This session will provide instruction on knowing what to file with the regulatory agencies and when in order to maximize the success of your drug development program. You will learn how important it is to have a thorough understanding of the critical quality attributes of the drug substance and drug product to not only improve your ability to make meaningful decisions during development, but also to be able to establish and justify suitable specifications for your dosage form. This presentation will cover the relevant ICH and compendial requirements and what data is needed to support your drug substance and drug product specifications.

Note: Use these promocode(117660) for 10% discount.