EMA and Swissmedic to share H1N1 medicines information
The European Medicines Agency (EMA) and the Swiss Agency for Therapeutic Products, Swissmedic, have agreed to exchange information about the authorization and safety of H1N1 pandemic medicines.
The European Medicines Agency (EMA) and the Swiss Agency for Therapeutic Products, Swissmedic, have agreed to exchange information about the authorization and safety of H1N1 pandemic medicines. The information will be shared as part of the agencies' regulatory and scientific processes both before and after a medicine has been approved.
According to a statement from the EMA, the agencies will exchange confidential scientific and technical information to ensure the safety, quality, efficacy and post-authorization follow-up of medicines used in the context of the H1N1 pandemic.
"This closer co-operation will provide two authorities earlier access to information on the basis for their respective recommendations on pandemic medicines and complete the overall view in their safety," said the EMA statement. "It will also create the opportunity to exchange experience regarding 'lessons learned' during the H1N1 pandemic."
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
The Role of Forced Degradation in Method Development, Manufacturability, and CMC Strategy
April 28th 2025Forced degradation studies are critical in biologics development, particularly for monoclonal antibodies (mAbs). These studies simulate long-term environmental stressors to uncover degradation pathways and ensure the stability of critical quality attributes (CQAs), aiding in robust chemistry, manufacturing, and controls (CMC) strategies and regulatory compliance.
