Conference Hashtag - #VI_AC

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1 Conference Hashtag - #VI_AC Key Speakers Include:- Ed Wheatley, Regional Investigations Director EMEA, Global Security, AstraZeneca Wendy Greenall, Counterfeit Medicines Laboratory Manager EMEA, Pfizer Ulrike Kreysa, Vice-President Healthcare, GS1 Global Office Monika Derecque-Pois, Director General, European Association of Pharmaceutical Full-Line Wholesalers (GIRP) Mustafa A. Zaman, Senior Consultant Integrated Product Development (IPD), Parexel Jim Thomson, Chair, European Alliance for Access to Safe Medicines (EAASM) Olgun Yenersoy, CEO, ADVANCO Tanvi Goel, Global Serialization Manager, Mylan Pharmaceuticals-(EGA representative) Neil Lawrence, AIDC Programme Lead Department of Health, NHS Maarten Van Baelen, Medical Affairs Manager, EGA (European Generic Medicines Association) Taha Yayci, Chief Executive Officer, TechNarts Lisa Lovell, Managing Director & Anti-Counterfeiting, Brand Enforcement Marietta Ulrich-Horn, General Manager, Securikett Silver Sponsor Associate Sponsor Supported By Organized By

2 CONFERENCE INTRODUCTION:- Counterfeit Pharmaceuticals do not only provoke immense economic damage to pharmaceutical companies but are a great risk to the public. The increasing threat calls for immediate action against counterfeit medicines. Steps must be taken by governmental and international authorities as well as by every single affected pharmaceutical company. Counterfeit APIs and medicines pose a growing threat to patients worldwide, with increasing numbers in Europe and the USA. Customs all over the world find more and more illegally produced drugs. Moreover, drugs are increasingly sold via the Internet making it much easier to put counterfeits into circulation. Counterfeiting of drugs and medical devices cost the pharmaceutical and medical device industry billions of dollars annually in lost revenues. This loss is amplified by the serious threats fake drugs pose to the health and safety of consumers. Directing your organization toward an successful brand protection system can be a daunting task given the sophistication of counterfeiters and the difficulty in tracking and prosecuting perpetrators. This in-depth workshop will teach you how to ensure you have a solid counterfeit program and help you to gain a better understanding of how to develop an efficient brand protection program. It is estimated that counterfeiting is a $600 billion a year problem. In fact, it s a problem that has grown over 10,000% in the past two decades, in part fuelled by CONSUMER DEMAND. The real truth is people who purchase counterfeit merchandise risk funding nefarious activities, contributing to unemployment, creating budget deficits and compromising the future of this country in the global economy. The real truth is counterfeiters are hardened criminals, exploiting consumers, businesses both large and small, inventors and artists and children labouring in sweatshops in Third World countries. The Facts: Counterfeiting costs U.S. businesses $200 billion to $250 billion annually. Counterfeit merchandise is directly responsible for the loss of more than 750,000 American jobs. Since 1982, the global trade in illegitimate goods has increased from $5.5 billion to approximately $600 billion annually. Approximately 5%-7% of the world trade is in counterfeit goods. U.S. companies suffer $9 billion in trade losses due to international copyright piracy. Counterfeiting poses a threat to global health and safety. 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 Competences to Combat Counterfeits in EU & USA KEY THEMES DISCUSSED AT THIS CONFERENCE:- Anti-Counterfeiting and Product Security in EU and USA: government policies & strategies Identifying current developments in counterfeits & ways to overcome threats Discovering successful business models - Opportunities & Challenges Identify main challenges and methods to improve Global Security International partnerships and EU & U.S. regulations to combat counterfeit medicines Practical Tips - Strategies for securing the supply chains of the 21st century - authentication, digital serialization, track and trace technologies and government enforcement Best Practices on risk based approach to predict & prevent counterfeiting Protect your products - Learn how to use the right packaging identification systems effectively Discuss the impact of parallel trade and re-imports on counterfeiting medicines 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 Include anti-counterfeiting in your business plan in order to secure product and supply chain safety in your company 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 WILL YOU MEET:- Brand Protection & Enforcement Units VPs, Heads, Directors and Managers with the following responsibilities: Anti-Counterfeiting Operations, Brand Protection, Brand Enforcement, Brand Security, Brand Integrity, Brand Management, Corporate Security, Global Security, Intellectual Property, Trademark Protection Supply Chain VPs, Heads, Directors and Managers with the following responsibilities: Supply Chain, Product Safety, Regulation & Quality, Quality Assurance, Track and Trace, Manufacturing Technologies, RFID WHY SHOULD YOU ATTEND:- Pharma Anti-Counterfeiting 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.

3 08:30 Coffee and registration 09:20 Morning Chair's opening remarks 09:30 Morning Keynote Address 1: Topic TBC 10:00 Morning Keynote Address 2 "Case studies of counterfeit medicines entering the legitimate Supply Chain from an AstraZeneca perspective Specific AstraZeneca case studies involving counterfeit medicines and the supply chain Examples from UK and across EMEA region How AZ manages the issue of Supply Chain Integrity Key risks and how AZ mitigate them Ed Wheatley, Regional Investigations Director EMEA, Global Security, AstraZeneca (http://uk.linkedin.com/pub/edwheatley/11/761/418) 10:30 Morning Keynote Panel Discussion: Challenges and Opportunities As globalization has created more steps between production and consumption of pharmaceuticals, manufacturers have implemented various approaches to detect and prevent counterfeit products. A combination of anti-tamper, serialization and authentication technologies can be used to detect real versus counterfeit products, creating several layers of security for original pharmaceutical producers. The Dark Side of Globalization: Conquering counterfeit medicine now requires a global solution Advice to brand owners about how to coordinate/participate in government efforts Internet Buying: Is it so Dangerous? How to make it safer and thus bring the benefits of Internet prices to all. Identifying the scope of the problem of counterfeit medicines and medical devices 11:30 The real life experience in the Health care Supply chain The reform in the Healthcare Supply Chain including all stakeholders Experience in Turkey Manufacturers problems, both for production and warehousing with serialization Wholesalers problems and solutions Live examples Point of view of business processes and the IT solution Turkey s regulation and the best practices complying with Gs1 standards Olgun Yenersoy, CEO, ADVANCO 12:00 Combating Counterfeits Online, a patient-led approach Delivering the online elements of the FMD Alerting the potential victim Changing behaviour Communicating risk vs benefit Jim Thomson, Chair, European Alliance for Access to Safe Medicines (EAASM) (http://uk.linkedin.com/pub/jim-thomson/1b/47b/969) 12:30 The GS1 System and its relationship to Anti Counterfeiting initiatives Introducing GS1 and GS1 Healthcare; who they are, what they do, current status, benefits and future trends Exploring GS1 Standards and their importance to the industry Identifying the relationship between GS1 Standards, Traceability and Anti-Counterfeiting initiatives Ulrike Kreysa, Vice-President Healthcare, GS1 Global Office (http://be.linkedin.com/pub/ulrike-kreysa/1/23/13b) 13:00 - Networking luncheon - Take your discussions further & build new relationships in a relaxed & informal setting... Moderator Panelists Mustafa A. Zaman, Senior Consultant Integrated Product Development (IPD), Parexel (http://uk.linkedin.com/pub/mustafa-a-zaman/3/a30/721) Neil Lawrence, AIDC Programme Lead Department of Health, NHS (http://uk.linkedin.com/pub/neil-lawrence/4/986/24b) Taha Yayci, Chief Executive Officer, TechNarts (http://tr.linkedin.com/in/tahayayci) 11:10 Morning Coffee & Networking

4 14:00 Afternoon Keynote Panel Discussion: A complete methodology to brand protection manufacturer's standpoint Securing the pharmaceutical supply chain tactics and compliance Finding the business case for state, federal, regulatory requirements Building an internal product safety & security team Developing A robust yet flexible anti-counterfeiting strategy for The modern age To ensure patient safety & reduce Ipr enforcement costs Practical advice for anti-counterfeiting and brand protection 2015 readiness assessment how to ensure preparedness pitfalls to avoid Moderator: Panelists: (http://pl.linkedin.com/pub/tomasz-dzitko/11/24a/762) Wendy Greenall, Counterfeit Medicines Laboratory Manager EMEA, Pfizer (http://uk.linkedin.com/pub/wendy-greenall/15/5a3/619) Tanvi Goel, Global Serialization Manager, Mylan Pharmaceuticals-(EGA representative) (http://ie.linkedin.com/pub/tanvi-goel/15/6b2/692) Lisa Lovell, Managing Director & Anti-Counterfeiting, Brand Enforcement (http://uk.linkedin.com/in/lisalovell) Marietta Ulrich-Horn, General Manager, Securikett (http://at.linkedin.com/pub/marietta-ulrich-horn/0/679/a9a) 14:50 European Medicines Verification system and the Good Distribution Practice guideline revision Modalities of medicines verifications System structure and governance Country requirements: Interoperability and system integration Challenges and economic impact of proposed new GDP guidelines on wholesale distributors Monika Derecque-Pois, Director General, European Association of Pharmaceutical Full-Line Wholesalers (GIRP) (http://be.linkedin.com/pub/monika-derecque-pois/8/b26/7aa) 16:10 Panel Discussion: Recent legislative and regulatory developments Pharmaceutical manufacturers, industry suppliers and governments have been uniting to combat counterfeit drugs. While international regulations and guidelines have been developed to help accomplish this, regional and local regulations vary at present. To address this issue new EU Serialization will be introduced in 2014 followed by the new FDA/California Serialization standard in Both of these initiatives aim to harmonize coding and require manufacturer to implement serialization systems. Analysing legal procedures after finding counterfeit drugs Insight into initiatives to promote a global anti-counterfeiting law What governments expect from brand holders when addressing IP cases How businesses can partner with EU & US customs and border protection to protect their rights Collaboration & Interaction between stakeholders & law enforcement - Building an interactive network with government & police for investigating & to monitor, track, trace counterfeiting drugs How the FBI is currently addressing counterfeit products and IP crime Moderator: Panelists: Monika Derecque-Pois, Director General, European Association of Pharmaceutical Full-Line Wholesalers (GIRP) (http://be.linkedin.com/pub/monika-derecque-pois/8/b26/7aa) Maarten Van Baelen, Medical Affairs Manager, EGA (European Generic Medicines Association) (http://be.linkedin.com/pub/maarten-van-baelen/4/200/544) 16:50 Chairperson's closing remarks and end of conference 17:00-18:00 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting... 15:20 Afternoon coffee & Networking 15:40 Initiatives of Parallel Distributors in the context of Falsified Medicines Directive Good Parallel Distribution Guidelines Early Warning Anti-Counterfeit Platform Joint Audits Initiative Collaboration with other stakeholders (http://pl.linkedin.com/pub/tomasz-dzitko/11/24a/762)

5 For Multiple Bookings - Photocopy this form... DELEGATE DETAILS: REGISTRATION:- Title Mr Mrs Ms Miss Dr First Name Surname Position Company Address Postcode Fax Telephone RESERVATION PRICING: Standard Pricing VAT per delegate Group Booking (2 and more delegates) VAT per delegate PAYMENT: Please send me a VAT invoice I enclose a cheque for Our purchase order no.is Payable to Virtue Insight Ltd Please charge my card Card type: Visa Mastercard Maestro Amex Card Number Security No Issue Date / Expiry Date / Cardholder s Name Cardholder s Registered Address Postcode Signature FOR BANK TRANSFER: Date Account Name - Virtue Insight LTD Account Number Bank Name - HSBC Sort Code TERMS AND CONDITIONS: Payment terms: Virtue Insight requires the full amount to be paid before the conference. Virtue Insight may refuse entry to delegates who have not paid their invoice in full. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, or . There is a no refund policy for cancellations received on or after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places between conferences and executive briefings. However, if you cannot attend the conference, you may make a substitution/name change at any time, as long as we are informed in writing by , fax or post. Name changes and substitutions must be from the same company or organization and are not transferable between countries. Indemnity: Virtue Insight reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of Virtue Insight. If such a situation arises, we will refund your registration fee and we will try to reschedule the event. Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel or hotel accommodation. How we will contact you: Virtue Insight's preferred method of communication is by and phone. Please ensure that you complete the registration form in full so that we can contact you.

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