Agenda

All times displayed for Europe/Paris timezone.

Conference: Session 1: Regulatory Changes and Impacts

Welcome coffee breakfast
08:30 - 09:00
Conference
Opening address by chairs: The importance of packaging with regard to the information about and proper use of health products
09:00 - 09:30
Conference
Hospital Pharmacist, Chief of Pharmacy Department
Hospital Bichat-Claude Bernard AP-HP
CEO/CSO
Cabinet WHITE-TILLET
ISO 21296 Tamper Verification Features on Medicinal Product Packaging
09:30 - 10:00
Conference
Project Engineer Pharma
Edelmann GmbH

• 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

Child resistant packaging - poison emergency, legislation, standards, successful examples
10:00 - 10:30
Conference
Managing Director
Institut VerpackungsMarktforschung GmbH

• International legislation for child resistant packaging (CRP)
• Standards for child resistant packaging
• Examples of CRP for pharmaceutical products
• Testing and certification process for CRP

Coffee break, exhibition visit
10:30 - 11:00
Conference
Moving from the MDD to the MDR – what will be the impact on sterile packaging?
11:00 - 11:30
Conference
Regulatory Affairs Director (Europe, Middle-East & Africa)
DuPont Medical and Pharmaceutical Protection

• 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

Are current and future regulatory requirements satisfactory? What are the areas for improvement?
11:30 - 12:30
Panel Discussion
President
ACIDIM
Managing Director
Institut VerpackungsMarktforschung GmbH
Project Engineer Pharma
Edelmann GmbH
Counsel
Hogan Lovells International LLP
Regulatory Affairs Director (Europe, Middle-East & Africa)
DuPont Medical and Pharmaceutical Protection
Lunch break, exhibition visit
12:30 - 14:00
Conference

Conference: Session 2: Challenges in Packaging & Devices Development

Key factors for successful collaboration on pharmaceutical packaging development for biologics
14:00 - 14:50
Keynote
Group Head Risk Management
Novartis AG
Group Head Packaging Technology
Novartis AG

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.

Polymeric PDC Technology: an integrated approach towards better auto-injector design
14:50 - 15:10
Conference
Mechanical Engineer
Oval Medical Technologies

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.

Coffee break, exhibition visit
15:10 - 15:40
Conference
Ensuring drug safety through tight analytical studies on glass containers: an innovative perspective
15:40 - 16:00
Conference
Product Manager - Special Projects
Ompi - Stevanato Group

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.

Driving Circular Economy Solutions in Healthcare Plastics: A Value Chain Approach
16:00 - 16:30
Conference
Project Leader for Circular Economy
Aarhus University Hospital
Director of Global Marketing
Nelipak Healthcare Packaging

• 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

Expectations towards packaging suppliers in order to limit variation and reduce customer/client impact, main challenges and outcome
16:30 - 17:30
Roundtable
Quality Assurance, Audit Director
IPSEN
Head of Purchasing, Solids and Packging Cluster
Ferring Pharmaceuticals
Managing Director
VAL-U Advisory

• 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

Conference closes, exhibition visit
17:30 - 17:45
Conference
Pharmapack Awards Ceremony
17:45 - 18:00
Awards Ceremony
Exhibitor Cocktail Reception
18:00 - 19:30
Conference

Symposium: Serialisation, Track & Trace

Sponsored by:

Welcome coffee
09:00 - 09:30
Symposium
Introduction by moderator
09:30 - 09:45
Symposium
Senior Consultant and Founder
Nad Pharma Consulting
Achieving serialization through best practices and international standards
09:45 - 10:15
Symposium
Healthcare Manager
GS1 France
  • 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
Coffee break, exhibition visit
10:15 - 10:45
Symposium
Serialization for CMOs in Europe: ISPE workshop output
10:45 - 11:15
Symposium
Formerly Fareva Corporate Quality Director Pharma & API
Fareva
Working for an Open Standard for Data Exchange in Serialization
11:15 - 11:45
Panel session
Director of Strategy & Development
Antares Vision
  • 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
Panel discussion with speakers in the morning
11:45 - 12:15
Panel Discussion
Lunch break
12:15 - 13:30
Symposium
Introduction by moderator
13:30 - 13:45
Symposium
Case study 1: Managing Serialization Challenges
13:45 - 14:15
Case study
Vice President Global Sales and Service
Jekson Vision Pvt. Ltd.
  • Handling blister and bottle lines
  • Tamper evidence (verification challenges)
  • Software architecture and third party integration
Case study 2 by Atlantic Zeiser
14:15 - 14:45
Case study
Case study 3: Challenges and Best Practices of Real-Life Serialization
14:45 - 15:15
Case study
Business Manager Track & Trace
WIPOTEC-OCS GmbH
  • Developing a common concept
  • Best practices
  • Real life serialization experience at MAH & CMO
Coffee break
15:15 - 15:30
Symposium
Case study 4: Developing an end-to-end serialization solution for CMOs and brand owners
15:30 - 16:00
Case study
Director of Strategy & Development
Antares Vision
  • 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
Case study 5: Practical Lessons and Next Steps for Serialisation Implementation
16:00 - 16:30
Case study
Director Product Line Management
Optel Vision
  • 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
Case study 6: How to ensure reliable and seamless management, sharing and reporting of your serialization data?
16:30 - 17:00
Case study
Professional Services Director, EMEA
Adents
  • 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?
Panel discussion
17:00 - 17:45
Panel session
Symposium closes
17:45 - 17:50
Symposium

Learning Lab

The Best Plastic Vial & Syringe for Biologics
10:10 - 10:40
Learning Lab
Researcher
Mitsubishi Gas Chemical Company, Inc.

Sponsored by:

• Multilayer Plastic Vial & Syringe for Biologics
• Glass-like Oxygen Barrier
• Very Low Extractables
• Good UV Barrier
• High Break Resistance

Market evolution of needlestick prevention systems to meet regulatory requirements
10:50 - 11:20
Learning Lab
Product Manager Injection Devices
Gerresheimer Regensburg GmbH

Sponsored by:

• Overview of needlestick prevention regulations
• Classification of needlestick prevention systems
• Latest reforms and product requirements
• Challenges & solutions for new safety solutions

Setting new standards for coated stoppers
11:30 - 12:00
Learning Lab
Senior Business Project Manager
Aptar Pharma

Sponsored by:

• 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

Excellence in moulded pharma glass
12:10 - 12:40
Learning Lab
Group Sales Director Pharma & Medical
St”lzle Glass Group

Sponsored by:

• Moulded glass production
• Type III moulded glass in flint and amber
• Decoration for pharmaceutical and cosmetic requirements

Lunch Break
12:40 - 13:40
Learning Lab
Meeting the evolving needs of the healthcare industry - Innovations in ethylene vinyl acetate (EVA) copolymers
13:50 - 14:20
Learning Lab
Manager T&I
EVA Polymers, Celanese Corp.

Sponsored by:

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

Catalent
14:30 - 15:00
Learning Lab
Multidose eyedropper for preservative-free treatments
15:10 - 15:40
Learning Lab
Product Management and Innovation
Gerresheimer Plastic Packaging

Sponsored by:

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

Innovative Respiratory Solutions for Expanding Your Product Portfolio
15:50 - 16:20
Learning Lab
Director Business Development
Aptar Pharma

Sponsored by:

• Rise in allergies and air pollution across the globe
• Significant increase in upper respiratory tract diseases.
• Treatment with a combination of OTC medications and household remedies, like visiting salt caves or rinsing with saline solutions.
• Household solutions are proven and effective, but do not fulfill the need of today’s population for “on-the-go” and easy lifestyle medication.
• Presentation of innovative respiratory solutions that meet market needs

Case study from the winner of the HCPC Europe Columbus Awards 2017
16:30 - 17:00
Case study