Error loading player: No playable sources found

47178

M4Q and Digital Regulatory Assessment

Date
October 17, 2022
This product is not available for individual purchase, but it is available as part of the following products:

Digitalisation is already transforming industries and its application in the world of regulatory assessment is on the horizon. Multiple recent efforts have focused on digitalisation and its potential to increase efficiency in submission and review, for both industry and agencies. Initiatives such as Accumulus, data standardization, and the revision of M4Q are all intended to facilitate global harmonization, thereby enhancing submission efficiency, regulatory assessment, and enabling pharmaceutical supply to patients worldwide. This session will focus on several key efforts in this space and will explore the specific activities ongoing in each, as well as reflections from Industry and Regulatory Agencies perspectives.  

Session Speakers:
EMA Perspectives on ICH M4Q(R2) and Digital Regulatory Assessments
Klara Tiitso, EMA-European Medicines Agency, Netherlands

FDA Perspective on Opportunities for Modernization of Regulatory Submissions
Ingrid Markovic, CBER, FDA, United States

M4Q ICH Current Status and Vision from Industry
Sarah Pope Miksinski, AstraZeneca, United States

The Power of Data Exchange CMC Interoperability and a Cloud-based Ecosystem
Michael Abernathy, Amgen Inc., United States

Related Products

Thumbnail for CASSS Welcome and Introduction / Welcome to the 16th European CMC Strategy Forum
CASSS Welcome and Introduction / Welcome to the 16th European CMC Strategy Forum
Kathy Lee, Genentech, a Member of the Roche Group, United States and Tara Sanderson, UCB Pharma Ltd…
Thumbnail for Innovation for Products and Processes
Innovation for Products and Processes
There are lots of exciting developments and innovations for biopharma products and processes that have the potential to transform healthcare treatment and delivery…
Thumbnail for EFPIA Biomanufacturing Working Group Satellite Session
EFPIA Biomanufacturing Working Group Satellite Session
The EFPIA Biomanufacturing Working Group is a cross-company industry team working to aid the development of biological products for patients. Through areas of special interests, the group supports and develops cutting edge science and technology strategies…
Thumbnail for New Technologies for Analytical Control - Multi-attribute Methodology, HCP-MS, etc.
New Technologies for Analytical Control - Multi-attribute Methodology, HCP-MS, etc.
To meet the demands of increasingly complex medicinal products, technologies like mass spectrometry are needed – also in a QC lab. However, for methods like MAM by LC-MS and HCP by MS little experience on how to handle mass spectrometry in a QC lab is currently available…