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Workshop Day

9:00 AM - 9:30 AM REGISTRATION AND NETWORKING COFFEE

9:30 AM - 12:00 PM A Hands-on, Best Practice Guide to Labelling, Artwork and Package Layout

Horst Kastrup, Senior Regulatory Advisor, MEDA Pharma
Do you ever wish you could have direct exposure to, and tailored attention from,
a genuine Pharmaceutical Packaging/Labelling and Artwork expert? Someone
who knows the regulatory expectations inside-out, as well as the best ways to
practically implement them? Someone with experience training internal teams
in the absolute best practice across packaging, labelling and artwork? Well this
is your chance!

Attend this session to:
  • Integrate flexibility into packaging lines in order to modify manufacturing processes in a timely manner
  • Identify cost effective and efficient packaging options which can strengthen your supply chain and ensure patient adherence
  • Explore solutions to the biggest challenges packaging designers face in improving patient compliance
  • Decipher the use of different colours in your artwork to prevent medication
  • Go into detail about the ISO - standards (IDMP) on labelling
  • Collect information on various artwork management systems and gain clarity over the complexity of artwork management
  • Find out more about the latest innovations and learn about solutions that could work for you
  • Discuss tamper evidence techniques in detail

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Horst Kastrup

Senior Regulatory Advisor
MEDA Pharma

12:00 PM - 1:00 PM NETWORKING LUNCH

1:00 PM - 3:30 PM Hands Off My Package! Anti-counterfeiting and Tamper Evidence Techniques

Dieter Moessner, Chairman, German Standards Institute DIN/the European Committee for Standardisation CEN
The European Standard EN 16679 specifies 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. Of course, achieving airtight compliance is no easy
feat, there will be challenges to overcome and that’s why the industry needs to
prepare and be ready.

The lack of time, knowledge and specialist skills can be the biggest barrier
towards compliance. This workshop has been designed to provide you with
the specialist knowledge and skills needed to help you get there!

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

Workshop Outline:
1) Regulatory, legal and Normative Foundation:
  • Requirements of the FMD/Delegated Regulation regarding tamper verification and anti-counterfeiting
  • Regulatory / EMA Requirements of the FMD/Delegated Regulation regarding tamper verification and anti-counterfeiting
  • Contents of “EN 16679 Tamper verification features” and its practical implementation
2) Qualification, Validation and Practical Implementation of Tamper Verification
and Anti-Counterfeiting Technologies on Packaging for Medicinal Products
  • Rating & evaluation matrix for tamper evidence features
  • Case study on the definition and selection of tamper verification features at the pharmaceutical manufacturer
  • Practical guideline tamper verification features on medicinal product packaging
3) Group work of participants
  • What are your next steps in your company in order to implement the required tamper verification and anti-counterfeiting features?
  • What are the challenges and solutions?
  • How can you successfully accomplish the given tasks in the given time frame?

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Dieter Moessner

Chairman
German Standards Institute DIN/the European Committee for Standardisation CEN