Navigating the Pharma R&D Regulatory Landscape 2023
Introduction
In today’s rapidly evolving world, the pharmaceutical industry plays a crucial role in enhancing global health and well-being. The industry though requires a deep understanding of the complex web of regulations & guidelines playing a crucial role in ensuring the safety and efficacy of the approved drugs.
From the moment a pharmaceutical drug is conceptualized to its final journey into the hands of patients, countless regulations shape the processes involved. These regulations are put in place to safeguard public health, ensure product quality, and maintain ethical standards within the industry. However, navigating through the ever-changing landscape of regulations can be daunting.
Our ‘Navigating the Regulatory Landscape’ eBook has been designed to provide you with invaluable insights into the intricacies of regulations & policies surrounding the challenges and opportunities of Real-World Data, genome editing, biomedical informatics, manufacturing and many more.
We would like to invite you to embark on this educational journey with Oxford Global as we unravel invaluable insights and showcase the latest innovation in this space.
Contents
- Damion Nero, Head of Data Science, Takeda on the regulatory challenges and opportunities of Real-World Data
- John Parrington, Associate Professor of Cellular & Molecular Pharmacology & Fellow of Worcester College, University of College on the regulatory challenges and opportunities surrounding genome editing Single Cell Proteomics: Advancements and Potential
- Virginia Acha, Associate Vice President - Global Regulatory Policy, MSD – Revision of the EU Pharma Legislation: a Framework “Fit for Innovation”?
- Arvind Rao, Associate Professor of Biostatistics, University of Michigan on the regulatory challenges and opportunities of biomedical informatics
- Sridevi Nagarajan, Head Digital Regulatory Strategy, AstraZeneca on the importance of artificial intelligence, strategic collaboration, and the role of the metaverse in unlocking the future of digital regulatory
- Andrew Robertson, Vice President, Head of Global Regulatory Policy and Innovation, Takeda on working with regulators and the current regulatory paradigm
- Good Manufacturing Practices: Overcoming Regulatory Approval Hurdles
- Approaches to Combinational Immunotherapies: From Clinic to Approval
- Selection Biomarkers: Shaping the Future of Drug Development and Regulatory Approval
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