Implications of the EU Falsified Medicines Directive for Dispensers

Life Sciences, Pharma Manufacturing and Supply Chain, Pharmaceutical, Pharmaceutical Regulation ,
  • June 06, 2018 | (Wednesday) 8am EDT (NA) / 1pm BST (UK) / 2pm CEST (EU-Central)
  • 60 min

The EU Falsified Medicines Directive requires that by February 9, 2019, pharmaceutical companies must serialise prescription medicines using a 2D barcode that contains the following information: product code, serial number, national reimbursement number (where required), batch number, and expiration date. This information must also be delivered in human readable text on the medicine’s package.

Entities responsible for dispensing medication, namely hospitals and retail pharmacies, must be able to scan the 2D bardcode at the point of dispensation (wherever that occurs in the facility) to verify that the pharmaceutical product is authentic and decommission it before distributing it to patients. In addition to affecting dispensers, the EU Falsified Medicines Directive legislation impacts many other pharma supply chain stakeholders, including market authorization holders, wholesalers, and parallel importers.

This 60-minute webinar will focus primarily on the impact of EU Falsified Medicines Directive on dispensers, including doctors, hospitals, and pharmacies throughout Europe. Our experts will address the following questions:

  • Where could the serialized medicines be scanned/dispensed?
  • What hardware and software is needed, and how does it work? (And who pays for it?)
  • What is the responsibility of the dispensing site regarding returned, recalled or withdrawn medicine?
  • What do I need to know about parallel imported/distributed medicines?
  • What is my role in interfacing with the European Medicines Verification System (EMVS) and the National Medicines Verification Systems (NMVS)?
  • How is EU Falsified Medicines Directive different than the U.S Food and Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA), and how do I avoid making the mistakes my North American counterparts made duringDSCSA implementation?
  • What is the potential for additional benefits beyond compliance, such as patient engagement?
  • What medication is on the black list and what is on the white list or products that aren’t aggregated (i.e., which meds need to be scanned and which ones don’t? Will the dispenser need more resources?

The featured speakers will also provide an update on the Oxford Hospital decommissioning pilot, which is extremely important for the European healthcare industry because it will help define how hospital management teams can use this requirement to improve patient safety.

With only a few months before the EU Falsified Medicines Directive’s “big bang,” dispensers must make decisions now to be ready for this directive. If you have been tasked with quickly get up to speed on how the EU Falsified Medicines Directive impacts dispensers, join us for this hour-long webinar, which features a 15-minute question and answer session.

Speakers

Barry Holleman, Account Director, Healthcare, OPTEL Group

Barry has 20 years of experience in healthcare technologies and healthcare logistics centered around hospital pharmacies. He is passionate about optimizing medication logistics, deploying medication automation and engineering of the pharmacy workflow in order to accomplish the safest way for medication delivery. Barry holds a master’s degree from the University of Nijmegen, Netherlands and is associated with the Logistics Institute of the University of Hull, UK.

Dhermita Desai, Senior Project Manager, UK and EU, Verify Brand Software®, part of OPTEL

Dhermita Desai’s operational skills have been honed through 16 years of work in the Life Sciences industry. Before coming to OPTEL, Dhermita worked as a serialisation programme manager for Concordia International, where she coordinated the Concordia International programme for implementation of serialisation across all defined markets and SKUs. Her responsibilities at Concordia included authoring validation documents and onboarding more than 100 trading partner CPOs and CMOs.  

She has also held quality and program management roles at Amdipharm Mercury Company, Mercury Pharma, Lexon UK and Reckitt Benckiser Healthcare International. She views constantly evolving regulatory compliance mandates as tremendous opportunities to leverage her organizational and management skills to ensure that her clients’ serialization projects meet regulatory market and business requirements. Dhermita has a degree from De Montfort University in Pharmaceutical Chemistry.

Who Should Attend?

  • Professionals from hospitals, retail pharmacies and other organizations that are required to comply with EU FMD, including the following positions:
  • Director of Pharmacy / Chief Pharmacist / Head of Pharmacy
  • IT Manager / Director of IT
  • Compliance Manager / Director of Healthcare Compliance / Hospital Compliance Officer

What You Will Learn

Learn your responsibilities in detail with regard to the Falsified Medicines Directive before the legislation is applied.

Xtalks Partners

OPTEL

Founded in 1989, OPTEL is now a multinational, leading global provider of traceability systems practicing responsible human capitalism. The company’s mission is to use its innovative technologies to help create a better world. Namely, its renowned solutions ensure the quality of consumer health products and help stop counterfeiting of pharmaceuticals and medical devices throughout the world. In addition, OPTEL is adapting its technologies to create efficiencies in various other sectors ─ from health-related industries to smart manufacturing and more, all can benefit from global traceability. Through advanced characterization and cutting-edge algorithms ─ now all connected through the Internet of Things ─ OPTEL’s expert traceability solutions will allow diverse industries to measure, inspect, control and track a wide range of elements to improve product quality and make better use of resources. Based in Canada with additional facilities in the U.S., Ireland, India, and Brazil, as well as employees worldwide, OPTEL has expanded significantly in the past few years in order to meet growing industry needs and to support its humanitarian values. OPTEL is also a Certified B Corporation.

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