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Wednesday 24 February: Workshop 1: 9:00 am - 12.00 pm
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Parallel Trade and Reimportation: European and American Perspectives
Jim Thomson, European Alliance for Access to Safe Medicines,
Marvin D Shepherd, Center for Pharmacoeconomic Studies, University of Texas; Director, SafeMeds
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What does parallel trade mean for European pharmaceutical distributors and patients? What lessons are there in the European experience for the USA as it considers its reimportation policy? And what can Europe learn from the US experience? As the EU and the US consider the issue of parallel trade and reimportation, this workshop brings the knowledge and expertise of two leading opinion formers in each region to examine the issues. Through participating in this workshop you will gain up to date knowledge of the latest policy developments, insights in to the issue and how it could affect you as a patient and your organization in terms of management of the distribution chain.
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Course Leaders:
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Jim Thomson is firm advocate of patients' right to be protected from fake medicines. He founded the European Alliance in 2006 and it has rapidly become established at the heart of European policy making. The Alliance's first project was a report on medicines distribution in Europe, which examined parallel trade and has proved a seminal work. He is European liason and and a director of the Partnership for Safe Medicines.
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Marvin Shepherd, in addition to his University position, is Chairman of the Partnership for Safe Medicines. He has researched and published widely on drug importation, in both specalist and general media, including CNN, NPR, Wall St Journal and the NY Times. He also testified on issues before congress.
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Workshop 2: 1.00 pm - 4.00 pm
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Authentication and Traceability: Complementary Procedures for the Most Effective Strategy
David Howard, Director Product Protection, Johnson & Johnson Medical Devices & Diagnostics Group
John Spink, Anti-Counterfeiting & Product Protection Program, Michigan State University |
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In this workshop you will learn how to develop effective authentication and tracing programs. Do you need tracing, authentication, or both? What is required for an effective tracing and authentication program? How do they differ and compliment each other? How to develop a risk model for my business which helps to identify the need for tracing and/or authentication? What problems do tracing and authentication solve? How to integrate tracing and authentication into business process planning and strategy?
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Course Leaders:
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David Howard has many years experience in devising and implementing
anti-counterfeiting and anti-diversion procedures which recognize the
difference between knowing where your product is and whether it is
genuine. He is first Chairman of the International Authentication
Association.
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John Spink has devised and introduced an Anti-Counterfeiting in-service
distance learning course program at MSU, probably the first of its kind
anywhere. He therefore fully understands the demands of packaging
managers, security managers and others in understanding and
implementing anti-counterfeiting strategies.
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Thursday February 25 |
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8.30 am
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Forum Welcome and Introduction
Ian M Lancaster, Randall Burgess, Reconnaissance International
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SESSION 1: END-TO-END PROTECTION - WHY IT'S NEEDED
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This session explains how and why End-to-End protection goes beyond the patient, why it's necessary and how the policies can be put in place to deliver this protection. |
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8.45 am
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Counterfeit Medicines - the Cost to Healthcare Budgets
Jim Thomson, European Alliance for Access to Safe Medicines
Ian Banks, European Men’s Health Forum
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While counterfeit medicines cost lives, they also have a real impact on
healthcare budgets, not just in enforcement but also through wasted
prescriptions and the higher cost of delayed diagnosis of some conditions which
are disguised by “treatment” with fakes. In this paper Jim Thomson and Ian
Banks calculate that cost, with particular reference to European and US
healthcare budgets.
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9.10 am
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The Impact of Counterfeits on Parallel Trade & Pharmaceutical Distribution
Karen Mostert, Business Insights |
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At the previous Global Forum Jonathan Harper reported his findings on
the dangers to patients of parallel trade. In this paper Karen Mostert examines
the other side of the coin – the bottom-line impact to pharmaceutical
manufacturers and distributers, drawing on the data in Business Insights’
recently published report.
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9.35 am |
Global Policy Developments and Political Challenges
Laurie Self & Lisa Peets, Covington & Burling |
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Combating counterfeit pharmaceuticals requires a co-coordinated effort
between the public and private sectors. In the last few years governments and NGOs
around the world have instituted new strategies, policies and regulations.
There are too many for all of them to be the focus of papers at this Forum, so
Laurie Self offers an overview of public sector developments around the world.
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10.00 am
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Refreshment Break and Exhibition Viewing |
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10.30 am
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National Requirements for the Authentication of Pharmaceutical Products
Andres Diaz Cote, Figurazione (tbc) |
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Security products specialist Figurazione works closely with the
authorities in Colombia to control the incidence of counterfeits. Andres Diaz
Cote examines what is required for a strategic national approach which combines
the contributions of commerce, drug regulators and law enforcement.
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10:55 |
Generic Medicines: Friend or Foe?
D.G. Shah, Indian Pharmaceutical Alliance |
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Generic medicines offer a low-cost alternative to branded
pharmaceuticals, thus removing the temptation to buy fakes. But they come with
baggage - the issue of IP and patent protection. Representing the biggest
national source of generics, Mr Shah explains the opportunities and the
dilemma.
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11:20
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The Role of Donor Organizations in Building Anti-Counterfeiting Capacity
Thomas Woods, Woods International
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Thomas Woods spent time at US AID and the US State Department with
responsibility for Africa. Since leaving the government he has built on this
experience to work with aid agencies and other donor organisations to build
strategic progams to support safe medicines strategies in Africa. Here he
explains how these organizations can help to build anti-counterfeiting capacity
in developing countries.
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11:45 |
USAID's "Promoting the Quality of Medicines" Program
US Agency for International Development; US Pharmacopeia |
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USAID and the US Pharmacopeia have joined forces to introduce a $35m
program to help ensure that sub-standard medicines and medical products,
including counterfeits, are kept away from patients in low-resource countries. The two organizations
explain the program and how it can contribute to the fight against
counterfeits. In this context, they also review the relevance and use of key screening technologies to meet the program's objectives.
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12:15 pm
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Q&A & Panel Discussion
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12:30 pm
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Lunch & Exhibition Viewing
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SESSION 2: KEEPING THE SUPPLY AND DISTRIBUTION CHAINS CLEAN
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From bulk manufacturer, through
pharmaceutical producer to packager and distributor, supply and distribution
chains are the weak point for exploitation by counterfeiters. This session
examines how a combination of policy, strategy and technology can be used to
keep these fakes out of the system.
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1.45 pm
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Details to follow |
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2.10 pm
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Progress Report on EFPIA’s Data Matrix Pilot Project
Anthony Barron, EFPIA |
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EFPIA sees data matrix codes as a low-cost, efficient and effective way
to track medicines and thus minimizing the insinuation of fakes in to the supply chain. Accordingly it
recently launched a pilot project in Sweden, and Anthony Barron, who is directly
involved in this Coding and Identification Project, describes how it works and
presents preliminary results.
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2:35 pm |
IsThatgenuine: GS1’s Web Authentication and Pharmaceutical Tracking Project
Laurent Vieille, GS1 France |
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GS1, the key authority for the development and control of global article
numbering systems, has devised a system which links article codes to the overt
authentication device on a product. Still in its early stages this could
provide the solution to the authentication/tracking dilemma, as explained by
Laurent Vieille, who leads this project.
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3:00 pm
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Break & Exhibition Viewing |
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3.30 pm
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Progress and Policy at NAFDAC
Paul Orhii, NAFDAC |
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Nigeria’s NAFDAC is an exemplar of what can be achieved to control fake
medicines in a developing country with commitment and imagination. Paul Orhii,
it’s new Director, describes how he plans to continue and build on the work of
Prof Dora Akunyili, his predecessor.
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4.15 pm |
Deployment of fully portable Raman devices for product authentication
Mike Claybourn, AstraZeneca |
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Raman spectroscopy was introduced at the fourth Global Forum as a method
to assay the composition of medicines in the field. Mike Claybourn shows how
AstraZeneca is deploying these devices, in cooperation with DRAs, to detect
fakes before they are given to patients.
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4.45 pm
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Training to Ensure Meditag is Effective
Ismail Mazlan, Ministry of Health, Malaysia
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The Malaysian Ministry of Health mandates the use of Meditag®, a serialized holographic
label, on all registered medicines sold in the country. This has been very
effective in reducing the presence of unregistered or counterfeit medicines.
Part of the success lies in the training given to MoH inspectors, which Ismail
Mazlan describes and explains.
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5:10 pm |
Question & Answer Panel Discussion |
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5.25 pm
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Networking Cocktails to relax
and chat with the day’s speakers, to view the exhibition of anti-counterfeiting
providers and to catch up with all participants.
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Friday February 26 |
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SESSION 3: PROTECTION FROM PHARMACY TO PATIENT
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Pharmacies and pharmacists are the front line
in delivering medicines to patients so they could have a vital role in protecting
patients. But there is also an increasing focus on patient-managed protection
from fakes. Both aspects are explored in this session.
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8.30 pm
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Internet Buying: Is it so Dangerous
Roger Bate, American Enterprise Institute |
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Buying healthcare products over the internet is fraught with risk, as
shown vividly at the fourth Global Forum, but Roger Bate presents the findings
of his study into internet pharmaceutical sales which shows that it doesn’t
have to be all bad. He indicates how to make it safer and thus bring the
benefits of internet prices to all.
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8.55 pm |
Protecting and Risk Management for Pharmaceutical Companies
Vaughn Volpi, Pica Corporation
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Details to follow |
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9.20 am
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Forensic Analysis in Support of Counterfeit Investigation
Anthony L Zook, Merck |
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Details to follow |
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9.45 am
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The Role of On-Dose Technologies
Dean Hart, NanoGuardian
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Details to follow |
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10.10 am
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Break & Exhibition Viewing
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10.40 am
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Unit Level Serialization and Cell Phone Authentication
Stephen Wood, Covectra
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This paper explains how barcodes and human readable codes can be used as
a key to grant access to valuable patient support, product education and even
product promotion information. A practical demonstration will show how products
can be authenticated using the iPhone to scan the barcode and how human
readable codes are entered into a laptop. Once the codes are accessed, the full
variety of various other information that can be derived will also be
demonstrated.
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11.05 am
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Will Serialization Make Authentication Obsolete
Jim Rittenburg, Authentix
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This presentation examines the intersection between the digital
verification processes that are developing through serialization initiatives,
and the physical authentication systems that are associated directly with the
product or its packaging. Examples of different serialization and
authentication initiatives will be highlighted along with a vision of how these
are likely to evolve over time.
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11.30 am
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Engaging the Consumer
Huda Midani, Schreiner ProSecure |
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Engaging the consumer increases their awareness that counterfeit
products are out there and that they present a real threat. It also
demonstrates that the brand owner is focused on consumer safety and brand
integrity. Huda Midani of systems integrator Schreiner ProSecure explains how
this works to benefit producers.
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11.55 am
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Authentication in the Hands of the Patient
Alex Dodoo, Pharmaceutical Society of Ghana; Ashifi Gogo, Sproxil
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Last year Dr Dodoo conducted a survey of patient attitudes to
counterfeits and how they could be involved in detecting them, in particular
whether mobile phone detection systems could would be attractive. The results
are given in this joint paper presented by Ashifi Gogo of Sproxil.
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12.20 pm
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Question & Answer Panel Discussion
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12.30 pm
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Lunch |
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SESSION 4: TECHNOLOGIES FOR PREVENTING AND DETECTING COUNTERFEITS
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Recently there has been a rapid increase in
the sophistication of technologies to authenticate products and detect
counterfeits, matched by better understanding of how to deploy these
technologies. This final session of the Global Forum presents some of these
technologies with case studies on how they are being used. The Forum finishes
with presentations on new and emerging technologies which might have
application in pharmaceutical anti-counterfeiting.
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1.45 pm
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Industry Co-operation to Combat Fakes in Brazil
Jose Werner, Dannemann Siemsen
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Details to follow
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2.10 pm
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PCIDs and Other Dosage Based Authenticators
David Schoneker, Colocon |
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In July 2009 the US FDA issued its draft guidance on Incorporation of Physical-Chemical
Identifiers (PCIDs) into Solid Oral Dosage Form Drug Products for
Anticounterfeiting. This paper examines the PCID draft guidance as well as
tablet film coating additives including pearlescent pigments and covert markers
which enable rapid, non-destructive field authentication of solid oral doses.
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2.35 pm
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Product Brand Integrity in Latin America
Stephanie Brecht, Baxter Healthcare
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Details to follow
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New and Emerging Technologies |
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3.00 pm
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Photonic Crystals for Pharmaceutical Anti-Counterfeiting
Andre Arsenault, Opalux |
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This paper illustrates Opalux’s Photonic Color platform, which uses
tunable crystals. The different means of activation of these materials will be
covered, and their potential in the pharmaceutical authentication sector.
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3.15 pm |
Laser Surface Authentication
Mark McGlade, Ingenia Technology (tbc)
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Laser Surface Authentication (LSA) records the nano-size composition of
a surface to create a unique “fingerprint” of that surface, to authenticate the
product under that surface.
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3:30 pm |
Integral Lens Arrays and Edible Security
Daniel L Lau, University of Kentucky
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Integral lens arrays can be integrated into tablet coatings to create
images which float above the surface. Difficult to copy and easy to recognize,
are they a candidate for pharmaceutical authentication?
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3.45 pm |
Internet Governance to Stop Counterfeit Medicines
John Horton, LegitScript |
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Details to follow
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4:00 pm |
Question & Answer Panel Discussion
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4:15 pm
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Summary and Close of Fifth Global Forum
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