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EXPERIENCE WITH IMPLEMENTATION OF THE LIFECYCLE APPROACH

Track:
Pharmaceutical Quality in the 21st Century

Day & Time:
March 27, 11:00AM - 12:30PM (Central European Standard Time)

Session Number:
1206

Room Number:
Room K

Type:
Session

Title:
EXPERIENCE WITH IMPLEMENTATION OF THE LIFECYCLE APPROACH

Chair(s):
Michael J. James, PhD, MSc
Director of CMC Regulatory Advocacy and Intelligence
GlaxoSmithKline R&D, United Kingdom

Description:
EXPERIENCE WITH IMPLEMENTATION OF THE LIFECYCLE APPROACH

Presentation(s) & Speaker(s):
Opportunities from the Variations Regulations
Michael J. James, PhD, MSc
Director of CMC Regulatory Advocacy and Intelligence
GlaxoSmithKline R&D, United Kingdom

Experiences with the Review/Approval of Post-Approval Protocols in Vaccines/Biopharmaceuticals
Mats Welin
Medical Products Agency (MPA), Sweden

Industry Experiences with Post-Approval Protocols
Markus Goese
EMA Liaison
F. Hoffmann-La Roche Ltd, Switzerland