Press Release: The Pharmaceutical Compliance Forum's Eighteenth Pharmaceutical and Medical Device Compliance Congress Features Demonstrating the Value of the Compliance Organization; Agenda-at-a-Glance Available
  • Sponsored by the Pharmaceutical Compliance Forum
  • November 6 - 8, 2017
  • 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
  • www.PharmaCongress.com

PRESS RELEASE
Phone: 800-503-7419
Email: registration@hcconferences.com
Website: www.PharmaCongress.com
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AGENDA-AT-A GLANCE
Click here for Agenda-at-a-Glance

FEATURING DEMONSTRATING THE VALUE OF THE COMPLIANCE ORGANIZATION BY

Kathleen M. Boozang, JD, LLM
Dean and Professor of Law, Seton Hall University School of Law, Newark, NJ

Jonathon L. Kellerman
Executive Vice President, Global Chief Compliance Officer, Allergan PLC, New York, NY

Michael Shaw, JD
Vice President and Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services; Former Member, PCF Executive Committee, Philadelphia, PA

Erinn Hutchinson
Partner, Advisory Services, PwC, Philadelphia, PA (Moderator)

WASHINGTON, DC USA -- PHARMA UPDATE NEWS SERVICE™ -- AUGUST 31, 2017: The Pharmaceutical Compliance Forum's Eighteenth Pharmaceutical and Medical Device Compliance Congress, www.PharmaCongress.com, will be held November 6 - 8, 2017 at the Mandarin Oriental in Washington, DC. Registrants may attend the event in person or online (live webcast and archived for 6 months).

AGENDA-AT-A GLANCE
MONDAY, NOVEMBER 6, 2017
MORNING INVITATION-ONLY CCO ROUNDTABLE
MORNING PRE-CONFERENCES:
  • Advanced Medical Affairs Compliance Issues
  • The Basics of Managed Markets
  • Medical Device Best Practice Compliance Updates
  • Government Programs for the Compliance Officer
AFTERNOON OPENING PLENARY SESSION:
  • OIG Compliance Update
  • DOJ Evaluation of Corporate Compliance Programs
  • DOJ, SEC and FBI FCPA Enforcement Update
  • AUSA Roundtable
  • Chief Compliance Officer Roundtable
  • Networking Reception
TUESDAY, NOVEMBER 7, 2017
MORNING PLENARY SESSION:
  • FDA Compliance Update
  • Qui Tam Roundtable
  • Demonstrating the Value of the Compliance Organization
MORNING MINI SUMMIT BLOCK A:
  • Using Behavioral Economics to Improve Compliance Messaging Stickiness
  • HCP Engagement: The Road to Proactive Risk Management
  • Best Practices for Patient Assistance and Reimbursement Support
  • Managed Market Considerations for Hub and Specialty Pharmacy Arrangements
  • Compliance and Ethics Consideration in R&D
  • Using Data Analytics to Tell the Compliance Effectiveness Story
  • International Organization for Standardization (ISO) 37001
NETWORKING LUNCHEON AND
LUNCHEON MINI SUMMITS:
  • FDA Regulation and Cutting Edge Technology
  • Advancing Compliance: Pulling Critical Levers to Improve Effectiveness
  • The Evolution of Compliance Programs after Wells Fargo
  • Innovation and Compliance, They are not Mutually Exclusive
AFTERNOON MINI SUMMIT BLOCK B:
  • Third Party Risk Management/Due Diligence Update
  • Compliance in the Transactional Context
  • Managing an Internal Investigation under CIA, DPA and Data Analytics Failure
  • Recent FDA Guidance: Manufacturer Communications and Off-Label Memo
  • Small and Mid-Sized Pharma and Device Companies Compliance Considerations
  • Advanced Issues in Global Compliance
  • Effective and Balanced Monitoring Program based on Risk
AFTERNOON MINI SUMMIT BLOCK C:
  • Advanced Compliance Issues When Contracting with Third Parties
  • The Next Generation of Agg Spend Solutions
  • Cyber Security for Pharma and Medical Device Companies
  • Pricing Considerations (Mylan Epipen, Marathon Pharmaceuticals, et al)
  • Optimizing Data Collection for Risk Assessments, Monitoring, and Auditing
  • Balancing Risks in Patient and Product Support
AFTERNOON CLOSING PLENARY SESSION:
  • Role of Behavioral Economics in Ethics and Compliance
  • PhRMA Priorities and Policy Initiatives
  • Overview of the Policy and Politics of Pharma Pricing
  • Rewarding Results: Value-Based Contracting for Biopharmaceuticals
WEDNESDAY, NOVEMBER 8, 2017
MORNING INDUSTRY-ONLY COMPLIANCE BEST PRACTICES THINK TANK
  • (Industry-only session for pharmaceutical company compliance professionals and in-house counsel only)
KEYNOTE SPEAKERS

Thomas W. Abrams, RPh, MBA
Director, Office of Prescription Drug Promotion, US Food and Drug Administration, Silver Spring, MD

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

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

James Sheehan, JD
Chief, Charities Bureau, Attorney General of New York, Former Chief Integrity Officer, New York City Human Resources Administration, Former, NY Medicaid Inspector General, Former AUSA, US Attorney's Office, Eastern District of Pennsylvania, New York, NY

Jim Stansel, JD
Executive Vice President, General Counsel and Corporate Secretary, PhRMA, Former Acting General Counsel, US Department of Health and Human Services, Washington, DC

KEYNOTE DOJ CIVIL AND CRIMINAL DIVISIONS ROUNDTABLE

Colin M. Huntley, JD
Assistant Director, Fraud Section, Civil Division, US Department of Justice, Washington, DC

Pablo Quiñones, JD
Chief, Strategy, Policy and Training Unit, Fraud Section, Criminal Division, US Department of Justice, Former Assistant United States Attorney in the Criminal Division, US Attorney's Office for the Southern District of New York, Washington, DC

Gejaa T. Gobena, JD
Partner, Hogan Lovells, Former Deputy Chief, Fraud Section, Criminal Division, Former Trial Attorney, Civil Division, Fraud Section, US Department of Justice, Washington, DC (Moderator)

KEYNOTE DOJ, SEC AND FBI FCPA ENFORCEMENT ROUNDTABLE

Charles Cain, Esq.
Deputy Chief, FCPA Unit, US Securities and Exchange Commission, Washington, DC

Tarek Helou, Esq.
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC

Darryl Wegner, JD
Unit Chief, International Corruption Unit, FBI, Washington, DC

Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings, Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY (Moderator)

KEYNOTE AUSA ROUNDTABLE

Jacob T. Elberg, JD
Chief, Health Care and Government Fraud Unit, United States Attorney's Office, District of New Jersey, US Department of Justice, Newark, NJ

Jason Mehta, JD
Assistant US Attorney, United States Attorney's Office Middle District of Florida, US Department of Justice, Jacksonville, FL

Gregg Shapiro, JD
Assistant US Attorney, US Attorney's Office, District of Massachusetts, US Department of Justice, Boston, MA

John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP, Former Special Counsel for Healthcare Fraud, and Chief Privacy Officer, US Department of Justice, Washington, DC (Moderator)

KEYNOTE QUI TAM ROUNDTABLE

Neil V. Getnick, JD
Managing Partner, Getnick & Getnick LLP, Former Assistant District Attorney, Manhattan District Attorney's Office, New York, NY

Michael A. Morse, JD
Partner, Pietragallo, Gordon, Alfano, Bosick & Raspanti, Former Assistant District Attorney, Philadelphia District Attorney's Office, Philadelphia, PA

Robert Patten, JD
President and Chief Executive Officer, Taxpayers Against Fraud and TAF Education Fund, Former Assistant Attorney General and Managing Attorney, Medicaid Fraud Division, Office of the Attorney General, Commonwealth of Massachusetts, Washington, DC

Virginia "Ginny" A. Gibson, Esq.
Partner, Hogan Lovells LLP, Former Executive Assistant U.S. Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA (Co-Moderator)

Kathleen Meriwether, JD
Principal, Fraud Investigation & Dispute Services, Ernst & Young LLP, Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA (Co-Moderator)

KEYNOTE DEMONSTRATING THE VALUE OF THE COMPLIANCE ORGANIZATION

Kathleen Boozang, JD LLM
Dean and Professor of Law, Seton Hall Law School, Newark, NJ

Jonathon L. Kellerman
Executive Vice President, Global Chief Compliance Officer, Allergan PLC, New York, NY

Michael Shaw, JD
Vice President and Compliance Officer, US Pharmaceuticals, GlaxoSmithKline, Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services, Former Member, PCF Executive Committee; Philadelphia, PA

Erinn Hutchinson
Partner, Advisory Services, PwC, Philadelphia, PA (Moderator)

KEYNOTE CCO ROUNDTABLE

Jill Dailey, MBA, JD
Vice President and Chief Compliance Officer, Incyte, Former Assistant General Counsel and Asia Pacific Compliance Lead, Pfizer, Former Head of US Ethics and Compliance, Novartis, New York, NY

Margaret K. Feltz, MA, JD
Vice President, Ethics & Compliance, Purdue Pharma LP, Former Member, PCF Executive Committee, Stamford, CT

Arjun Rajaratnam, JD, MS
Chief Compliance Officer, Smith & Nephew, Former Compliance Officer, US Pharmaceuticals, GlaxoSmithKline, Former Member, PCF Executive Committee, Raleigh, NC

David Ralston, JD, MPH
Senior Director, Associate General Counsel, Business Conduct, Gilead Sciences, Former Section Head, Abbott Laboratories, Former Senior Legal Director, Schering Plough, Foster City, CA

Paul Silver
Principal, Regulatory & Compliance Life Sciences Leader, Deloitte Advisory, Deloitte, Atlanta, GA

FEATURED FACULTY

Sergio Alegre, JD
Vice President, Global Compliance, Osmotica Pharmaceutical Corp., Former Executive Director Compliance, Pacira Pharmaceuticals, Inc., New York, NY

Yogesh Bahl, CPA, MBA
Managing Director, Alix Partners, New York, NY

Ann Beasley, JD
Director, Navigant Consulting, Former Senior Vice President, Chief Compliance Officer, Biogen, Boston, MA

Thomas W. Beimers, Esq.
Partner, Hogan Lovells, Former Senior Counsel for Administrative and Civil Remedies, Office of the Inspector General, Department of Health and Human Services, Minneapolis, MN

Andy Bender, MS, MBA
President and Founder, Polaris, New York, NY

Anthony Brennan, MBA
Senior Manager, Fraud Investigation and Dispute Services, Ernest & Young, Former Senior Director, Governance, Metrics and Reporting, Health Care Compliance, Johnson & Johnson, Iselin, NJ

Katherine Buckley, MBA
Principal, Pharmaceutical and Life Sciences Advisory Practice, PwC, Philadelphia, PA

Terra Buckley
Head of US Compliance, Helsinn, Former Director, Ethics & Compliance, North America, Ipsen, Former Associate Director, Compliance, Aptalis Pharma, Iselin, NJ

Jennifer Chillas, JD
Senior Corporate Counsel, Bristol-Myers Squibb, Princeton Pike, NJ

Robert F. Church, JD
Partner, Hogan Lovells US LLP; Former, Associate General Counsel/Executive Director, Amgen, Los Angeles, CA

Kellie B. Combs, JD
Partner, Ropes & Gray, Washington, DC

Joseph Coniker
Principal, Enterprise Performance Management (EPM) Analytics, Grant Thornton LLP, Raleigh, NC

Brian Conner
Vice President, Head of Corporate Compliance, Strongbridge BioPharma plc, Feasterville Trevose, PA

Tom Costa, JD
Pharmaceutical Consultant, Sanofi Board of Directors; Former Vice President, US Compliance & Ethics, Bristol-Myers Squibb, Washington, DC

Clarissa Crain
Senior Manager, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, Philadelphia, PA

David Cromley, JD
Associate Vice President, Merck, Philadelphia, PA

Meenakshi Datta, JD
Partner, Sidley Austin LLP, Chicago, IL

Mark A. DeWyngaert, MBA, PhD
Managing Director, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, New York, NY

Michelle Drozd, ScM
Deputy Vice President, Policy and Research, Pharmaceutical Research & Manufacturers of America (PhRMA), Washington, DC

Gildas Durand
Partner/Principal, Fraud Investigation and Internal Audit, Ernst & Young LLP, Miami, FL

Liisa Eisenlohr, PhD, MBA
Associate Director, Navigant, Former Senior Director, Global Medical Information, Clovis Oncology, Former Clinical Scientist, Genentech, San Francisco, CA

Jill Fallows-Macaluso, JD
Chief Compliance Officer and Vice President, Novo-Nordisk, Princeton, NJ

David J. Farber, JD
Partner, Healthcare Lobbyist and Litigator, King & Spalding LLP, Washington, DC

Alison Fethke, JD
Counsel, Ropes & Gray LLP, Former Counsel, Legal, Regulatory & Compliance, AbbVie, Chicago, IL

Nereyda Garcia, JD
Global Head, Ethics and Compliance, Alnylam Pharmaceuticals, Alnylam Pharmaceuticals, Former Sr. Director, Compliance, Biogen Idec, Boston, MA

Jonathan Glazier, JD, MBA
Senior Legal Counsel, Legal Compliance, Philips Electronics North America, Former Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America, Andover, MA

Wendy C. Goldstein, JD
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY

Pamela W. Guthrie, JD
Senior Counsel, Professional Affairs and Compliance, MicroPort Orthopedics, Arlington, TN

Andrew R. Van Haute, JD
Associate, Sidley Austin LLP, Former Associate General Counsel, AdvaMed, Washington, DC

Lindsay Havern, JD
Vice President and Assistant General Counsel, Pfizer, New York, NY

Laura G. Hoey, JD
Partner, Ropes & Gray LLP, Former Assistant US Attorney, US Attorney's Office, Eastern District of Arkansas, US Department of Justice, Chicago, IL

Brian Van Hoy
Vice President, G & M Health LLC, Former Director, Ethics and Compliance, Eli Lilly, Bridgewater, NJ

Jamil N. Jaffer, JD
Vice President for Strategy & Business Development, IronNet Cybersecurity, Adjunct Professor and Founder, National Security Law & Policy Program, Antonin Scalia Law School, George Mason University, Washington, DC

Darren R. Jones, CIA
Managing Partner, Polaris Management Partners, New York, NY

Anup Kharode, MBA
Principal, Pharmaceutical & Life Sciences R&D Advisory Services, PwC, Philadelphia, PA

Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC

Daniel A. Kracov, Esq.
Partner and Head, FDA and Healthcare Practice, Arnold & Porter, Washington, DC

Holly Kramen, JD
Vice President, Global Compliance Officer, Circassia, Morrisville, NC

Monica Kwacinski, PharmD
Head of External Medical Affairs, Purdue Pharma LP, Stamford, CT

Mark Lange, JD
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN

Terri Ledva, MS
Healthcare Compliance Leader, Former Ethics & Compliance Leader, Iroko Pharmaceuticals, Former Associate Director, Ethics & Compliance, Bristol-Myers Squibb, Philadelphia, PA

Jonathan Levy, JD
Corporate Compliance Lead, Spark Therapeutics, Former Associate Director of Compliance and Ethics, US Pharmaceuticals, Bristol-Myers Squibb, Philadelphia, PA

Maureen Lloyd
Director Pharmaceutical and Life Sciences, PwC, Former Executive Director, Medical - External Medical Communications, Pfizer Inc., New York, NY

Pamela Lonzer, MJ
US Medical Advisor, Shire, Former Associate Director, Global Medical Affairs Compliance, Baxalta, Former Assistant Director, R&D-Global Compliance, Astellas Pharma, Chicago, IL

Michael K. Loucks, JD
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, United States Department of Justice, Washington, DC

Chia-Feng Lu, JD
Associate, Baker McKenzie, Washington, DC

Meghan Naas, MA
Senior Finance Manager, Compliance TESARO, Inc., Waltham, MA

Michael O'Connor, MS
Senior Director, Global Head Compliance and Ethics Operations, Alexion Pharmaceuticals, Inc., New Haven CT

Neil O'Flaherty, JD
Partner, Baker McKenzie, Washington, DC

Amy Pawloski
Global Lead, Compliance Risk Mitigation and Monitoring Strategy, Bristol-Myers Squibb, Philadelphia, PA

Paul J. Peterson, CPA, CIA, CFE, CFF
Senior Manager, Forensic Advisory Services, Grant Thornton, Arlington, VA

Kathryn Pryze, CCEP
Compliance Director, US Medical Affairs, and US Corporate Affairs, AstraZeneca, Wilmington, DE

John Seungjoo Rah, JD
Partner, DLA Piper, Washington, DC

Louis Ramos, JD
Partner, DLA Piper, Former Assistant General Counsel, Compliance Division, Pfizer, Former Assistant U.S. Attorney, US Attorney's Office, District of Columbia, US Department of Justice, Washington, DC

Kelly N. "Nikki" Reeves, MPA, JD
Partner, King & Spalding LLP, Washington, DC

Jennifer Sanfilippo, JD
Vice President, Commercial Integrity Counsel, The Medicines Company, New York, NY

Sue Seferian, JD
Health Care Compliance Officer, Johnson & Johnson, Titusville, NJ

Brian Sharkey, JD
Porzio, Bromberg & Newman, PC, Morristown, NJ

Greg Sherman, JD
Commercial Counsel, Gilead Sciences, Foster City, CA

Michelle Shwery, MSc, MBA
Senior Director, Ethics and Compliance, Eli Lilly and Company, Indianapolis, IN

Jon Smollen, MA, JD
Director, Center for Compliance and Ethics, Temple Law School, Former EVP and CCO, Endo, Former VP and CCO, Siemens Healthcare USA, Former VP, Commercial Excellence and Compliance, Wyeth, Philadelphia, PA

Oliver Steck
Principal, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, New York, NY

Tracy Strong, JD
Vice President, International Compliance Officer, Laboratory Corporation of America, Burlington, NC

Cortnaye Swan
Sr. Manager, Deloitte & Touche LLP, Kansas City, MO

Jack Tanselle, MBA
Managing Director, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, Indianapolis, IN

Bryan Timer
Associate Director, Data Analytics & Transparency, Merck, Allentown, PA

Julie Ritchie Wagner, JD
Assistant General Counsel, PhRMA, Former Senior Counsel, Office of Counsel to the Inspector General, US Department of Health and Human Services, Washington, DC

Lisa Walkush
Principal, Advisory Services; National Life Sciences Sector Leader, Grant Thornton LLP, Philadelphia, PA

Caroline West, JD
Global Chief Compliance Officer, Olympus Corporation, Former Senior Vice President, Chief Compliance and Risk Officer, Shire, Former Vice President Global Legal Compliance, Aventis, Philadelphia, PA

Donna White, CCEP
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, Former Interim Chief Compliance Officer, Misonix, Inc., West Chester, PA

2017-2018 GLOBAL PHARMA COMPLIANCE CONGRESSES

ELEVENTH INTERNATIONAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS
Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)
Cosponsored by Pharmaceutical Compliance Forum (PCF)
May 15 - 17, 2017
Lisbon Marriott Hotel
Lisbon, Portugal
www.International PharmaCongress.com
SEVENTH 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) and Pharmaceutical Compliance Forum (PCF)
September 13 - 15, 2017
InterContinental Shanghai, Shanghai, China
www.Asian PharmaCongress.com
EIGHTEENTH ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS
A Hybrid Conference and Internet Event
Sponsored by Pharmaceutical Compliance Forum (PCF)
November 6 - 8, 2017
Mandarin Oriental
Washington, DC
www.PharmaCongress.com


INDIAN PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS
International Society of Healthcare Compliance Professionals (ETHICS)
Cosponsored by International Society of Healthcare Compliance Professionals (ETHICS) and Pharmaceutical Compliance Forum (PCF)
Spring 2018
Mumbai, India
Coming Soon


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.

CO CHAIRS

Matthew D'Ambrosio, JD, MBA
Senior Vice President, Chief Compliance and Ethics Officer, Sunovion Pharmaceuticals Inc., Chair, Pharmaceutical Compliance Forum, Marlborough, MA


Sujata T. Dayal, JD
Vice President, Health Care Compliance & Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ


Jeffrey Kawalek, MBA
Senior Director, Ethics & Compliance, North America, Ipsen Biopharmaceuticals, Inc., New York, NY


Jennifer McGee, JD
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD


Margaret Sparks, JD
Associate Vice President, North America Ethics and Business Integrity, Sanofi, US, Bridgewater, NJ

GRANTORS:
PLATINUM


SILVER








BRONZE






























MEDIA PARTNERS:






CONTINUING EDUCATION CREDITS:
Accounting Professionals: Pending approval for NASBA CPE credits.

Attorney Credits: Pending Approval for PA 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.

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

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PAST GLOBAL PHARMA COMPLIANCE CONGRESSES


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