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Pharmaceutical GMP

Pharmaceutical Packaging, Labelling and Artwork Origination

2-3 May 2018

GBP EUR USD
Standard 1499 2099 2338
Excluding VAT @ 20.00%

Venue: Cavendish Hotel, London

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Bespoke training

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Course overview

This conference has been designed to present a number of important developments in pharmaceutical packaging and labelling regulations, standardisation, technology, innovation and artwork origination. The importance of packaging and labelling trends to improve patient safety and compliance and increase efficiency will be a particular focus of this event. New technologies and packaging innovations will be discussed and examples and case studies will be illustrated.

Why you should attend

Benefits in Attending:

  • Gain an update on current regulatory issues and packaging changes
  • Comply with the Falsified Medicines Directive
  • Discover the latest anti-counterfeiting strategies
  • Hear about tamper verification features for medicinal packaging
  • Discuss country specific ways to serialisation
  • Access key opinion leaders in packaging and labelling for the pharmaceutical industry
  • Hear the latest trends in packaging design and development
  • Understand how good design makes safer medicines
  • Gain an understanding of artwork asset management
  • Plan your packaging design to meet patient needs
  • Participate in practical round table discussions and workshops

Who should attend

This conference will be of benefit to all those working in the following areas:-

  • Artwork/Origination
  • Packaging Technology
  • Business Development
  • Project Management
  • Good Manufacturing
  • Purchasing
  • Practice
  • Quality Assurance /Control
  • Logistics
  • Regulatory Affairs
  • Packing/Design/Labelling
  • Technical Writing

Programme - Day one

09.30 Chairmen’s Introduction and Welcome
Tony Harper and George Barrie

09.40 Current Regulatory Issues and Packaging Changes

  • Labelling for Safety
  • Falsified Medicines Directive and the delegate acts – implementation for the UK
  • Information Provision for the 21st Century – the “shortcomings” report and where next
    Jan MacDonald

10.20 Challenges Facing the Industry and Future Trends and Developments

  • What is happening in this fast moving field?
  • The Falsified Medicines Directives requirements in practice
  • Key industry trends in commercial packaging
  • Innovative packaging solutions
  • Patient compliance and safety
  • Visibility and control within the supply chain
    George Barrie

11.00 Discussion

11.10 Coffee

11.30 Round Table Workshop on Key Issues – Falsified Medicines Directive: Complying with the Regulations
Led by George Barrie and Jan MacDonald

12.30 Workshop Feed Back

13.00 Lunch

14.00 Packaging – A Strategic Differentiator in Delivering Cost Effective Solutions and Patient Adherence Improvements

  • Deliver short-run manufacturing capability for leaflets and booklets to maximise communication effectiveness
  • The benefits; cost, manufacturing flexibility, environmentally friendly, patient outcome increases, all without costing the earth
  • Utilising packaging and labelling technologies to increase patient adherence rates
     Chris Waterhouse

14.40 QMS and PS 9000

  • Benefits of a QMS in a GMP artwork studio
  • A GMP compliant artwork process
  • Standards
  • The Customer/Vendor relationship
  • How Asset Management and Workflow Technologies improves effectiveness
    Suzanne Ivory

15.30 Tea

15.40 Serialisation of Pharma Folding Cartons

  • Overview about country specific ways to serialisation
  • Information gathering and processing at the pharma company
  • Printing and reading of serialised information on the pack
  • Investments, project planning and lessons to be learned
    Dieter Moessner

16.20 The Life Cycle of Outsourcing Artwork Services

  • Outsourcing of artwork services need not be a one way street
  • The decision to make or buy artwork services is difficult and full of pitfalls
  • Successfully outsourcing artwork development
  • A cradle to grave journey of sourcing artwork services
    Nathy Feely

17.00 Discussion

17.15 End of Day One

Programme - Day two

09.00 Chairmen’s Introduction to Day Two
George Barrie and Tony Harper

09.10 EN 16679 – The European Standard – Tamper Verification Features for Medicinal Product Packaging

  • Which safety features does the EU – Falsified Medicines Directive require?
  • Which Tamper Verification guidelines are available?
  • Target and process of European Standardisation
  • Structure and contents of EN 16679 Tamper Verification features for medicinal products packaging
  • Conclusions / Recommendations for the practice
    Dieter Moessner

09.50 Securing the Supply Chain
Key Aspects:

  • Use of Packaging Design to minimise “attack”
    • Innovative technologies
  • Responses to Supply Chain “attack”
    • Identification
    • Diagnosis
    • Responses/Action
  • The 3rd Shift: practical controls
  • Track and Trace/e-Pedigree – is unit dose an issue??
    Chris Waterhouse

10.30 Discussion

10.40 Coffee

11.00 Round Table Workshop on Key Issues – Practical Anti-Counterfeiting and Tamper Evidence Techniques
Led by George Barrie and Dieter Moessner

12.00 Workshop Feedback

12.30 Lunch

13.30 Patient Needs and Requirements – Packaging Solutions for Patient Compliant Packaging

  • Why is there a need for patient compliant packaging?
  • Concept of patient compliant packaging – How to improve patient compliance?
  • Structural and technical design of folding boxes
  • Artwork design and layout of medicinal product packaging
  • Logistical and technical optimization of packaging for medicinal products
  • Case studies and practical examples
    Dieter Moessner

14.15 Tea

14.30 New & Developing QMS Standards

  • ISO 9001:2015
  • ISO 15378 – revisions
  • PS 9000 – revision
    Tony Harper

15.15 Discussion and Q & A

15.30 Chairmen’s Concluding Remarks

15.45 End of Conference

Presenters

Jan MacDonald

Jan MacDonald is a pharmacist by profession and is currently Group Manager for the Access, Information and Medicines Standards Group in the Vigilance and Risk Management of Medicines Division at the MHRA. She has undertaken a number of assessment and management roles within the agency. Prior to this she was principal pharmacist for quality assurance and quality control in the NHS.

George Barrie

George Barrie is a Consultant to the Pharmaceutical Packaging Industry.
Until recently he was with Actavis where his role was to bring all elements of packaging design, regulatory requirements and production together and explore design-led solutions, thus aiding compliance and embracing forward-thinking across the packaging process and value chain. He headed up a team that provided a centralised ‘Packaging Centre of Excellent’ supplying Actavis operations globally. The team was and continues to be, driven by the philosophy of “Making Medicine Accessible”.
He started out with a background in design and subsequently moved into the print and packaging field 12 years ago where he gained broad experience working for a supplier to innovator pharmaceutical companies. Experience on both sides of the packaging value-chain has given him a unique insight into some of the key problems and solutions facing the Pharmaceutical sector.
He is an active member of a number of Pharmaceutical industry bodies and firmly believes that successful packaging design and development will be best achieved by a fully consultative process.

Tony Harper

IRCA Certified QMS & PS 9000 Lead Auditor.

After working for over 30 years in the pharmaceutical industry, Tony Harper provides auditing, consultancy, training and certification services for the Pharmaceutical and Medical Device Industries and their suppliers particularly those implementing ISO 9000, ISO 13485, ISO 15378, PS 9000 and PS 9100. He also carries out Notified Body CE Medical Device audits.
He was instrumental in setting up the Institute of Quality Assurance (IQA), Pharmaceutical Quality Group (PQG) in 1977 and was its Chairman for 15 years. He was a Committee Member until 2005 and is currently a member of the PQG Partners Team who have developed the PS 9000 Series of documents. He is also a Trustee, Board Member and Honorary Treasurer of the Chartered Quality Institute (CQI). In addition, Tony lectures on Quality Management at the Brighton University QP Post-Graduate Diploma course.
As the UK principal expert, he is working with the International Standards Organization drafting standards (ISO 9001, ISO 9004) and ISO 15378 for Pharmaceutical Packaging Materials and with BSI, CEN and ISO on Braille, patient information and tamper evidence. He is Chairman of the Braille Medicines Forum. Tony is also working on pharmaceutical artwork/origination guidelines.

Nathy Feely

Nathy Feely, Short Mountain Consulting, is a highly experienced professional in the field of packaging, artwork and organisational design. As an independent consultant he is in an excellent position to assess organisations, advise on strategic options and implement agreed plans. His expertise is in procurement and management of outsourced services, as well as product security and anti-counterfeiting technologies. 
Prior to establishing Short Mountain Consulting he was Director, Packaging Services at Wyeth (and after acquisition, Pfizer) where he established EMEA Packaging services, primarily concerned with integrating Packaging and Artwork elements into the greater product Supply field.  

Dieter Moessner

Edelmann GmbH, Heidenheim/Germany
Dieter Mößner has been working as Project Engineer Pharma and was previously a team leader in the Prepress area for Edelmann GmbH. He has been responsible for artwork services and for print data communication for the Edelmann group (www.edelmann.de) producing folding cartons, leaflets and labels for the pharmaceutical and cosmetics industries in 13 sites world-wide. His job is to consult customers and artwork agencies in artwork creation, print data communication and typesetting workflows.
He composed parts of the “Technical Guidelines Braille on folding cartons”, published by the German Folding Cartons Association FFI (www.ffi.de), and the guidelines “Braille on Folding Cartons”, published by the European Carton Makers Association ECMA (www.ecma.org). He is Convenor of CEN/TC 261/SC 5/WG 12 “Marking”. This working group at the European committee for standardisation CEN (www.cen.eu) has created the European standard EN 15823:2010 “Braille on Packaging for Medicinal Products”. It has just recently completed the works on the creation on EN 16679 – the European standard on “Tamper verification features for medicinal product packaging”. Up to its publication in January 2013 the contents of the European standard EN 15823 had been transformed into an International standard ISO 17351 “Braille on packaging for medicinal products” within ISO/TC 122 packaging. This project has been processed within ISO/ TC 122/WG 9 “Accessible design” with Dieter Mößner / Germany as project leader.
He is also Chairman of the German working groups NA 115-03-01 AA “Braille on packaging” and “Tamper verification features for medicinal product packaging”. After six years being the Vice-chairman of the packaging standards committee NAVp (www.din.navp.de) at the German Standards Institute DIN (www.din.de) he became its Chairman in March 2013.

Christopher Waterhouse

Chris Waterhouse is an experienced Project Manager specialising in the integration of manufacturing and supply chain operations with packaging technology. 

Highly motivated and an innovative thinker with a track record of delivery in demanding situations he has a wide ranging expertise in Supply Chain operations and processes, originally centred on the manufacturing and packaging arenas. 

In recent years he has worked at senior level in Regulated Industries; Agro-Chemical, Pharmaceutical and Healthcare and as such has been regularly involved with the subject area. 

Recent programs of work have included:

a. Packaging redesign to facilitate improved protection

b. JIT Packaging Manufacture, not manufacturing!

c. Development of digital approaches for anti-counterfeit purposes

Chris is a Fellow of the Institute of Packaging.

Suzanne Ivory

Suzanne Ivory joined the Perigord Group in 2005 where she currently works as the Group Quality Manager for the software development, artwork management and printing sections of the business.
She has 18 years experience as a Quality Manager implementing and managing quality systems such as ISO 9001:2008 and PS 9000 in a range of companies which service the pharmaceutical industry including Printing, Finishing, Packaging, Artwork studio’s and Software development. Suzanne is a qualified IRCA auditor for ISO 9001: 2000, ISO 14000 and PS 9000.
Over the last 3 years she was heavily involved in updating the PS9000:2011 standard which was published on the 14th September 2011. This involved working with a team of industry experts from pharmaceutical companies and suppliers to the pharmaceutical industry giving her a detailed insight into the audit requirement and best practises within the pharmaceutical packaging environment.

Jerome Bertin

Jerome Bertin is General Manager at SecurMed UK.
Jerome brings a strong track record in business change, consulting and technology delivery from a commercial industry background. For the past eighteen months, Jerome has been leading packaging artwork and serialisation programmes for GlaxoSmithKline pharmaceutical and consumer health divisions, and has a good understanding of the challenges and complexities in implementing serialisation solutions for the medicines supply chain.
Prior to GlaxoSmithKline, Jerome spent 15 years in the oil & gas industry delivering enterprise scale business-to-business change, technology and infrastructure programmes for BP, Shell and BG Group. Jerome is professionally certified in Managing Successful Programmes (MSP) and as a PMI Project Management Professional. As the General Manager of SecurMed UK, Jerome is responsible for the implementation of the UK repository and interfaces, using an IT service provider (Blueprint Service Provider, or BSP) selected by the SecurMed UK Board. Jerome represents SecurMed UK in day-to-day business with medicines supply chain stakeholders, the UK Competent Authority, and other government and regulatory authorities and third parties in the four countries of the United Kingdom. He will also manage the SecurMed UK relationship with the European Medicines Verification Organisation (EMVO). SecurMed UK is the UK Medicines Verification Organisation, a not-for-profit organisation which will deliver the UK Medicines Verification System. SecurMed UK has been incorporated by the principle representative supply chain stakeholder associations (Association of British Pharmaceutical Industry, British Association of European Pharmaceutical Distributors, British Generics Manufacturers Association, Company Chemists Association, Healthcare Distribution Association and National Pharmacy Association) as required by the EU Falsified Medicines Directive.

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Previous customers include...

  • (MHRA) Medicines & Healthcare Products Regulatory Agency
  • Actavis UK Ltd
  • AJ Vaccines
  • AJ Vaccines A/S
  • ALLERGAN PHARMACEUTICALS (IRELAND) LTD
  • Auden McKenzie Group
  • Bilthoven Biologicals B.V.
  • Bio-Technology General (Israel) Ltd.
  • Biogen Idec
  • Celgene Logistics Sàrl
  • Chesapeake Pharmaceutical & Healthcare Packaging
  • DADA Consultancy BV
  • Eisai Manufacturing Limited
  • European Medicines Agency
  • F. Hoffmann-La Roche Ltd
  • Health Products Regulatory Authority
  • Horizon Pharma plc - Corporate Headquarters
  • Martindale Pharma
  • Napp Pharmaceutical Group Ltd
  • Norgine
  • Norgine Limited
  • Norgine Ltd
  • Norgine Ltd (Head Office)
  • Owen Mumford Ltd
  • Shire Aqisitions
  • Takeda GmbH
  • Takeda Pharma A/S
  • Teva UK Limited
  • The Boots Company PLC
  • Zogenix International

What previous delegates say...

A very well put together course covering the current labelling challenges facing the pharma industry in meeting the latest regulations. The speakers were all very enthusiastic about sharing their knowledge and giving guidance to improve how we work in this industry. I have been on one of these courses before and think it is essential to attend every few years to keep abreast of the latest topics.

Liz Campbell, Artwork Co-ordinator, Britannia Pharmaceuticals

An excellent course to broaden the mind of packaging-orientated employees with presentation from passionate industry-leading key figures giving me confidence that what I was being taught was the best information/opinion available.

Adam Goodall, Artwork Specialist, Otsuka Pharmaceuticals Europe Ltd