Conference on 3rd Annual Packaging and Labelling Congress

Key Speakers
• Sylvie Noirault, Global Head Clinical Supply Chain Trial Management, Sanofi -Aventis
• Tassilo Korab, Executive Director, Health Compliance Packaging Council- Europe
• Dr. Thomas Dries, Market Manager - Europe, Pharmaceutical, Honeywell
• Janice Kite, Global Project Manager, Traceability in Healthcare, GS1
• Nigel Cryer, Interim Head of Global Quality, Manufacturing & Supply Chain, Norgine
• Horst Kastrup, Director Regulatory Affairs & Quality Assurance, Meda Pharma
• Stephen Jones, Partner, Baker & McKenzie LLP
• Julian Harris, Analyst, International Policy Network
• Steve Carden, Managing Consultant, PA Consulting Group
• Mukesh Patel, Director, CommQP Pharmaceutical Services
• Theresa L. Mock, Director, Marketing, OpSec Security

Pharmaceutical packaging and labelling is considered an essential aspect of the product. The role of packaging and labelling has increased considerably and constantly advancing over the last few decades. This area has been experiencing emerging regulatory issues and stringent restraints.

This 2-day event will provide you with practical insights into the regulatory and scientific issues that will help you develop breakthrough business strategies to improve your product launches and expand markets.

Key Benefits:

• Stay up-to-date on the latest innovations in packaging and labelling
• Learn how can you turn a cost and hygiene factor into a commercial benefit?
• Examine new strategies in fighting counterfeiting
• Gain knowledge about legislation and existing models – EU, USA, Greece, Italy, Belgium, Turkey
• Find out about the supply chain security and compliance
• Seize this opportunity to network with leaders from pharma-biotech, healthcare and regulatory agencies

Who should attend?

VPs, Directors, Heads and Managers of:
• Packaging
• Labelling
• Supply Chain and Logistics
• Regulatory Affairs and Compliance
• Quality Assurance
• Product Information
• Operations
• Quality Control and Assurance
• Licensing
• Marketing and Sales
• Patient Compliance
• Purchase / Facilities
• Manufacturing Technology
• International Labelling Liaison
• Packaging Designer
• Global Labelling

Counsels, Analysts, Consultants of:
• Packaging
• Labelling
• Supply Chain
• Logistics

Day 1
Day One, Thursday 18th February 2010

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Can packaging contribute to the value of medicines? Customer satisfaction in the pharma business
• Who are the customers?
• Ways to improve adherence to medicinal therapies
• Improving patient adherence by packaging design
• Examples of thoughtful packaging design
• Benefits of improved patient compliance

Tassilo Korab
Executive Director
Health Compliance Packaging Council- Europe

10:50 Healthcare packaging that is value-based
• Key stakeholder needs & aspirations related to primary packaging (oral solids)
• Benefits of thermoformed pack designs for
- Passing stability in all climatic zones
- Speeding up development timelines
- Reducing complexity costs
- Lowering total costs of ownership over the full drug life time
- Enhancing patient loyalty
• Best practices for stability testing

Dr. Thomas Dries
Market Development Manager Healthcare and Packaging
Honeywell

11:30 Morning refreshments

11:50 Presentation to be announced

12:30 Application of GMP to pharmaceutical print origination
• Explain the importance of getting the artwork origination process right and identify risks in this process
• Highlight recent artwork errors which have resulted in product recalls
• Explain how GMP can be applied to help minimise errors in this area

Mukesh Patel
Director
CommQP Pharmaceutical Services

13:10 Networking lunch

14:30 Packaging pharmaceuticals for clinical trials
• Clinical Trials : What are the different phases and designs?
• Labeling : How to optimize validation process and improve flexibility in IP usage?
• Industrialization of packaging and labeling
- Use of Industrial methods
- Automation of processes
• Study cases

Sylvie Noirault
Global Head Clinical Supply Chain Trial Management
Sanofi-Aventis

15:10 Pharmaceutical packaging and labelling for blind and partially sighted people
• Demographics
• Labelling requirements
• Inclusion of braille to packaging

15:50 Afternoon refreshments

16:10 GS1 standards in healthcare: raising the bar on patient safety
• The need for global harmonisation and the global GS1 healthcare user group
• Regulatory requirements across the globe
• Why do we need standards
• Automatic identification & data capture: from standards development to implementation
• How to meet traceability requirements worldwide

Janice Kite
Global Project Manager, Traceability in Healthcare
GS1

16:50 Supply chain security and compliance: How can you turn a cost and hygiene factor into a commercial benefit?
• Regulations on maintaining supply chain security are strict and only going to get stricter
• Many companies only see the cost of compliance with regulations and put the minimum effort into meeting regulations as a license to operate
• However, supply chain security can provide extraordinary benefits to virtually all stakeholders in the supply chain
• Accelerating supply chain security will release those benefits early

Steve Carden
Managing Consultant
PA Consulting Group

17:30 Closing remarks from the chair

17:35 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2

Day Two, Friday 19th February 2010

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Identity preservation: technologies and legislation
• Emerging technologies – the market’s latest responses to counterfeiting
• Legislation and existing models – EU, USA, Greece, Italy, Belgium, Turkey
• Options for emerging economies.

Julian Harris
Analyst
International Policy Network

10:50 Management and control of labelling
• Analysing the challenges of global label management across the world
• Examining the strategies for optimising content and layout
• Novel technologies to improve label production

11:30 Morning refreshments

11:50 Aspects important to patients
• Whom to complaint?
• Specific list of contacts
• Improving patient information systems

Nigel Cryer
Interim Head of Global Quality,Manufacturing & Supply Chain
Norgine

12:30 Combating the threat of counterfeit medicines
• What is a counterfeit?
• Counterfeits in the supply chain and on the Internet
• Effective IP enforcement against counterfeits?
• Criminal sanctions and customs notices
• Trade marks; parallel imports and other supply routes

Stephen Jones
Partner
Baker & McKenzie LLP

13:10 Networking lunch

14:30 Formulating a proactive strategy to combat counterfeit drugs
• Counterfeit drugs in the pharmaceutical supply chain
• Proactive measures to combat counterfeiting
• Leveraging an integrated brand protection strategy

Theresa Mock
Marketing Director and Julie Tomlinson, Sales Director
OpSec Security

15:10 Assessing the growth trends and opportunities in packaging and labelling
• Introduction of high packaging standards
• High value-added containers, closures and accessories
• RFID Labelling

Steve Carden
Managing Consultant
PA Consulting Group

15:50 Afternoon refreshments

16:10 Challenges for pharmaceutical packaging due to draft new legislation/ administrative processes at the authorities – the industry perspective
• The EU-Pharma-Package: Pharmacovigilance regulation/ directive
• The new readability guideline requirements
• The product information management process (PIM) between agencies and marketing authorisation holders

Horst Kastrup
Director Regulatory Affairs & Quality Assurance
MEDA Pharma

16:50 Chair’s closing remarks

17:00 End of Conference

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