Education Session

404 - Anticounterfeiting – Can Chemistry Trump Bureaucracy?

Get Agenda 10 November 14.15-17.15
ISPE CEUs: 0.25


Tracks: SurvivalSupplyRegulatoryQuality

Counterfeiting, diversion, and economically motivated adulteration are growing threats. Increasingly skilled counterfeiters can now defeat protective features in six to nine months. Mass serialization offers a way to verify that a package is genuine, but it imposes a tracking burden at each stage in the supply chain, and one weak link can compromise legitimate product as well. Repackaging is a challenge: it removes tamperproofing and complicates tracking. Tagging and tracking the product itself could keep patients safe … if it can be done simply and inexpensively with open standards. This session explores new methods of anti-counterfeiting that blur the traditional lines between overt, covert, and forensic methods. These methods do not need to be kept secret in order to be effective because criminals cannot reverse engineer them. They use simple detectors, usable by field testers, so forensic does not have to mean “takes weeks for the lab to provide results.”

How you will Benefit

At the end of this session, participants will be able to:

  • Understand how repackaging and counterfeiting interact
  • Describe which covert and forensic features are at risk when disclosed and which are not
  • Evaluate the burden of compliance against the ease with which a determined counterfeiter can defeat a protective method
  • Evaluate packaging-based and product-based anticounterfeiting measures by cost, complexity, and effectiveness
  • Develop a cost-effective, phased-in supply chain integrity program

Who Should Attend

Professionals from logistics and distribution, purchasing, warehousing, manufacturing, quality assurance, risk management, regulatory affairs, research and development, senior experts, corporate security, regulators, suppliers, and patient organizations (pharmacists, physicians, and distributors)

ISPE Communities of Practice (COPs)

API, Biotech, C&Q, Containment, ESB, GAMP, GCLP, IP, OSD, Packaging, PAT, PPD, PM, SPP, and SF

View the ISPE Community of Practice (COP) Guide

Session Leader

Session Presenters

  • Saaed Hashemi, Manager, Irvine Pharmaceutical Services USA
  • Bryan Liang, M.D., Ph.D., J.D., E. Donald Shapiro Professor of Law, California Western School of Law USA

Annual Meeting Sponsors