Pharma Anti-Counterfeiting 2014
Offering our customers the knowledge and connections for a profitable business
Speakers
  • Stephen Wilkins Child-Safe Packaging Group

  • Ruth Hoy DLA Piper

  • Ashvin Patel European Regulatory Solutions

  • Sultan Dajani Royal Pharamaceutical Society

  • David Franklin NetNames

  • Mark Davison Blue Sphere Health

  • Cyntia Genolet Fight the Fakes

  • Franklin Apfel World Health Communication Associates

  • Sandy Eisen Frontline Pharma Consulting

  • Sophie Molle WCO (World Customs Organization)

  • Pipasha Biswas Symogen

  • Jose Henrique Vasi Werner Dannemann Siemsen Advogados (Brazil)

  • Graham Smith Aegate

  • Michael Gallagher Thermo Scientific

  • Andrew O'Neil SciMed

  • Neil Piper GS1

  • Mike Isles European Alliance for Access to Safe Medicines (EAASM)

  • Matthias Heck German Pharmaceutical Industry Association

  • Gregory Mandoli Homeland Security Investigations (HSI) - US Embassy London

  • Maarten Van Baelen EGA - European Generic Medicines Association

  • Sumit Munjal Takeda

  • Wendy Greenall Pfizer

23rd & 24th September 2014, Marriott Hotel Maida Vale, London, UK

“Competences to Combat Counterfeits in EU & U.S”

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  • Conference Info
  • Day One
  • Day Two
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Early Discount (12th July 2014 - 15th August 2014): Conference Delegate Pass (£ 700 + VAT per delegate) – You can simply email or call and book your conference delegate seats on – TEL: +44 2036120886. Email – delegate.uk@virtueinsight.com

Standard Registration (16th August 2014):- Conference Delegate Pass (£ 1000 + VAT per delegate) – You can simply email or call and book your conference delegate seats on – TEL: +44 2036120886. Email – delegate.uk@virtueinsight.com

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CONFERENCE INTRODUCTION:-

Growing cases of counterfeiting have resulted in execution of anti counterfeit technologies. Anti counterfeit technologies are of two types namely authentication packaging and track and trace packaging technologies. North America currently holds a major share of the global anti counterfeit market. Asia is said to be the one who has the highest growth rate due to untapped market and significant level of counterfeiting. Europe has a lower growth rate due to a relatively lower number of cases of counterfeiting.

The global anti counterfeit packaging market is predictable to be worth US$79.3 billion by 2014, growing at an predictable CAGR of 8.6% from 2009 to 2014. Bar code forms the largest market segment; and is expected to reach US$26 billion by 2014. However, as the bar code market is attaining development it is growing at a very low CAGR of 0.4% for the same period. RFID market has the highest growth likely and is expected to grow with a CAGR of 20.2% for the same period. North America is the largest segment in the anti counterfeit market and is predictable to reach US$49 billion by 2014, accounting for nearly 62% of the revenues rising at a CAGR of 6.8%. Asia is the second largest market and is expected to range US$14 billion by 2014 with a highest CAGR of 19.7%

Overall world revenue for pharmaceutical anti-counterfeiting technologies will reach $1.11bn in 2014. Rising concerns about counterfeit drugs worldwide will stimulate demand for drug security, authentication and verification solutions. According to a research company, a market intelligence company specializing in global connectivity and emerging technology, drug counterfeiting is a worldwide criminal enterprise, costing drug manufacturers $30 billion a year in lost revenue and brand deterioration. The Federal Drug Administration (FDA) and World Health Organization (WHO) estimate that 10% of all drugs worldwide are counterfeit. It is also predicted that 'Pharmaceutical Anti-counterfeiting Technologies Market Will Reach $1.2bn in 2015'. The worldwide prescription drug market is worth approximately $800 or $900 billion. The global market in counterfeit prescription drugs is approximately $75 billion per year. 80% of counterfeit drugs originate overseas

The wake-up call is that counterfeits REMAIN a SERIOUS THREAT AND GETTING BIGGER while the industry and various stake-holders are mobilizing on their sides for a serious battle. This conference will gather government bodies, pharmaceutical companies and solution and technology providers to discuss the in-depth insights into the strategies and cutting edge technologies for pharmaceutical anti-counterfeiting.

It gives us immense pleasure in welcoming you to “Pharma Anti-Counterfeiting 2014 - Competences to Combat Counterfeits in EU & USA”

KEY THEMES:-

  • What issues decide the future of this industry and market?
  • Anti-Counterfeiting and Product Security in EU and USA: government policies & strategies
  • Discovering successful business models - Opportunities & Challenges
  • Develop strategies for using the latest technology throughout your supply chain
  • International partnerships and EU & U.S. regulations to combat counterfeit medicines
  • US law is changing – Keep yourself updated
  • Practical Tips - Strategies for securing the supply chains of the 21st century - authentication, digital serialization, track and trace technologies and government enforcement
  • Improve consumer trust by utilizing authentication technologies and educate the public
  • Protect your products - Learn how to use the right packaging identification systems effectively
  • Plan for your most pressing security concerns
  • Effective drug packaging design and technologies enhancing product efficiency, patient and health personnel security, compliance, ease of use
  • Establish robust pharmaceutical anti-counterfeiting and brand protection strategy to protect product and brand revenue
  • Involve the latest cutting edge serialisation & track & trace technologies for anti-counterfeiting
  • Monitor the internet effectively to combat cybercrime and illegal online pharmacies
  • Include anti-counterfeiting in your business plan in order to secure product and supply chain safety in your company
  • Lead successful diversion and gray market investigations by overcoming investigative barriers
  • How the FBI is currently addressing intellectual property crime and partnering with U.S. government agencies?
  • Network in our combined exhibition and catering area
  • Evening networking reception for all attendees

WHO SHOULD ATTEND:-

  • Pharmaceutical manufacturers and distributors
  • Healthcare professionals
  • Pharmacists
  • Brand – protection, enforcement, security, integrity and management companies
  • Drug regulatory agencies, customs and police
  • Intergovernmental organizations (IGOs) involved in healthcare and IPR protection
  • Non-governmental organizations (NGOs) active in healthcare
  • Patients’ representatives
  • Healthcare research organizations
  • Pharmaceutical associations
  • Anti-counterfeiting organizations
  • Packaging, labelling and converting companies
  • Authentication technology suppliers
  • Anti-counterfeiting service suppliers – IP specialists, investigators, lawyers

WHY SHOULD YOU ATTEND:-

“Pharma Anti-Counterfeiting 2014 - Competences to Combat Counterfeits”

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading companies showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.

08:30 – Coffee and registration

09:40 – Morning Chair’s opening remarks

Mark Davison, CEO, Blue Sphere Health

MARKET ANALYSIS & CURRENT OVIERVIEW

09:50 – Morning Keynote Address 1: Trade and the Dark Net

  • Discussion of the Intellectual Property Rights Center and Homeland Security Investigations (HSI)
  • Overview of black market, online market places and crypto-currency
  • HSI investigative efforts

Gregory Mandoli, Special Agent, Homeland Security Investigations (HSI) - US Embassy London

10:30 – Morning Keynote Address 2: Risk management plan – Protecting your product

  • Risk Management Regulations as per GVP modules
  • Challenges of conducting Pharmacovigilance Risk Management for Counterfiet products
  • Introducing a system to combine risk and signal tracking actions, whilst conducting quality control activities for counterfiet products
  • Improving and adjusting the risk management processes by measuring them correctly
  • Assessing different tools in context to counterfiet products in drug risk minimisation strategies

Pipasha Biswas, Director, Symogen

11:10 – Morning Coffee & Networking Time

CHALLENGES & OPPORTUNITIES

11:40 – Morning Keynote Panel Discussion: Challenges and Opportunities

  • Ensuring effective post-marketing surveillance systems to detect and mitigate counterfeits
  • How should organizations work together to combat the problem of counterfeiting
  • Combating the illegal sale or supply of medicines over the internet sales
  • Predicting and dealing with common pitfalls and challenges
  • Case study: learning from recent real-world examples

Moderator –

Mike Isles, Executive Director of the EAASM, European Alliance for Access to Safe Medicines (EAASM)

Panelists –

Wendy Greenall, Head of Anti-Counterfeiting Laboratory for Europe, Middle East & Africa, Pfizer

David Franklin, Director - Brand Protection, NetNames

Franklin Apfel, Managing Director, World Health Communication Associates

Cyntia Genolet, Fight the Fakes

Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting

BUSINESS MODELS

12:30 – Fighting Fakes

  • Framing for (re)action- making the case for action
  • Crafting policies that can make a difference- "fighting fakes" as a health diplomacy issue
  • Using  whole-of-goverment and whole-of-society approaches- “fighting fakes “ as a governance issue
  • Applying technology to protect health and well being  for all - “fighting fakes” as a human rights issue

Franklin Apfel, Managing Director, World Health Communication Associates

Cyntia Genolet, Fight the Fakes

13:10 – Networking luncheon / Networking / Exhibition Visit

14:20 The NHS mandate for GS1 Coding

  • How the NHS has mandated the use of GS1 Coding across its estate and in private providers.
  • The impact of this mandate on the choice of a coding standard for serialisation.
  • How the NHS will use GS1 Coding beyond the supply chain for patient safety, product verification and Electronic Health Records.
  • How GDSN (Global Data Synchronisation Network) will be used by the NHS and how this can offer competitive advantage to manufacturers

Neil Piper, Consultant, GS1

15:00 – Counteracting counterfeiting in the UK

Sultan Dajani, Community Pharamacist, Royal Pharamaceutical Society

15:40 – Afternoon coffee & Networking

ANTICOUNTERFEIT - PACKAGING & LABELLING TECHNIQUES

16:00 – Packaging – staying a step ahead of counterfeiters

  • What factors to take into account for packaging
  • Primary and secondary packaging: what solutions are most effective
  • Using packaging materials and technologies to stay one step ahead of counterfeiters
  • Interactions of drug product with primary packaging and processing equipment
  • Strategies for handling changes in packaging materials

Stephen Wilkins, Secretary General, Child-Safe Packaging Group

16:40 Chairperson’s closing remarks and end of conference

Mark Davison, CEO, Blue Sphere Health

16:50 – 18:00 Networking Drinks Session

08:30 – Coffee and registration

09:30 – Morning Chair’s opening remarks

Mark Davison, CEO, Blue Sphere Health

SERIALISATION

09:40 – Morning Keynote Address 1: Serialisation – is coming to the global pharmaceutical supply chain

  • How serialisation works and which countries are now having traceability laws
  • Scoping out your strategy, tactics and implementation for serialisation
  • Find out how to avoid in investing in wrong places
  • Adherence promotion, case management and follow up
  • Profiting from serialisation - grey market diversion monitoring and detection; patient communications; controlled substance abuse and misuse; patient adherence and outcomes monitoring.
  • Developing a cost-effective approach to implementing serialisation globally

Mark Davison, CEO, Blue Sphere Health

IMPACT OF TECHNOLOGY

10:20 – Using molecular spectroscopy (NIR and RAMAN) as reliable tools for counterfeit product detection

  • Spectroscopy can detect differences that the eye can't see
  • Raman provides accurate material signature
  • 1064nm provides greater information than usual 785nm
  • Small portable NIR ideal for mobile detection

Andrew O'Neil, NIR & RAMAN Product Manager, SciMed

11:00 – Morning Coffee & Networking

11:20 Portable Spectroscopy: Screening for Fake Drugs

  • Fake Drugs screening
  • Counterfeit medicine identification
  • Sub-Standard medicine identification
  • Chemical fingerprint screening

Michael Gallagher, Global Applications Manager, Thermo Scientific

INTELLECTUAL PROPERTY

12:00 – Online brand protection and IP infringement

  • How to have a have a secure and adaptable online strategy to protect your brand
  • How to control you brand in an expanding online market
  • How to protect against IP infringement with a concrete detection, prevention and response strategy.
  • How to leverage the relationship between trademark/IP professionals and the brand protection programme managers for successful results
  • Discussing what trademarks brand owners are now registering, what criteria to use and how to protect them thoroughly
  • Update on EU policy and legislation update in enforcing brand protection and combating counterfeiting

David Franklin, Director - Brand Protection, NetNames

12:40 – Networking luncheon / Networking / Exhibition Visit

13:50 – Aegate – The practical experience gained in running a real-time end-to-end medicines verification service

Graham Smith, Commercial Director, Aegate

14:30 – New compliance rules in Brazil

  • The new Law 12846/13;
  • Positive and negative aspects of the Law;
  • What to expect from enforcement authorities;
  • “Go do”

Jose Henrique Vasi Werner, Partner, Dannemann Siemsen Advogados (Brazil)

15:10 – Afternoon coffee & Networking

15:30 WCO IPR activities IPM: a global standard platform between stakeholders in the fight against counterfeiting

  • WCO focus on health and safety issues
  • IPM mobile application with scanning possibility
  • Interception operations
  • How can brand owners and security feature providers contribute to this battle?

Sophie Molle, IPM Senior Manager, WCO (World Customs Organization)

REGULATORY

16:10 – Panel Discussion: Recent legislative and regulatory developments

  • Update yourself on the recent legal enforcements in EU and US towards Anti-counterfeiting
  • Insight into initiatives to promote a global anti-counterfeiting law
  • What governments expect from brand holders when addressing IP cases
  • Legal aspects of anti-counterfeiting measures for EU & US pharmaceutical stakeholders
  • Collaboration & Interaction between stakeholders & law enforcement - Building an interactive network with government & police for investigating & to monitor, track, trace counterfeiting drugs
  • Practical legal advice on anti-counterfeiting and brand protection

Moderator –

Ashvin Patel, Director of Regulatory Affair (CMC Biologics), European Regulatory Solutions

Panelists –

Maarten Van Baelen, Medical Affairs Manager, EGA - European Generic Medicines Association

Sumit Munjal, Medical Director, Takeda

Matthias Heck, Head of Brussels Office, German Pharmaceutical Industry Association

Ruth Hoy, Partner - Intellectual Property & Technology Group, DLA Piper

16:50 – Chairperson’s closing remarks and end of conference

Mark Davison, CEO, Blue Sphere Health

17:00 End of Pharma Anti-Counterfeiting 2014

Stephen Wilkins

Secretary General

Child-Safe Packaging Group

Ruth Hoy

Partner - Intellectual Property & Technology Group

DLA Piper

Ashvin Patel

Director of Regulatory Affair (CMC Biologics)

European Regulatory Solutions

Sultan Dajani

Community Pharamacist

Royal Pharamaceutical Society

David Franklin

Director - Brand Protection

NetNames

Mark Davison

CEO

Blue Sphere Health

Cyntia Genolet

Fight the Fakes

Franklin Apfel

Managing Director

World Health Communication Associates

Sandy Eisen

Chief Medical Officer

Frontline Pharma Consulting

Sophie Molle

IPM Senior Manager

WCO (World Customs Organization)

Pipasha Biswas

Director

Symogen

Jose Henrique Vasi Werner

Partner

Dannemann Siemsen Advogados (Brazil)

Graham Smith

Commercial Director

Aegate

Michael Gallagher

Global Applications Manager

Thermo Scientific

Andrew O'Neil

NIR & RAMAN Product Manager

SciMed

Neil Piper

Consultant

GS1

Mike Isles

Executive Director of the EAASM

European Alliance for Access to Safe Medicines (EAASM)

Matthias Heck

Head of Brussels Office

German Pharmaceutical Industry Association

Gregory Mandoli

Special Agent

Homeland Security Investigations (HSI) - US Embassy London

Maarten Van Baelen

Medical Affairs Manager

EGA - European Generic Medicines Association

Sumit Munjal

Medical Director

Takeda

Wendy Greenall

Head of Anti-Counterfeiting Laboratory for Europe, Middle East & Africa

Pfizer

ORGANISED BY

Virtue Insight

Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.

Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.

SILVER SPONSOR

SciMed

Scientific & Medical Products supply laboratory instruments and systems for research, development and quality control applications. We offer a wide range of equipment from leading manufacturers and have built an excellent reputation in the areas of Process Chemistry, X-Ray Fluorescence, Ultrasonic Processing, Electrochemistry and Raman Spectroscopy. Within the Raman field we represent Foster and Freeman and Rigaku Raman Technologies on both micro and macro/handheld respectively. These Systems can be used both in the lab and in the field for detecting counterfeit products.

Thermo Scientific

Developed with in-depth pharmaceutical industry experience, Thermo Scientific handheld analyzers provide manufacturers with a portable solution to achieve quality initiatives throughout the manufacturing process.  Our analyzers are used by 37 of the top 40 global pharmaceutical manufacturers to verify the identity of raw materials or finished products.  

With greater than 500 GMP facility installations worldwide, we’ve successfully implemented our solutions into the top pharmaceutical companies and regulatory enforcement agencies worldwide – enabling them to increase productivity and realize a rapid return on their investment.  Regulatory agencies in North America, Europe, Asia and Africa rely on our analyzers to bolster their anti-counterfeiting efforts.

The Thermo Scientific TruScan RM, based on Raman spectroscopy, and the Thermo Scientific microPHAZIR RX, based on Near-Infrared spectroscopy, offer complementary field-ready solutions to support the war against pharmaceutical counterfeiters. With these analyzers in hand, brand owners and government agencies can create new and powerful anti-counterfeiting strategies. 

The Thermo Scientific TruScsan RM and microPHAZIR RX examine the chemical composition of all components of a pharmaceutical dosage, including APIs, excipients, fillers, dyes, and coatings to create a unique spectral fingerprint representing the authentic medicine. Deviation from the original formulation will lead to a detectable change in the measured spectrum, making these tools ideal for the rapid detection of counterfeit pharmaceuticals.  Substandard products with the right ingredients, but inadequate amounts of active ingredient, can also be identified by their spectra.  Both analyzers are 21 CFR part 11 compliant and meet the requirements of global pharmacopeias.

BRONZE SPONSOR

Aegate

Aegate is the leading and most experienced specialised provider of medicine verification and authentication services in the World. Through integration with pharmacy Patient Medication Record (PMR) systems, Aegate services protect over 17 million patients across Europe.

PLD SPONSOR

Byte Mindz

We the ByteMindz an emerging company incorporated with an aim of providing business solutions across Web Designing, Web Application Development, Software Development and Multimedia Services inclusive of various value-added services. We work on a diverse product line of services which are developed compatible for various frameworks, providing a complete project design and development using our high standard technical team.

We believe not only to produce exceptional in-house application we focus also on enhancing the commercial values for the customer end user applications. We extend our power of imagination across various verticals of IT services making the customer highly satisfied by providing an individual attention to each and every customer irrespective of the high, medium & large scale of organization.

Our Value Added service includes the service apart from our core standard service, we give a valuable testing unit and a complete support from our back end .We would like to hear from the customer periodically and we monitor our growth based on the customer quotes & comments and work hard on fixing those reported problems and include the fixes in our library based on the system designs and code compatible requirements. For more information log on to www.bytemindz.com

EXHIBITOR

Intertek (Schweiz) AG

Intertek is a leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value for its customers by helping improve the quality and safety of their products, assets and processes with a network of more than 1,000 laboratories and offices and over 36,000 people in more than 100 countries. Intertek offers a tailored supply chain surveillance programs focused on ensuring the quality and safety of the supply chain through the global reach of our audit and inspection network, underpinned by our expert scientific investigational testing services.

Our programs essentially provide quality surveillance for various project lifetimes. On a short term perspective, we can provide a rapid response program initiated within 24 hours to address fast evolving counterfeit incidents providing assessment and investigational outputs to assist the stakeholders in their decision making process to combat the issue. On a mid to long term perspective Intertek focuses on the supply chain to help the stakeholder maintain the long term quality and safety of official supply chains. Intertek carries out comprehensive analytical screening programs. These include photographic documentation, visual inspection of samples, and analysis by scanning electron microscopy (SEM) in combination with x-ray diffraction (SEM-EDX) with a focus on the elemental composition, analysis by infrared spectroscopy (FT-IR), nuclear magnetic resonance spectroscopy (NMR) and liquid chromatography-mass spectrometry (LC-MS) with a focus on the active ingredients. Contact Intertek to discuss how our global supply chain solutions and network of expert pharmaceutical analysis laboratories can help you to maintain the quality and safety of the pharmaceutical supply chain. http://www.intertek.com/

AlpVision

AlpVision is the world’s leader in digital invisible technologies for product authentication and counterfeit protection. Simple and industry-proven, AlpVision’s cost-effective, high-security digital authentication solutions protect billions of branded products and packaging across industries worldwide. Product protection is either done by working on the packaging or on the product itself. AlpVision Cryptoglyph is a digital solution to protect packaging and packaging components, such as labels, by applying an invisible marking using standard visible ink or varnish. Integrated into the artwork file and printed without modifying the standard printing process, the Cryptoglyph is the most effective and efficient solution for large volume products. AlpVision Fingerprint is a digital solution to authenticate the product directly by exploiting inherent surface characteristics of the material. The Fingerprint solution applies to a wide variety of products, including molded parts such as bottles and caps, electrical appliances, mechanical parts, imaging supplies, and most plastic molded products available on the market today. For both solutions, Cryptoglyph and Fingerprint, a standard smart phone is used to authenticate the protected item.

Other services provided by AlpVision include Quality Assessment devices, a server-based Web application to manage security features, custom developments, and staff training. More information is available at www.alpvision.com.

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Pharmaphorum

pharmaphorum is the primary facilitator of thought leadership and innovation within pharma. We support the next generation of pharmaceutical industry leaders through producing, curating and publishing media that will help pharma embrace the challenges of being a healthcare solutions provider in the 21st century.

Our services include:

  • Publication of interesting new written, audio and video content addressing critical pharma issues from around the world.
  • Showcasing key service providers who can work with pharma executives to forge the business models of the future.
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Advice and support on the use of social media within pharma to effectively connect companies, improve PR and share innovation.

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Our highly researched conference agenda delivers all the latest information and our world-class speakers attract delegates from around the world to attend. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.


What is the format of our conference programme?
The conference programme consists of world-class keynote addresses, case study presentations and panel discussions.


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  • Meet your peers in an interactive, discussion-based format designed to maximize knowledge transfer and networking
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Coming Soon...

Organisers who didn't stop all-day to ensure the conference was consistently seamless, flowing smoothly and who ensured everyone's needs were well catered for. Top venues and top speakers cannot hide or replace poor professional service so well done to all involved for organising a platinum starred, all-round highly successful conference

Sultan 'SIDí Dajani
Treasurer, Royal Pharmaceutical Society

The conference was superb! Very organized and with an excellent content. Congratulations!

Jose Henrique Vasi Werner
Partner, Dannemann Siemsen Advogados (Brazil)

Great mix of presenters & material would love to see presence of regulators to add dimension to content

Steven lubesk
Sr.Manager Global Security, Alexion Pharmaceuticals

Event organize couldn’t be more helpful and friendly they were very good at meeting my requirements

Charcotte Miller
Brand Enhancement Manager, Colorcon

It was a worthy exercise in preparations for the changing legislation in relations to one global supply chains operations and the fight against counterfeit products

Steve Osaghae
Data Analyst, Mallincrodt Pharmaceuticals

For access to the presentations for this conference, please email us at presentations@virtueinsight.com

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