Author: [AUTHOR] Published on 11/18/2019 1:35:00 PM
ASCPT Members-Only Webinar presented by the Early Development & Drug Safety and Systems Pharmacology Community
Title: Model-Informed Drug Discovery and Development (MID3): Current Industry Good Practice, Regulatory Expectations and Future Perspectives
Date and Time: Wednesday, December 4, 2019, 10:00 am ET
Speakers: Scott Marshall, PhD, Efthymios Manolis, MS, and Rajnikanth Madabushi, PhD
Moderator: Lakshmi Vasist, PharmD
Description: Good practices around model-informed drug discovery and development (MID3) aim to improve the implementation, standardization, and acceptance of these approaches within drug development and regulatory review. Furthermore, these model-informed approaches continue to have an increased focus within future guideline development such as in the EMA extrapolation concept paper, PDUFA 6 that aims at advancing model-informed drug development, and ICH E11. In this special presentation, the following learning objectives will be discussed:
Registration Link: https://zoom.us/webinar/register/WN_4m_9xKY2SlKPzuz9Wli3TA
- Do the recently documented industry good practices match with regulatory expectations?
- How do these practices fit with future viewpoints from both industry and regulatory perspectives of the role of MID3 in making R&D and regulatory review more efficient?
- What are the gaps and opportunities in the Pharma-Regulatory alignment, technical aspects and documentation, and how should these gaps be addressed?