Day 1 – Opening Spotlight Session – Clinical Supply Chain: A New Recognized R&D Dimension Tackling R&D Challenges and Serving the Patients
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.*
Stephen Mitchell, Quality Lead Logistics Partnerships, 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 invest and improve on.
Day 2 – Opening Keynote Address – Preparing for a Regulatory Inspection –Questions Answered
Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. Products must be of consistent high quality, appropriate to their intended use and meet the requirements of the marketing authorisation (MA) or product specification. Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.*
Nigel Cryer, Head of Compliance & Inspection Readiness, Sanofi will be exploring the types of regulatory inspection, looking at key areas to focus on in preparation for a regulatory inspection and what the future of good distribution practice will look like.
Here’s a few of last year’s attendees:
Clinical Supply Chain Manager | Director, Global Logistics & Supply Chain | GDP Compliance Manager Europe | Global Clinical Distribution Lead | Global Head – Pharmaceuticals & Life Sciences | Global Head Supply Chain Quality | Global Technology Leader, Transport Protection | Head of Compliance & Inspection Readiness | Head of Distribution | Head of European Logistics | Head of Operations | Manager, GMP Compliance | Quality & Compliance Warehousing Manager | Quality Lead Logistics Partnerships | Senior Director International Supply Chain Operations | Senior Director, Global Transportation and Logistics | Senior Manager, Special Cargo | Temperature Control Logistics | Vice President, Commercial Operations Americas & EMEA + more!
Download the full attendee list in the download centre: www.coldchain-distribution.com/phq
For those looking to attend, there is currently a £300 early-bird saving, only valid online! Register today!
SMi presents the 13thannual industry leading conference:
Cold Chain Distribution 2018
Date: 10th – 11th December 2018
Location: Copthorne Tara Hotel, London UK
Website: www.coldchain-distribution.com/phq
Sponsors: SmartCAE | Topa Thermal | Yourway Transport
Sources: biomap | GMP-Compliance.org | MarketsandMarkets | gov.uk
Leave a Reply