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Pharmaceuticals and Medical Devices put a strong emphasis on safe, manageable, compliant packaging that maintains the product in its intended state, can be used easily by the consumer/patient and represents the efficiency that companies wish to be associated with their brand. Representing a huge market in itself (it has been estimated that the Pharmaceutical packaging market will increase to $18.2 billion by 2005), packaging and labelling plays a crucial role in the commercial value of a drug or device.

This global Conference aims to take a close look at current and pending regulations governing packaging and labelling and how to ensure compliance. The event hopes to provide an interactive forum whereby representatives from Pharmaceutical and medical device companies, packaging manufacturers/contracters and regulatory authorities can come together to assess the regulations and their impact on the industry.

The event would look at how to communicate information and instructions to the consumer, how best to design packaging, how to ensure it meets the criteria in terms of useability, child resistance and protection from potentially harmful environmental factors. The event will also cover topical issues such as bar coding and will take a look at some of the issues surrounding security.

This event hold a high appeal for anyone trying to stay at the forefront of developments, from technical/engineering issues, to manufacture, from quality assurance and compliance to security and safety. A unique opportunity to learn from leading industry experts including:

Dr Julia Coombes, Senior Assessor Product Information Unit, Medicines & Healthcare Products Regulatory Agency (MHRA) Dr Claudia Okeke, Associate Director, Information & Standards Development, United States Pharmacopeia (USP) Dr Leander Fontaine, Vice President, International Labelling Liaison, Wyeth Barbara Lachmann, Head, Global Labelling, Merck Dr Patty Kiang, Director, Packaging Support, Worldwide Technical Service, Schering-Plough Ralph Dillon, Director, Quality Engineering, Pfizer Dr John Lively, EFPIA Leader, PIM Project, Eli Lilly Dr Francis Petit, Senior Manager, Labelling Europe, Cardiovascular & Insulin Products, Aventis Peter Mayberry, Executive Director, Healthcare Compliance Packaging Council

Benefits of Attending:

  • PACKAGING & LABELLING REGULATIONS: Discover the latest from the US and UK
  • THE PIM FINAL REPORT: Hear about the new way of submitting and managing product information
  • COMBATING COUNTERFEIT DRUG PRODUCTS: Gain an insight into innovative packaging processes
  • EXTRACTABLE/LEACHABLE STUDIES: Learn about the impact of these studies on pharmaceutical packaging labels
  • ELDERLY ADULT-ACCESSIBLE CHILD-RESISTANT PACKAGING: Understand the current situation and regulatory developments
  • INTERACTIVE DISCUSSION SESSION: Assessing the impact of recent regulatory changes to the industry
  • Conference programme

    8:30 Registration and Coffee

    9:00 Chairman's Opening Remarks

    Roy Gray

    Roy Gray, Consultant, 2P Packaging (formerly AstraZeneca)

    9:10 THE REGULATORY ISSUES BEHIND PHARMACEUTICAL PACKAGING & LABELLING

    Dr Julia Coombes

    Dr Julia Coombes, Senior Assessor Product Information Unit, Medicines & Healthcare Products Regulatory Agency (MHRA)

    9:40 COMPLYING WITH REGULATORY GUIDELINES

    Peter Mayberry

    Peter Mayberry, Executive Director, Healthcare Compliance Packaging Council

  • Efforts to alter CR packaging standards
  • Ensuring distribution of useful patient information when prescriptions are filled
  • Status of FDA efforts to require bar codes with drug products
  • Deterring counterfeit drugs: FDA focus on packaging and labelling
  • PACPAC guidelines: cleaning up any confusion
  • 10:20 PIM FINAL REPORT & IMPLEMENTATION

    Dr John Lively

    Dr John Lively, EFPIA Leader, PIM Project, Eli Lilly

  • Final results of project
  • Implementation plan for routine use of PIM for PI submission
  • Current progress
  • 11:00 Morning Coffee

    11:20 INTERACTIVE PANEL DISCUSSION

    Dr Julia Coombes

    Dr Julia Coombes, Senior Assessor Product Information Unit, Medicines & Healthcare Products Regulatory Agency (MHRA)

    Peter Mayberry

    Peter Mayberry, Executive Director, Healthcare Compliance Packaging Council

    12:00 HOW IMPORTANT IS EFFECTIVE PACKAGING?

    George Barrie

    George Barrie, International Packaging Design Manager, Alpharma

  • Meeting regulatory and commercial expectations
  • Having brand identity with quality of product: relation to packaging
  • Adding value through effective labelling and packaging
  • Deciding the packaging media
  • 12:40 Networking Lunch

    14:00 USP & PACKAGING ACTIVITIES

    Dr Claudia Okeke

    Dr Claudia Okeke, Associate Director, Information & Standards Development, United States Pharmacopeia (USP)

  • USP and USP standards
  • Current USP activities in packaging
  • Current USP activities in distribution
  • Current storage and labelling proposals
  • Future activities
  • 14:40 REDUCING COSTS & INCREASING PATIENT SAFETY

    Alaster Purchase

    Alaster Purchase, Senior Executive, Business Development, e.centre

  • Unique identification of products, assets, returnable assets, clinicians and patients
  • How to improve supply chain efficiency
  • Utilising best practice from all industries
  • Industry responsibility
  • 15:20 Afternoon Tea

    15:40 POWER TO THE PEOPLE

    Beverley Law

    Beverley Law, Head, Pharmaceutical & Healthcare Branding, Enterprise IG

  • Results from a recent study with patients in soft ethical therapy areas
  • How insights can be used to create more effective packaging
  • The five dynamics of packaging as a marketing tool
  • Being creative within a regulatory framework to address real sufferer needs
  • 16:20 CR PACKAGING IN PHARMACEUTICALS

    Roy Gray

    Roy Gray, Consultant, 2P Packaging (formerly AstraZeneca)

  • History and background
  • The new standard
  • Recent regulatory developments
  • Elderly adult-accessible child-resistant packaging
  • Uncertainties
  • Mechanical testing
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Roy Gray

    Roy Gray, Consultant, 2P Packaging (formerly AstraZeneca)

    9:10 A NEW AGE OF INFORMATION FOR PHARMACEUTICAL LABELLING

    Dr Francis Petit

    Dr Francis Petit, Senior Manager, Labelling Europe, Cardiovascular & Insulin Products, Aventis

  • What information do you need to provide?
  • Establishing relationships with the consumer: brand credibility
  • Language / legibility
  • Channels of communication
  • 9:40 PHARMACEUTICAL ARTWORK ORIGINATION

    Neil Gleghorn

    Neil Gleghorn, Managing Director, Kallik

  • Reducing cycle times
  • Improving efficiency of artwork production
  • Technology opportunities to remove all artwork costs
  • 10:20 PROVIDING ADEQUATE PACKAGE LEAFLETS IN THE EU

    Barbara Lachmann

    Barbara Lachmann, Head, Global Labelling, Merck

  • The variety of guidance documents
  • The relationship between Package Leaflet and SPC
  • Presentation of complex information for the general public
  • 11:00 Morning Coffee

    11:20 AN UPDATE ON LABELLING IN THE UNITED STATES

    Dr Leander Fontaine

    Dr Leander Fontaine, Vice President, International Labelling Liaison, Wyeth

  • The new format for prescribing information
  • A new approach for labelling adverse reactions
  • The ‘private sectors’ initiatives to provide patient information for prescription drugs
  • A step towards EU – US labelling harmonisation?
  • 12:00 PRACTICAL INNOVATIONS FOR MANAGING MULTI-LANGUAGE LABELLING

    Bob Tilling

    Bob Tilling, Director, Life Sciences Division, Map 80 Systems

  • EU local language requirements
  • Implications of 2004 EU expansion
  • Existing local language labelling solutions
  • New country-specific labelling systems
  • 12:40 Networking Lunch

    13:40 EXTRACTABLE / LEACHABLE STUDY ON PHARMACEUTICAL PACKAGING LABELS

    Dr Patty Kiang

    Dr Patty Kiang, Director, Packaging Support, Worldwide Technical Service, Schering-Plough

  • Regulatory requirement
  • Packaging qualification
  • Polymeric material properties
  • How to set up an extractable study strategy
  • How to work with outside testing laboratories
  • How to work with package component suppliers
  • 14:20 BARCODING

    Ralph Dillon

    Ralph Dillon, Director, Quality Engineering, Pfizer

    15:00 SMART LABELS & SMART PACKAGING IN THE PHARMACEUTICAL INDUSTRY

    Dr Peter Harrop

    Dr Peter Harrop, Chairman, IDTechEx

  • Diagnostics – responsive ink and electronic
  • Electronic conformance monitoring
  • Electronics to deter counterfeit, tampering and diversion
  • RFID for tracking, error prevention, proof of innocence and more
  • Dramatically clearer instructions and warnings by sound, moving colour etc
  • Iontophoresis skin patches, electronic aerosols and other advanced dispensing
  • 15:40 Afternoon Tea

    16:00 THE CONTRIBUTION OF THE SELF ADHESIVE INDUSTRY

    Mike Cooper

    Mike Cooper, Managing Director, PAGO

  • The general pressures in the packaging market
  • Brief history of the self adhesive industry
  • Decoration, identification and functionality
  • Specific child-resistant solutions
  • Tracking into the future
  • 16:40 COMBATING COUNTERFEIT DRUG PRODUCTS – INNOVATIVE PACKAGING PROCESSES

    Tassilo Korab

    Tassilo Korab, Director, Business Development, TEICH

  • The share of counterfeit drugs world-wide and by regions
  • General recommendations
  • Overt features
  • Covert features
  • Safety is not a feature but a system
  • 17:20 Chairman's Closing Remarks and Close of Conference

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    Workshops

    Innovative Packaging
    Workshop

    Innovative Packaging

    The Hatton, at etc. venues
    27th February 2004
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

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    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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