Workshop Day - Monday 18th June
9:30 am - 11:30 am Packaging & Labelling for Patient Safety and ComplianceOmar Ali - Visiting Lecturer, University of Portsmouth & Former Advisor NICE
Facing a complex regulatory landscape, as well as diversified markets and medications, ensuring patient safety and compliance is more complicated than ever. Not only does patient non-compliance harm the patient, it is hugely costly for healthcare providers and extremely damaging for pharmaceutical manufacturers. Up to 33% of medication errors are attributed to packaging and labelling – what can you do to bring this number down?
Attend this workshop to:
- Increase brand loyalty by ensuring your products are used safely and correctly - we look at the packaging design that assists patient adherence to prescribed medicine regimens including resistance, senior-friendly, and tamper-evident features
- Add significant value to your business and consumers with new strategies and technologies
- Gain an advantage over your competitors - Ensure patients choose your brand over others by learning which kinds of packaging and labelling patients want to use
- Increase patient safety - a deep analysis of the importance of labelling
- Protect your brand AND stay innovative - learn how to think outside the box whilst staying within the regulations
Omar AliVisiting Lecturer, University of Portsmouth & Former Advisor
11:30 am - 12:30 pm Networking Lunch Break
12:30 pm - 2:30 pm Airtight EU Regulatory Compliance – Ensuing your Packaging, Labelling and Artwork Strategies are 100% Regulatory Compliant and Inspection ReadyHorst Kastrup - Senior Regulatory Advisor MEDA Pharma
Maintaining 100% regulatory compliance is no easy feat! Knowing the regulations isn’t enough – you need to know how to interpret them, and develop strategies to practically implement them. Moreover, there is increasing pressure on packaging, labelling & artwork professionals to save costs across the entire product life-cycle. Put this all together and meeting regulatory expectations has never been harder.
Attend this workshop to:
- Overcome the practical challenges of implementing the Falsified Medicines Directive in a cost-effective way
- Better understand the ISO - standards (IDMP) on pharmaceutical labelling
- Figure out what best-practice looks like when it comes to tamper evidence packaging features inline with ISO 21296
- Understand current Good Manufacturing Practice (cGMP) guidelines and principles to avoid any safety issues
- Decipher the complexities of the global regulatory landscape – know the local differences
Horst KastrupSenior Regulatory Advisor
3:30 pm - 6:00 pm Anti-counterfeiting and Tamper Evidence TechniquesDieter Moessner - Chairman German Standards Institute DIN / the European Committee for Standardisation CEN
The European Standard EN 16679 and the International Standard ISO 21976 specify requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products. Whilst these stringent regulations might seem like a drag, a regulation like the FMD can only bring benefits to the industry.
Counterfeit pharmaceuticals cost the pharma industry an estimated £36.9bn per year, according to research by the World Health Organisation, as well as risking the lives of patients. This workshop has been designed to provide you with the specialist knowledge and skills needed to achieve compliance!
Attend this session to:
- Decipher exactly which anti-counterfeiting and tamper evident features the EU falsified medicines directive requires
- Learn about tried and tested techniques for perfecting anti-counterfeiting and tamper evident features in your packaging
- Get ahead of the steep learning curve by gaining an in-depth understanding of the latest strategies to identify and overcome counterfeited drugs and their effects on the market
German Standards Institute DIN / the European Committee for Standardisation CEN