April 3–4, 2017
Hilton Washington, D.C./Rockville Hotel and Executive Meeting Center, Md
Goals and Objectives
A number of stability studies are undertaken during drug development and in support of commercial distribution that are not addressed in the International Conference on Harmonisation (ICH) Quality documents. Examples include studies to assess the impact of temperature excursions during distribution, in-use stability studies to establish use periods for product after opening, holding of bulk drug substance and drug product, freeze/thaw studies for biologics, semi-solids, and liquids, microbiological quality of drug products after penetration of the container system for dose preparation prior to patient administration, photostability studies of light-sensitive products, and developing stability indicating methods for biologics. The challenges to establish meaningful studies are not only technical/scientific but also require an understanding of how products are distributed throughout the supply chain as well as the regulatory expectations for demonstrating the product is delivered to patients without any change as it may relate to the safety or effectiveness.
This interactive workshop will focus on challenges and successes of addressing stability concerns affecting real world development, manufacturing, distribution, and use of drug substances and products for which no harmonized guidance exists.
- Learn from industry experts on their experience and recommendations to meet stability challenges that are not addressed by ICH stability guidelines during product development and life-cycle management.
- Share best practices and solutions with a network of pharmaceutical scientists who are facing similar challenges through discussion of real world examples.
- Engage in face-to-face discussion with members of regulatory agencies to explore opportunities to align on more effective ways to address stability concerns through science and risk-based approaches.
Who Should Attend
Experienced pharmaceutical scientists and authorities responsible for marketing authorization decisions for human medicinal products.