This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation, technology, innovation and artwork origination.
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
Programme - Day one
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
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
*Round table workshop on key issues – Falsified Medicines Directive: complying with the regulations
Update on the UK Medicines Verification System (MVS)
QMS and PS 9000
- Benefits of a QMS in a GMP artwork studio
- A GMP compliant artwork process
- The customer/vendor relationship
- How asset management and workflow technologies improves effectiveness
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
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
Programme - Day two
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
Securing the supply chain Key aspects:
- Use of packaging design to minimise “attack”
- Innovative technologies
- Responses to supply chain “attack”
- The 3rd shift: practical controls
- Track and trace/e-pedigree – is unit dose an issue?
Round table workshop on key issues – practical anti-counterfeiting and tamper evidence techniques
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
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 optimisation of packaging for medicinal products
- Case studies and practical examples
New and developing QMS standards and guidelines
- ISO 9001:2015 quality management
- ISO 13485:2016 medical devices
- ISO 15378:2015 packaging materials QMS and a further revision
- PS 9000:2016 packaging materials revision for ISO 9001:2015
- Origination guidelines
Mr Tony Harper,
Lead Auditor ,
Braille Medicines Forum
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.
Mr George Barrie,
Pharmaceutical Packaging Industry
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.
This conference will be of benefit to all those working in the following areas:
- Packaging Technology
- Business Development
- Project Management
- Good Manufacturing
- Quality Assurance /Control
- Regulatory Affairs
- Technical Writing
The Cavendish Hotel
81 Jermyn Street