BRIAN P. SHARKEY is a Vice President and Privacy Officer with Porzio Life Sciences, LLC.  Mr. Sharkey collaborates with company directors, managers, and regulatory professionals to maintain the content of our products and services.

Mr. Sharkey focuses on international transparency laws, codes, and regulations affecting the life sciences industry. Specifically, he analyzes the reporting obligations that companies have under governmental regulatory schemes or industry self-regulation in countries outside the United States and counsels clients on how to comply with them. Mr. Sharkey has also been involved in the development of Porzio’s International Life Sciences Transparency Database, and has written and spoken extensively on the topic of international transparency.

Mr. Sharkey is also a Principal of Porzio, Bromberg & Newman PC and a member of the firm’s Life Sciences Compliance and Regulatory Counseling Department. 

Mr. Sharkey received a J.D. from Seton Hall University School of Law, magna cum laude, and his B.A. from The College of New Jersey.  Mr. Sharkey is recognized on the New Jersey Super Lawyers "Rising Stars" List, 2007, 2009 - 2015.

"European Healthcare Compliance Certification," Seton Hall European Healthcare Compliance Program, Paris, France, June 2014.

PUBLICATIONS

  • "A Whirlwind of Activity Leading Up to April 20, 2018," Porzio Marijuana Series, April 23, 2018.
  • "Dear New Jersey Residents Interested in Marijuana Reform," Porzio Marijuana Series, April 12, 2018.
  • "Legislation to Reform New Jersey's Medicinal Marijuana Program Advances / Gov. Murphy Reiterates Support," Porzio Marijuana Series, March 26, 2018.
  • "The Latest Updates On The Efforts To Legalize Marijuana In New Jersey," Porzio Marijuana Series, March 22, 2018.
  • "Big Pharma's" Entry Into the Cannabis Market," Porzio Marijuana Series, March 20, 2018.
  • "New Jersey Marijuana Politics Are Fluid, But Governor Murphy Remains Committed to Legalization," Porzio Marijuana Series, March 14, 2018.
  • "Governor Murphy's Nominee for Health Commissioner Discusses Marijuana While the NJ State Association of Chiefs of Police Announces Its Opposition to Legalization," Porzio Marijuana Series, March 13, 2018.
  • "New Jersey Assembly Oversight, Reform and Federal Relations Committee Holds First Hearing on the Impact of Potential Marijuana Legalization," Porzio Marijuana Series, March 12, 2018.
  • "Senator Gardner Ends Absolute Hold on Department of Justice Nominees," Porzio Marijuana Series, February 20, 2018. 
  • "Members of Congress Busy Writing Letters About Marijuana," Porzio Marijuana Series, February 16, 2018.
  • "Attorney General Sessions and Senator Gardner Battle Over Marijuana," Porzio Marijuana Series, February 15, 2018. 
  • "Governor Murphy Addresses Marijuana In His First 'Ask Governor Murphy' Episode," Porzio Marijuana Series, February 14, 2018. 
  • "The Murphy Administration Looks to Expand New Jersey's Medical Marijuana Program," Porzio Marijuana Series: Part 3, February 13, 2018
  • "Reaction of US Attorneys to Rescission of Cole Memo," Porzio Marijuana Series: Part 2, February 6, 2018. 
  • "Creating a Legal Framework in New Jersey for a Drug That is Illegal Under Federal Law, Porzio Marijuana Series: Part 1, February 2, 2018. 
  • "Like Beauty and Art, Transparency is in the Eye of the Beholder," Porzio Life Sciences, LLC, by D. Jeffrey Campbell and Brian P. Sharkey, August 2017.
  • "A Milestone Moment (or a Dead Jellyfish) for the Global Transparency Movement," Porzio Life Sciences, LLC, by D. Jeffrey Campbell and Brian P. Sharkey, August 2016.
  • "The Sun Never Sets on Transparency," Medical Writing by the European Medical Writers Association, March 2016.
  • "Ready Or Not, Full Speed Ahead For The Global Transparency Movement," Porzio Life Sciences, LLC, by D. Jeffrey Campbell and Brian P. Sharkey, August 2015.
  • "C-O-N-S-E-N-T: Find Out What it Means to You," prepared for distribution at CBI's 12th Annual Pharmaceutical Compliance Congress, January 2015.

SPEAKING ENGAGEMENTS

  • "HCP Engagement Strategies and Contracting," CBI's 15th Annual Pharmaceutical Compliance Congress, Washington, DC, April 24, 2018.
  • U.S. Enforcement Landscape," Medical Device Regulation and MedTech Europe Code of Ethics Business Practices Summit, London, UK, April 10, 2018.
  • "Countdown to May 25th GDPR Deadline - Getting Ready and Thinking Beyond," qordata Webinar, March 21, 2018.
  • "Incident and Breach Response, Gap Analysis and Risk Management within the GDPR," CBI's Life Sciences GDPR Prep Forum, Philadelphia, PA, March 12, 2018.
  • "Updates and Projections for Transparency, Disclosures and Pharma Integrity Initiatives," CBI's Global Compliance Congress, London, England, November 16, 2017.
  • "Gain the Edge on the EU General Data Protection Regulation (GDPR) - Are You Prepared for May 2018?," CBI's Global Compliance Congress, London, England, November 16, 2017.
  • "Mini Summit XVII: Advanced Issues in Global Compliance," 18th Annual Pharmaceutical and Medical Device Compliance Congress, Washington, DC, November 7, 2017.
  • "National and International Perspectives on the Threat Environment," Porzio Life Sciences Privacy & CyberSecurity Forum, Morristown, NJ, October 25, 2017.
  • "Transparency and Disclosure Reporting," Seton Hall Law School's Latin America Healthcare Compliance Certification Program, Buenos Aires, Argentina, September 28, 2017. 
  • "EFPIA Reporting and Consent Management," qordata Webinar, August 24, 2017.
  • "Progress Report of the Implementation of EFPIA Disclosure Code," CBI's 11th Annual East Coast Forum on Transparency & Aggregate Spend, Washington, DC, August 15, 2017.
  • "New HCP Regulations: What AP and Compliance Teams Should Know," Concur Webinar, June 20, 2017.
  • "Global Transparency Trends & Challenges," Seton Hall's European Healthcare Compliance Certificate Program, Paris, France, June 9, 2017.
  • "EFPIA Reporting and Consent Management," CBI's 8th Annual West Coast Forum on Transparency and Aggregate Spend, San Diego, CA, May 24, 2017.
  • "Aggregate Spend – 20 Things to Know About Transparency," 13th Annual Medical Device Compliance Congress, San Diego, CA, May 22, 2017.
  • Moderator, "Impact of Self-Regulation Schemes on Industry Relationships with HCPs, HCOs and Patient Organizations," PCF International Pharmaceutical Compliance Congress, Lisbon, Portugal, May 16, 2017.
  • "World Showcase - Adhere to Global Laws and Codes in Emerging Markets," CBI's 14th Annual Pharmaceutical Compliance Congress, Washington, DC, April 27, 2017.
  • Moderator, "Cross-Borders Transparency Reporting," CBI's 7th Annual Global Transparency Reporting Congress, London, UK, April 5, 2017.
  • Moderator, "The Evolution of Company Compliance Programs With An Eye Towards Monitoring," Porzio Compliance Forum, Newark, NJ, February 10, 2017.
  • "EFPIA Disclosure and Consent Management – Experiences from the First Round of Disclosure in 2016," qordata Webinar, February 2, 2017.
  • "The Intersection of Global Meetings and Global Transparency," CBI's 5th Annual Global Pharmaceutical and Medical Meetings Summit, Philadelphia, PA, February 1, 2017.
  • Moderator, "EFPIA Disclosure Panel," CBI's 3rd Annual Global Compliance Congress, London, UK, November 17, 2016.
  • "Optimize Global Transparency Reporting and HCP Relationship Management Strategies," CBI's 7th Annual West Coast Compliance Congress, San Francisco, CA, November 10, 2016.
  • "EFPIA Data Demonstrates the Challenges Confronting Companies," 17th Annual Pharmaceutical and Medical Device Compliance Congress, Washington, DC, October 19, 2016.
  • "The Challenges of EFPIA Reporting are Disclosed by the Data," Pharma Compliance Europe, London, UK, October 6, 2016.
  • "First Round of EFPIA Reporting: The Data Reveals the Challenges," AHM's Life Sciences European Compliant HCP Interactions & Risk Mitigation Seminar, Windsor, UK, October 4, 2016.
  • "Transparency Disclosure Guidelines Around the World," CBI's 10th Annual Forum on Transparency and Aggregate Spend, Washington, DC, August 16, 2016.
  • "Global Transparency Trends & Challenges," Seton Hall's 2016 European Healthcare Industry Training: Compliance Certification Program, Paris, France, June 9, 2016.
  • "Tips for Moving From Domestic to International Reporting and EFPIA-U.S. Reporting Requirements," CBI's 7th Annual West Coast Forum on Transparency and Aggregate Spend, San Diego, CA, May 18, 2016.
  • "Lessons Learned from EU Sunshine Reporting Statistics and Best Practices," ACI's 10th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, New York, NY, April 28, 2016.
  • "Data Aggregation - Challenges with Managing Cross-Border Spend," CBI's 13th Annual Pharmaceutical Compliance Congress, Washington, DC, April 26, 2016.
  • Moderator, "EFPIA/Sunshine Act," The 12th Annual Meeting of ISMPP, National Harbor, MD, April 12, 2016.
  • "Data Transparency - Domestic and Abroad," The 12th Annual Meeting of ISMPP, National Harbor, MD, April 12, 2016.
  • "The Latest Transparency Disclosure Guidelines Around the World," CBI's 6th Global Transparency Reporting Congress, Frankfurt, Germany, April 8, 2016.
  • "HCP Payments Transparency Outside of the US: An Evolving Complex Environment with Implications for Medical Device Companies," Porzio Life Sciences, LLC Webinar, March 23, 2016.
  • "Transpa Going Global: How Reporting in the US Matches Up to the O-US Reporting Regime," Porzio Life Sciences, LLC Webinar, March 3, 2016.
  • "European Transparency: Lessons Learned from the American Experience," Porzio Compliance Forum, Newark, NJ, December 3, 2015.
  • "Global Transparency of HCP Data - The Current Environment and Future Direction of Disclosure Code," CBI 2nd Global Compliance Congress for Life Sciences, Munich, Germany, November 19, 2015.
  • Moderator, "HCP Relationship Management Post-Reporting - Lessons Learned from U.S. Sunshine Act," CBI 2nd Global Compliance Congress for Life Sciences, Munich, Germany, November 18, 2015.
  • "Current Environment and Future of HCP Spend Reporting Codes Globally," CBI West Coast Compliance Congress, San Francisco, CA, November 6, 2015.
  • "Implementation of EFPIA's Code on Disclosure of Transfers of Value - The Impact on Publication Strategy and Planning" at the CBI Publication and Clinical Trial Disclosure Congress, Brussels, BE, June 24, 2015.
  • "Anti-Corruption and Disclosure - How the Two Work Together to Boost Compliance Using Disclosure Obligations to Fight Corruption," ACI Inaugural Summit on International Transparency, Chicago, IL, June 11, 2015.
  • "Global Transparency Trends & Challenges," Seton Hall European Healthcare Compliance Certification Program, Paris, France, June 2, 2015.
  • Moderator, "Mini Summit IV: Advanced Issues in Global Transparency, Disclosure and Aggregate Spend Compliance," The International Pharmaceutical Compliance Congress and Best Practices Forum, Brussels, BE, May 12, 2015.
  • "The Sunshine Act and the Impact on Global Enforcement: How to Satisfy Reporting Obligations and Assess the Risks Posed by the Disclosed Data," ACI's 9th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, New York, NY, April 28, 2015.
  • "The Sunshine Act, One Year Later," Workshop, 11th Annual Meeting of ISMPP, Optimizing Scientific Value:  Smart and Systematic Approaches to Medical Publications, Arlington, VA, April 27, 2015.
  • "Around the World in 80 Days - A Tour of Various National Reporting Mandates,"  CBI's 5th Annual Global Transparency Reporting Congress, London, UK, April 15, 2015.
  • "Global Transparency of HCP Data - Current Environment and Future of HCP Spend Reporting Code," CBI's 12th Annual Pharmaceutical Compliance Congress, Washington District of Columbia, March 3, 2015.
  • "Scientific Publications and Transfer of Value Reporting," Q1 Productions, January 27, 2015.

37 Ex-US Jurisdictions Served

3 Offices

370 Companies Served

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