An event by Pharma Dialogue, the Healthcare division of
8.45 - 9.00: Co-chair Opening Speech
9.00 - 9.45: Yoram Eshel, CEO, LOGINOR Ltd.
Selection of time and temperature-controlled shipment technologies and integration according
Corrective selection of technologies in minimising excursions
Synchronising cold chain solutions according to requirements at destination
Accounting for new changes and maintaining the pace
9.45 - 10.15: Thomas De Bie, CEO, CAPPI
Packaging Innovation: a Unique Combination of Air and Water to Guarantee Temperature Controlled
Discover why listening is such a valuable skill – hear how collaboration with the pharma industry led to a new pallet-in-pallet solution
Capitalise on first-class engineering and benefit from great thermal performance with green materials
10.15 - 11.00: BREAK
11.00 - 11.45: Olivier Simonnot, Senior Manager Strategic Marketing Life Sciences EMEA, Sensitech
11.45 - 12.30: Marloes Seesing, Global Healthcare Quality Director, Yusen Logistics
A GDP compliant end to end supply chain: a case of global standards, building a global network and Third Party Management
How to develop a GDP global standard?
How to implement this outside the EU?
What is the role of Third Party Management?
Which licenses and/or certificates do we need to aim for?
Which parameters can we use for the Route Risk Assessment and how can we limit the risks
12.30 - 13.45: LUNCH
13.45 - 14.15: Markus Haase, International Sr. Market Manager – Solutions Division, Testo
More confidence – less paper. How digitization of environmental monitoring of your site and your transport helps you to make swift decisions and avoid loss of money.
How to optimize the monitoring of environmental parameters in storage and during transport
How to replace different systems in the same company with one single use system in place
Benefits for you as an audited company to have data from different sites available for a short term audit
Merging the monitoring from manufacturing over transport to storage – Total Cold Chain Control
14.15 - 14.45: Fabian De Paoli, Director of Vaccine Distribution & Cold Chain, GSK Vaccines
Continuous Improvement in the Pharma Supply Chain through anticipation and visibility
Good Distribution practices requirements for proactive Risk Assessments
Which data are critical to map and pro-actively assess the Supply Chain robustness
Challenge for data collection
Trends analysis and improvement
14.45 - 15.30: BREAK
15:30 - 17:00 Master Class Workshop
Intermodal Shipping V Multimodal Shipping: understanding the fundamental differentiation in relation to responsibility and liability of movement subject to pharmaceutical logistical and compliance requirements:
Coverage: GDP, Serialization FMD, WHO, FDA among other key requirements.
What is Intermodal and key advantages?
Intermodal is focused on movement of cargo from original destination subject to a variety of modes of transport, where the modes have different transport carriers responsible, each subject to its independent contract.
One single journey via multiple carriers.
Key advantages Intermodal:
A capacity to be greener subject to selection process and the desire to demonstrate lower carbon footprint
Pharmaceutical Shippers gain a higher capacity to access equipment and can better control and selection of transit schedules.
Pharmaceutical Shippers can select the carrier subject to own cost and quality assessment
Enhanced security over products given both selection and managing of carriers per mode
A flexible approach to loading and unloading of medicine at various ports
In relation to current regulation and requirements, the Intermodal group will identify key parameters in evaluating, selecting and ensuring the correct regulatory requirements are included within their report to the workshop leader.
Results of Intermodal Group is thereby shared with the conference as whole.
What is Multimodal and key advantages?
Multimodal is focused on pharmaceutical shipment of cargo from original destination by several modes of transport and storage, where each mode may have a different carrier, yet the overall contract of cargo is managed by one single forwarder. The transport carrier is the ultimate responsible; therefore, one contract.
Key advantages of Multimodal:
Reducing the overall cost of logistical costs and expenses
Pharmaceutical shippers can expect to access rather difficult and or hard to access geo-locations globally subject to reliability of carrier and liability of shipping with one carrier.
A pharmaceutical shipper can expect a higher-level efficiency in monitoring the one transport carrier door to door – or as it is known End to End.
Delivery time is highly efficient subject to a higher level of contract
In relation to current regulation and requirements, the Multimodal group will identify key parameters in evaluating, selecting and ensuring the correct regulatory requirements are included within their report to the workshop leader.
Results of Multimodal Group is thereby shared with the conference as whole.
17.00 - 17.15: Co-chair Closing Speech
END OF DAY 1
8.45 - 9.00: Co-chair Opening Speech
9.00 - 9.45: Reinhard E. Voglmaier, Computerised Systems Manager, GSK
How to conduct an IT supplier audit in GDP critical business processes
How to setup Audit universe / Risk Map
Supplier Life Cycle
Audit planning based on Risk assessment
How to prepare the audit
Areas to audit
Suppliers for technologies/ artificial intelligence/ cloud computing/ software as a service
9.45 - 10.30: drs. B.D van Beek, Sr. Quality Management Consultant, BD van Beek Quality Consultancy
Global Logistics: Licensing and GDP Authorization in Switzerland and relation to EU GDP:
Within the framework of the international trade in medicinal products, a key role is played by firms trading abroad with medicinal products, i.e. without the goods entering the territory of the country in which the firm concerned has its registered offices. Switzerland is one of the few countries that make it mandatory for this type of business activity to be licensed. Firms that trade out of Switzerland with medicinal products and without these products ever entering Switzerland therefore require an establishment license granted by Swiss-medic.
In this speech the key elements for a successful GDP licensing process including the inspection by Swiss Medic is elaborated on. What are the elements to take into account and how do they relate to other global legislation for trade in pharmaceutical products? What are the key expectations for a successful conclusion of an inspection?
10.30 - 11:15: BREAK
11.15 - 12:00 Francesca Burberi, Technical Service & Manufacturing Science, TSMS Sr. Manager, Eli Lilly
Warehousing and shipping of biological products worldwide 2°C/ 8° C: best practices in validation approach and impact on monitoring
Define critical quality attributes, URS and acceptance criteria
Perform a risk assessment
Cluster the lanes
Develop a master transport validation plan and templates for DQ, IQ, OQ, PQ 5. qualify the transport system (DQ, IQ, OQ for dispatch, transportation and receiving)
Validate the transport processes (PQ ) through validation runs on the worst-case lanes of each cluster
12:00 - 12.45: Amer Alghabbar, Managing Director, Compliance & Training Partner
Good Cold Chain Management Practices (GCCMPs) for Medicinal Products: The critical link in maintaining quality from GMP to the patient/subject:
Why is Cold Chain important?
Cold Chain Challenges
Impact of Cold Chain Failure on Medicinal products
Service Providers and Partners
Are Global Regulatory Requirements Mitigating the Risks?
12.45 - 14:00: LUNCH
14:00 - 14.45: Petra Zartner, Senior Manager QA/QC, Immunomedics
An assessment on the impact of Good Manufacturing Practice (GMP) and its impact on
Good Distribution Practice (GDP)
This speech is intended to provide an assessment regarding good manufacturing practice (GMP) for the
manufacturing of drug Products.
It is also intended to help ensure that drug products meet the quality and purity characteristics that they purport, or are represented, to possess.
In this speech, the term manufacturing refers specifically to storage and distribution
of drug products throughout their life-cycle
14.45 - 15.30: Riekert Bruinink, Senior GMP/GDP Inspector, Dutch Health Agency
An inspector’s perspective: The best approach to preparing for Good Distribution Practice Audit. Who is the ultimate responsible for the GDP audit and who is under audit?
• Fundamental points of preparation according to GDP text?
• Fundamentals points of consideration subject to practice and examples of weakness within inspection?
• The optimised approach subject to GDP guidelines requirements. Assessing facilities, such as airport-based example among others
15.30 - 16.00: BREAK
16:00 - 16.45: Andrea Zangara, Scientific Marketing Manager, EUROMED
Issues and challenges in quality control and supply chain management of phytomedicines
The demand for botanical ingredients increases every year, and so do the risks of quality issues such as frauds and adulterations along the supply chain. Developing an integrated supply chain, where each step is traceable, accountable and transparent is the goal, as well as adhering to the most stringent Good Agricultural and Collection Practices (GACP) and GMP regulations. An effective quality assurance system for the collection, harvest, storage, transportation and primary processing of the plant material is essential to ensure quality and batch to batch consistency.
Zangara, A; Mulà, A; Villar, A; Garcia, E
16:45 - 17:00 Co-chair Closing Speech
END OF DAY 2 - END OF SYMPOSIUM