Dr. Mark R. Willis, LP.D
Dr. Willis is a seasoned
Pharmaceuticals and Medical Device professional with over 20 years’ experience
in the industry. He has extensive experience
leading global regulatory programs as both a project manager (PMP) and as a
software quality engineer participant (certified SQE and Quality Auditor). With a doctorate in law and public policy as
well as a participant in construction of the recent ISO 9001 update, Mark has
provided consultation on how to “right size” an organizations regulatory
compliance so that their software implementations are able to meet their needs
without distracting from daily operations.
Dr. Willis supported medical device and pharmaceutical corporations
through U.S. FDA and EMA audits acting as the lead contact as well as managing
the site “war room”. Beyond product
implementation and audits, Dr. Willis has supported corporations in compliance
of regulations such as REACH, RoHS, Corporate Social Responsibility, etc.
As a professor at
Northeastern University and at Massachusetts College of Pharmacy and Health
Sciences, Mark has been training and mentoring the next generation of project
managers with a concentration on execution within a regulated environment as
well as health economics. Mark is
currently working with global health authority agencies as well as the UN and
USAID to conduct research for technological solutions like Blockchain and PCIDs
to secure the pharmaceutical supply chain and is the author of “Counterfeit
Pharmaceuticals: Are the U.S. Consumers Aware of the Potential Risks?”
Education
NORTHEASTERN UNIVERSITY, Boston, Massachusetts
Doctorate of Law and
Public Policy
Dissertation: Counterfeit Pharmaceuticals: Are the U.S.
consumers aware of the risk?
July 2018
NORTHEASTERN UNIVERSITY, Boston, Massachusetts
Master of Science in
Regulatory Affairs for Drugs, Biologics, and Medical Devices
Sigma Epsilon Rho Honors
Society
May 2009
NOTRE DAME de NAMUR UNIVERSITY, Belmont, California
Bachelors of Science
Degree in Finance/Economics
June 1999
Professional
Items of Note
Presenter:
Drug Information Association (DIA) conference 2014 – San Diego, CA
Presenter:
Project Management Education Forum 2015 – Boston, MA
Lecturer:
Harvard University School of Business (2014)
Speaker:
NAAAP's 2016 National Leadership Conference – Boston, MA
Speaker:
IQPC’s 2017 Pharmaceutical Serialisation & Traceability Conference –
Vienna, Austria
Guest Speaker:
8th Annual Pharma Anti-Counterfeiting, Serialisation, Track &
Trace Conference – London, England
Keynote Speaker:
IQPC’s 2018 Pharmaceutical Serialisation & Traceability Conference –
Zurich, Switzerland
Keynote Speaker:
IQPC’s 2018 Pharmaceutical Traceability Conference – Philadelphia, PA, US
Keynote Speaker:
IQPC’s 2019 Pharmaceutical Brand Protection & Traceability Conference –
Zurich, Switzerland
Keynote Speaker:
IQPC’s 2020 Pharmaceutical Brand Protection & Traceability Conference –
Prague, Czech Rep
Good Will Ambassador: Fight the Fakes Organization
Brazilian Business Visa – 5 years,
multiple entry (2015)
Chinese Business Visa – 10 years,
multiple entry (2015)
Check out the incredible speaker line-up to see who will be joining Mark.
Download The Latest Agenda