Daiichi Sankyo to address importance of labelling investigational medical products

LONDON - Feb. 19, 2016 - PRLog -- The exponential growth of the clinical trials logistics market is partnered with significant changes to the regulatory landscape. With the implementation of Annex 15 of the Good Manufacturing Practice (GMP) and the development of the new EU Clinical Trials Regulation, all parties involved in the clinical supply chain will be impacted and would need to adapt for successful compliance.

SMI’s 10th Clinical Trial Logistics event will bring together leading industry experts to address the latest regulatory developments, explore how to reduce costs, learn about the logistical challenges in emerging markets, examine the latest innovations including maintaining temperature in shipment and correct labelling. Details of the conference can be found on https://www.smi-online.co.uk/pharmaceuticals/uk/clinical-trial-logistics

Moreover, SMi is pleased to announce that Tony Moult, Director of Clinical Supplies Operations at Daiichi Sankyo, will be presenting on Day One of the conference to address the importance of labelling. His notable presentation entitled “EU CTR Annex VI: Labelling of investigational medicinal products (IMPs)” will cover the following topics:

· CTR timing with respect to labels on IMPs

· Examining the increased complexity of packaging and labelling of IMPs

· Understanding what information must be included on labels

· How to deal with this change and what process should be implemented to ease adherence

· The current status of the industry efforts to have Annex VI changed

Other notable presentation from expert speakers include:

• Implementing a compliant and patient-centric clinical supply strategy
Rocio Cuadrado, TSOM Leader Clinical Supplies SCP - Studies & Distribution, Sanofi

• The Importance of forecasting and supply planning in avoiding logistical delays
Elisabetta Carli, Head - Operations Clinical Vaccines Management, GlaxoSmithKline

• Comparators in clinical trials: effective meets flexible supply chain
Jasmin Hellwig, Senior Comparator Specialist, Merck Sharp and Dohme

• Challenges in air freighting time and temerature shipments
Alan Dorling, Global Head - Pharmaceuticals & Life Sciences, IAG Cargo

• Temperature excursion management
Alexandra Tsioni, Clinical Supply Chain Lead – Global Clinical Operations, Teva

• PANEL DISCUSSION: The Falsified Medicine Directive
Geoffroy Bessaud, Associate Vice President, Anti-Counterfeiting Coordination, Sanofi
Amer Alghabban, VP GxP Quality Assurance, Compliance & Training, Karyopharm Therapeutics
Ulrike Kreysa, Vice President Healthcare, GS1 Global Office

Visit the event website at and take advantage of the Early Bird offer. Register before 29 February to save £400 off the conference price here: https://www.smi-online.co.uk/pharmaceuticals/uk/clinical-....

For sponsorship opportunities contact Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk.

For delegate bookings contact Fateja Begum on +44 (0) 20 7827 6184 or email fbegum@smi-online.co.uk.

For media enquiries contact Honey de Gracia on +44 (0) 20 7827 6102 or email hdegracia@smi-online.co.uk.

10th Clinical Trial Logistics
18-19 May 2016
London, UK
Event Website: www.clinical-trial-logistics.com