New Drug Product Packaging – Life Cycle Analysis

• New drug product packaging during development and post launch

• Drug product and packaging life cycle

• Thermoforming or cold forming

• Determination of shelf life

Michiel van den Berg; Tekni-Plex Europe N.V, Erembodegem, Belgium
 

Recent Advances in Desiccant Technology for the Healthcare Industry

• Understand desiccants and how to use them correctly

• Find out the latest developments and advances in desiccant technology

• Know which is the best desiccant to use for your application

• Keep up to date with how desiccants comply with the latest pharmaceutical  legislation

Ian Buckley; Silgell Packaging Ltd., Telford, Shropshire, United Kingdom

Modelling as a Reliable Method for Migration Estimation

• Fundamentals of modelling

• Advantages of modelling

• A specific online solution

• Q&A Session

Christophe Cabarry; SpecialChem, Paris, France

The Growing Importance of Extractable Testing for Pharmaceutical

Containers and Medical Devices

• Regulatory consideration

• Material characterization

• General Approach to Migration

• Toxicological Assessment

Piet Christiaens; Toxikon Europe, Leuven, Belgium

Improving Medical Treatment and Patient Compliance with Intelligent Packaging

• Overcoming patient compliance problems

• User studies and story telling

• Intelligent drug administration

• Lessons learnt from real life implementation

Paul Erik Fabricius; Bang & Olufsen Medicom a/s, Struer, Denmark

A New Microbial Barrier Test for Porous Medical Packaging Materials

• The need for a rapid, easy to use “physical” test

• Selection of equipment

• Establishment of a correlation with a recognised microbiological test

• Development of a commercial test unit and an International Standard Test Method

Paul Fielding; On behalf of the Barrier Test Consortium; DuPont Medical Packaging,
Bristol, United Kingdom
 

COC (Cyclic Olefin Copolymer) - Your Clear Advantage for Medical and Pharmaceutical Packaging

• Morphology and manufacturing

• Typical product properties

• Regulatory and approvals

• Applications in pharmaceutical and medical packaging

• Sterilisation and processing

Michael Grimm; Ticona GmbH, Kelsterbach, Germany

The Challenge of Predicting Shelf Life for Drugs

• Unit dose distribution of drugs

• The advantages of unit dose packaging

• The challenges and solutions

Vagn Neerup Handlos; H:S Apoteket, Rigshospitalet, Copenhagen, Denmark

Packaging and Getting Access to the Contents

• Unacceptable packaging – the popular movement take action

• The Swedish Standardization process

• Future outlook – labelling accessibility

• Applications in pharmaceutical and medical packaging

Leif Hansson & Göran Wernqvist; Reumatikerförbundet, Stockholm, Sweden

Combating Drug Counterfeiting

• Counterfeiting, a worldwide problem

• Drug counterfeiting, endangering health-care and lives

• What WHO and FDA have to say

• What packaging can do to prevent counterfeiting?

• Technologies available today

• Technologies of the future

• Combating counterfeiting: a number of measures or a system?

• An outlook

Tassilo Korab; Alcoa Flexible Packaging, Vienna, Austria

Blind Reading Expressed in Braille format on the Packaging

• European Union Directive 2004 – article 54 and article 56a

• Braille on boxes

• Quality assurance

• Future step
Peter Mardov-Egvang; Novo Nordisk A/S. Bagsværd, Denmark
 

Implementing Directive 2004/27/EU, The Realisation of the Packaging Information Leaflet (PIL) for the Reading Disabled

• Braille on labels

• PIL for partially sighted and the blind

• Design guidelines
• Challenges for the printing industry

Anette Molin, Nycomed  Danmark ApS, Roskilde, Denmark
 

Exploiting New Bar-Coding and Allied Technologies for Supply Control and Tracking in the Pharmaceutical Marketplace

• The FDA ruling on unit dose bar-coding, including batch and expiry date information

• The implications to the EAN UCC system of the Sunrise Date, the GTN number

• RSS barcodes and the alternatives including Datamatrix and RFID

• Italian Bollini (Vignette) tracking solutions

Paul Osborne; Romaco Laetus GmbH, Alsbach Hähnlein, Germany

The Importance of Extractables Testing for a Successful Product Launch

• Key regulatory guidances mentioning packaging considerations

• Discussion of container closure guidance

• General approach to extractable/leachable studies (Pre-screening method development and
   validation, leachable studies on stability samples)
• Sources of extractables/leachables

• Case studies

Mike Schaefers; West Pharmaceutical Services Deutschland GmbH & Co. KG, Eschweiler, Germany
 

Anti-counterfeiting Features on Aluminium

• Pharmaceutical counterfeiting and features on packaging materials

• Options of the substrate aluminium to prevent counterfeiting

• New technology to mark plain aluminium foil

• Outlook and trends for safer medicines

Stefan Schmid; Teich AG, Weinburg, Austria
 

The Emerging Role of Prefilled Syringes for Auto-Injection Devices – Trends, Requirements and Chances for the Use of Prefilled Syringes

• Market trends auto-injection based medication

• Technical requirements for the use of prefilled syringes in auto-injection devices

• Future trends in using prefills for self injection devices – worldwide needle stick legislation and its

   effect on self-injection application

Thomas Schoenknecht, Gerresheimer PharmaSystems, Bünder Glas GmbH, Bünde, Germany

High Precision, automatic Head Space Gas Analysis Machines

• Fully automatic, high-speed in-line application

• Measurement of oxygen levels and absolute pressure

• Validation

• Comparison to other testing technologies

Gerhard Schramm; Wilco AG, Wohlen, Switzerland 

RFID in Supply Chains – FMCG and Pharma NEW Danish Testcenter

• Introduction to RFID in fast moving consumer supply chain (EPC) global

• Status: Requirements and commercial drivers: GlobalRetail and US department of defence (FDA?)

• Interdependency between global data synchronisation and RFID packaging/product RFID challenges

• Presentation of RFID EPC compliant test-center to open at Danish Technological Institute 21/6/2005

Jens-Christian Soerensen; Danish Technological Institute, Tåstrup, Denmark
 

Risk assessment of Migrants from Pharmaceutical Packaging Materials

• Pragmatic approach to determine migrants from pharmaceutical packing materials

• Risk assessment based on potential exposure, toxicity and comprehensive analysis

• Use of threshold of toxicological concern

• Food packaging versus pharmaceutical packaging

A.A.M. Stolker; TNO Quality of Life, AJ Zeist, The Netherlands
 

ISO/DIS 15378: GMP Standard for Primary Packaging Materials

• Purpose of the standard

• Development of the standard and current progress

• Structure and requirements

• Cost and benefit

• Outlook

Juergen Thuerk; Forma Vitrum AG, St. Gallen, Switzerland

The Latest Developments in Child Resistant Packaging for Medicines and Concomitant Openability after the 2003 UK Medicines (Child Safety) Regulations

• Making blister packs child resistant – true affordance to adults, false affordance to children.

• Standard blisters in reclosable containers, safety, openability and added value

• Back to bottle and closure? – Can we breathe life into an old product by improving it? An example

  of reclosable and dispenses units singly

• Will RFID produce added value, greater compliance and safer dosing?

Stephen Wilkins, Child-Safe Packaging Group, Wrexham, North Wales, United Kingdom

Anti-counterfeiting, Security and Solutions

• Covert technology - Colour-spectra films

• Covert technology -Bio-molecular marker

• Economic considerations

•Application example

Laurie K. Williams; DuPont, Wilmington, DE, USA