Spekers
Speakers

Dominique Delforge, GCP Inspector DG Inspection, Division Industry GCP, Federal Agency for Medicines and Health Products Belgium

Christophe Golenvaux, Chief Executive Officer, Lambda-Plus s.a./n.v.

Benoît Verjans, Scientific Advisor, Aseptic Technologies

Michael Kelly, Chief Operating & Chief Financial Officer, Piedmont Pharmaceuticals, LLC 

Stefanie Rud, Vice President, Ortner-Group

Agnès Feltkamp M.Sc., Translator of Medical Texts, Missing Link

Werner stilmant, Senior Consultant, Pauwels Consulting

Thomas De Rijdt, President of the Belgian Association of Hospital Pharmacists, & Assistant-Director of Pharmacy Department of University Hospitals Leuven

Hilde Vanaken, Clinical Trial Innovation Director, Janssen

Peter Scheyltjens, Chief Executive Officer, Advipro

Vimal Unewal, Planning Manager, Ferring Pharmaceuticals

Vladimir Shnaydman, PhD, Chief Executive Officer, ORBee Consulting

Dr. Chirag Ashvinkumar Trivedi, Deputy Director – Project Management & Strategic Initiatives, Sanofi

Dr. Robert Gfrerer, MPH, Cluster Manager, Human Technology Styria

Spekers
Attendees
30 points why I should attend?
  • Multi-language Labelling Booklet
  • Leverage IVRS technologies
  • Material forecasting
  • Segregation and stock keeping
  • Drug supply management
  • Do more with less
  • Site seeding and/or safety stock
  • Patient enrolment and drug usage data
  • Ambient or cold/cool chain
  • Drug reconciliation
  • Project planning
  • Technical agreements
  • Costing and budget
  • Medication label design
  • Batch records
  • ICH stability setup guidelines
  • Stability study and data
  • Shelf-life and condition transport
  • Batch release and QP
  • Source data/documents
  • Comparator (s) and placebo
  • Logistics and transport
  • Custom and airport
  • Supply Chain Management
  • New EU GDP in relation IMPs
  • Timely delivery of IPs to Instigators
  • Shipping documentation
  • Recall, Deficient products and Expiry product reclaim
  • Product stability over period of use
  • Packaging and Insufficient blinding
     
Spekers
Hot Topics
  • GMP: EudralexVol 4 – EU GMP Orange Guide
  • Risk mitigation and cost fail safe techniques
  • Process harmonisation and standardisation
  • Conditions during transport and distribution
  • Ambient Products and the EU GDP guidelines
  • electing vendors or logistics providers
  • Handling excursions
  • Risk mitigation
  • Cold Chain Optimisation
  • Passive and Active packaging
Spekers
Key Benefits
  • Correct interpretation of GCP/GMP
  • Address fundamental points concerning transportation and logistics
  • GCP/GMP experts addressing the Label Booklets
  • Best practice in dealing with stability data
  • Multi sites and Emerging markets
  • Customs and international standards
  • Address a risk based approach to CTS chains
  • Practical case studies shared from the Field
  • Cost V Quality and to Do Dore with Less
  • Cool/Cold/Ambient sensitive products

Clinical Trial Supplies: CTS2013

JOIN OUR MAILING LIST

The Brussels CST2013 – Clinical Trial Supply 2013 symposium is a premier discussion designed with direct contribution and aid of practitioners. Colleagues and experts engaged in both strategic and daily activities concerning bottle necks within the clinical trial supply management. CTS 2013 is intended for professionals from the field concerned with expanding their knowledge base, learning and bench marking from practical and new clinical trial supply cases.
The programme draws strength from addressing fundamental difficulties and critical points within the CTS Chain such as Technology (IVRS) and Data integration, Labelling (booklets) and packaging,Qualified Person (role) to Material Forecasting among others. Other issues such as the corrective interpretation of regulatory, standardisation of processes and international requirements are also assessed.  These may include Good Clinical Practice (GCP), EU Clinical Trials Directive 2001/20/EC – Good Manufacturing Practice (GMP): Article 9 or Article 13.  And GMP: EudralexVol 4 - EU GMP Guide; Orange Guide, part one as well as annex 13 dedicated Investigational Medicinal Products (IMPs).
The symposium covers key drivers and inhibitors in relation to where the main focus will be within the next 12 to 18 months.  A homogenous set of challenges have been identified subject to the nature of clinical supplies/studies.  We suggest the requirements to deal and manage them effectively be they multi-country CTS chains or inventory limitations are similar in nature.  Accordingly if you are dealing or responsible for CTS chain/s you will find the conference to be an unmatched learning experience. 


EVENTS

  • Open Panel Dialogue
  • Master Workshop A
  • Master Workshop B
  • Round Table Dialogue
Cold Supply Chain Conference 2013 Day1

Day1

Contingency/back up plans if and so when delays occur. A criterion based approach toward cost vs quality.

Read More
Cold Supply Chain Conference 2013 Day2

Day2

Cold chain compliance and risk assessment. Developing a cold chain management for biological products

Read More
  •  

    Thank you the platform as promised was end user driven and I really appreciate that only two other competitors were accepted on site. We do not see the need to for any further marketing investment. I thank you again and will see again next year.

    - Mr MertensLeClercq, Wallonia, Belgium
  •  

    All in one approach! I certainly enjoyed the sessions – but the networking was exceptionally outstanding.

    - Dr Jurgen Becker, Darmstadt, Germany
  •  

    The symposium was refreshing to say the least, and while it is true that it is was end user driven I must admit to see a limited quality vendors was something I have not experienced before.

    - Mr A. Blanc – Montpelier, France
  •  

    joined this event to learn and benchmark from other pharma companies – but the support I received in meeting and hearing all the presentation was truthfully outstanding. This is a must attend event if you want to learn something new and unique.

    - Mrs A. Van De Lange, Netherlands
  •  

    We attend many conferences and must admit your current strategy of non-commercial approach must be the key to have so many end users attending. I can truthfully say we learned what the market and customers are looking for and we will reposition for next year.

    - Mr C. Atkins, Cambridge, United Kingdom
  •  

    “We are very pleased to be part of this event; I describe it as a fantastic opportunity to network with a list of who is who in the market.”

    - Senior Manager, Germany

Testimonials