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.
What is happening in this fast moving field?
Your business…why is security so important?
Understanding the SC: where do the risks exist?
Which safety features does the EU – Falsified Medicines Directive require?
Which Tamper Verification guidelines are available?
Why is there a need for patient compliant packaging?
Concept of patient compliant packaging – How to improve patient compliance?
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 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.
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, 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 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.
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.
b. JIT Packaging Manufacture, not manufacturing!
Chris is a Fellow of the Institute of Packaging.
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.