Drug regulatory harmonization in biopharmaceutics is a crucial aspect of ensuring the consistent and efficient evaluation and approval of biopharmaceutical products across different regions. Biopharmaceutics focuses on understanding the relationship between the drug formulation, its release, and the subsequent therapeutic effect in the human body. Harmonizing regulations in this field facilitates a streamlined and standardized approach to assessing the safety, efficacy, and quality of biopharmaceuticals.
By aligning regulatory requirements, countries can minimize redundancies in the approval process, encourage innovation, and expedite patient access to advanced biopharmaceutical therapies. This harmonization enhances collaboration among regulatory authorities, promotes information exchange, and fosters a global framework for evaluating the complex nature of biopharmaceuticals. Ultimately, a harmonized approach ensures that patients worldwide benefit from timely access to cutting-edge biopharmaceutical treatments, advancing healthcare on a global scale.
Title : Principles and standards for managing healthcare transformation towards personalized, preventive, predictive, participative precision medicine ecosystems
Bernd Blobel, University of Regensburg, Germany
Title : From marker to mechanism: Ligand discovery enables functional analysis of OR51E1, an ectopic olfactory receptor, in prostate cancer
Vladlen Slepak, University of Miami School of Medicine, United States
Title : Hydrogen sulfide in sepsis: From bench to bedside
Madhav Bhatia, University of Otago, New Zealand
Title : Tailored cellular environments to enable drug design
Lan Wang, Paretor LLC, United States
Title : Development of novel drug delivery pathways enabled by perillyl alcohol (NEO100), A monoterpene with multifaceted biomedical applications
Axel H Schonthal, University of Southern California, United States
Title : A NAMs-compatible mechanopharmacological model of drug penetration in the urinary bladder
Kunal Sharma, Swisss Federal Institute of Technology Lausanne, Switzerland
Title : Application of quality by design for pulmonary liposomes: Preliminary study to nano in-microparticle
Lucas Amaral Machado, University of Sao Paulo State – UNESP, Brazil
Title : Integrated Raman, SERS and computational approaches for the study of bioactive molecules in pharmaceutical chemistry
Maria Cristina Gamberini, University of Modena and Reggio Emilia, Italy
Title : The impact of metal-decorated polymeric nanodots on proton relaxivity
Paulo Cesar De Morais, Catholic University of Brasilia, Brazil
Title : Hepatotoxic botanicals-shadows of pearls
Consolato M Sergi, University of Alberta, Canada