An event by Pharma Dialogue, the Healthcare division of

DAY 1

DAY 2

 

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

to requirements:

 

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

Shipments:

 

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

 

Learn how IoT technology is improving real-time supply chain visibility for increased supply chain

performance and efficiency.  Implementing proactive solutions to track, manage, and induce action – in real time – mitigates the risks associated with supply chain disruptions during transit.

 

•         Review IoT sensor technology being used for supply chain management today, and have a look at where the technology is going in the future.

•         Understand how real-time sensor alerts can help address supply chain disruptions before they negatively impact customer service.

•         Discover post-shipment compliance reporting, and how to use data to improve supply chain operations and carrier performance.

•         Examine ways that IoT technology can be integrated into existing supply chain systems and processes.

 

 

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 - 15.15: Snežana Vukmirović, Director, External QA Strategic Alliance, EMEA  Russia & CIS, MSD

 

Agility: Old approach in modern Pharma supply chain

 

In January 2019, three leading Pharma companies launch Responsible Health Initiative. Main idea is to leverage digital sustainability intelligence to more effectively select and partner with suppliers who shared company values. Facing with significant challenges as: healthcare reforms, competitive intensity, growing of product portfolio, high standards and changing quality regulation force us to make our supply chains even more robust. Therefore, redefining supply chain become must in terms of understanding true demand, close collaboration in business network, oversight quality at CMO, effective management of distribution and quick adoption to changed market needs. So, why we need agile approach in modern supply chain?

Core values of agile supply are responsiveness, competency, flexibility and quickness on daily basis. Agile supply chain uses real-time data and updated information in a way to leverage current operation against demand forecast, which support company to improve overall efficiency and productivity. Such supply chain is able to adapt to rapidly changing environment and respond to customer demands immediately.

 

 

15:15 - 16:00: BREAK

 

16:00 - 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

Opening Speech 8.45 - 9.00: Coen Boonen, Managing Director, Tservice

 

Abstract: Every thermal challenge presents an opportunity to develop solutions:

 

Temperature is becoming ever more important in our line of work. Climate change is making the weather more extreme and increasingly unpredictable. A striking example of this was the heat wave in The Netherlands at the end of July 2018. A changing environment presents new challenges for GDP companies and will necessitate adaptative and innovative new strategies. The solutions are sometimes difficult but can often be deceptively simple. Tservice specialises in providing fitting and cost-effective solutions for every problem, which we will illustrate with a few of our more interesting case-studies.

 

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