Designing Stability Programs for Drug Substances and Products

Register Free: https://www.biopharminternational.com/bp_w/products

Event Overview:

Stability testing programs are a vital step in getting a new biologic drug product or drug substance to market. International Council for Harmonization (ICH) guidelines are in place to ensure drug quality isn’t compromised while stored in proper conditions, and to determine the shelf life of new drugs. These guidelines also help determine proper shipping and distribution of a product and how a drug product should be administered in its final clinical setting.

This webinar will help drug companies design an in-use stability program while overcoming the potential challenges that may hamper a drug development program. Some of the topics to be discussed include:

• Program design
• Storage conditions and time points
• Storage and testing plans
• Material supply
• Testing schedule and interpreting results

Key Learning Objectives:

Attendees will be able to design and conduct stability studies that:

• Meet international regulatory requirements
• Address constraints in resources
• Provide the most cost-effective approach for their resources

Speaker:

Niall Dinwoodie BSc MSc CChem MRSC, Senior Director, Global Analytical Services

Time and Date:

Tuesday, April 13, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

Sponsor: Charles River

Register Free: https://www.biopharminternational.com/bp_w/products