Stand Number: 52
Masterclass Presenter: Michael Fleischer, Director, Quality-Transport, World Courier
Masterclass Title: Ensuring GDP and GMP compliance in logistics vendor sourcing: How to best use the risk based approach to meet regulatory requirements
International GMP and GDP regulations place the responsibility to qualify a Logistics Service Provider with the wholesaler or manufacturer. The Regulators’ expectation is that the legality, suitability and competence of a potential subcontractor should be assessed. Furthermore a full review and control of all outsourced activities is called for, using a risk based approach.
A continuous assessment of the quality and performance of a logistics partner should identify and implement possible improvements. There are various ways to fulfil these requirements. This workshop will equip you with specific tools and easy-to-follow guidance on how to approach Supplier Qualification and Regulatory Compliance in International Biopharm Logistics.
Date and Time: Tuesday 25th April, 16:00pm
Presenter: Matthias Wagner, Regional Sales Director - Northern, Central and Eastern Europe, World Courier and Fernando Marascio, Associate Director, Head of Warehousing and Distribution – Intercompany, Merck Group
Presentation Title: How to design your supply chain to accommodate your changing product portfolio requirements
While there is no doubt about the growth and potential of specialty drugs, biological products and especially biosimilars, there are still unavoidable or even unpredictable challenges affecting the introduction in the current global markets as well as endangering the undisruptive, reliable supply of those products to providers and payers once approved. This uncertainty requires a general rethinking as it highly affects the supply chain strategy of manufacturers and changes the requirements for logistics service providers in relation to flexibility, reliability and their service portfolio while not losing sight of cost-efficiency
Date and Time: Wednesday 26th April 2017, 16:50pm - Track A: Rethinking Supply Chain Strategy