• Which safety features does the EU-falsified medicines directive require?
• Which tamper verification guidelines / “standards” are available?
• How to comply with the regulations? Contents of the European standard EN 16679 / technical characteristics of tamper verification features
• Qualification of tamper evident techniques
• ISO 21296 - The New International Standard on Tamper Verification Features
• International legislation for child resistant packaging (CRP)
• Standards for child resistant packaging
• Examples of CRP for pharmaceutical products
• Testing and certification process for CRP
• Analysis of key differences between essential requirements in annex I of the MDD and general safety and performance requirements of annex I of the MDR
• Thoughts on the ongoing revisions of EN ISO 11607 part 1 and 2, dealing with the changed regulatory requirements
• Potential impacts on how to test, how to evaluate usability, how to label…
• Status of harmonisation of these standards with the MDD and future harmonization with the MDR
As the global population ages, the demand for healthcare is expected to rise considerably. In particular biologic molecules continue to be as important as medicine. Biologics are the growth area in the pharmaceutical industry, now and in the future, both for Innovative Medicines and Biosimilars.
Biologics are difficult to make and require special skills and expertise along the whole life cycle of the product in research, technical development and commercialization, manufacturing and product maintenance as well as specific infrastructure to produce on a significant scale. This not only affects the internal activities of pharmaceutical companies but also the collaboration with external partners like CMOs, suppliers and service providers. Only if all involved parties work seamlessly together will we be able to deliver the right medicine to the right patient at the right time.
This keynote presents how Novartis develops biologic combination products and how the organizational structure of the device development department has been adapted accordingly. It will sketch out what pharmaceutical companies expect from suppliers by sharing lessons learned about components sourced from suppliers and by giving insights into a success story from a recent product development and launch.
Over the past 20 years, there has been a shift in pharmaceutical pipelines towards the development of biologics, which make up ~70% of drugs currently in development. However, the most recent innovations in biologics involve high viscosity formulations that present new challenges to the design of glass-based delivery platforms.
Polymeric PDC technology provides opportunities to overcome these challenges through an integrated device design philosophy. Combined with drug characterisation and user research, such platforms can pave the way towards greater compatibility between auto-injectors and the delivery of biologics.
A holistic approach based on synergy is nowadays mandatory to achieve a superior level of know-how about primary packaging systems for parenteral drugs, dealing with physical, chemical, and biological performance. Several materials are interacting with drugs and regulatory, pushing to increase the level of safety, while pharmaceutical companies are more and more trying to maximize the efficacy of the drug.
The expertise in glass container packaging, combined with an expertise in technology and analytics, is the solution that allows for reaching a comprehensive and complete understanding of primary packaging systems, defining a new standard of analytical services.
This presentation aims to demonstrate with real cases the superior results of a partnership approach that builds a key reference for pharmaceutical companies in support of the definition for adequate primary packaging system solutions in combination with drugs.
• Acknowledge current state, challenges and opportunities related to recycling healthcare plastics
• Create awareness of need for sustainable packaging in design, production and use of medical packaging systems
• Provide insight from a manufacturer perspective
• Provide insight from a hospital perspective
• Discuss potential circular economy solutions
• Where / area where those variations are the most sensitive and could have higher impact for the patients
• What is done today to check whether packaging suppliers could demonstrate this reliability (whether done through audit, routine monitoring, way of working...)
• What are the main 'unmet' needs from suppliers i.e. where /which area would the packaging suppliers need to improve / raise capability as the current level achieved or demonstrated by packaging suppliers are insufficient to guarantee this reliability
- Get a summary of pharmaceuticals identification and marking requirements related to the European regulation for medicines
- Learn international best practices to comply with the regulation
- Discover international recommendations for aggregation
- Data exchange is a critical component in any serialization project
- the lack of standard requires today huge efforts and high costs to establish such communications
- OPEN-SCS, a group of vendors and large pharma companies, is working to provide the industry with a reliable standard
- During the presentation we will update on the achievements and the plans of the group for the next future
- This includes the latest news on the Launch of Work product 1.0, the next Planning of Work product 2.0 and the next steps
- Handling blister and bottle lines
- Tamper evidence (verification challenges)
- Software architecture and third party integration
Alexander Schäfer, Business Development Manager, Sharp Europe
Jean-Marie Aulnette, VP EMEA, TraceLink Europe Ltd
- Developing a common concept
- Best practices
- Real life serialization experience at MAH & CMO
- Insight on the challenges
- Lessons learned and benefits in the implementation of a comprehensive track & trace platform for small-sized CMOs and large multinational companies
- Lessons learned ─ Real European case study from a pharmaceutical company
- Serialisation and aggregation in Europe ─ What to do
- Looking towards the future ─ Data interpretation and Industry 4.0
- L4 serialization and traceability Cloud System: what does it really mean / what for?
- How to easily ensure connectivity with multiple trading partners and facilitate their on-boarding?
- What are the types of data and formats you need to handle now and in the future?
- How to future-proof your system to cope with an ever-shifting and complex environment?
- What do you need to consider to guarantee data security?
The purpose of this presentation is to identify and present a cost effective method and devices to self-administration of biosimilar drugs and molecules while keeping the entire process safe and easy to use.
Disposable auto-injectors have their advantages of safe and simplicity, but pose an additional cost of materials to a bio-similar drug / molecule.
Reusable auto injectors are more cost effective, but the ones in the market are complicated, are not easy to use and not completely safe.
In this presentation we will present a new, innovative, method for easy and safe yet cost effective way for self-administration of biosimilar drugs/ molecules. These innovative devices might be a perfect partner with the biosimilar drug as they are not only cost effective, safe and easy to use, but also have a lower environmental impact of plastic parts and trash.
We will discuss mechanical auto-injectors and electronic auto-injectors while in both the only disposable part is the cassette that holds the PFS with the drug inside.
• Multilayer Plastic Vial & Syringe for Biologics
• Glass-like Oxygen Barrier
• Very Low Extractables
• Good UV Barrier
• High Break Resistance
• Overview of needlestick prevention regulations
• Classification of needlestick prevention systems
• Latest reforms and product requirements
• Challenges & solutions for new safety solutions
• PremiumCoat™ features a homogenized Fluorinated (ETFE) film resulting in a more effective barrier
• Combining years of elastomer development expertise with best practice coating technology
• “Ready to Sterilize” product designed for organizations that have sterilization facilities in place
• “Ready-to-Use” product is gamma radiated – the leading-edge process for sterilization
• By minimizing the amount of extractables, we enable our clients to fully focus on drug formulation
• Moulded glass production
• Type III moulded glass in flint and amber
• Decoration for pharmaceutical and cosmetic requirements
Ateva® G Medical grade ethylene vinyl acetate (EVA) copolymers from Celanese are biocompatible, optically transparent, flexible and stable thermoplastic materials. Ateva® G Medical EVA resins are fully compliant with various international regulatory requirements and are commercially successful around the world. This presentation will focus on technical aspects of recent innovations in the Ateva® G portfolio:
- Ateva® G Medical CP grade for critical packaging including stem cell storage containers
- Ateva® G Medical X grade for high quality film and tubing applications
- New development of EVA copolymers with improved kink resistance for single layer tubing
• Practical Considerations of handling biological products through the manufacturing process from thawing to storage of final product. • Effectively managing product sensitivities at the commercial scale. • Beyond the vial towards patient centric delivery systems
Eye care treatments are affecting a growing number of people and are in several treatments boosted by the growth of the older population and increase of wealth in emerging markets. The increase of chronical eye disease requires more efficient treatment with fewer side effects, which are widely known to be caused by preservatives that have been present in conventional multi-dose eye-dropper solutions. Gerresheimer Plastic Packaging offers:
• First multi-dose eyedropper for preservative-free solutions suitable for standard eye-dropper bottles.
• Easy to implement on existing filling lines
• Cost effective alternative to conventional mono-dose treatments
• The success of any medication is dependent on the individual's adherence to the dosing regimen.
• Today 60% of patients fail to take their medication properly. The impact of those compliance issues doesn’t just manifest themselves in the patient – they extend throughout the supply chain – from pharmaceutical company through hospital services and to the physician.
• The annual cost of non-adherence to the healthcare system is approximately $300 billion in the US alone.
• Connected devices and digital healthcare can increase patient engagement, improve dose adherence resulting in better health outcomes.
- How accurate dosing of medicines increases therapy adherence
- Creating an affordable solution that works
- The advantages of Abbott's Metered Liquid Dosing Concept