Exploring the recent PQG / ECA guide to GDP
The Pharmaceutical Quality Group (PQG) issued a monograph on Pharmaceutical Distribution in 1997 and initiated planning to revise this in line with the new EU GDP regulatory guideline (a final revised version was issued in March 2013 with an effective date of 8 September 2013).
Although the 2013 EU-GDP guidelines provide far more details than previous guidelines, it is clear that there was and is a need for further guidance on the interpretation and implementation of the regulatory expectations.
It was also identified that the European Compliance Academy (ECA) was also planning to produce some guidance in response to requests from members. So, both the PQG and the ECA Foundation with its European GDP Association started a project which began with the creation of a series of individual chapter guides, and the eventual formation of a single document.
Stephen Mitchell, Quality Lead Logistics Partnerships, at GSK will address the key points in the newly published guide to good distribution practice. He will look into what messages you should be taking home, and which areas you should be looking to, to invest and improve on.
Cold Chain Industry Experts:
With huge interest from leaders in the field, we have worked closely with an expert panel of speakers to present an agenda that is shaping up to be the most engaging event to date!
This year’s event will continue to lead with its unrivalled panel of experts bringing you the most insightful presentations and issues in the field of temperature controlled distribution:
Chair’s for 2018:
– Bob Hayes, Director, SeerPharma (UK)
– Tony Wright, CEO, Exelsius
– Stephen Mitchell, Quality Lead Logistics Partnerships, GSK
– Gianne Olaes-Dénis, Supply Chain Quality Manager, Sanofi Genzyme Europe
– Stefan Braun, Managing Director, SmartCAE
– Gianpiero Lorusso, Director, Supply Operations and GS, Merck
– Francicso Rizzuto, Cargo Specialist, Manager for Europe, IATA
– Marco Gaudesi, Pharmacist – GDP and Cold Chain Referent, MSF
– Henk Mulder, Head, Digital Cargo, IATA
– Didier Basseras, Vice President, Clinical Supply Chain Operations Head, Sanofi-Aventis
– Sue Lee, Director, Hexagon Supply Chain
For those looking to attend, there is currently a £300 early-bird saving, ending September 28th.
To register or download the brochure, please visit the website at: www.coldchain-distribution.com/phpr
SMi presents the 13th annual industry leading conference:
Cold Chain Distribution 2018
Date: 10th – 11th December 2018
Location: Copthorne Tara Hotel, London UK
Sources: biomap | GMP-Compliance.org | MarketsandMarkets
For all media inquiries contact Pavan Solanki on Tel: +44 (0)20 7827 6048 / Email: email@example.com
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk