Europe's No. 1 Time & Temperature Controlled Logistics Conference

 

2018 Draft Agenda

An event by Pharma Dialogue, the Healthcare division of

DAY 1

DAY 2

8.45 - 9.00: Conference Chair Opening Speach

 

9.00 - 9.30: Riekert Bruinink Senior GMP/GDP Inspector, Dutch Health Agency

 

Best Practice Approach when preparing for GDP Audits: Identifying the ‘Dos’ and the ‘Donts’ when presented with an inspection

 

- GDP inspections

- Results of GDP inspections

- What to improve ?

 

9.30 - 10.00: Bart Pouwels, Business Development Director, Amsterdam Airport

Schiphol

 

 

 

Amsterdam Airport Schiphol is a Skyteam hub. Our vast route network connects Amsterdam to 322 direct destinations around the globe (by air), and extensive trucking destinations throughout Europe. In 2016 Schiphol welcomed 63,6 million passengers and handled 1,7 million tonnes of Cargo. At Schiphol Cargo, we believe in bringing different parties within the public, private and business sectors together. Only by creating partnerships can we excel in our industry. With a dedicated team of 9 people we provide full support to all partners in the field. By supporting the Cargo Community to create viable solutions for efficient and high standard supply chains we strive to facilitate and promote a competitive logistics marketplace.

 

10.00 - 10.45: Turhan Özen, Chief Cargo Officer, Turkish Airlines

 

A global case for best practice in Air Cargo subject to CIEV-IATA certification and total compliance with Good Distribution Practice

 

 

Transportation of time and temperature sensitive cargo without breaking the Cold Supply Chain is very critical both for patients’ health and commerically. IATA CEIV Pharma certification process, developed to target excellence in transportation of such healthcare products, has been accomplished by Turkish Airlines successfully in August 2016 and our company has been nominated by IATA CEIV Pharma certificates both as an Airline and its ground Handling operations.

 

This presentation will focus on our reason to apply for IATA CEIV Pharma certificate, our achievements during the validation process, gainings of this certificate not only to us but also to our esteemed customers and our goals and future objectives.

 

 

 

10.45 - 11.30: BREAK

 

 

11.30 - 12.15: Stefanie De Ghey,Quality Manager Benelux & Qualified Person

Benelux at Movianto Belgium NV and O&M – Movianto Nederland B.V.

 

Challenges of temperature controlled transport within European Distribution Centers

 

Pharma, Medical Devices and Diagnostics are increasingly being included within the scope of temperature controlled storage and transport. With the changing regulations, companies are shifting their focus on temperature control. Due to the business model of companies to ship from a  few Distribution Centres to multiple countries, several challenges need to be taken into account to ensure a compliant and product safe supply chain.

 

 

 

12.15-13.00:: Olivier Simonnot, Senior Manager Strategic Marketing, Life Sciences

EMEA, Sensitech

 

Real-time data collection to ensure valuable decision making within the supply chain.

 

This presentation will evaluate the collection of data in real-time, as well as best practices associated with its value for decision making at the shipment and at the strategic levels.

Key takeaways:

 

- Address problems at the shipment level before they escalate – know the what, where, when, and why

- Understand where to focus resources to increase carrier performance

- Improve performance and reduce costs by analyzing lane performance over time

- Never lose sight of a shipment brokered to a third-party

- Implement geo-fences, red zones, and driver tracking to ensure that SOPs are being followed

 

 

 

 

13.00 - 14.15: LUNCH

 

 

 

14.15 - 15.00: Jan Walbrecker, Senior Software Developer, SmartCAE

 

Using the Virtual Cold Chain for Cost-Effective Lane Risk Analysis

 

The virtual cold chain offers a cost and time effective way to analyze the thermal performance of passive shipper systems on arbitrary lanes. We achieve this by combining an accurate thermodynamic simulation of the shipper, including payload, with real-life temperature data of actual lanes. Having assembled and verified a virtual model of a shipper, its thermal performance under any realistic temperature conditions can be simulated, thus minimizing the number of expensive cold chamber testings. This can be extended to a full thermal lane risk analysis by studying the shipper performance on a specific lane by using historical weather data along the lane. In a case study we demonstrate how this analysis can help quantify the risk of shipper failure and lead to a more economic balancing between thermal risk and total costs.

 

 

 

15.00 - 15.30: Reinhard E. Voglmaier, Computerised Systems Manager, GSK

 

How to setup and conduct an IT Audit compliant with GDP

 

Computerised Systems Validation (CSV) was for long time a discipline in Good Manufacturing Practices (GMP) only. In the recent years only Regulatory Agencies in different countries added also to their Good Distribution Practices (GDP) statements concerning CSV. Meanwhile the GDP now state what have to be done for CSV they give not the information how this can be achieved. It is therefore the single enterprise to be define in their Quality Management System (QMS) how to implement CSV.

The presentation is useful not only for who has to perform an audit in an GDP critical business Environment but also for who has to prepare a department for an audit of their computerized systems used for the distribution of Pharmaceutical Products.

 

 

15.30 - 16.15: BREAK

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

17.150 - 18.00: Jackie Peck  Managing Director, Pharmacy Consulting Limited

 

 

GDP Workshop: Harmonisation of GDP across the EEA and also Harmonisation within each member state

 

This workshop will be preceded by a short presentation by way of introduction. The workshop will be facilitated by Jackie Peck of Pharmacy Consulting. Each of the ten groups will tackle one of the topics below. The groups will focus on the key GDP areas the regulators focus on during their audits and prepare responses. Their spokesperson will present back to the group and host a short Q & A secession on their topic. By sharing ideas and best practice we aim to help prepare you for your own GDP audit.

 

 

 

 

 

Gino Vleugels, Senior

Manager Temperature Control, Johnson & Johnson

 

 

Inspired by Clinical Supply in Africa

 

a. Setting up a supply chain in in an outbreak situation

b. Cultural interaction and challenges

c. Why we all do this for

 

16.15 - 16.45:

Sven Sachsse, Transport Expert - Supplier

Qualification, Bayer Pharma

 

 

End to End Distribution Risk Assessment at Bayer based on EU GDP guideline

 

Risk management, which consists of risk assessment, risk identification and risk mitigation, is a very important topic in the EU GDP. The EU GDP requires that every quality system includes a procedure for dealing with risk management. In transport, the following three questions are key to performing a thorough risk assessment:

1. Know your product

2. Know your transport route and mode

3. Know the capabilities of your partners

Therefore we, as Bayer, provided a concept and developed an IT-Tool which ensures a sustainable risk assessment lane by lane for

- All modes of transport

- Transportation risk (Exposure time vs Mitigation

Assessment for Origin, Route, Destination, intermediate storage facilities risk and Temperatures)

- Mitigation Assessment by Risk Area

- Qualification process of Logistic Service Provider (LSP), Carrier and their Subcontractors.

 

 

 

 

Frank Peeters Life Sciences

Consultant, Tobeas

 

 

How to assure the Cold Chain in the local vaccination centers in the Democratic Republic of Congo (RDC)

 

1) What is the "Programme Elargissement Vaccins" (PEV) in RDC and how does it work, who is responsible, who does what, and where is the money eventually coming from?

2) How can the cold chain for the vaccination program be assured at the local level in the hospitals and health centers?

3) Which equipment can be used to adequately store the vaccines? How should future equipment look like and which functions must it have besides keeping the temperature within the correct limits?

4) How to build a network with the governments and involved NGO’s (e.g. Unicef and the Vaccine Alliance GAVI) in order to stay in control of your cold chain over time?

 

 

Isabela Furtado, Supply Chain Manager EMEA &

Olivia Yalung, Supply Chain Business Partner,

Terumo BTC

 

Creating high performance and cost effective supply chain operations

 

• The importance of a company’s global vision for the SC

• How to optimize flow of goods

• How to establish a strong partnership with global partners

• Standardizing processes and meeting customer requirements

• How to better tailor our services to customers: How to segment customers and adapt services accordingly

• How to turn forecasts into a value tool to drive flexibility and optimize cost

• Improving forecast accuracy and communication between sales, marketing, planning and production: How can we work better together?

 

 

 

16.45 - 17.15:

 

 

 

9.00 - 9.45:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9.45 - 10.30:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10.30 - 11.15: BREAK

 

 

11.15 - 11.45:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11.45 - 12.15:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

12.15 - 13.45: LUNCH

 

13.45 - 14.15

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14.15 - 14.45

 

 

 

 

 

 

 

 

 

 

 

 

 

14.45 - 15.30: BREAK

 

15.30 - 16.00

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

16.00 - 16.45: Mark Edwards, Managing Director, Modalis

 

Workshop: GDP and focus on Transportation

 

This workshop will look at the basics of GDP and focus on transportation. From it you will

learn:

• different ways of achieving GDP compliance

-through temperature control

- or as a more risk-based approach

• how to make contracts GDP compliant

- quality agreements

- statement of works

- SOP

- Service level agreements

• How to mitigate risk but minimise cost of compliance

The intention is that delegates go

 

 

16.45 - 17.00: Conference Chair Closing Speech

 

 

 

END OF DAY 2

 

END OF CONFERENCE

 

 

 

 

         Ahmet Ceylan, Qualified Person &

Murat Ates, Qualified Person, Medcor

Pharmaceuticals

 

Transport and storage of narcotics - Supplier qualification and cold chain transport qualification

 

As a wholesaler you are in business with many other suppliers. According to the GDP guidelines these suppliers need to be qualified. What is the best practice to qualify these suppliers and what is the role of the RP? Furthermore, what are the critical aspects to qualify the cold chain transport? Transportation and storage of narcotics requires additional attention, you have to think about the possible dangers for these goods. As a wholesaler we have to meet strong (security) requirements of the local authorities. During this presentation we will tell about the possible dangers and our measures to transport and store these sensitive goods safely.

 

 

 

Jeroen Janssens, Sr. Manager Vaccine

Distribution & Cold Chain, GSK Vaccines

 

Qualified suppliers and transport solutions – GDP requirements in focus today

 

For the transportation of temperature sensitive products, the pharmaceutical industry often outsources their transportation and logistics activities to third party suppliers. In order to meet the Good Distribution Requirements, pharmaceutical companies have to qualify the different transport solutions as well as the suppliers executing the transport. A company shipping worldwide by air- road- and sea freight, faces multiple challenges to comply with the expectations of the regulators. This presentation aims to provide an approach to balance product quality requirements, regulatory expectations and the capabilities of the transport industry to comply with the GDP requirements.

 

 

Francesca Burberi,  TS/MS Senior

Manager, Eli Lilly

 

Qualification of ocean shipments of temperature sensitive products

 

Nowadays, temperature sensitive products need to have a strong shipping validation strategy in order to fulfill the GDP Cold Chain requirements and provide adequate data to be submitted to the Health authorities to get the Marketing Authorization.

Data driven qualifications and/ or technical studies related to all the steps involved in the cold chain are necessary in compliance with the GDP expectations: scientific and documented evidences should be provided to an inspector, in order to guarantee the correct transportation of temperature sensitive products. A final report covering the validation of the transportation process should be prepared to support the shipment methods (i.e. route, containers, monitoring, shock and vibration) and made available to health authorities, if required.

This case covers an example related to design and execution of an Ocean transportation line introduction for temperature sensitive products (range 2-8°C), which have requirements with respect to time out of refrigeration, configuration of the load and transport method while maintaining the security and integrity of the goods.

Jost Bunse, Logistics Consultant,

Die Logistik Experten

 

Associated Challenges for Pharma Transport in Germany and in Europe compared to other industries, e.g. food

 

• Addressing the issues of low competition due to limited specialized forwarders compared to other industries

• Addressing how to prepare a tender for pharma transport to create competition resulting in rates in line with market

• Addressing the differing requirements for companies due to product stability and transport lead times considering the risk based approach

• Addressing how corporation with Third Party Logistic Providers and Transportation partners can alleviate some of the problems of the German and European market

 

 

Gabriel Bolland, Supply Chain

Manager, Amni

 

How to keep the “GMP stamp” of the product during transportation at -20°C or requested temperature

 

- Chalenge: GMP lost if we don’t maintain the temperature as requested by procedure (Quality of supply chain)

- Options : - vehicle under controlled temperature - temperature recorder - real time temperature surveillance - certified box

- Looking beyond : Stability studies - Best way for a startup company

 

 

Eveline van Schie – van Waaij,

Qualified Person, Amstelfarma

 

Challenging intra-continental transportation of medicinal goods

 

• Best practices based on EU GDP guidelines

• Challenges with suppliers/transport companies

• Review of past 6 years of monitoring sea/air transport

 

 

 

         Ulrike Kreysa, Vice President Healthcare,

GS1 Global Office

 

UDI – a major change for the medical device industry and patients globally

 

• UDI – why do we all need it

• Worldwide regulatory requirements for UDI

• The challenges of implementation

• Imagine – changes ahead

 

 

Chris Wallace, International Supply

Chain Director, Global Commercial Supply

Chain, Genzyme

 

New Product Implementation within Emerging Markets – Case Study in Supply Chain challenges: A case study from Sanofi Genzyme

 

• Best practices based on EU GDP guidelines

• Challenges with suppliers/transport companies

• Review of past 6 years of monitoring sea/air transport

 

 

 

Serge Van Houten, Manager

Logistics, Plasma Industries

 

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

 

 

 

Ulrike Kreysa, Vice President Healthcare,

GS1 Global Office

 

The value of global standards for track & Trace and serialisation

 

 

• Track & Trace – why and how

• Compliance with regulatory requirements across the world

• Traceability in the developing countries

• Serialisation – the challenges and the benefits

• A vaccine for every child

 

 

 

 

 

Katia Toebosch, QA Specialist,

Volcano Philips

 

Good distribution practices in a small distribution center in medical devices

 

• Incoming inspections and receiving of devices

• Return material process

• Storage and handling of devices

• Segregations – recalls

 

 

 

Robert Potts, Director, International Quality,

Vertex Pharmaceuticals

 

How to Maintain Quality during Global Expansion

 

 

• Ensuring Compliance in the Global Market Place.

• QA a key partner in the Global expansion process

• Tools to be used to ensure on-going Quality Excellence as part of Global Expansion

 

 

Rob Dekkers Global Logistics Manager

SPECT/PET and Dangerous Goods Compliance, GE Healthcare

 

The challenge of shipping made to order, radioactive, pharmaceuticals

 

The presentation will cover

• The challenge of shipping made to order, radioactive, pharmaceuticals

• Radiopharmaceuticals have to follow both the pharmaceutical regulations as well as the dangerous goods regulations.

• To be able to ship within 24 hours manufacturing companies also have to be Known Consigner and AEO authorized.

• On top of that radiopharmaceuticals have an extreme short shelf-life, from hours to days. Any delay in shipment can have a direct patient impact.

• GDP imposes extra challenges with regards to temperature controlled shipping