Overview

The 3rd PDA-EMEA Conference covers legislation, guidance and initiatives from the European Commission and EMEA. Three parallel tracks will address: (1) Supply chain quality, (2) Implementation of ICH Q8-9-10, and (3) Manufacturing and GMP. Key topics include:

• The QP: role in outsourcing; responsibilities in light of ICH guidance
• Inspection of importers, pedigree, and management of supply chain
• Risk based inspections - planning and practice by inspectorates
• QbD and Inspections
• Translating design space into CMC section of dossier
• Investigational Medicinal products and GMP Annex 13
• Advanced Medicinal therapies and GMP Annex 2
• Dedicated facilities
• Good distribution practise
• And much, much more

Based on your requests, we will be allowing extra time for discussions of key issues and to focus on ‘real life’ and practical experiences. As in previous years, more than 50 inspectors and 400 total delegates will join us for this unique European opportunity. This is the only event in Europe with direct support from the EMEA to reach affected stakeholders. As an attendee last year commented, “....more than a conference, more than training, a one-of-a-kind opportunity that can’t be missed.”

Contact

For conference information, contact:

PDA Europe gGmbH
Adalbertstr. 9
16548 Glienicke/ Berlin, Germany
Phone: +49 (0) 33056- 237710
Fax: +49 (0) 33056- 237777
Email: info-europe@pda.org

For exhibition and sponsorship information, contact:

Katharina Keisers-Engstfeld
Event Manager, Europe
Tel: + 49 (0) 33056-237714 
Email: keisers@pda.org