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                 Pharmaceutical
                 Packaging and Labelling
                                                               Summit 2012
DATE:                                     VENUE:                                    Pre-Conference Focus Afternoon:
26 - 27 June, 2012                        Grand Hotel Les Trois Rois, Basel,        25 June, 2012
                                          Switzerland
 Prepare for the Falsified Medicines Directive, maximise patient compliance
 and protect your supply chain

 Benefits of attending                                         Expert speaker panel includes:
 r	Implement the forthcoming Falsified                         Walter Bisson – Global Programme Manager – Novartis
 	 Medicines Directive effectively with guidance 	             Pharma AG (EFPIA representative)
 	 from, SwissMedic, MHRA and senior EFPIA 	                   Mathieu Aman - Global Program Manager « Coding,
 	 representatives                                             Serialization and Tracking & Tracing - F. Hoffmann-La
 r	Maximise your track and track system                        Roche Ltd (EFPIA representative)
 	 by understand the pitfalls, as well as the                  Dr Ruxandra Rogosca – Medical Manager Balkans – Reckitt
 	 advantages of these systems with an exclusive 	             Benckiser
 	 case study showcasing implementation in Turkey.             Ian Holloway – DMRC Manager – MHRA
 r	Cost-effectively increase patient compliance by 	           Al Iannuzzi – Senior Director in worldwide Environment,
 	 adapting your packaging: learn how from HCPC 	              Health & Safety department – Johnson & Johnson
 	 and Novo Nordisk                                            Mark Freeman – Packaging Services Manger - Pfizer
 r	Increase sustainability by reducing volume and 	            Hicham Safine – Europe Quality Consultant – Eli Lilly
 	 upgrading packaging: benchmark against global 	
                                                               Tanvi Goel – Global Supply Chain Manager – Mylan
 	 leaders Johnson & Johnson
                                                               Pharmaceuticals
 r	Gain critical insight into industry packaging 	
                                                               Horst Kastrup – Director of Regulatory Affairs – Meda
 	 decisions: join Pfizer in a practical session 		            Pharmaceuticals
 	 evaluating different manufacturer’s technique.
                                                               Keith Howard – Regulatory Affairs Labelling – ViroPharma
                                                               SPRL

 Traceability and Supply Chain Security                        Dr Catherine Manigley – Head of Division Market Monitoring
                                                               of Medicines – SwissMedic
 Focus Afternoon | 25 June 2012
                                                               Tassilo Korab – Executive Director – HCPC Europe
 Protect your Supply chain by Joining GS1 representatives,
 a cross-industry track and track expert and industry          Michael Ritter – Project Manager – Novartis Pharma AG
 leaders Sandoz to discuss and advance in the newest           Mark Davison – CEO – Blue Sphere Health
 technologies, understand developments in legislation and
 examine case studies in this crucial area.                    Janice Kite – Director Healthcare Traceability – GS1


 2012 Sponsors
                                                               “Selection of speakers was well done, experts of the
                                                               industry!”
                                                                                       - Marietta Ulrich-Horn – Securikett

                                                                 “Very interesting-networking allowed me to meet
                                                                people dealing with the same problems I face every
                                                                day. Sharing experiences is very valuable and helps
                                                                            to analyse from another point of view”
                                                                                                             - UCB Worldwide




 T: +44 (0)20 7036 1300 F: +44 (0)20 7368 9301 E: Enquire@iqpc.co.uk W: www.pharmapackaginglabelling.com
Saving costs by preparing for implementation of the Falsified Medicines Directive, maximising patient
                               compliance and protecting your supply chain.

2011 was a tough year for the pharmaceutical packaging industry. It saw the passing of the falsified medicines
directive (FMD); counterfeit drugs cost the pharmaceutical industry $75 billion dollars and to top it off $30 billion was
lost due to lack of patient compliance. Unfortunately 2012 looks to have similar challenges in store as pharma
companies look to regain profit lost due to lack of patient compliance, implement serialisation and put in place cost-
effective anti-counterfeiting programmes.

With this in mind Pharma-IQ is pleased to bring you the 2nd Annual Pharmaceutical Packaging and Labelling Summit,
which brings together all the leading packaging and labelling experts to thrash out the core issues and give you
practical approaches and top tips to take back to your company.

So what’s new for 2012?

Bored of 2 solid days of presentations? This year has been built with interactivity in mind, with sessions such as
serialisation clinics; panel discussions and roundtable discussions taking centre stage to allow you to find solutions for
your specific challenges. This is on top of the regulatory and case study driven presentations that you’ve come to
expect from our event with all sessions taking place in the heart of pharmaceutical territory - Basel.

A quick taste of what’s to come for 2012:

-     Top tips for cost-effective implementation of the FMD on a pan-European level

-     Best approaches for optimising your packaging to ensure the highest possible patient compliance. $30 billion a
      year is lost due to medicines not being taken as prescribed, will this affect you?

-     Protecting your supply chain: preventing counterfeit pharmaceuticals entering your packaging line

-     Overcoming the practical challenges faced with new readability guidelines

-     A regulators perspective on the serialisation requirements at a country specific level

In this challenging environment with constantly changing regulations and patient safety ever paramount join us in
developing the best approaches to keep you ahead of the game in 2012!

I look forward to seeing you in Basel this June.

Anna Fraenkel

Conference Producer




                                www.pharmapackaginglabelling.com
Speakers & Advisory Board

Introducing your 2012 Advisory Board:


   -   Phil Marley – Packaging Intelligence Manger – AstraZeneca (HCPC)


   -   Horst Kastrup – Director of Regulatory Affairs – Meda Pharmaceuticals


   -   Dr Ruxandra Rogosca – Medical Manager Balkans – Reckitt Benckiser


2012 Confirmed Speakers:


   -   Walter Bisson – Global Programme Manager – Novartis Pharma AG (EFPIA representative)
   -   Mathieu Aman - Global Program Manager Coding, Serialization and Tracking & Tracing -
       F. Hoffmann-La Roche Ltd (EFPIA representative)
   -   Mark Freeman – Packaging Services Manager- Pfizer
   -   Hicham Safine – Europe Quality Consultant – Eli Lilly
   -   Dr Ruxandra Rogosca – Medical Manager Balkans – Reckitt Benckiser
   -   Ian Holloway – DMRC Manager – MHRA
   -   Soren Skovlund – Global Director, Patient Research, Advocacy and Support – Novo
       Nordisk A/S
   -   Tanvi Goel – Global Supply Chain Manager – Mylan Pharmaceuticals
   -   Horst Kastrup – Director of Regulatory Affairs – Meda Pharmaceuticals
   -   Inal Kose - FDF Warehouse Specialist – Sandoz
   -   Dr Roberto Frontini – President – European Association of Hospital Pharmacists
   -   Dr Catherine Manigley – Head of Division Market Monitoring of Medicines – SwissMedic
   -   Al Iannuzzi – Senior Director Worldwide Environment Health & Safety – Johnson and
       Johnson
   -   Tassilo Korab – Executive Director – HCPC Europe
   -   Michael Ritter – Project Manager – Novartis Pharma AG
   -   Keith Howard – Regulatory Affairs Labelling – ViroPharma SPRL
   -   Janice Kite – Director Healthcare Traceability – GS1
   -   Mark Davison – CEO – Blue Sphere Health
   -   Richard Wishart – Owner - Delivery Management Ltd
   -   Tod Urquhart - Sales Director - kezzler




                  www.pharmapackaginglabelling.com
PRE CONFERENCE WORKSHOPS


25th June 2012

Workshop (A) 09.00-12.00

 Minimising costs by delivering right-first-time artwork to a global market - Understanding all
   the capability elements required to deliver accurate artwork in a global pharmaceutical
                                            company.

Join the former Director of Global Pack Management from GlaxoSmithKline to discuss:
    -   The challenges facing artwork capabilities, internally and externally
            o Introduction to SWAT analysis
            o Sub-group break-outs to develop SWAT for artwork capabilities

    -   Introducing model capability
             o Discussing the elements of a full artwork capability model

    -   Defining capability elements
            o sub-group break-outs to develop key contents of each capability on a sliding
                scale of “In Control” through to “World Class”

    -   Personal gap analysis
            o Tailored input into your challenges. The opportunity to give a personal review of
               where your organisation is and what gaps they might have and receive expert
               feedback

Andrew Love, Vice president B4ward (former Director Global Pack Management,
GlaxoSmithKline)

Focus Afternoon: 13.00 – 17.00
An afternoon dedicated to providing you with the most up to date and advanced
information in traceability and supply chain security

Cost-effectively implement the best possible track and trace system you can. Join us for a jam
packed afternoon with experts from the industry, GS1 and a cross industry perspective from a
track and trace professional.

Open Q&A panels, Interactive practical sessions and case study based discussions will provide
attendees with the most current and innovative information on protecting your supply chain from
counterfeits. Learn from those who already have the experience. Allow them to show you the
best way forward in implementing your supply chain security.

Join out expert panel:
Janice Kite – Traceability Director Healthcare – GS1 Global Office
Inal Kose - FDF Warehouse Specialist – Sandoz
Richard Wishart – Owner - Delivery Management Ltd

    (1) Supply Chain Standards: Critical to Traceability and Product Serialisation?

Supply chain standards are the foundation to facilitating effective implementation of product
serialisation and traceability systems across healthcare globally. Join Janice Kite, Traceability
Subject Matter Expert to arm you with the expertise to implement these processes effectively.

Gain understanding of the relevant regulations and understand the IT models most effective for
successful implementation of traceability.

GS1: The Supply Chain Standards Organisation

        -   Who are GS1?
        -   The standards development journey so far: how and why
        -   Collaboration and harmonisation
        -   Work in progress: possible information technology systems choreographies


                   www.pharmapackaginglabelling.com
PRE-CONFERENCE WORKSHOPS

Effective data management and IT models to improve healthcare traceability. Join this open
interactive session to discuss:
    -    Industry concerns related to IT models for traceability: operational efficiency impact, data
         availability, ownership and confidentiality. Better than the status quo?
    -    The Pros/Cons of the possible IT models

    (2) Developing Effective Supply Chain Security and Anti-counterfeiting Methods: Experiences
        from Implementing Serialisation and Drug Tracking in Turkey

Follow Sandoz’s implementation of track and trace projects in Turkey. The second phase of
serialisation requirements is being implemented in Turkey in 2012. Now is the perfect time to learn
from others, facilitating your decisions for future global supply.

    -   Analyzing existing and approaching regulatory and customer requirements on
        product identification & traceability worldwide and examining regional legislation in
        Turkey
    -   Understanding 2D Datamatrix code to ensure supply chain visibility and describing
        the needs to improve tracing
    -   Exploring whole information system and data flow to understand traceability with
        Datamatrix
    -   Identifying the technical requirements to effectively apply and read the code
    -   Examining practical experiences from Daiichi-Sankyo Turkey to develop your
        international serialisation system.

    (3) Track and Trace: What can we learn from a cross industry representative

Richard Wishart is a professional in logistics with extensive experience and knowledge in tracking
technologies. Here he discusses what can be learned from industries outside of pharmaceuticals.
    -  Use QR codes to effectively promote your product.
    -  Understand the best implementation for RFID’s and the future of this technology

    (4) Panel Discussion: Cost effective implementation of track and trace technologies
Join our broad panel of experts from across the industry. This is your chance to quiz them on their
knowledge and experience. Don’t miss the chance to get answers to those questions that keep
you up at night.

Janice Kite – Traceability Director Healthcare – GS1 Global Office
Inal Kose - FDF Warehouse Specialist – Sandoz
Richard Wishart – Owner - Delivery Management Ltd


27th June 2012

Breakfast briefing: 7.30am – 9am

Sign up for our interactive breakfast discussion. With open decisions, and plenty of coffee, this is
your chance to get a head start to day two by delving into methods to authenticate your
products

Differentiating the genuine from the fake: authentication using digital and physical packaging
security features
     -  Developing visual inspection and the use of physical features to differentiate your
        packaging
    -   Update on physical authentication techniques
    -   Coding and future digital authentication approaches
    -   Best practice for combining physical security features and codes on the production line

Mark Davison – CEO – Blue Sphere Health




                   www.pharmapackaginglabelling.com
CONFERENCE AGENDA

Day one: 26th June 2012

08.30     Registration and networking coffee
08.50     Pharma IQ welcome and Chairperson’s opening address
Serialisation: optimising the implementation of cost-effective strategies to comply with new
legislation
09.00     Implementation of the Falsified Medicines Directive (FMD) on a pan-European level:
          current thoughts for a practical guide on how to comply on a country by country basis
               -    An overview of the FMD: why, when and how?
               -    The EFPIA approach towards a European Pan Verification System
               -    Understanding the timelines to ensure an effective implementation strategy is in
                    place for the future
          Mathieu Aman - Global Program Manager Coding, Serialization and Tracking & Tracing
          F. Hoffmann-La Roche Ltd, Basel (EFPIA)
09.30     Adapting to the Falsified Medicines Directive: an industry perspective
               -    An overview of the biggest changes currently affecting the pharmaceutical
                    manufacturing.
               -    The key challenges and impact when adapting to the FMD across Europe
               -    Lessons learned from early implementations
               -    Evaluating the impact on pharma: what will the implications of the FMD be?
          Walter Bisson – Global Program Manager – Novartis Pharma AG (EFPIA)
10.00     Breakout session: Open discussion with EFPIA
          Two EFPIA representatives both with extensive experience in the pharmaceutical
          packaging and labelling industry. This is your chance to get ask those questions that
          keep you up at night!
               -    Mathieu Aman – Global Programme Manager – Coding, serialization and
                    tracking and tracing – F. Hoffmann- La Roche Ltd, Basel
               -    Walter Bisson – Global Programme Manager – Novartis Pharma AG
10.30     Technology spotlight session: For more information on sponsorship and exhibition
          opportunities please contact Onkar Sumal on +44 2073699300 or email
          sponsorship@iqpc.co.uk
11.00     Networking Coffee Break
11.30     A cost effective approach to supplying Turkey: facing the challenges involved in
          complying to serialisation requirements
               -    Outlining our strategy for complying with Turkish requirements
               -    Analysis of the problems encountered in adapting to the new regulations
               -    What went right, what went wrong and how we faced these problems
               -    Best practice approaches for successfully implementing serialisation in Turkey
               -    The future: what our experiences have taught us for future implementation of
                    serialisation requirements across the globe
          Hicham Safine – Europe/AMEA/CIS Quality Consultant– Eli Lilly
12.00     Technology spotlight session: For more information on sponsorship and exhibition
          opportunities please contact Onkar Sumal on +44 2073699300 or email
          sponsorship@iqpc.co.uk
12.30     Initial thoughts looking towards implementation of the Falsified Medicines Directive: a
          regulatory perspective
               -    Overview of the international requirements: what is required and by when
               -    Tamper evidence and its place in preventing counterfeit
               -    Problems arising in the development of adapting to this directive
               -    Best practice recommendations for preparation towards implementation of the
                    falsified medicines directive
          Ian Holloway – DMRC Manager - MHRA

13.00    Networking Lunch Break


                   www.pharmapackaginglabelling.com
CONFERENCE AGENDA

14.00   Analysing the challenges of complying to recent packaging regulations in the global
        market
            -   Supplying the world: overview of the challenges faced in adapting packaging
                for the global market
            -   Understanding the various recent or upcoming requirements re serialization and
                tracking in key markets: India, China, Latin America and the USA
            -   Technical approaches to integrate overt and hidden originality signs and markers
                in your packaging for global product delivery
            -   Tamper proof packaging: what may we learn from the food industry?
        Horst Kastrup – Senior Regulatory Advisor – MEDA Pharma GmbH
14.30   Mass-serialisation forum:
        An open discussion into the challenges and solutions faced in the potential
        harmonisation of standards across Europe. Discuss your opinions and issues with key
        peers, association and regulators
                                                                                                INTERACTIVE
        Tanvi Goel – Global Supply Chain Manager – Mylan Pharmaceuticals
        Janice Kite - Director Healthcare Traceability – GS1
        Other Mediators to be confirmed visit www.pharmapackaginglabelling.com for updates
15.00   Databases: no longer fit for the purpose of serialisation and track & trace
            -    The challenge of serialisation
            -    Data management requirements
            -    Performance statistics of large databases vs. Kezzler solution
            -    Impact on companies
         Tod Urquhart - Sales Director- Kessler A.S
15.30   SwissMedic’s approach to the global threat of falsified medicines: a regulatory overview
            -    International pharmaceutical crime – a global threat
            -    International legislative Initiatives – the “Medicrime Convention”
            -    International collaboration against counterfeits
            -    National activities against pharmaceutical crime
            -    Future of falsified medicines and the global fight
        Dr Catherine Manigley – Head of Division Market Monitoring of Medicines – SwissMedic
16.00   Networking coffee break
16.30   Back by popular demand: Roundtable Discussion Session
        You can choose to attend one of four informal discussion sessions, depending on your
        goals and strategies. Join our resident experts for a no holds barred, frank discussion on
        the topic of your choice
        Topics include:

        Tamper proof             User testing: the    Is patient              Harmonised
        evidence Horst           challenges are       compliance worth        serialisation across the
        Kastrup –Director of     still out there!     investing in? Tassilo   EU: A choice in
        Regulatory Affairs -     Keith Howard –       Korab – Executive       coding: 1D, 2D, or RFID
        Meda Pharma              Regulatory Affairs   Director – HCPC         – Mathieu Aman –
                                 Labelling -                                  Project Manager
                                 ViroPharma                                   Global Logistics –
                                                                              F.Hoffmann-La Roche




                  www.pharmapackaginglabelling.com
CONFERENCE AGENDA


      17.30      Introducing GS1 and an update on Standards development and implementation in
                 Healthcare
                      -  Overview of important regulatory and industry developments
                      -  GS1 Standards for Healthcare: Process and technical (“Identify, Capture, Share”)
                         standards
                      -  Examining the move to implementation of standards
                      -  Understanding how GS1 standards assist in compliance to regulations, e.g. the
 ALL NEW                 Directive for Falsified Medicines directive
PRODUCT          Janice Kite - Traceability Director Healthcare - GS1 Global Office

SHOWCASE!       Product Launch and Technology Innovation Spotlight
                Leading providers will unveil their latest technology developments and product launches for
                2012 in this industry first showcase.
                Each company will provide a succinct 5 minute overview of their new developments for 2012
                and beyond.


      18.00      Chairpersons closing remarks and close of day one.




      Day Two: 27th June 2012


      Breakfast briefing: 7.30am – 9am
      Sign up for our interactive breakfast discussion. With open decisions, and plenty of coffee, this is
      your chance to get a head start to day two by delving into methods to authenticate your
      products

      Differentiating the genuine from the fake: authentication using digital and physical packaging
      security features
           -  Developing visual inspection and the use of physical features to differentiate your
              packaging
            -   Update on physical authentication techniques
            -   Coding and future digital authentication approaches
            -   Best practice for combining physical security features and codes on the production line

      Mark Davison – CEO – Blue Sphere Health

                                           CONFERENCE AGENDA

      8.30            Registration and Coffee
      8.50            Day two Chairperson’s Opening Address
      Pharmaceutical packaging and labelling streamed sessions: We aim to really focus these sessions
      for you, as such we have streamed this afternoon. Track A focuses on the understanding and
      implementation of readability guidelines and track B looks at effectively tackling counterfeit drugs.

                 Labelling and Leaflets: cost-effectively      Fighting Counterfeit: best approaches for
                 adapting your labelling process to supply     preventing counterfeit drugs entering your
                 international markets                         packaging line




                           www.pharmapackaginglabelling.com
9.00    (A) Launching your product into a new             Protecting your customers: using pack
            market: Belgium – a case study                    security features to help prevent counterfeit
                -   Overview of key challenges faced          pharmaceuticals infiltrating your supply
 TAILOR             in adapting your packaging to a           chain
                    new market                                        Coding and tracking your product
  YOUR                                                            -
                -   Special considerations, language                  to promote accurate stock control,
AGENDA
                    difficulties: adapting to a tri-lingual           patient safety and prevention of
                    market                                            counterfeits
                -   Our experiences: what went well               -   Implementing the best solutions:
                    and the key challenges faced                      cost-effectively preventing
                -   Top tips for cost effective product               counterfeit drugs entering your
                    launch into a new market                          chain
            Keith Howard – Regulatory affairs Labelling           -   Best practice for combining
            Manager – ViroPharma SPRL                                 physical security features and
                                                                      serialisation codes on the
                                                                      production line
                                                              Mark Davison – CEO- Blue Sphere Health

    9.30    Adapting your labelling process for global        Strategy to implement Serialization and
            delivery: complying to international              Product Tracking (SPT) in Europe to comply
            readability guidelines                            with China SFDA requirements
                -   Discuss your approach for                 Identifying the need to upgrade your
                    delivering drugs to a global market       packaging line in order to comply with
                -   The key challenges faced by the           legislation
   OPEN             labelling industry for worldwide              -    Scope and timelines of the SPT
  FORUM             drug delivery                                      regulations
                -   Best approaches for adapting the              -    Cost effectively adapting the
                    labelling process for the worldwide                existing packaging lines to comply
                    industry                                           to new emerging regulations
            With input from key experts across our                -    Using IT to support SPT
            speaker faculty                                            implementation
                                                                  -    Outlook and next steps
                                                                  Michael Ritter - Project Manager -
                                                                  Novartis Pharma

    10.00   Technology spotlight session: For more information on sponsorship and exhibition
            opportunities please contact Onkar Sumal on +44 207 369 9300 or email
            sponsorship@iqpc.co.uk

    10.30        Networking Coffee Break
                 Patient compliance and adherence: implementing the best packaging solution
    11.00        Optimising your packaging to ensure the highest possible patient compliance: $30
                 billion is lost every year due to medicines not being taken as prescribed. Will this be
                 from your pocket?
                      -    Overview of patient compliance packaging: cost effective strategies to
                           increase patient adherence
                      -    Maximising patient compliance through innovative technology. What can
                           be done and why should we care?
                      -    Maximising profit by effectively packaging your product to reduce areas of
                           error and improve patient compliance
                 Tassilo Korab – Executive Director - European Healthcare Packaging Compliance
                 Council




                      www.pharmapackaginglabelling.com
CONFERENCE AGENDA
    11.30     Designing your packaging to facilitating patient compliance: an industry
              perspective
                   -   Patient compliance: an overview of current industry trends and opinions
                   -   What is driving the change process in the pharmaceutical industry?
                       Understanding the motivation for increasing patient compliance.
                   -   Challenges faced in adapting your packaging to increase patient
                       adherence
                   -   Best approaches for effectively increasing patient compliance
                   Soren Skovlund – Global Director, Patient Research, Advocacy and Support –
                   Novo Nordisk A/S
    12.00     Single dose, Barcoding and Patient safety in hospitals: the need for traceability of
              medicines in hospitals
                   -   Increasing patient safety by tracking of the drug right through to patient
                       administration
                   -   Why we ask for single dose coding
                   -   Introducing the technologies surrounding primary packaging coding
                   -   Implementation of these technologies: the successes and challenges seen in
                       case studies
              Dr Roberto Frontini – President - European Association of Hospital Pharmacists
    12.30     Technology spotlight session: For more information on sponsorship and exhibition
              opportunities please contact Onkar Sumal on +44 2073699300 or email
              sponsorship@iqpc.co.uk
    13.00     Networking Lunch Break
    14.00     Interactive practical session:               Blue Sky Innovation Boardroom:
              An open forum where attendees get the No vendors, no press, no recordings. This
              chance to gain insight into different        will be a closed discussion for you to
              manufactures approach to packaging.          freely share your experiences and
              Bring a sample of your packaging to          discuss best approaches for packaging
INTERACTIVE   participate in this exciting opportunity to  and labelling.
              learn from experts in the field and discuss
              different methods used by competitors.        Due to the exclusive nature of the Blue
                                                           Sky boardroom there will be a limited
              Facilitated and opening examples by:         number of seats available. When
              Mark Freeman – Packaging Services            registering please indicate that you
              Manager - Pfizer                             would like to be considered or contact
                                                           anna.fraenkel@iqpc.co.uk for more
                                                           information.
    15.00     Technology spotlight session: For more information on sponsorship and exhibition
              opportunities please contact Onkar Sumal on +44 2073699300 or email
              sponsorship@iqpc.co.uk
    15.30     Networking Coffee Break
              Creating a sustainable packaging line: demonstrating your corporate responsibility?
    16.00     Cost-effectively adapting your packaging line: target driven changes to making
              your packaging more sustainable
                   -   Johnson & Johnson’s Sustainable Product / Package design process:
                       EARTHWARDS ™
                   -   How we drive sustainable packaging at Johnson and Johnson
                   -   Reducing packaging volume vs. changing your packaging materials.
                   -   Examples of more sustainable packaging
                   -   Best practice for moving towards sustainable packaging in your supply
                       chain
              Al Iannuzzi – Senior Director Worldwide Environment Health & Safety – Johnson and
              Johnson




                   www.pharmapackaginglabelling.com
CONFERENCE AGENDA


              Tracing primary packaging: protecting the packaging line promoting patient safety,
              reduced counterfeit drugs and better stock control
16.30         "Good Advertising Practice" (GAP) - Adapting your labelling to comply with
              advertising legislation: effectively promoting your product while complying with
              European standards
                  -   Overview of different requirements on a country by country basis
                  -   Methods adopted to comply and overcoming the challenges that were
                      faced
                  -   Regulatory compliance - an aim for "Good Advertising Practice" (GAP)
                  -   Best approach in adapting the advertising for various territories: identifying
                      emerging future trends
              Dr Ruxandra Rogosca – Medical Manager Balkans – Reckitt Benckiser
17.00         Chairperson’s Closing remarks and close of Day two.


                                   WHO SHOULD ATTEND?

Who should attend?                                                2011 attendees by country:

Directors, Heads of:

    -   Packaging
    -   Labelling
    -   Regulatory affairs
    -   Anti-counterfeit
    -   Supply Chain
    -   Quality Assurance




2011 saw representatives from these companies and associations:

    -   AstraZeneca
    -   Bayer AG
    -   Reckitt Benckiser
    -   Meda Pharma GmbH
    -   Bausch & Lomb
    -   Janssen Biologics
    -   Merck Sharp and Dohme
    -   Novo Nordisk
    -   Baxter
    -   Egis Pharmaceutical
    -   European Alliance for Access to Safer Medicines
    -   HCPC-Europe
    -   EFPIA
    -   GS1




                                      ABOUT THE EVENT
                   www.pharmapackaginglabelling.com
Media Partners




About us:
Pharma IQ, a division of IQPC, is an international online community focusing on providing
pharmaceutical professionals with knowledge, information and articles. We are dedicated
to creating a learning environment for sharing ideas, best practices and solutions within the
pharmaceutical community

Through Pharma IQ, you will be able to access pharmaceutical information resources such as presentations and podcasts, as well as events
such as webinars, seminars and conferences.

By signing up to the Pharma IQ membership, you will gain access to our growing database of multimedia presentations from leading pharma
practitioners, weekly newsletters to keep you updated on latest pharmaceutical content and Pharma IQ members-exclusive discounts on
pharma events that offer solutions to your everyday business problems.

Pharma IQ and IQPC provide useful training courses, conference and expositions for pharmaceutical executives to network and learn the latest
pharma business development and trends occurring in organizations today. Pharma IQ focuses on establishing an interactive experience
featuring practical, objective and up-to-date insight from pharma industry leaders.

Join our Linked In groups and follow us on Twitter for all the latest news about the event, special offers
and begin networking now!




 Maximise Your Involvement: Sponsorship and Exhibition Opportunities
 The new falsified medicines directive requires pharma companies to update their packaging lines to comply with varying
 international regulations. When surveyed*, 32.4% of those asked are currently looking to increase spending by more
 than 10% in response to new serialisation guidelines. Pharma packaging and labelling professionals are looking to
 invest NOW!

 The Pharmaceutical Packaging and Labelling event is attended by senior officials and decision-makers from industry,
 bringing together buyers and suppliers in one location.
 Focused and high-level, the event will be an excellent platform to initiate new business relationships. With tailored
 networking, sponsors can achieve the face-to-face contact that overcrowded trade shows cannot deliver.
 Exhibiting and Sponsorship options are extensive, and packages can be tailor-made to suit your individual company’s
 needs. Most packages include complimentary entry passes, targeted marketing to industry officials and executives, and
 bespoke networking opportunities.
 Other features of sponsorship include:
 • Prominent exhibition space in the main conference networking area
 • Participation in comprehensive pre-event marketing campaigns
 • Tailored marketing strategies to suit your organisation’s size, capabilities and individual requirement
 For more information and to discuss the right opportunity, contact us on +44 (0)207 368 9300 or
 sponsorship@iqpc.co.uk
 * Survey by IQPC (January 2012)



                                                      SPONSORS & EXHIBITORS

                                     www.pharmapackaginglabelling.com
Sponsors & Exhibitors
                          Founded in 1976, Pharmaceutical companies in 36 countries across 5 continents are now using
                          Perigord artwork services and solutions to manage their brands.

                          Perigord have artwork hubs at our offices in Dublin, Connecticut and Singapore. Each hubs has a
                          dedicated pharmaceutical artwork teams which enables us to deliver a 24 hour, ‘follow the sun’
                          support service throughout all regions. We believe our in-dept pharma knowledge and experience,
                          coupled with our internal technology and systems is our unique selling point. GLAMS, or our
                          Global Artwork Management Solution is a unique product. Developed to GAMP guidelines, GLAMS
                          has now been validated in numerous implementations.

                          Website: www.perigordgroup.com


                          Website: www.virtify.com


                          SICPA is a Swiss company, founded in 1927, with headquarters in Lausanne, and is a leading global
                          provider of integrated security and traceability solutions to both, governments and companies of
                          various industry verticals.

                          The company employs more than 2’500 people and is established on 5 continents, with business
                          activities in most countries worldwide. In the pharmaceutical and healthcare sector, the customer
                          specific solutions and services delivered by SICPA help companies enhance the visibility and the
                          integrity of their supply chains, while providing value-adding business intelligence and ensuring
                          product protection and regulatory compliance. SICPA has successfully deployed and is
                          operating product authentication and traceability systems on all continents.

                          Website: www.sicpa.com

                          Kezzler is a world leader and a pioneering company in serialisation. Our solutions assist brand
                          owners in protecting their products, patients and their supply chain. The Kezzler SSP platform has
                          created a paradigm shift in technology where high performance unit level serialisation and secure
                          track and trace can be delivered in a consistent, scalable and cost effective manner.

                          It has been used in volume on manufacturing lines for five years and is highly respected by our
                          customers. Today by ten [10] global Pharmaceutical companies use the SSP platform for
                          serialisation, consumer verification, patient adherence and supply chain track & trace.

                          Website: www.kezzler.com

                          Systech International is a global leader in serialization and an innovator of packaging execution
                          systems (PES) for the pharmaceutical industry. Systech's purpose is to "Enable manufacturers to
                          protect the trust and confidence of their consumers in the product integrity & authenticity of their
                          brand purchases." Systech's Serialized Product Tracking (SPT) solutions manage your packaging
                          serialization processes supporting all packaging methods, number formats, data carriers and
                          packaging levels. Since 2006 our serialization solutions have been deployed worldwide and are
                          trusted to meet diverse regulatory requirements and ensure data integrity all while maintaining
                          packaging line throughput.

                          Website: www.systech-tips.com




                        www.pharmapackaginglabelling.com
26 – 27 June 2012
                                             Pharmaceutical                                                                Conference: 	
                                                                                                                           Pre-Conference 	 25 June 2012               Complete the form
                                             Packaging and Labelling                                                       Focus Afternoon:	
                                                                                                                                                                       and click submit
                                                                           Summit 2012                                     Venue:	           Basel, Switzerland

                             To speed registration, please provide the priority code located on the mailing label or in the box below.                                 5 Ways to Register
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                                                                                27th January 2011*
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                                                                                                                     25th May 2012*                                    Post: 	
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                                  	Conference**+ 2Focus day + 	
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                                                                                     Save €300                         Save €200

                                  	Conference Only                                      €1,749
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                                                                                                                        €1,799
                                                                                                                       Save €100                    €1,899             Team Discounts*
                                  	 Focus Afternoon (or workshop) Only                  €649                              €649                      €649               IQPC recognises the value of learning in teams.
                                                                                                                                                                       Groups of 3 or more booking at the same time from the
                                  	 Breakfast Briefing Only                             €249                              €249                      €249               same company receive a 10% discount.
                                                                                        €550                              €550                      €550
                                                                                                                                                                       5 or more receive a 15% discount.
                                  	Conference Recordings Only
                                                                                                                                                                       7 receive a 20% discount.
                             NB: UK Companies will pay UK VAT, all other companies are VAT exempt. VAT Registration #: GB 799225967                                    Only one discount available per person. Team discounts
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                             ** This package includes full access to conference recordings. Please tick this box if not required (reducing price by €550) 6
                             *** Please select your pre-conference choice: Morning Workshop 6 Focus Afternoon 6
                                                                                                                                                                       VENUE & ACCOMMODATION
                                                                                                                                                                       Venue: Grand Hotel Les Trois Rois Blumenrain 8
                              Delegate Details - Simply complete this form and Click submit                                                                            CH-4001 Basel , Switzerland
                                                                                                                                                                       Phone +41 61 260 50 50
                             Please photocopy for each additional delegate
                                Mr     Mrs     Miss     Ms      Dr     Other
                                                                                                                                                                       Accommodation: Travel and accommodation is not included in
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                             Organisation                                                                                                                              Digital Conference On CD-ROM
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                                                                                                                                                                           	Pharmaceutical packaging and labelling 2011
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                                                                                                                                                                       within one year from the date of cancellation. In the event that IQPC postpones
                                                                                                                                                                       an event for any reason and the delegate is unable or unwilling to attend in on
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CONFERENCE CODE: 20085.002




                                                                                                                                                                       paid. You may use this credit for another IQPC event to be mutually agreed with
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                                                                                                                                                                       is cancelled, rescheduled or postponed due to a fortuitous event, Act of God,
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Pharmaceutical Packaging and Labelling Summit 2012

  • 1. Bo Apr UP 27 V E ok il 2 TO Presents SA & 012 €5 P a a 00 y nd by Pharmaceutical Packaging and Labelling Summit 2012 DATE: VENUE: Pre-Conference Focus Afternoon: 26 - 27 June, 2012 Grand Hotel Les Trois Rois, Basel, 25 June, 2012 Switzerland Prepare for the Falsified Medicines Directive, maximise patient compliance and protect your supply chain Benefits of attending Expert speaker panel includes: r Implement the forthcoming Falsified Walter Bisson – Global Programme Manager – Novartis Medicines Directive effectively with guidance Pharma AG (EFPIA representative) from, SwissMedic, MHRA and senior EFPIA Mathieu Aman - Global Program Manager « Coding, representatives Serialization and Tracking & Tracing - F. Hoffmann-La r Maximise your track and track system Roche Ltd (EFPIA representative) by understand the pitfalls, as well as the Dr Ruxandra Rogosca – Medical Manager Balkans – Reckitt advantages of these systems with an exclusive Benckiser case study showcasing implementation in Turkey. Ian Holloway – DMRC Manager – MHRA r Cost-effectively increase patient compliance by Al Iannuzzi – Senior Director in worldwide Environment, adapting your packaging: learn how from HCPC Health & Safety department – Johnson & Johnson and Novo Nordisk Mark Freeman – Packaging Services Manger - Pfizer r Increase sustainability by reducing volume and Hicham Safine – Europe Quality Consultant – Eli Lilly upgrading packaging: benchmark against global Tanvi Goel – Global Supply Chain Manager – Mylan leaders Johnson & Johnson Pharmaceuticals r Gain critical insight into industry packaging Horst Kastrup – Director of Regulatory Affairs – Meda decisions: join Pfizer in a practical session Pharmaceuticals evaluating different manufacturer’s technique. Keith Howard – Regulatory Affairs Labelling – ViroPharma SPRL Traceability and Supply Chain Security Dr Catherine Manigley – Head of Division Market Monitoring of Medicines – SwissMedic Focus Afternoon | 25 June 2012 Tassilo Korab – Executive Director – HCPC Europe Protect your Supply chain by Joining GS1 representatives, a cross-industry track and track expert and industry Michael Ritter – Project Manager – Novartis Pharma AG leaders Sandoz to discuss and advance in the newest Mark Davison – CEO – Blue Sphere Health technologies, understand developments in legislation and examine case studies in this crucial area. Janice Kite – Director Healthcare Traceability – GS1 2012 Sponsors “Selection of speakers was well done, experts of the industry!” - Marietta Ulrich-Horn – Securikett “Very interesting-networking allowed me to meet people dealing with the same problems I face every day. Sharing experiences is very valuable and helps to analyse from another point of view” - UCB Worldwide T: +44 (0)20 7036 1300 F: +44 (0)20 7368 9301 E: Enquire@iqpc.co.uk W: www.pharmapackaginglabelling.com
  • 2. Saving costs by preparing for implementation of the Falsified Medicines Directive, maximising patient compliance and protecting your supply chain. 2011 was a tough year for the pharmaceutical packaging industry. It saw the passing of the falsified medicines directive (FMD); counterfeit drugs cost the pharmaceutical industry $75 billion dollars and to top it off $30 billion was lost due to lack of patient compliance. Unfortunately 2012 looks to have similar challenges in store as pharma companies look to regain profit lost due to lack of patient compliance, implement serialisation and put in place cost- effective anti-counterfeiting programmes. With this in mind Pharma-IQ is pleased to bring you the 2nd Annual Pharmaceutical Packaging and Labelling Summit, which brings together all the leading packaging and labelling experts to thrash out the core issues and give you practical approaches and top tips to take back to your company. So what’s new for 2012? Bored of 2 solid days of presentations? This year has been built with interactivity in mind, with sessions such as serialisation clinics; panel discussions and roundtable discussions taking centre stage to allow you to find solutions for your specific challenges. This is on top of the regulatory and case study driven presentations that you’ve come to expect from our event with all sessions taking place in the heart of pharmaceutical territory - Basel. A quick taste of what’s to come for 2012: - Top tips for cost-effective implementation of the FMD on a pan-European level - Best approaches for optimising your packaging to ensure the highest possible patient compliance. $30 billion a year is lost due to medicines not being taken as prescribed, will this affect you? - Protecting your supply chain: preventing counterfeit pharmaceuticals entering your packaging line - Overcoming the practical challenges faced with new readability guidelines - A regulators perspective on the serialisation requirements at a country specific level In this challenging environment with constantly changing regulations and patient safety ever paramount join us in developing the best approaches to keep you ahead of the game in 2012! I look forward to seeing you in Basel this June. Anna Fraenkel Conference Producer www.pharmapackaginglabelling.com
  • 3. Speakers & Advisory Board Introducing your 2012 Advisory Board: - Phil Marley – Packaging Intelligence Manger – AstraZeneca (HCPC) - Horst Kastrup – Director of Regulatory Affairs – Meda Pharmaceuticals - Dr Ruxandra Rogosca – Medical Manager Balkans – Reckitt Benckiser 2012 Confirmed Speakers: - Walter Bisson – Global Programme Manager – Novartis Pharma AG (EFPIA representative) - Mathieu Aman - Global Program Manager Coding, Serialization and Tracking & Tracing - F. Hoffmann-La Roche Ltd (EFPIA representative) - Mark Freeman – Packaging Services Manager- Pfizer - Hicham Safine – Europe Quality Consultant – Eli Lilly - Dr Ruxandra Rogosca – Medical Manager Balkans – Reckitt Benckiser - Ian Holloway – DMRC Manager – MHRA - Soren Skovlund – Global Director, Patient Research, Advocacy and Support – Novo Nordisk A/S - Tanvi Goel – Global Supply Chain Manager – Mylan Pharmaceuticals - Horst Kastrup – Director of Regulatory Affairs – Meda Pharmaceuticals - Inal Kose - FDF Warehouse Specialist – Sandoz - Dr Roberto Frontini – President – European Association of Hospital Pharmacists - Dr Catherine Manigley – Head of Division Market Monitoring of Medicines – SwissMedic - Al Iannuzzi – Senior Director Worldwide Environment Health & Safety – Johnson and Johnson - Tassilo Korab – Executive Director – HCPC Europe - Michael Ritter – Project Manager – Novartis Pharma AG - Keith Howard – Regulatory Affairs Labelling – ViroPharma SPRL - Janice Kite – Director Healthcare Traceability – GS1 - Mark Davison – CEO – Blue Sphere Health - Richard Wishart – Owner - Delivery Management Ltd - Tod Urquhart - Sales Director - kezzler www.pharmapackaginglabelling.com
  • 4. PRE CONFERENCE WORKSHOPS 25th June 2012 Workshop (A) 09.00-12.00 Minimising costs by delivering right-first-time artwork to a global market - Understanding all the capability elements required to deliver accurate artwork in a global pharmaceutical company. Join the former Director of Global Pack Management from GlaxoSmithKline to discuss: - The challenges facing artwork capabilities, internally and externally o Introduction to SWAT analysis o Sub-group break-outs to develop SWAT for artwork capabilities - Introducing model capability o Discussing the elements of a full artwork capability model - Defining capability elements o sub-group break-outs to develop key contents of each capability on a sliding scale of “In Control” through to “World Class” - Personal gap analysis o Tailored input into your challenges. The opportunity to give a personal review of where your organisation is and what gaps they might have and receive expert feedback Andrew Love, Vice president B4ward (former Director Global Pack Management, GlaxoSmithKline) Focus Afternoon: 13.00 – 17.00 An afternoon dedicated to providing you with the most up to date and advanced information in traceability and supply chain security Cost-effectively implement the best possible track and trace system you can. Join us for a jam packed afternoon with experts from the industry, GS1 and a cross industry perspective from a track and trace professional. Open Q&A panels, Interactive practical sessions and case study based discussions will provide attendees with the most current and innovative information on protecting your supply chain from counterfeits. Learn from those who already have the experience. Allow them to show you the best way forward in implementing your supply chain security. Join out expert panel: Janice Kite – Traceability Director Healthcare – GS1 Global Office Inal Kose - FDF Warehouse Specialist – Sandoz Richard Wishart – Owner - Delivery Management Ltd (1) Supply Chain Standards: Critical to Traceability and Product Serialisation? Supply chain standards are the foundation to facilitating effective implementation of product serialisation and traceability systems across healthcare globally. Join Janice Kite, Traceability Subject Matter Expert to arm you with the expertise to implement these processes effectively. Gain understanding of the relevant regulations and understand the IT models most effective for successful implementation of traceability. GS1: The Supply Chain Standards Organisation - Who are GS1? - The standards development journey so far: how and why - Collaboration and harmonisation - Work in progress: possible information technology systems choreographies www.pharmapackaginglabelling.com
  • 5. PRE-CONFERENCE WORKSHOPS Effective data management and IT models to improve healthcare traceability. Join this open interactive session to discuss: - Industry concerns related to IT models for traceability: operational efficiency impact, data availability, ownership and confidentiality. Better than the status quo? - The Pros/Cons of the possible IT models (2) Developing Effective Supply Chain Security and Anti-counterfeiting Methods: Experiences from Implementing Serialisation and Drug Tracking in Turkey Follow Sandoz’s implementation of track and trace projects in Turkey. The second phase of serialisation requirements is being implemented in Turkey in 2012. Now is the perfect time to learn from others, facilitating your decisions for future global supply. - Analyzing existing and approaching regulatory and customer requirements on product identification & traceability worldwide and examining regional legislation in Turkey - Understanding 2D Datamatrix code to ensure supply chain visibility and describing the needs to improve tracing - Exploring whole information system and data flow to understand traceability with Datamatrix - Identifying the technical requirements to effectively apply and read the code - Examining practical experiences from Daiichi-Sankyo Turkey to develop your international serialisation system. (3) Track and Trace: What can we learn from a cross industry representative Richard Wishart is a professional in logistics with extensive experience and knowledge in tracking technologies. Here he discusses what can be learned from industries outside of pharmaceuticals. - Use QR codes to effectively promote your product. - Understand the best implementation for RFID’s and the future of this technology (4) Panel Discussion: Cost effective implementation of track and trace technologies Join our broad panel of experts from across the industry. This is your chance to quiz them on their knowledge and experience. Don’t miss the chance to get answers to those questions that keep you up at night. Janice Kite – Traceability Director Healthcare – GS1 Global Office Inal Kose - FDF Warehouse Specialist – Sandoz Richard Wishart – Owner - Delivery Management Ltd 27th June 2012 Breakfast briefing: 7.30am – 9am Sign up for our interactive breakfast discussion. With open decisions, and plenty of coffee, this is your chance to get a head start to day two by delving into methods to authenticate your products Differentiating the genuine from the fake: authentication using digital and physical packaging security features - Developing visual inspection and the use of physical features to differentiate your packaging - Update on physical authentication techniques - Coding and future digital authentication approaches - Best practice for combining physical security features and codes on the production line Mark Davison – CEO – Blue Sphere Health www.pharmapackaginglabelling.com
  • 6. CONFERENCE AGENDA Day one: 26th June 2012 08.30 Registration and networking coffee 08.50 Pharma IQ welcome and Chairperson’s opening address Serialisation: optimising the implementation of cost-effective strategies to comply with new legislation 09.00 Implementation of the Falsified Medicines Directive (FMD) on a pan-European level: current thoughts for a practical guide on how to comply on a country by country basis - An overview of the FMD: why, when and how? - The EFPIA approach towards a European Pan Verification System - Understanding the timelines to ensure an effective implementation strategy is in place for the future Mathieu Aman - Global Program Manager Coding, Serialization and Tracking & Tracing F. Hoffmann-La Roche Ltd, Basel (EFPIA) 09.30 Adapting to the Falsified Medicines Directive: an industry perspective - An overview of the biggest changes currently affecting the pharmaceutical manufacturing. - The key challenges and impact when adapting to the FMD across Europe - Lessons learned from early implementations - Evaluating the impact on pharma: what will the implications of the FMD be? Walter Bisson – Global Program Manager – Novartis Pharma AG (EFPIA) 10.00 Breakout session: Open discussion with EFPIA Two EFPIA representatives both with extensive experience in the pharmaceutical packaging and labelling industry. This is your chance to get ask those questions that keep you up at night! - Mathieu Aman – Global Programme Manager – Coding, serialization and tracking and tracing – F. Hoffmann- La Roche Ltd, Basel - Walter Bisson – Global Programme Manager – Novartis Pharma AG 10.30 Technology spotlight session: For more information on sponsorship and exhibition opportunities please contact Onkar Sumal on +44 2073699300 or email sponsorship@iqpc.co.uk 11.00 Networking Coffee Break 11.30 A cost effective approach to supplying Turkey: facing the challenges involved in complying to serialisation requirements - Outlining our strategy for complying with Turkish requirements - Analysis of the problems encountered in adapting to the new regulations - What went right, what went wrong and how we faced these problems - Best practice approaches for successfully implementing serialisation in Turkey - The future: what our experiences have taught us for future implementation of serialisation requirements across the globe Hicham Safine – Europe/AMEA/CIS Quality Consultant– Eli Lilly 12.00 Technology spotlight session: For more information on sponsorship and exhibition opportunities please contact Onkar Sumal on +44 2073699300 or email sponsorship@iqpc.co.uk 12.30 Initial thoughts looking towards implementation of the Falsified Medicines Directive: a regulatory perspective - Overview of the international requirements: what is required and by when - Tamper evidence and its place in preventing counterfeit - Problems arising in the development of adapting to this directive - Best practice recommendations for preparation towards implementation of the falsified medicines directive Ian Holloway – DMRC Manager - MHRA 13.00 Networking Lunch Break www.pharmapackaginglabelling.com
  • 7. CONFERENCE AGENDA 14.00 Analysing the challenges of complying to recent packaging regulations in the global market - Supplying the world: overview of the challenges faced in adapting packaging for the global market - Understanding the various recent or upcoming requirements re serialization and tracking in key markets: India, China, Latin America and the USA - Technical approaches to integrate overt and hidden originality signs and markers in your packaging for global product delivery - Tamper proof packaging: what may we learn from the food industry? Horst Kastrup – Senior Regulatory Advisor – MEDA Pharma GmbH 14.30 Mass-serialisation forum: An open discussion into the challenges and solutions faced in the potential harmonisation of standards across Europe. Discuss your opinions and issues with key peers, association and regulators INTERACTIVE Tanvi Goel – Global Supply Chain Manager – Mylan Pharmaceuticals Janice Kite - Director Healthcare Traceability – GS1 Other Mediators to be confirmed visit www.pharmapackaginglabelling.com for updates 15.00 Databases: no longer fit for the purpose of serialisation and track & trace - The challenge of serialisation - Data management requirements - Performance statistics of large databases vs. Kezzler solution - Impact on companies Tod Urquhart - Sales Director- Kessler A.S 15.30 SwissMedic’s approach to the global threat of falsified medicines: a regulatory overview - International pharmaceutical crime – a global threat - International legislative Initiatives – the “Medicrime Convention” - International collaboration against counterfeits - National activities against pharmaceutical crime - Future of falsified medicines and the global fight Dr Catherine Manigley – Head of Division Market Monitoring of Medicines – SwissMedic 16.00 Networking coffee break 16.30 Back by popular demand: Roundtable Discussion Session You can choose to attend one of four informal discussion sessions, depending on your goals and strategies. Join our resident experts for a no holds barred, frank discussion on the topic of your choice Topics include: Tamper proof User testing: the Is patient Harmonised evidence Horst challenges are compliance worth serialisation across the Kastrup –Director of still out there! investing in? Tassilo EU: A choice in Regulatory Affairs - Keith Howard – Korab – Executive coding: 1D, 2D, or RFID Meda Pharma Regulatory Affairs Director – HCPC – Mathieu Aman – Labelling - Project Manager ViroPharma Global Logistics – F.Hoffmann-La Roche www.pharmapackaginglabelling.com
  • 8. CONFERENCE AGENDA 17.30 Introducing GS1 and an update on Standards development and implementation in Healthcare - Overview of important regulatory and industry developments - GS1 Standards for Healthcare: Process and technical (“Identify, Capture, Share”) standards - Examining the move to implementation of standards - Understanding how GS1 standards assist in compliance to regulations, e.g. the ALL NEW Directive for Falsified Medicines directive PRODUCT Janice Kite - Traceability Director Healthcare - GS1 Global Office SHOWCASE! Product Launch and Technology Innovation Spotlight Leading providers will unveil their latest technology developments and product launches for 2012 in this industry first showcase. Each company will provide a succinct 5 minute overview of their new developments for 2012 and beyond. 18.00 Chairpersons closing remarks and close of day one. Day Two: 27th June 2012 Breakfast briefing: 7.30am – 9am Sign up for our interactive breakfast discussion. With open decisions, and plenty of coffee, this is your chance to get a head start to day two by delving into methods to authenticate your products Differentiating the genuine from the fake: authentication using digital and physical packaging security features - Developing visual inspection and the use of physical features to differentiate your packaging - Update on physical authentication techniques - Coding and future digital authentication approaches - Best practice for combining physical security features and codes on the production line Mark Davison – CEO – Blue Sphere Health CONFERENCE AGENDA 8.30 Registration and Coffee 8.50 Day two Chairperson’s Opening Address Pharmaceutical packaging and labelling streamed sessions: We aim to really focus these sessions for you, as such we have streamed this afternoon. Track A focuses on the understanding and implementation of readability guidelines and track B looks at effectively tackling counterfeit drugs. Labelling and Leaflets: cost-effectively Fighting Counterfeit: best approaches for adapting your labelling process to supply preventing counterfeit drugs entering your international markets packaging line www.pharmapackaginglabelling.com
  • 9. 9.00 (A) Launching your product into a new Protecting your customers: using pack market: Belgium – a case study security features to help prevent counterfeit - Overview of key challenges faced pharmaceuticals infiltrating your supply TAILOR in adapting your packaging to a chain new market Coding and tracking your product YOUR - - Special considerations, language to promote accurate stock control, AGENDA difficulties: adapting to a tri-lingual patient safety and prevention of market counterfeits - Our experiences: what went well - Implementing the best solutions: and the key challenges faced cost-effectively preventing - Top tips for cost effective product counterfeit drugs entering your launch into a new market chain Keith Howard – Regulatory affairs Labelling - Best practice for combining Manager – ViroPharma SPRL physical security features and serialisation codes on the production line Mark Davison – CEO- Blue Sphere Health 9.30 Adapting your labelling process for global Strategy to implement Serialization and delivery: complying to international Product Tracking (SPT) in Europe to comply readability guidelines with China SFDA requirements - Discuss your approach for Identifying the need to upgrade your delivering drugs to a global market packaging line in order to comply with - The key challenges faced by the legislation OPEN labelling industry for worldwide - Scope and timelines of the SPT FORUM drug delivery regulations - Best approaches for adapting the - Cost effectively adapting the labelling process for the worldwide existing packaging lines to comply industry to new emerging regulations With input from key experts across our - Using IT to support SPT speaker faculty implementation - Outlook and next steps Michael Ritter - Project Manager - Novartis Pharma 10.00 Technology spotlight session: For more information on sponsorship and exhibition opportunities please contact Onkar Sumal on +44 207 369 9300 or email sponsorship@iqpc.co.uk 10.30 Networking Coffee Break Patient compliance and adherence: implementing the best packaging solution 11.00 Optimising your packaging to ensure the highest possible patient compliance: $30 billion is lost every year due to medicines not being taken as prescribed. Will this be from your pocket? - Overview of patient compliance packaging: cost effective strategies to increase patient adherence - Maximising patient compliance through innovative technology. What can be done and why should we care? - Maximising profit by effectively packaging your product to reduce areas of error and improve patient compliance Tassilo Korab – Executive Director - European Healthcare Packaging Compliance Council www.pharmapackaginglabelling.com
  • 10. CONFERENCE AGENDA 11.30 Designing your packaging to facilitating patient compliance: an industry perspective - Patient compliance: an overview of current industry trends and opinions - What is driving the change process in the pharmaceutical industry? Understanding the motivation for increasing patient compliance. - Challenges faced in adapting your packaging to increase patient adherence - Best approaches for effectively increasing patient compliance Soren Skovlund – Global Director, Patient Research, Advocacy and Support – Novo Nordisk A/S 12.00 Single dose, Barcoding and Patient safety in hospitals: the need for traceability of medicines in hospitals - Increasing patient safety by tracking of the drug right through to patient administration - Why we ask for single dose coding - Introducing the technologies surrounding primary packaging coding - Implementation of these technologies: the successes and challenges seen in case studies Dr Roberto Frontini – President - European Association of Hospital Pharmacists 12.30 Technology spotlight session: For more information on sponsorship and exhibition opportunities please contact Onkar Sumal on +44 2073699300 or email sponsorship@iqpc.co.uk 13.00 Networking Lunch Break 14.00 Interactive practical session: Blue Sky Innovation Boardroom: An open forum where attendees get the No vendors, no press, no recordings. This chance to gain insight into different will be a closed discussion for you to manufactures approach to packaging. freely share your experiences and Bring a sample of your packaging to discuss best approaches for packaging INTERACTIVE participate in this exciting opportunity to and labelling. learn from experts in the field and discuss different methods used by competitors. Due to the exclusive nature of the Blue Sky boardroom there will be a limited Facilitated and opening examples by: number of seats available. When Mark Freeman – Packaging Services registering please indicate that you Manager - Pfizer would like to be considered or contact anna.fraenkel@iqpc.co.uk for more information. 15.00 Technology spotlight session: For more information on sponsorship and exhibition opportunities please contact Onkar Sumal on +44 2073699300 or email sponsorship@iqpc.co.uk 15.30 Networking Coffee Break Creating a sustainable packaging line: demonstrating your corporate responsibility? 16.00 Cost-effectively adapting your packaging line: target driven changes to making your packaging more sustainable - Johnson & Johnson’s Sustainable Product / Package design process: EARTHWARDS ™ - How we drive sustainable packaging at Johnson and Johnson - Reducing packaging volume vs. changing your packaging materials. - Examples of more sustainable packaging - Best practice for moving towards sustainable packaging in your supply chain Al Iannuzzi – Senior Director Worldwide Environment Health & Safety – Johnson and Johnson www.pharmapackaginglabelling.com
  • 11. CONFERENCE AGENDA Tracing primary packaging: protecting the packaging line promoting patient safety, reduced counterfeit drugs and better stock control 16.30 "Good Advertising Practice" (GAP) - Adapting your labelling to comply with advertising legislation: effectively promoting your product while complying with European standards - Overview of different requirements on a country by country basis - Methods adopted to comply and overcoming the challenges that were faced - Regulatory compliance - an aim for "Good Advertising Practice" (GAP) - Best approach in adapting the advertising for various territories: identifying emerging future trends Dr Ruxandra Rogosca – Medical Manager Balkans – Reckitt Benckiser 17.00 Chairperson’s Closing remarks and close of Day two. WHO SHOULD ATTEND? Who should attend? 2011 attendees by country: Directors, Heads of: - Packaging - Labelling - Regulatory affairs - Anti-counterfeit - Supply Chain - Quality Assurance 2011 saw representatives from these companies and associations: - AstraZeneca - Bayer AG - Reckitt Benckiser - Meda Pharma GmbH - Bausch & Lomb - Janssen Biologics - Merck Sharp and Dohme - Novo Nordisk - Baxter - Egis Pharmaceutical - European Alliance for Access to Safer Medicines - HCPC-Europe - EFPIA - GS1 ABOUT THE EVENT www.pharmapackaginglabelling.com
  • 12. Media Partners About us: Pharma IQ, a division of IQPC, is an international online community focusing on providing pharmaceutical professionals with knowledge, information and articles. We are dedicated to creating a learning environment for sharing ideas, best practices and solutions within the pharmaceutical community Through Pharma IQ, you will be able to access pharmaceutical information resources such as presentations and podcasts, as well as events such as webinars, seminars and conferences. By signing up to the Pharma IQ membership, you will gain access to our growing database of multimedia presentations from leading pharma practitioners, weekly newsletters to keep you updated on latest pharmaceutical content and Pharma IQ members-exclusive discounts on pharma events that offer solutions to your everyday business problems. Pharma IQ and IQPC provide useful training courses, conference and expositions for pharmaceutical executives to network and learn the latest pharma business development and trends occurring in organizations today. Pharma IQ focuses on establishing an interactive experience featuring practical, objective and up-to-date insight from pharma industry leaders. Join our Linked In groups and follow us on Twitter for all the latest news about the event, special offers and begin networking now! Maximise Your Involvement: Sponsorship and Exhibition Opportunities The new falsified medicines directive requires pharma companies to update their packaging lines to comply with varying international regulations. When surveyed*, 32.4% of those asked are currently looking to increase spending by more than 10% in response to new serialisation guidelines. Pharma packaging and labelling professionals are looking to invest NOW! The Pharmaceutical Packaging and Labelling event is attended by senior officials and decision-makers from industry, bringing together buyers and suppliers in one location. Focused and high-level, the event will be an excellent platform to initiate new business relationships. With tailored networking, sponsors can achieve the face-to-face contact that overcrowded trade shows cannot deliver. Exhibiting and Sponsorship options are extensive, and packages can be tailor-made to suit your individual company’s needs. Most packages include complimentary entry passes, targeted marketing to industry officials and executives, and bespoke networking opportunities. Other features of sponsorship include: • Prominent exhibition space in the main conference networking area • Participation in comprehensive pre-event marketing campaigns • Tailored marketing strategies to suit your organisation’s size, capabilities and individual requirement For more information and to discuss the right opportunity, contact us on +44 (0)207 368 9300 or sponsorship@iqpc.co.uk * Survey by IQPC (January 2012) SPONSORS & EXHIBITORS www.pharmapackaginglabelling.com
  • 13. Sponsors & Exhibitors Founded in 1976, Pharmaceutical companies in 36 countries across 5 continents are now using Perigord artwork services and solutions to manage their brands. Perigord have artwork hubs at our offices in Dublin, Connecticut and Singapore. Each hubs has a dedicated pharmaceutical artwork teams which enables us to deliver a 24 hour, ‘follow the sun’ support service throughout all regions. We believe our in-dept pharma knowledge and experience, coupled with our internal technology and systems is our unique selling point. GLAMS, or our Global Artwork Management Solution is a unique product. Developed to GAMP guidelines, GLAMS has now been validated in numerous implementations. Website: www.perigordgroup.com Website: www.virtify.com SICPA is a Swiss company, founded in 1927, with headquarters in Lausanne, and is a leading global provider of integrated security and traceability solutions to both, governments and companies of various industry verticals. The company employs more than 2’500 people and is established on 5 continents, with business activities in most countries worldwide. In the pharmaceutical and healthcare sector, the customer specific solutions and services delivered by SICPA help companies enhance the visibility and the integrity of their supply chains, while providing value-adding business intelligence and ensuring product protection and regulatory compliance. SICPA has successfully deployed and is operating product authentication and traceability systems on all continents. Website: www.sicpa.com Kezzler is a world leader and a pioneering company in serialisation. Our solutions assist brand owners in protecting their products, patients and their supply chain. The Kezzler SSP platform has created a paradigm shift in technology where high performance unit level serialisation and secure track and trace can be delivered in a consistent, scalable and cost effective manner. It has been used in volume on manufacturing lines for five years and is highly respected by our customers. Today by ten [10] global Pharmaceutical companies use the SSP platform for serialisation, consumer verification, patient adherence and supply chain track & trace. Website: www.kezzler.com Systech International is a global leader in serialization and an innovator of packaging execution systems (PES) for the pharmaceutical industry. Systech's purpose is to "Enable manufacturers to protect the trust and confidence of their consumers in the product integrity & authenticity of their brand purchases." Systech's Serialized Product Tracking (SPT) solutions manage your packaging serialization processes supporting all packaging methods, number formats, data carriers and packaging levels. Since 2006 our serialization solutions have been deployed worldwide and are trusted to meet diverse regulatory requirements and ensure data integrity all while maintaining packaging line throughput. Website: www.systech-tips.com www.pharmapackaginglabelling.com
  • 14. 26 – 27 June 2012 Pharmaceutical Conference: Pre-Conference 25 June 2012 Complete the form Packaging and Labelling Focus Afternoon: and click submit Summit 2012 Venue: Basel, Switzerland To speed registration, please provide the priority code located on the mailing label or in the box below. 5 Ways to Register phone: My registration code PDFW +44 (0)20 7036 1300 Please contact our database manager on +44(0) 207 368 9300 or database@iqpc.co.uk quoting the Fax: registration code above to inform us of any changes or to remove your details. 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Please tick this box if not required (reducing price by €550) 6 *** Please select your pre-conference choice: Morning Workshop 6 Focus Afternoon 6 VENUE & ACCOMMODATION Venue: Grand Hotel Les Trois Rois Blumenrain 8 Delegate Details - Simply complete this form and Click submit CH-4001 Basel , Switzerland Phone +41 61 260 50 50 Please photocopy for each additional delegate Mr Mrs Miss Ms Dr Other Accommodation: Travel and accommodation is not included in Rank First Name the registration fee. However a number of discounted bedrooms have been reserved at the Grand Hotel Les Trois Rois. Please call the hotel directly on Tel: +41 61 260 50 50 and quote booking Family Name Job Title reference IQPC to receive your discounted rate, prices start from CHF 365.00 including vat, but excluding breakfast. There is limited Tel No. availability for our discounted rate until the 25th of May, so we do encourage attendees to book early to avoid disappointment. Email Yes I would like to receive information about products and services via email Free Online Resources To claim a variety of articles, podcasts and other free resources please visit www.pharmapackaginglabelling.com Organisation Digital Conference On CD-ROM A digital version of the conference proceedings, Nature of business including all presentations, is available to buy.  Recent digital conferences available £599+VAT each Address Pharmaceutical packaging and labelling 2011 Serialisation and traceability Postcode Country Anti-counterfeiting I have filled out credit card details below Telephone For further information Please call: 0207 368 9300 or email: knowledgeb ank@iqpc.co.uk To search IQPC’s archived conference documentation visit: www.iqpcknowledgebank.com Approving Manager Terms and Conditions Name of person completing form if different from delegate Please read the information listed below as each booking is subject to IQPC Ltd standard terms and conditions. Payment Terms: Upon completion and return I agree to IQPC’s cancellation, substitution and payment terms of the registration form, full payment is required no later than 5 business days from the date of invoice. Payment of invoices by means other than by credit card, Special dietary requirements: Vegetarian Non-dairy Other (please specify) or purchase order (UK Plc and UK government bodies only) will be subject to a €65 (plus VAT) per delegate processing fee. Payment must be received prior to Please indicate if you have already registered by: Phone Fax Email Web the conference date. We reserve the right to refuse admission to the conference if payment has not been received. IQPC Cancellation, Postponement and Please note: if you have not received an acknowledgement before the conference, please call us to confirm your booking. Substitution Policy: You may substitute delegates at any time by providing reasonable advance notice to IQPC. For any cancellations received in writing not less than eight (8) days prior to the conference, you will receive a 90% Payment Method credit to be used at another IQPC conference which must occur within one year from the date of issuance of such credit. An administration fee of 10% of the contract fee will be retained by IQPC for all permitted cancellations. No credit Total price for your Organisation: (Add total of all individuals attending): will be issued for any cancellations occurring within seven (7) days (inclusive) of the conference. In the event that IQPC cancels an event for any reason, you Card Number: VISA M/C AMEX will receive a credit for 100% of the contract fee paid. You may use this credit for another IQPC event to be mutually agreed with IQPC, which must occur within one year from the date of cancellation. In the event that IQPC postpones an event for any reason and the delegate is unable or unwilling to attend in on the rescheduled date, you will receive a credit for 100% of the contract fee CONFERENCE CODE: 20085.002 paid. You may use this credit for another IQPC event to be mutually agreed with Exp. Date: IQPC, which must occur within one year from the date of postponement. Except as specified above, no credits will be issued for cancellations. There are no refunds given under any circumstances. IQPC is not responsible for any loss or damage as a result of a substitution, alteration or cancellation/postponement of Name On Card: an event. IQPC shall assume no liability whatsoever in the event this conference is cancelled, rescheduled or postponed due to a fortuitous event, Act of God, unforeseen occurrence or any other event that renders performance of this conference impracticable, illegal or impossible. For purposes of this clause, a fortuitous event shall include, but not be limited to: war, fire, labour strike, extreme weather or other emergency. Please note that while speakers and topics were confirmed at the time of publishing, circumstances beyond the control of City/County/Postcode Cheque enclosed for: € (Made payable to IQPC Ltd.) the organizers may necessitate substitutions, alterations or cancellations of the speakers and/or topics. As such, IQPC reserves the right to alter or modify the advertised speakers and/or topics if necessary without any liability to you (Please quote 20085.002 with remittance advice) whatsoever. Any substitutions or alterations will be updated on our web page as soon as possible. Discounts: All ‘Early Bird’ Discounts require payment at time Bank account details (EUR): Account name: International Quality & Productivity Centre Ltd. of registration and before the cut-off date in order to receive any discount. Any discounts offered by IQPC (including team discounts) also require payment at the Bank: HSBC Bank Plc 67 George Street, Richmond Surrey TW9 1HG, United Kingdom time of registration. Discount offers cannot be combined with any other offer. Account number: 59090618 Sort code: 400515 IBAN: GB98MIDL40051559090618 SWIFT: MIDLGB22 PAYMENT MUST BE RECEIVED CLICK HERE TO SUBMIT FORM NOW VIA EMAIL PRIOR TO THE CONFERENCE