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Conference Documentation: Clinical Trial Logistics

Conference Documentation: Clinical Trial Logistics

SMi proudly presents the return of the 10th annual Clinical Trial Logistics to London in 2016. According to recent market research the clinical trial supplies market is expected to reach 1.2 Billion USD by 2020*, with the logistics and distribution services segment accounting for the largest share of the market.

This rapid market growth is partnered with a huge change in the regulatory landscape. With the implementation of annexe 15 of the Good Manufacturing Practice (GMP) on the 1st October 2015, the SMi’s 10th annual Clinical Trial Logistics event will provide the perfect platform to raise and discuss the challenges associated since the implementation.

Moreover, the development of the New EU Clinical Trials Regulation will impact all parties involved in the clinical supply chain – this conference will aim to address uncertainties and examine best practices to ensure compliance.

SMi’s 10th annual Clinical Trial Logistics event will bring together leading industry professionals to discuss the latest regulatory developments, explore how to reduce costs, learn about the logistical challenges in emerging markets and examine the latest innovations made on maintaining temperature in shipment.


Day 1
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Rebecca Jackson, IVR/IWR Manager, Randomization & Trial Supply Services, Janssen
9:10
The importance of forecasting and supply planning in avoiding logistical delays?
Elisabetta Carli, Head, Operations Clinical Vaccines Management, GSK Italy
9:50
How to ensure and maintain a successful contractor relationship
Dawn Padfield, Director of Pharmaceutical Development and Clinical Supply, Norgine Ltd
10:30
Morning Coffee
11:00
RTSM or AI? Human v. machine in the clinical supply chain
Rebecca Jackson, IVR/IWR Manager, Randomization & Trial Supply Services, Janssen
11:40
Challenges of operation for paediatric clinical supply
12:20
Networking Lunch
13:50
GS1 standards – for improved patient care and supply chain efficiency
Ulrike Kreysa, Vice President Healthcare, GS1
14:30
Challenges in air-freighting time & temperature shipments
Alan Dorling, Global Head - Pharmaceuticals & Life Sciences, IAG Cargo
15:10
Afternoon Tea
15:40
Temperature Excursion Management
Alexandra Tsioni , Mgr, Clinical Supply Chain Study Lead, Teva Pharmaceuticals Ltd
16:20
EU Clinical Trial Regulation Annex VI: Labelling of investigational medicinal products
Anthony Moult, Director, Clinical Supply Operations, Daiichi Sankyo Ltd
17:00
Chairman’s Closing Remarks and Close of Day One
Rebecca Jackson, IVR/IWR Manager, Randomization & Trial Supply Services, Janssen
Day 2
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Rebecca Jackson, IVR/IWR Manager, Randomization & Trial Supply Services, Janssen
9:10
Update to ICH GCP E6 (R2)
Amer Alghabban, Vice President Gxp Quality Assurance, Compliance Training , Karyopharm Therapeutics Inc.
9:50
GDP: Gaps discovered and prioritised Case Study - a risk-based approach to the EU GDP guidelines
Sanjay Nadarajah, Quality Director, Inglasia Pharma Solutions
10:30
Morning Coffee
11:00
Understanding the impact of the EU GDP guidelines
Amy Shortman, Consultant, Director, ASC Associates Ltd
11:40
Visibility in the supply chain to fight counterfeiting
12:20
Networking Lunch
13:50
Panel Discussion: The Falsified Medicines Directive
Amer Alghabban, Vice President Gxp Quality Assurance, Compliance Training , Karyopharm Therapeutics Inc.
13:50
Panel Discussion: The Falsified Medicines Directive
Ulrike Kreysa, Vice President Healthcare, GS1
14:30
Comparators in clinical trials: Effective meets flexible supply chain
Jasmin Hellwig, Senior. Comparator Specialist, Merck Sharp & Dohme
15:10
Afternoon Tea
15:40
Implementing a compliant and patient centric clinical supply strategy: Direct To Patient
Rocio Cuadtado, TSOM Leader , Sanofi
16:20
Clinical trial supply challenges in the Middle East
Abdulkareem Ghanayem, Clinical Trial Operations Project Manager , Takeda Pharmaceuticals
17:00
The planning face: Phase I, biological products
Lis Hansen, Clinical Trial Supply Coordinator , Genmab A / S
17:40
Chairman’s Closing Remarks and Close of Day Two
Rebecca Jackson, IVR/IWR Manager, Randomization & Trial Supply Services, Janssen

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