The Programme

Day One
Tuesday 29 September 2009

08:30

Registration

09:00

Opening remarks from the Chair

Clarifying the readability guideline: strategic approaches to achieving compliance fast

09:10

Klaus Menges
Director and Professor Head of Scientific Quality Assurance
Federal Institute for Drug and Medical Devices (Bfarm)

Keynote presentation:
Analysing the evolution of readability requirements in the European Union (EU)

• Reviewing how readability has become a hot topic in the EU
• Making medicines easier and safer to use: describing the main requirements of the new readability guideline
• Assessing the impact of this new guideline on the packaging and labelling process
• Listing the major challenges of this guideline for manufacturers
• Readability testing: an incontrovertible step to comply with the new requirements

09:40

Dr. Beate Schaper
Head of Labelling, Information officer
Wyeth Pharma GmbH

Labelling and leaflets in focus: strategic compliance approaches

• Overview of the most challenging requirements in the readability guideline
• New requirements from the “Pharmacovigilance Package” EU Directive 2001/83/EG
• Analysing the impact on label text and artwork creation
• Experiences from artwork build and production including multi-language leaflets
• Strategic approaches for optimising content and layout (or rethinking the content and size information)
• Future trends: expectations and feasibility

10:10

Dr. Fatma Kabaoglu
Manager, International Regulatory Affairs
Woerwagpharma

Outlining the key amendments: how will both packaging and labelling processes be impacted by these guidelines?

• Reviewing the legal framework

• Clarifying the major components of the readability guideline
• Summarising the changes: before vs. now
• Guidance concerning consultations with target patient groups for the package leaflet
• What are the challenges for the manufacturers?

10:40

Morning refreshments

11:10

Industrial experience with the readability user test in Europe

• Reviewing the legal background
• Considering the patient’s point of view before writing a Patient Leaflet (PL)
• Points to consider when writing a PL
• Steps to take a readability test
• Assessment of a PL by authorities
• Consequences for the applicant

11:40

Effectively responding to evolving industry trends and legislation affecting label management

• Managing the changing demands on label space and legally required label information
  
• Meeting the challenges of global label management across disparate locations
  
• Taking advantage of new technologies to improve label production accuracy and efficiency

Ensuring patient safety in your packaging production

12:10

Dr. Thomas Jakob
R&D Manager Competence Center Components
Raumedic AG

Innovative pharmaceutical packaging focused on patient safety

• Requirements for pharmaceutical packaging
• Innovative polymer packaging
• Sandwich-technology for pharmaceutical applications
• Product stability improvement by barrier functions
• Antiplagiarism technologies
• Polymer packaging against product counterfeiting
• Quality assurance by automated camera inspections

Future perspectives in pharma packaging: innovation and sustainable development

12:40

Diarmuid Wilson
Director of Business Development
Catalent Pharma Solutions

Realizing Global Compliance with Innovative Technologies for Printed Components

• Challenges faced by Pharma printed component vendors and customers
• Current technologies capable of delivering quicker more controlled results in origination and proofing
• Combating cost drivers while maintaining quality and product consistency E-Magineering web based solutions for a leaner supply chain

14:10

Dr. Manfred Zurkirch
CEO
Dividella

Effectively measuring sustainability in Pharmaceutical Packaging

• Short history of sustainability
  
• Introduction of the life-cycle assessment concept
  
• Numerical analysis of environmental footprint of different pack styles
• Interpretation of the data and suggestions on how to improve
  
• Potential positive impact of small environmental footprint on packaging costs
  

14:40

Case study:
The challenges of developing sustainable packaging solutions

• Reviewing the parameters to consider and measure
• Analysing the complexity involved in getting the corresponding reliable numbers
• Proposals for implementation based on the objective of reducing the complexity of implementation
• How to extend these proposals to more global ones: considering more parameters for future developments
• Why implementing sustainable packaging can bring savings to companies and how long will it take to profit from these savings?
• Some success stories from industry
  

15:10

Afternoon refreshments

Anti-counterfeiting and diversion: innovative systems for ensuring a unique lifecycle history for each individual package

15:40

Robert Nientker
EMEA Business Development Director Life Sciences
ORACLE HEALTHCARE & LIFE SCIENCES

Making mass serialisation a European reality

• The global political environment and challenges for serialisation
• Reasons for change in Europe and trends amongst developers
• Solutions and preparing for a global future in tackling counterfeiting

Christoph Krahenbuhl
Technology Stream Lead, Pack Coding and Product Security Global Operations Information
AstraZeneca

AND

Frederic Menardo
General Manager Europe, SYSTECH INTERNATIONAL

Case study
Real experiences of an early serialisation adopter and the value of a strategic approach based on standardised solutions

• Benefits of serialisation
• Technology components and the need for a new technology architecture
• How to leverage an enterprise standards based approach to rolling out a serialisation strategy
• Lessons learned

Panel discussion:
Identifying best practice strategies to prepare for serialisation
A panel made up of speakers from throughout the two days will discuss the best strategies to implement and optimise your track and trace systems in preparation for mass serialisation.

Effectively complying with international packaging requirements

17:10

Dr. Michael Spallek
Director of Packaging Development
Boehringer Ingelheim

Exploring Japan-specific requirements for packaging

• Japanese patients compared to EU patients: fundamental differences
• Differentiating Japanese and European and US packaging requirements
• Global development teams: weighing up the risks and benefits
• Oral solids in Japan: the impact on packaging development and analytics
• Pharma production in Japan
• Challenges for the global sourcing of packaging materials
• EU/US suppliers offering "Japanese quality”
• Japanese packaging supply for EU/US

17:40

Closing remarks from the Chair and evening refreshments

Day Two
Wednesday 30 September 2009

Registration

Opening remarks from the Chair

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of packaging or labelling.

Lunch

Maria Boese
Vice President, Labelling and IT
Novo Nordisk

Pil Arnild Mortensen
Manager, Global Artworks
Novo Nordisk 

Keynote presentation:
Case study:
LEAN activities in the process of developing printed packaging material: how can you stay competitive?

• Novo Nordisk A/S approach to developing printed packaging material: from authority approval of labelling text to final country-specific printed packaging material
• The implementation of LEAN
• Results obtained and targets for the next few years
• Change management and overcoming future barriers

Developing strategies to optimise the cost-effectiveness and the speed of production

• Gaining an overview of the production chain
• Using better machines (overwrapping, broche, scan machines)
• Overcoming machine adjustment issues
• Ensuring the speed of the production process
• Overcoming the regulatory issues related to a transfer of production from one country to another

Ansgar Kaupp,
General Manager
EYEC

Integrated incoming material inspection processes

• Inspecting incoming material for compliance with the approved master in text, artwork, barcode and Braille
• Achieving fast and easy compliance with GAMP
• Ensuring processes are well documented for inspection purposes

Erasmus Kuhlmann
Packaging Plants Project Manager
Bayer Schering Pharma AG

Systematic process optimisation for effective packaging machine management

• How can the building effectively support the packaging process?

• What organisational structures support effective processes?

• Exemplary technical solutions for optimisation of the packaging lines
• Managing the complexity of multiple vendors of the machines
• Material Flow and Personnel Flow
• Utilizing [using?] OEE for management and leadership

Afternoon refreshments

Pushing the boundaries: using active packaging to increase shelf-life and improve safety

16:00

Considering the utilisation of active packaging for pharma

• Reviewing the effects of active packaging
• Analysing the interaction between the product and packaging
• Identifying how this packaging reduces the degradation of the product
• Studying how this action on the product can increase its safety

16:30

Case study:
Introducing new packaging materials to improve customer experience and increase productivity

• Using new materials to improve the quality of your packaging
• Analysing which materials are the most promising ones
• Reviewing the benefits of these materials
• Understanding why these new materials can improve your productivity
• Analysing how these packaging materials can enhance the customer experience
• Some examples of new packaging materials developed at Novartis

Effective approaches to clinical packaging

17:00

Exploring clinical packaging and its place in the supply chain

• Understanding clinical packaging operations
• Assessing future developments within the field
• Reviewing the synergic relationship with industrial operations

17:30

Closing remarks from the Chair and end of the conference