former Head of Risk Management, Novartis, Summit, NJ |
Regina G. Cavaliere, JD
Principal, Regulatory Enforcement & Compliance, Life Sciences Sector, KPMG LLP, Former VP and CCO, Otsuka America, Short Hills, NJ |
Nicole Chandonnet, JD
Associate, Covington & Burling, Washington, DC
|
Katherine Chaurette, JD
Senior Director, Assistant General Counsel, Regeneron Pharmaceuticals, Inc., Boston, MA |
Jennifer Chillas, JD
Senior Corporate Counsel, Bristol-Myers Squibb; Former Associate, Ropes & Gray, LLP; Princeton, NJ |
Craig Chiulli, MBA
Group Product Director, Metabolic Franchise, Johnson & Johnson, Titusville, NJ |
Craig Clesson, JD, CIPP/US
Assistant General Counsel and Global Privacy Officer, Syneos Health; Former Vice President and Ethics and Compliance Officer, Aegerion; Boston, MA
|
William Connelly, JD
Senior Counsel, Amgen; Former Staff Attorney, US DHHS, Washington, DC |
Brian Conner
Vice President, Head of Corporate Compliance, Strongbridge Biopharma plc, Trevose, PA |
Kellie Branson Combs, JD
Counsel, Ropes & Gray LLP, Washington, DC |
Lynn Costa
Senior Policy Advisor for the Western Hemisphere, U.S. Department of Commerce, Washington, DC
|
Thomas Costa, JD
Member, US Board of Directors, Sanofi; Former Vice President, US Compliance & Ethics, Bristol-Myers Squibb, Washington, DC |
Clarissa Crain
Senior Manager, Life Sciences Advisory, Deloitte, Philadelphia, PA |
Jill Dailey, MBA, JD
Vice President & Chief Compliance Officer, Incyte, Former AG, Asia Pac Lead, Pfizer, Former Head, US Ethics and Compliance, Novartis, New York, NY |
Meenakshi Datta, JD
Partner and Global Co-leader, Healthcare Practice, Sidley Austin LLP, Chicago, IL
|
Mahnu V. Davar, JD
Partner, Arnold & Porter Kaye Scholer LLP, Lecturer, University of Pennsylvania Law School, Fellow, Salzburg Global Seminar, Washington, DC |
BJ D'Avella
Senior Manager, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, Atlanta, GA |
Sharon R. Delshad, JD
Director, Compliance and Legal Affairs, Nalpropion, Former Director, Compliance and Legal Affairs, Orexigen Therapeutics, San Diego, CA |
Gary Del Vecchio
Health Care CO Cardiovascular & Metabolism, Janssen, Former ED US Pharma Compliance & Ethics, Bristol-Myers Squibb, Former PCF Co-chair, New York, NY
|
Mark A. DeWyngaert, MBA, PhD
Managing Director, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, New York, NY |
Sarah diFrancesca, JD
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY |
Christian A. Dingler
Managing Consultant, Navigant Consulting, Richmond, VA |
Stefanie A. Doebler, JD
Of Counsel, Covington & Burling LLP, Washington, DC
|
Suzanne E. Durrell, JD
Managing Member, Whistleblower Law Collaborative, LLC, Taxpayers Against Fraud Education Fund, 2017 Whistleblower Lawyer of the Year, Boston, MA |
Michael Dusseau
Vice President, Compliance Operations, Allergan, Former Vice President, Compliance, Bayer, Former Divisional Compliance Officer, Merck, Madison, NJ |
Eileen Erdos
Principal, Forensic and Integrity Services, Ernst & Young LLP, Chicago, IL |
Melanie Fagan
HCP Engagement Lead, Medical Affairs Compliance, GlaxoSmithKline, Philadelphia, PA
|
J. Mark Farrar, CPA, CFE, CFF
Managing Director, Navigant; Former Interim Global Chief Compliance Officer, Beckman Coulter, Atlanta, GA, USA |
Alison Fethke, JD
Counsel, Ropes & Gray LLP, Former Division Counsel, Legal, Regulatory and Compliance, AbbVie, Chicago, IL |
Kellie Fidler, MBA, PMP
Director, Global Compliance Risk Mitigation & Monitoring Strategy, Bristol-Myers Squibb, Princeton Pike, NJ |
Francisco Ribeiro Filho, MBA
Senior Director & Head of US Compliance, Tesaro, Inc., Former Sr. Dir., Corporate Compliance, Biogen, Former Sr. Dir., International Markets, Sandoz, Boston, MA
|
Paul Fishman, JD
Partner and Head, Crisis Management and Strategic Response Team, Arnold & Porter LLP, Former United States Attorney, District of New Jersey, Washington, DC |
Paul Flanagan, JD
Assistant Professor of Law, Thomas R. Kline School of Law, Drexel University, Former Chief Compliance and Privacy Officer, 21st Century Oncology, West Chester, PA |
Sarah A. Franklin, JD
Partner, Covington & Burling LLP, Former Attorney, Federal Trade Commission, Washington, DC |
Charlene Keller Fullmer, JD
Assistant United States Attorney and Deputy Chief, Affirmative Litigation, United States Attorney's Office, Eastern District of Pennsylvania, Philadelphia, PA
|
Alex Ganz, JD
Senior Manager of Compliance, Aegerion Pharmaceuticals, Former Compliance Manager, Shire and Vertex, Boston, MA |
Nereyda Garcia, JD
Global Heath, Ethics and Compliance, Alnylam Pharmaceuticals, Former Sr. Director, Compliance, Biogen Idec, Cambridge, MA |
Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc.; New York, NY |
Virginia "Ginny" A. Gibson, JD
Partner, Hogan Lovells LLP, Former First Assistant U.S. Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA
|
Jonathan Glazier, JD, MBA
Head, Legal Compliance, Philips, Former Sr. Dir., Corporate Compliance and Privacy Officer, Fresenius, Andover, MA |
Wendy C. Goldstein, JD
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY |
Anthony Greco, MBA
Director, Pharmaceutical & Life Sciences Advisory Services, PwC, Philadelphia, PA |
Adam Greene, JD, MPH
Partner and Co-chair, Health Information & HIPAA Practice, Davis Wright Tremaine LLP, Former Senior HIT & Privacy Specialist, OCR, DHHS, Washington, DC
|
Lillian S. Hardy, JD
Partner, Hogan Lovells LLP, Washington, DC |
Patricia J. Harned, PhD
Chief Executive Officer, ECI (Ethics and Compliance Initiative), Former President, Ethics Resource Center, Washington, DC |
Kate Heinzelman, JD
Counsel, Sidley Austin LLP, Former Deputy GC, US DHHS, Former Special Assistant and Associate Counsel, President Barack Obama, Washington, DC |
Laura G. Hoey, JD
Co-leader, Government Enforcement and White Collar Group and Health Care and Life Sciences Industry Group, Ropes & Gray LLP, Chicago, IL
|
Christine Hood
Director, Learning and Development, Chiesi, Former District Sales Manager, Boehringer Ingelheim, Former Sales Trainer, Biovail, Apex, NC |
Casey J. Horton, CFE
Director, Life Sciences, Governance, Risk & Compliance, Navigant, Chicago, IL |
Emily Huebener, MA
Forensic and Integrity Services, Ernst & Young LLP, Chicago, IL |
Erinn Hutchinson
Partner, Advisory Services, PwC, Philadelphia, PA
|
Michael Joachim, JD
Global Business Partner, Ethics & Business Integrity, Sanofi Genzyme, Cambridge, MA |
Elizabeth Jobes, JD
Head, Corporate Compliance & Legal Counsel, Spark, Former Senior VP & CCO, Auxilium, Former PCF Co-chair, Philadelphia, PA |
Darren R. Jones
Partner, Global Compliance Consulting Leader, Polaris Management, New York, NY |
Marci Juneau, MBA
Partner, Helio Health Group, Atlanta, GA
|
Kiley Smith Kelly, MBA
Partner, Forensic and Integrity Services, Ernst & Young LLP, Philadelphia, PA |
Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC |
Daniel A. Kracov, JD
Partner, Arnold & Porter Kaye Scholer LLP, Washington, DC |
Daryl Kreml, JD
VP & CCO, Sage, Former Head, US Compliance & Global Program Management, Biogen, Former Dir. & Sen. Managing Counsel, Int'l Compliance, Boston Scientific, Boston, MA
|
Joseph Lake, MS
Global Healthcare Compliance & Third Party Monitoring Lead, Bristol-Myers Squibb, Former Group Internal Audit, Sanofi, Former Director, Global Compliance Organization, Merck, Morristown, NJ |
Bharathram Lakshmivarahan, MBA
Life Sciences Strategy & Operations Consultant, PwC, San Francisco, CA |
Marc Levine
Director of Compliance, Insightec, Former Compliance Officer, Stryker Corporation, Former Business Conduct Specialist, MAKO Surgical, Fort Lauderdale, FL |
Jonathan Levy, JD
Corporate Compliance Counsel, Spark Therapeutics; Former Associate Director of Compliance and Ethics, US Pharmaceuticals, Bristol-Myers Squibb; Philadelphia, PA
|
Jodi Lindsey, JD
Senior Director & Head of US Healthcare Compliance, Alkermes, Former Associate Director, Commercial Compliance, Biogen, Boston, MA |
Richard Liner, JD
Senior Counsel, Compliance and Investigations, Bayer, Whippany, NJ |
Chad Londeree
Healthcare Industry Group Leader, SAI Global, Richmond, VA |
Pamela Lonzer, MSJ
Ass. Dir., Medical Operations, Compliance & Controls, Alexion, Former Ass. Dir. & US Medical Advisor, Global Compliance & Risk Management, Shire, Chicago, IL
|
Seth H. Lundy, JD
Partner, King & Spalding, Washington, DC |
Ali Lyons
Director, Ethics and Compliance, Aegerion Pharmaceuticals; Former Operations Lead, Ethics and Compliance, Eli Lilly and Company, Cambridge, MA |
Joe Mack, JD
Senior Compliance Counsel, Bayer, Former Assistant United States Attorney and Deputy Chief, Health Care and Government Fraud Unit, US Attorney's Office, District of New Jersey, New York, NY |
Stephanie Macholtz, JD, MBA
Director, Compliance and Ethics, Global Medical Affairs and Business Development, Alexion Pharmaceuticals, Inc.; Former Compliance Officer, Biogen, Boston, MA
|
Colette G. Matzzie, JD
Partner, Phillips & Cohen LLP, Former Civil Appellate Staff and Trial Attorney, Tobacco Litigation Team, US Department of Justice, Washington, DC |
Dennis McCloskey, JD
Compliance Officer, Olympus Corporation of the Americas, Former Assistant District Attorney, Homicide Unit, Philadelphia District Attorney's Office, Philadelphia, PA |
Vickie L. McCormick
Vice President, Janssen U.S. Commercial Health, Care Compliance & CIA Operations, Johnson & Johnson, Former Chief Compliance Officer, St. Jude Medical, Titusville, NJ |
Jennifer McGee, JD
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD
|
Jean McKiernan, MBA
Director, Pharmaceutical and Life Sciences Advisory Practice, PwC, Chicago, IL |
Jason P. Mehta, JD
Partner, Bradley Arant Boult Cummings LLP, Former Assistant United States Attorney, US Attorney's Office for the Middle District of Florida, US Department of Justice, Tampa, FL |
Stephanie J. Meltzer, JD
Vice President and Assistant General Counsel, Innovative Health, Pfizer, Former Assistant United States Attorney, United States Attorney's Office, District of Columbia, US Department of Justice, Boston, MA |
Kathleen Meriwether, JD
Americas Leader - Life Science, Forensic & Integrity Services, EY, Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA
|
Brian Miller, PhD
Dir. Compliance Training and Documentation, Otsuka, Former Senior Mgr, Learning Technologies, AstraZeneca, Former Ass. Dir. Learning Design & Technology, Merck, Princeton, NJ |
Vahan Minassian, JD
Director, US Promotional Monitoring Lead, Pfizer, Philadelphia, PA |
Gregory S. Moss, JD
Senior Vice President, Deputy General Counsel, Kadmon Corporation, New York, NY |
Melissa Murphy, MBA
Senior Compliance Specialist, Office of Ethics & Compliance, Medtronic, Minneapolis, MN
|
Kamleh J. Nicola, LLB
Partner, Baker & McKenzie LLP, Toronto, Canada |
Chrisoula Nikidis
Canadian Head of Compliance and Ethics Solutions, IQVIA; Former Executive Director, Ethics and Compliance, Innovative Medicines Canada, Ottawa, Canada |
Katherine Cartwright Norris, MPA
Dir., Berkeley Research Group, Former Sr Dir., Compliance, NSF Health Sciences, Former Dir., Corporate Compliance, Spectranetics, Washington, DC |
Susan P. Novak
Director, Corporate Policies Global Compliance, Celgene Corporation; Former Director of Compliance, Sandoz; Summit, NJ
|
Adam Oakley
Director, Potomac River Partners, Arlington, VA |
Laura C. O'Donnell
Vice President and General Counsel, GE Healthcare, Warsaw, IN |
Josh T. O'Harra, MS, JD
Assistant General Counsel, Eli Lilly and Company; Former Sr. Associate, King & Spalding, Washington, DC |
Agatha O'Malley, MStPH, JD
Privacy Officer and Senior Counsel, Otsuka Pharmaceuticals (US), Former Director - Head of Privacy, Shire, Philadelphia, PA
|
David W. Opderbeck, JD
Professor of Law, Seton Hall University Law School; Counsel, Gibbons PC, Newark, NJ |
Tricia Van Orden
Deputy Director, Trade Promotion Coordinating Committee Secretariat, International Trade Administration, US Department of Commerce, Washington, DC |
John Patrick Oroho, JD
Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman PC, Morristown, NJ |
Amy Pawloski
Compliance Officer - Operations at Endo Pharmaceuticals, Former Global Lead, Compliance Risk Mitigation and Monitoring Strategy, Bristol-Myers Squibb; Philadelphia, PA
|
Joe Philipose, JD
Vice President, US & Enterprise Compliance, Alexion, Former Director of Compliance, Salix, Former Director, PwC Life Sciences Consulting, Boston, MA |
Roy Pollitt
Managing Director, Americas Head, Investigations, Exiger, Former Special Agent, Federal Bureau of Investigation, New York, NY |
Perri Pomper, JD
Former Director – Ethics and Compliance Strategy & Education, Novo Nordisk, New York, NY |
John Seungjoo Rah, JD
Partner at DLA Piper, Washington, DC
|
Kelly N. "Nikki" Reeves, MPA, JD
Partner, King & Spalding LLP, Washington, DC |
John C. Richter
Partner, King & Spalding, Washington, DC |
Margaret Erin Rodgers-Schmidt, JD
Partner, Morgan Lewis & Bockius, Philadelphia, PA |
Jeffrey Rosenbaum, MBA
Partner and Co-founder, Dovetail Consulting Group, LLC, Former SVP, Chief Compliance and Risk Officer, Shire, Boston, MA
|
David Ryan, JD
Vice President and Chief Compliance Officer, Epizyme, Former Vice President, Associate GC and CCO, Haemonetics, Boston, MA |
Mark Scallon, MHA
Senior Principal, Polaris, IQVIA Global Compliance, Richmond, VA |
Philip Lo Scalzo, JD
Senior Vice President, Chief Compliance Officer, BioMarin; Former Assistant General Counsel, sanofi-aventis, Novato, CA |
Cheryl J. Scarboro, JD
Partner, Simpson Thacher & Bartlett, Former, Chief, FCPA Unit, Enforcement Division, US SEC, Washington, DC
|
Angela Schwartz, JD
Senior Manager, Fraud Investigations & Dispute Services, Life Sciences, EY, Philadelphia, PA |
Sue Seferian, JD
Health Care Compliance Officer, Johnson & Johnson, Titusville, NJ |
George Serafin, MS
National Health Care and Life Sciences Leader, Grant Thornton, LLP, Iselin, NJ |
Nicole Serena
Director, PSP Consulting Services, MATRIX Healthcare Strategists Inc.; Former Director, Patient Access, Bayer; Canada
|
Patterson Shafer
Managing Director, Health Care and Life Sciences, Grant Thornton, Stamford, CT |
Michael Shaw, JD
Vice President and Compliance Officer, US Pharmaceuticals, GlaxoSmithKline, Former Senior Counsel, Office of Inspector General, US DHHS, Former PCF Co-chair, Philadelphia, PA |
Laura (Munns) Skinner, MBA
Senior Manager, Life Sciences Advisory, Deloitte, Austin, TX |
Jon Smollen, MA, JD
Practice Professor of Law and Director, Center for Compliance and Ethics, Temple Law, Former EVP and CCO, Endo International, Philadelphia, PA
|
Eugene F. Soltes, MBA, PhD
Jakurski Family Associate Professor of Business Administration, Harvard Business School, Author, Why They Do It: Inside the Mind of the White-Collar Criminal, Cambridge, MA |
Oliver Steck
Principal, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, New York, NY |
Tim Stow, JD
Senior Vice President and Head of Legal International, Shire, Former VP, Head of Legal Europe, International & Asia Pacific, UCB, Boston, MA |
Silvija A. Strikis, JD
Partner, Kellogg Hansen Todd, Figel & Frederick, Former Law Clerk, Justice Sandra Day O'Connor, US Supreme Court, Washington, DC
|
Ravi Tayi, MD, MPH
Chief Medical Officer, US Ferring Pharmaceuticals; Former Vice President, Global Medical Affairs, Mallinckrodt; Former Vice President, Medical Affairs and Clinical Development, Cubist/Optimer, New York, NY |
Ann-Marie Tejcek, MA
Senior Director, Ethics & Compliance, Eli Lilly and Company, Indianapolis, IN |
Bryan Timer, MA Business Analytics
Director, Data Analytics & Transparency, Merck, North Wales, PA |
Nancy Schwalje Travis, MIA
Vice President, International Compliance and Governance, AdvaMed, Former Deputy Director, Office of Economic Policy, Asia-Pacific Bureau, US Department of State, Washington, DC
|
Brian Van Hoy
Vice President, G&M Health LLC, Former Director, Ethics and Compliance, Eli Lilly, Bridgewater, NJ |
Jennifer Vondee, MPH
Manager, Pharmaceutical & Life Sciences Risk Consulting, PwC, Durham, NC |
Julie Ritchie Wagner, JD
Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US DHHS; Washington, DC |
Lisa Walkush, EMTM
Partner, Grant Thornton, LLP, Philadelphia, PA
|
William Weinreb, JD
Partner, Quinn Emanuel, Former Acting United States Attorney and First Assistant US Attorney, Boston, Boston, MA |
Sarah Whipple, JD
Senior Corporate and Compliance Counsel, Akebia Therapeutics, Inc., Former VP, Global Compliance & Privacy Officer, Aegerion, Former CCO and Assoc. GC, AMAG, Boston, MA |
Donna White
Vice President, Contracts & Compliance, Chiesi USA, Inc., Former Sr. Director, Contracts and Compliance, Cornerstone Therapeutics, Cary, NC |
Seth B. Whitelaw, JD, LLM, SJD
President and Chief Executive Officer, Whitelaw Compliance Group, LLC, Editor, Life Science Compliance Update, West Chester, PA
|
Jonathan Wilkenfeld, MBA
Partner, Potomac River Partners, Washington, DC |
Russell Williams
Vice President, Government Relations and Public Affairs, Diabetes Canada, Patient Co-Chair, APEC Biopharmaceutical Working Group, Former President, Innovative Medicines Canada - Médicaments novateurs Canada, Ottawa, Canada |
Kathryn "Katie" E. Winson
Senior Manager, US HCC Monitoring, Celgene Corporation, Summit, NJ
|
|
|
2018-2019 GLOBAL PHARMA COMPLIANCE CONGRESSES
|
|
NINETEENTH ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS
|
A Hybrid Conference and Internet Event
Sponsored by Pharmaceutical Compliance Forum (PCF)
November 7 – 9, 2018
Mandarin Oriental
Washington, DC
www.PharmaCongress.com
|
|
THIRTEENTH INTERNATIONAL PHARMACEUTICAL AND
MEDICAL DEVICE COMPLIANCE CONGRESS
|
Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)
Media Partners: Life Sciences Compliance Update
April 8 – 10, 2019
Grand Hyatt Athens
Athens, Greece
www.International PharmaCongress.com
|
|
NINTH ASIA PACIFIC PHARMACEUTICAL AND
MEDICAL DEVICE COMPLIANCE CONGRESS
|
Sponsored by Asia Pacific Healthcare Industry Compliance Team
Cosponsored by International Society of Healthcare Ethics and Compliance Professionals (ETHICS)
Media Partners: Life Sciences Compliance Update
September, 2019
Shanghai, China
www.Asian PharmaCongress.com
|
|
|
|
|
|
SPONSORED BY
|
The Pharmaceutical Compliance Forum (PCF) is a coalition of senior compliance professionals and legal counsel from more than 70 of the largest research-based pharmaceutical manufacturers. The PCF was founded in early-1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compliance programs.
|
|
CONGRESS CO CHAIRS
|
Michael R. Clarke, JD
Vice President, Corporate Compliance, Indivior Inc., Richmond, VA
(PCF Co-Chair)
Sujata T. Dayal, JD
Vice President, Health Care Compliance & Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ
(PCF Secretary)
Jeffrey M. Kawalek, MBA
Senior Director, Ethics & Compliance, North America, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ
(PCF Chair)
Jennifer McGee, JD
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD
(PCF Treasurer)
Margaret Sparks, JD
Associate Vice President, North America Ethics and Business Integrity, Sanofi US, Bridgewater, NJ
(PCF Co-Chair)
Joe Zimmerman
Vice President and Chief Compliance Officer US, Ferring Pharmaceuticals, Parsippany, NJ
(PCF Co-Chair)
|
|
GRANTORS:
|
|
GOLD
|
|
|
SILVER
|
|
|
BRONZE
|
|
|
CONTINUING EDUCATION CREDITS
|
Accounting Professionals: Approved for up to 19.0 NASBA CPE Credits for onsite attendance only.
Attorneys: Approval for up to 1.00 Ethics and 13.50 Pennsylvania MCLE credits.
Compliance Professionals: This education activity has been submitted to the Compliance Certification Board (CCB)® and is currently pending their review for approval of CCB CEUs.
Click here for more information.
|
|
MEDIA PARTNERS:
|
|
|
PLANNING COMMITTEE
|
|
CO-CHAIRS
|
Michael R. Clarke, JD
Vice President, Corporate Compliance, Indivior Inc. (PCF Co-Chair)
Sujata T. Dayal, JD
Vice President, Health Care Compliance and Privacy, Pharmaceuticals Group, Johnson & Johnson (PCF Secretary)
Jeffrey M. Kawalek, MBA
Senior Director, Ethics and Compliance, North America, Ipsen Biopharmaceuticals, Inc. (PCF Chair)
Jennifer McGee, JD
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc. (PCF Treasurer)
Margaret Sparks, JD
Associate Vice President, North America Ethics and Business Integrity, Sanofi US (PCF Co-Chair)
Joe Zimmerman
Vice President and Chief Compliance Officer US, Ferring Pharmaceuticals (PCF Co-Chair)
|
|
MEMBERS
|
Kamil Ali-Jackson, JD
Co-Founder, Chief Legal Officer, Chief Compliance Officer and Corporate Secretary, Aclaris Therapeutics, Inc.
Michael Arbini
Global Marketing Communications Leader, Polaris Management
Timothy Ayers, JD, MPH
Group Vice President, Chief Compliance Officer, Horizon Pharma PLC
Dennis K. Barnes, JD, CPA
Vice President, Global Governance, Risk and Compliance, Mayne Pharma
Scott Bass, JD
Partner and Head, Global Life Sciences Team, Sidley Austin LLP
Ann E. Beasley, JD
Director, Life Sciences, Governance, Risk & Compliance, Navigant
John T. Bentivoglio, JD
Partner, Skadden Arps LLP
Kathleen M. Boozang, JD, LLM
Dean and Professor of Law, Seton Hall University School of Law
Scott Boyance
Associate Director, Forensic and Integrity Services, EY
Joseph Calarco
Chief Compliance Officer, Neos Therapeutics
Christie Camelio
Vice President and US Healthcare Compliance Officer, Celgene Corporation
Thomas Costa, JD
Member, US Board of Directors, Sanofi; Former Vice President, US Compliance and Ethics, Bristol-Myers Squibb
Paul Curtin, JD, CFE
Vice President, Global Chief Compliance Officer, Intercept Pharmaceuticals
Jill Fallows-Macaluso, BSN, JD
Vice President and Chief Compliance Officer, Novo Nordisk Inc.
Margaret K. Feltz, MA, JD
Vice President, Ethics and Compliance, Purdue Pharma LP
Alison Fethke, JD
Counsel, Ropes & Gray LLP
Alex Ganz, JD
Senior Manager of Compliance, Aegerion Pharmaceuticals
Gary F. Giampetruzzi, JD
Partner, Paul Hastings
Virginia "Ginny" A. Gibson, JD
Partner, Hogan Lovells
Jonathan Glazier, JD, MBA
Head of Legal Compliance, Philips North America LLC
Wendy C. Goldstein, JD
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP
Ive Grgas, MS
Director, Healthcare Compliance, Puma Biotechnology
Karen L. Hale, JD
Vice President, Chief Ethics & Compliance Officer, Abbvie
Bill Hrubes, MS
Vice President and Chief Compliance Officer, ACell, Inc.
Erinn Hutchinson
Partner, Advisory Services, PwC
Michael Joachim, JD
Compliance Business Partner, Sanofi Genzyme
Jonathon L. Kellerman
Executive Vice President, Global Chief Compliance Officer, Allergan PLC
Daniel A. Kracov, JD
Partner and Head, FDA and Healthcare Practice, Arnold & Porter Kaye Scholer, LLP
Holly Kramen, JD
Chief Compliance Officer and Privacy Officer, PolarityTE
Robert A. Ladd, JD
Vice President, Global Head Integrity & Compliance, Oncology, Novartis
Puja Leekha, JD
Vice President, Chief Compliance Officer and Corporate Counsel, Corporate Compliance Lundbeck
Gregory Moss, JD
Senior Vice President, Deputy General Counsel, Kadmon Corporation
Katherine Norris
Director, Berkeley Research Group
Neil F. O'Flaherty, JD
Partner, Baker Mckenzie
John Patrick Oroho, JD
Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC
Jennifer O'Toole
Events Manager, Americas, SAI Global
Amy Pawloski
Compliance Officer, Operations, Endo Pharmaceuticals
Lori Queisser
Senior Vice President and Global Chief Compliance Officer, Teva
David Ralston, JD, MPH
Senior Director, Associate General Counsel, Business Conduct, Gilead Sciences
Kelly N. "Nikki" Reeves, MPA, JD
Partner, King & Spalding
Jeffrey Rosenbaum, MBA
Partner, Dovetail Consulting Group, LLC
Michael Shaw, JD
Vice President and Compliance Officer, US Pharmaceuticals, GlaxoSmithKline
Paul J. Silver
Principal, Deloitte
Ann-Marie Tejcek, MA
Senior Director, Ethics and Compliance, Eli Lilly and Company
Brian Van Hoy
Vice President, G&M Health LLC
Donna Wachman
National Industry Marketing Leader, Grant Thornton LLP
Julie Wagner, JD
Assistant General Counsel, PhRMA
Caroline West, JD
Global Chief Compliance Officer, Olympus Corporation
Donna White
Vice President, Contracts and Compliance, Chiesi USA, Inc.
Seth B. Whitelaw, JD, LLM, SJD
President and CEO, Whitelaw Compliance Group, LLC
|
|
STAY CONNECTED
|
Tweet using #PharmaCongress
|
|
PARTICIPATION OPTIONS
|
|
TRADITIONAL ONSITE ATTENDANCE
|
Simply register, travel to the conference city and attend in person.
Pros: subject matter immersion; professional networking opportunities; faculty interaction
|
|
LIVE AND ARCHIVED WEBCAST PARTICIPATION
|
Watch the conference in live streaming video over the Internet and at your convenience at any time 24/7 for the six months following the event.
The archived conference includes speaker videos and coordinated PowerPoint presentations.
Pros: Live digital feed and 24/7 Internet access for next six months; Accessible in office, at home or anywhere worldwide with Internet access; Avoid travel expense and hassle; No time away from the office
|
|
WEBCAST INTERFACE SAMPLE
|
Click here for a sample stream
|
|
PAST GLOBAL PHARMA COMPLIANCE CONGRESSES
|
|
2007 - Brussels
2008 - Paris
2009 - Rome
2010 - Berlin
2011 - Istanbul
2011 - Singapore
2012 - Budapest
2012 - Shanghai
2012 - São Paulo
2013 - Madrid
2013 - Kuala Lumpur
2014 - Dubai
2014 - Mexico City
2014 - Shanghai
2015 - Manila
2016 - Warsaw
2017 - Lisbon
2018 - Vienna
|
|
|
|
|
|
