OVERVIEW

Preliminary Program Topics:

• ICH Stability Requirements and Challenges

• Design of Protocols for Early Development Stability Studies

• Stability-Indicating Methods for Biotechnology Products

• Stability Challenges of Combination Products

• How to Make Risk-based Stability Testing Decisions for Drug Substance(DS) Batches after Changes

• Advanced modeling for accelerated stability determinations

• New Analytical techniques for stability testing of Biopharmaceutical

• The Future of Medical Products

• Stability programs for Leachable Impurities

• Applications of Reduced Study Designs for Stability Programs

• Excipients in Drug product stability

• Forced Degradation Studies

• MonitoringStability of Fc Fusion Protein

• Stability challenges and rationale study design for biologics

KEY DATES

Event Start Date
14 May, 2014
Event Start Date
Event End Date
15 May, 2014
Event End Date

SPECIALITIES

Pharmacy and Medicine

SUGGESTED HOTELS

CONFERENCE VENUE

LocationSomerset
1

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