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12-01-2024
Joint Scientific Consultations – Advice for EU Health Technology Assessment
Get expert advice on your drug or device development through the EU's Joint Scientific Consultation. This voluntary program lets developers receive feedback from EU health technology assessment bodies on their clinical study designs and evidence needs....
14-12-2023
Understanding why the Patient Holds the Key to Successful Drug Development
Enhance drug approval success through Patient-Focused Drug Development (PFDD). This insightful white paper explores how systematically incorporating the patient voice throughout the development cycle can help address unmet medical needs and strengthen r...
14-11-2023
Ensuring Quality and Compliance: Foundational Principles for Drug Development
Maintaining quality and regulatory compliance is crucial for drug developers bringing new treatments to market. This white paper outlines the core principles and best practices, including understanding FDA and EMA requirements, implementing robust quali...
23-10-2023
Optimizing Preclinical Programs and Streamlining Clinical Translation
Translating scientific discoveries into approved treatments requires strategically navigating complex technical, regulatory and business issues at each development stage, from early testing through commercial scale-up, to maximize chances of delivering...
18-10-2023
The role of real-world evidence in regulatory decision making: Current use and future potential
The use of real-world evidence (RWE) in regulatory decision making is growing as drug development faces challenges like rare diseases and advanced therapies. While randomized trials remain the gold standard, rigorous RWE can provide valuable supplementa...
05-10-2023
PADE Inspections: What You Need to Know & Why
While PADE inspections build upon the successes or shortcomings of a company’s Clinically-focused Bioresearch Monitoring (BIMO) pre-approval inspections, preparing for PADE inspection is a separate effort that requires dedicated attention by the Head of...
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Building Better Biotechs
