2017 CONFERENCE AGENDA
> FREE WEBINAR REGISTRATION
8.45 - 9.00: Conference Chair Opening Speech
9.00 - 10.15: Frank Peeters, Managing Director, Tobeas
Workshop: Storage and transportation of Investigative Medicinal Products (IMPs) and finished Medical Products (commercial cargo) subject to Good Distribution Practice
• GDP, GCP and GMP in relation to storage and transport of such products, what is the correct compliance?
• The key similarities and differences in understanding of any medicine used for human consumption
• The key lessons learned in managing transport when engaging both clinical trial logistics and commercial cargo subject to GDP
• Best approach to managing storage, and thermal mapping of facilities/premises for storage of medicine for human consumption
• Conclusion, Recommendations and Q&A
10.15 - 11.00: BREAK
11.00 - 12.15: Reinhard E. Voglmaier, Computerised Systems Manager, GSK
How to prepare yourself for an audit of IT Systems used in GDP/GCP
• Changes in Information Technologies
• Computerised Systems and their Validation
• Enterprise Governance of IT
• Areas under Audit
• Supplier Life Cycle
• Checklist for Audits
12.15 - 13.30: LUNCH
13.30 - 14.15: Florian Siedenburg, CEO, Ecocool
Mitigation of Tarmac Time Risks 2.0
Modern technology enables us to assess the risk of temperature excursions for potential shipping lanes before starting real life shipments. This new technology allows for a better, more knowledge- based process of packaging selection. It is demonstrated that climate chamber tests can consistently be replicated via software simulation. Combining this possibility with historical weather information allows us to simulate potential failure rates of various packaging options for specific shipping lanes throughout the year. Finally, a worst case scenario including hot ambient temperatures and maximum solar irradiation is considered to compare the performance of different packing options.
14.15 - 15.00: Riekert Bruinink, Senior GMP/GDP Inspector, Dutch Health Agency
An optimal approach to preparing for Good Distribution Practice Audit and to what extent should Good Manufacturing Practice and or Good Clinical Practice be taken account in relation to GDP - based to Inspector’s Notes.
1) Which types of drugs are covered when engaging GDP text and how correctly interpret the text for any type of medicine for human consumption?
2) Fundamental points of preparation according to GDP text and how do they relate to commercial products and Clinical Trial Supply products?
3) Fundamentals points of consideration subject to practice and examples of weakness within inspection concerning both clinical trial products and commercial pharma products?
4) The optimised approach subject to GDP guidelines requirements and how to best engage both commercial pharma products and clinical trial
15.00 - 15.45: BREAK
15.45 - 16.30: Sonia Bradford, Research QA,
Qualified Person, Mundipharma International
Finding the Right Balance– An approach to assigning temperature
logger limits in the distribution of clinical trial supplies
• Applying GDP throughout the clinical trial supply process and comparison
to commercial product supply chain
• An approach to applying GDP in relation to site shipments for Ambient
• An approach to using allowable excursion limits within the dataloggers
• Challenges of comparator products –assigning allowable excursion limits
and potential rationales
• Recommendation and Q&A
15.45 - 16.30: Serge Van Houten, Manager Logistics, Plasma
Implement cold chain in a pharmaceutical environment below -20C
1. Short introduction concerning the product we handle at the PIBe Logistic site
2. Qualifying Cold Chain on 2 levels;
a. Define TOR and recovery times
b. Product studies
3. Validation approach: CIA – Configuration specifications – Qualifications
4. Risk Based analysis with FMEA studies on Cold Chain Flows
5. Follow-up in Practice:
a. Include TOR & Recovery times in SOP’s
b. Use of timers for tasks with a higher rated risk
c. Use of RF-ID to track TOR & recovery times
6. How to cope with power failures / technical breakdowns in Large freezer Rooms
GDP Pharma Logistics
Clinical Trial Supplies
16.30 - 17.15: Ramón López, Clinical Trials Manager, Thrombotargets Europe
Key challenges associated with Time and Temperature clinical trial
logistics from manufacturing to patient
• Understanding the parameters of your cotract logistics for clinical trial logistics
• The impact of deviation and excursion on your clinical trial – regardless of clinical trial phase
• Key constraints of human and economical/financial points to consider
• Best approach, key considerations, lessons learned and recommendation
16.30 - 17.15: Stephan Heck, Sr. Director Customer Quality
Management, DSM Nutritional Products
Clinical Trial Supplies
GDP Pharma Logistics
9.00 - 9.45: Julie Helsted-Winkel, Director, Clinical Supplies Trial Set-up & Sophia Aman Raza, Trial Label Designer, Novo Nordisk
Labelling: Improving productivity, agility and lead time
Introducing the journey taken within labelling over the last couple of years to improve productivity, agility and lead time. Outlining key learnings and gains in cleaning up local regulatory requirements. Introducing the process of insourcing booklet ARTwork creation from idea to proof of concept and finally implementation. Revealing next step and future ideas of further optimisation of the label process.
9.00 - 9.30: Maria D’Orazio, Distribution Manager, Dompe
Successfully identifying risk within the distribution model and suggested
approaches to alleviate challenges
• Understanding of how distribution chains work and how suppliers are managed to provide organization with a basis from which to implement a structured process in an international environment
• Leveraging constraints and GDP requirements when multiple international destination countries and customers
9.45 - 10.15: Sarah Vanrenterghem, QP Clinical Trials /
Quality Pharmacist, UZ Gent – Pharmacy
At the end of the supply chain… a precise case for the role of hospitals
in clinical trials supply chain
• What boundaries dictate the role of hospital in clinical trials supplies
• Manufacturing and the need for EU Directive 2001/20/EC Art 13 (1) ‘V’ Reconstitution
• Logistics within a hospital subject to stability, storage and transport
• Consistent issues in clinical trial supplies when considering what takes place within in hospital clinical trial supply
9.30 - 10.15: Valentina Marinkovic , Associate professor/ GxP Consultant & Coach, University of Belgrade
Risk Management Outsourcing in Pharmaceutical Supply Chain
This presentation will focus on strategies to enhance internal efficiencies while engaging key such as regulation, risk quality standards, market access among other key challenges. The overall engage is based on better understanding of the outsourcing process of pharma supply chain, its impact costs, quality and to provide engagement for such areas as manufacturing and distribution ways of unlocking hidden risks. Here the argument has been developed based on Quality Management System this includes control efficacy and efficiency for the outsourcing activities. The model suggested will focus on PDCA cycle – plan, do, check and act where the application within the outsourcing process of transport of medicines has proven and interesting results for consideration during practical tasks. The practicalities of the Pharmaceutical Supply Chain are engaged based on a practical case from within the industry where
behavioural and cultural factors are engaged as means of high importance to ensure efficiency and success of the both internal oversight and external partner.
10.15 - 11.00: BREAK
11.00 - 11.30: Tania Snioch, Director Healthcare,
Exploring how global standards can be used to address efficiency,
accuracy and surety in the clinical trial supply chain
• The benefits of globally standardised identifiers and barcodes for clinical trial products
• Leveraging the activities of the co mercial products supply chain
• Considering the impact of commercial products regulations on the clinical trials supply chain
• Clinical trials industry direction and activities to work with global standards
11.30 - 12.00: Thomas Thoma, Head Clinical Trial Supply, Teva Group
A paradigm shift in managing comparator forecasts. Increasing
comparator market vs. lean warehousing and market concentration
Highlight the concentration of Generic suppliers and general Pharma Supply Chain optimization
Understanding the role of forecasting and accurate communication within the chain
Assessing the impact of forecasting for clinical supply planning
The impact of the Pharmaceutical driven forecast on the clinical trial supply chain
Common lessons learned and key challenges in managing such approach
Recommendation and Q&A
11.00 - 12.30 : Jackie Peck, Managing Director, Pharmacy
Workshop: Harmonising of GDP across Europe
Good Distribution Practice of Medical Products for Human Use has raised the standards in the medicinal products supply chain. Since their introduction there has been an increased focus by the competent authorities on the evidence medicine wholesalers must justify compliance with GDP and prove the quality and integrity of their product throughout their whole supply chain. Across the EEA there are still some slight variance in standards and implementation
of GDP however as time goes on there is greater harmonisation and sharing of best practice across the EEA.
The work shop today is titled “Harmonising of GDP across Europe” and is looking at the main chapters of the current GDP Guidelines. While maintaining product integrity during supply chain is the key, it is also noticeable the current tightening of regulation for import/export where Good Manufacturing Practices are engaged to create a robust framework for both storage and transport of medicine for human consumption. While Investigational Medicinal Products (IMPs) are subject heavily to Good Clinical Practice, and GMP, given the recent changes In GDP requirements there is a growing need for
follow the GDP when engaging in storage and or transport of such products.
12.00 - 12.30: Florian Clemencon, Senior Clinical Supply Chain Coordinator, Ipsen
New IMP Estimation Process for Robust Clinical Study Supplies
Resulting from a one year fruitful work of a cross-functional core team of R&D and CMC Clinical Supply Chain department stakeholders, the IMP Estimation process is a new and robust way of working for both departments. This process secures assumptions for study design and supply strategy, working toward better efficiencies for securing patients drug supplies within clinical trials.
12.30 - 13.45: LUNCH
13.45 - 14.15: Antoine Freyss, Lead IRT Project
Reducing your clinical trial costs using an IRT system
• IRT, the central piece to bridge gap between Clinical and Supply and how this will enhance operations efficiency
• Understand your IRT partner and its supply parameters to better control re-supply strategy
• Managing IMP expiry date via IRT
• Drug pooling in IRT
• Improve patient retention and compliance
14.15 - 14.45: Lisbeth Nielsen, Distribution Coordinator, H.
The Lundbeck approach (as a case study) of temperature monitoring
shipments of Investigational Medicinal Products using the minimal
manual work hours and maintaining a sufficient overview of temperature
• Use of transport stability data/storage conditions
• Risk based shipment methods
• Single use loggers
• Trending on temperature excursions
• One system cover all worldwide type of shipments in Clinical Supply
• Maintenance of system
14.45 - 15.15: Florence Guiraud, Trial Supply Operations Manager Leader, Sanofi
Direct To Patient
We are in a world of digitalization with patients more and more connected needing less visits at Clinical sites. Patient centricity is a new concept for pharmaceutical companies, and shipment directly to patient (DTP) is becoming a reality in clinical trials but also in real world.
DTP is a process that needs a real investigation as logistic can be complex. There are also regulatory concerns in each country including data privacy, and secured flows of information can be a constraint. In DTP, the quality concept is also not negotiable. The presentation will give you insight on how the concept of DTP has been integrated at Sanofi for more than two years with all different steps and recommendations.
13.45 - 15.15: Nurettin Ekizoglu, Head Supply Chain, Novartis
Workshop: How to overcome the current challenges and create a
long term strategic roadmap for E2E Supply Chain
How to improve traceability across the supply chain?
• According to the Pharmaceutical Security Institute, the
number of worldwide counterfeit drug incidents increased from 196
in 2002, to 2,108 in 2012. Current estimations of the worldwide cost
of counterfeit drugs are in the range of 75$ Billion. In Europe alone,
counterfeit drugs cost the pharma industry over 10 Billion Euro each
• What are the risks that your company see?
• What are the actions you are taking to improve visibility and
traceability throughout the supply chain?
• What is your expectation from the regulators?
2. How to manage Temperature Controlled Logistics?
• The storage and distribution of temperature controlled products is
a complex process and requires attention at all levels from supplier
to manufacturer and final customer. Air, sea, rail, or road – each
have their own distinct advantages and disadvantages.
• What are the challenges that you currently face during cold
• What are the strategies that you use for temperature controlled
3. Digital Supply Chain of the Future
• In today’s world, a fully digitized pharma supply chain remains
a goal of the future. Industry 4.0 is intended to make the supply
chain more efficient, agile and customer-focused. Many of the
applications have not been widely used in the industry, but this
will change radically in the next 5 to 10 years.
• How Supply Chain and digitization can work together to increase
• Any usage of Industry 4.0 or digitalization in your company?
4. E2E Supply Chain planning in emerging markets
• Supply Chain management represents a major portion of the
profit and loss within the pharma industry. Therefore, E2E
planning is recognized as crucial to delivering competitive
advantage, despite the challenges in emerging markets such
as increasing demand-supply complexity, increased focus on
generics and cost containment, tender challenges, and import/
export requirements – localization initiatives.
• What are the biggest challenges that you see in emerging markets?
• Which planning initiatives are deployed in your companies to
successfully manage the Supply Chain in emerging markets?
15.15 - 16.00: BREAK
16.00 - 16.30: Pieter Klaassen, Director, WGK Ltd
NEW EU GDP Guidlines – Impact on non – commercial research
• Overview of IMP Activities
• GMP/GDP Interface
• EU GDP and Investigational Medicinal Products (IMPs)
• Logistical issues at sites
• Financial Impact
• Waste reduction and improved carbon footprint
• Serialisation – are research institutions ready
• Information Technology – Limitations of Sites
16.00 - 16.30: Tania Snioch, Director Healthcare, GS1
Developing regulatory environments driving pharma product traceability
and logistics efficiency
• Some drivers for regulatory developments towards global standards
• Trends and requirements alignment
• Benefits of implementation for all stakeholders
• What’s next?