Full-Day and 1/2-Day Pre-Conference Sessions

Full-Day Pre-Conference Session "Specific Requirements for IMPs" - 27 November 2013
Facilitated by the IMP Working Group

• New legislation impacting IMP QPs
• Presentation of Working Groups
       - GMP concept in various Development Stages
       - Future trends in Clinical Trials
       - IMP certification process
       - QP release in Investigator-Sponsored Trials
• Advanced therapy medicinal products: what’ it about?
• Interactive case studies – decision making of IMP QPs

Registration for Full Day Pre-Conference Session "Specific Requirements for IMPs"
Price Session: EUR 890

1/2-Day Pre-Conference Session "The Role of the QP in a global System in a multinational Company" -
27 November 2013

Facilitated by: Dr Ulrich Kissel / Frank Raisch / N.N. (EU-GMP Inspector)

• Responsibilities and delineation
• Interaction and delegation
• How ICH Q10 and EU-GMP Chapter 1 lead the way
• Case studies

Registration for ½ Day Pre-Conference Session: The Role of the QP in a global System in a multinational Company
Price Session: EUR 590

1/2-Day Pre-Conference Session "What the QP needs to know about Virtual Companies" - 27 November 2013
Facilitated by Dr Afshin Hosseiny, Ann McGee and Dr Jean-Denis Mallet

• What the QP in a virtual company needs to know and consider
• What a QP at a contract manufacturer needs to know and consider when co-operating with virtual companies

Registration for ½ Day Pre-Conference Session: "Virtual Companies"
Price Session: EUR 590