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: 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?

 

 

9.45 - 10.15: Yoram Eshel, Former Head of Global Transportation, Teva

 

The value associated with oceanic transportation and the practical approach for qualification/validation of such shipments

 

• Ocean shipments – Supply Chain aspects – speed, tractability, control • Operational and Quality aspects Vs. Air freight • Cost aspects –

is it always cheaper? • Insurance aspects

 

 

10.15 - 11.00: BREAK

 

 

11.00 - 11.45: Loraine Bout, Intelligence Manager EMEA, Sensitech

 

The what & how of cargo intelligence

 

• Hurdles in collecting data • Break down of the data obtained • Examples of actual incidents

• Zooming into cargo theft in The Netherlands, Germany, United Kingdom & Belgium • Peripheral Risks • Variety Intelligence products

 

 

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: Boris Vavra, Sales Director Pharma Division, Primaco & Petar Simic, CEO, Primaco

 

Evolution of safety & security requirements in road transportation of pharmaceuticals – an LSP view

 

• Understanding safety and security requirements of your pharma partners • The role of telematics in cool chain • Streaming data categories

with the aim to improve overall cargo visibility and process management • Recommendation and Q&A

 

 

14.15 - 14.45: Robert Potts, Director, International Quality, Vertex Pharmaceuticals

 

QMR across the pharma supply chain

 

Quality Risk Management continues to be a hot topic for inspectors; what is expected, what can we do and how can we make our QMR process

add value to our day to day job. During this talk we will consider:

• What is a risk • Areas of Concern • Overcoming weaknesses in QMR

- Action Plans - Risk Revaluation - Communication

 

 

14.45 - 15.30: BREAK

 

 

15.30 - 16.15: Round Table Dialogue

 

Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use

 

CHAPTER 3 GDP Guidelines — PREMISES AND EQUIPMENT (2013/C 343/01)

Wholesale distributors must have suitable and adequate premises, installations and equipment ( 1 ), so as to ensure proper

storage and distribution of medicinal products. In particular, the premises should be clean, dry and maintained within acceptable temperature

limits.

CHAPTER 4 GDP Guidelines — DOCUMENTATION (2013/C 343/01)

Good documentation constitutes an essential part of the quality system. Written documentation should prevent errors from

spoken communication and permits the tracking of relevant operations during the distribution of medicinal product

CHAPTER 5 GDP Guidelines — OPERATIONS (2013/C 343/01)

All actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the

wholesale distribution of medicinal products is performed according to the information on the outer packaging.

CHAPTER 9 GDP Guidelines — TRANSPORTATION (2013/C 343/01)

It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure

that temperature conditions are maintained within acceptable limits during transport.

Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise

their quality and integrity. A risk-based approach should be utilised when planning transportation.

 

 

 

16.15 - 17.15: Frank Peeters, Managing Director, Tobeas

 

How can we make temperature mapping easier

 

• Thermal mapping is a requirement of the GDP’s. This has to be performed prior to commencement of use of a warehouse or transportation

system, and when making modifications to the facility or temperature controlling equipment. Risk assessments can hereby help to handle the

different mapping operations in order to reduce the workload and still assure GDP compliance.

• What are the parameters to take into account when performing a temperature mapping study? Can we assume that a transportation system is a

warehouse on wheels, or do other factors play a role? How to we cope with the multitude of situations and their possible combinations?

• Performing a temperature mapping can therefore become a very tedious operation. We achieve effortless temperature mapping by combining

IoT loggers with a performant processing tool. We’ll give you a glimp of the future.

 

 

17.15 - 17.30: Co-chair Closing Speech - END OF DAY 1

 

 

8.45 - 9.00: Co-chair Opening Speech

 

9.00 - 9.30: Clive Badman, VP Pre Competitive Activities, GSK

 

Acceleration through Collaboration

 

We will explore through Project Remedies - RE-configuring MEDIcines End-to-end Supply chain - the value, opportunity and acceleration brought

to both the Clinical and Commercial supply chains through collaboration between industrial partners and academia.

 

 

9.30 - 10.00: Reinhard E. Voglmaier, Computerised Systems Manager, GSK

 

Supplier audit in GxP critical business processes

 

• What is Computerised System Validation • Why Supplieraudit • Riskassessment • Life Cycle of Supplieraudit • Audited Areas

 

 

10.00 - 10.45: BREAK

 

 

10.45 - 11.15: Stephan Heck, Sr. Director Customer Quality Management, DSM Nutritional Products

 

Good Distribution Practice for Active Pharmaceutical Ingredients (APIs) - Risk based approach

 

• Overview about the regulatory requirements for GDP including Transportation • How to secure product integrity in a global supply chain?

• Risked based approach for Good Transportation Practice for Active Pharmaceutical Ingredients avoiding non-added value logistic costs.

 

 

11.15 - 11.45: Rob Dekkers, Global Logistics Manager SPECT/PET and Dangerous Goods Compliance, GE Healthcare

 

The challenge of shipping made to order, radioactive, pharmaceuticals

 

• 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 patient impact.

• The availability of air freight capacity and denial of shipment is becoming an increased problem for these products

• GDP imposes extra challenges with regards to temperature controlled shipping

 

 

11.45 - 12.15: Eveline W. van Schie, Qualified Person, Amstelfarma

 

A best practice approach to managing global transportation of medicine for human use in emerging markets

 

GDP awareness of manufacturers & customers

Risk-based approach

Quality vs costs

 

 

12.15 - 13.30: LUNCH

 

 

13.30 - 14.15: 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

 

 

14.15 - 14.45: Rada Brujic, MBA – International Buyer, Octapharma

 

Does a sustainable approach of Supply Chain Management give a competitive advantage?

 

• The role of Supply Chain Management • Why is sustainability gaining in importance? • Trends affecting Sustainability

• Risks of Sustainability • Social and economic factors of sustainability

 

 

14.45 - 15.15: BREAK

 

 

15.15 - 15.45: Valentina Marinkovic, Associate professor/ GxP Consultant & Coach, University of Belgrade

 

Risk Management Framework for 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.

 

 

15.45 - 16.45: Jackie Peck, Director, Pharmacy Consulting Limited

 

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.

 

 

 

16.45 - 17.00: Co-chair Closing Speech - END OF DAY 2 - END OF CONFERENCE