EMEA restructures
The EMEA unveiled several changes to the organization, including a new structure and visual identity.
The EMEA has unveiled several changes to the organization, including a new structure and visual identity.
One primary structural change involves integrating human pre- and post-authorization activities into one unit, “to guarantee seamless lifecycle-management of medicines,” according to a press statement. Also, a group will be dedicated to the management of product data and documentation to help improve the efficiency of data-management processes throughout the agency.
This is the second time the EMEA has undergone restructuring. Established in 1995, the agency’s “responsibilities and tasks have grown, giving it a stronger role in the protection of public and animal health in Europe,” according to the press statement. “All of this has been underpinned by the creation of additional scientific committees and advisory groups, which bring with them the need for enhanced coordination and support. Legislative proposals currently being considered by the European Parliament and Council are expected to bring further responsibilities to the Agency.”
As part of the agency’s new visual, or public, identity, the EMEA will launch a new website in the coming months. The site is expected to be easier for the public to use and designed to meet readers’ needs.
Going forth, the agency will now be known as the EMA as opposed to the EMEA.
Why is the PDA Pharmaceutical Microbiology Conference the Hottest Ticket in the Industry?
October 10th 2024Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.
Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical Supplies
November 21st 2024Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
Your Ultimate Guide for CMC Testing Support for Gene and Cell Therapy
November 21st 2024Explore the complexities of gene and cell therapy development with our comprehensive guide to Chemistry, Manufacturing, and Controls (CMC) testing. Learn how our expertise ensures the safety, potency, and quality of advanced therapies, supporting your journey from product development through regulatory approval.
