Search
Search Results
-
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today
Artificial intelligence (AI)-enabled technologies in the MedTech sector hold the promise to transform healthcare delivery by improving access,...
-
Accelerating Rare Disease Drug Development: Lessons Learned from Muscular Dystrophy Patient Advocacy Groups
With scientific and molecular advancements related to disease pathogenesis, advances in gene and stem cell therapies, and the promise of lucrative...
-
Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View
For almost a decade, regulators and pharmaceutical industry groups have been interested in electronic source (eSource) in clinical trials (Nordo et...
-
Exosomal microRNAs as diagnostic and therapeutic biomarkers in non-malignant liver diseases
The liver is a vital organ responsible for various physiological functions, such as metabolism, immune response, digestion, and detoxification....
-
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data
Conducting clinical trials (CTs) has become increasingly costly and complex in terms of designing and operationalizing. These challenges exist in...
-
Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe
Real-World Evidence (RWE), which has historically been used to support post-approval safety studies, has recently gained acceptance for new drug...
-
Validation Studies of Some Stages of Drug Production from Equine Blood Plasma Regarding the Reduction of Extraneous Viruses
Russian and foreign pharmacopoeias require at least two stages in the manufacturing process of medicinal products based on animal serum-plasma to...
-
Barriers and facilitators for integration of guidelines on operating health shops: a case of family planning services
BackgroundThe Zambia Medicines Regulatory Authority (ZAMRA) piloted the implementation of Guidelines on Operating Health Shops in Zambia in 2016,...
-
An Evaluation of the Swissmedic Regulatory Framework for New Active Substances
BackgroundSwissmedic is a major regulatory agency that has been benchmarking its timelines for 20 years. To better understand the Swissmedic review...
-
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways
Reliance-based pathways for the marketing authorization of medical products have been identified as valuable regulatory tools for the timely...
-
Path Forward to Optimise Post-approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide
Post-approval changes (PACs) to the registered information of authorised medicinal products are introduced routinely worldwide to enhance the...
-
EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age
As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek...
-
Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review
BackgroundWorking with patients through meaningful patient engagement (PE) and incorporating patient experience data (PXD) is increasingly important...
-
Asia Partnership Conference of Pharmaceutical Associations (APAC) Report on Regulatory Agility Implemented During the COVID-19 Pandemic: Inspiring Partnerships and Recommendations for the Way Forward
PurposeAsia Partnership Conference of Pharmaceutical Associations (APAC) promote regulatory agility of four important best practices i.e. reliance,...
-
Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018
The EU is a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and therefore...
-
Selection of Adaptive Designs in Studies of Bioequivalence. Decision Criteria
Adaptive designs can be selected for bioequivalence studies of drugs for which there are no data on the variability of pharmacokinetic parameters...
-
Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape?
Digital health technology (DHT) is increasingly used to facilitate the conduct of clinical drug trials. The European regulatory environment would...
-
Simulation for Medication Safety and Patient Safety Practice
This chapter provides an overview of the use of simulation in medication safety and patient safety practices in healthcare settings. Simulation has...
-
Global Evidence on Assuring Quality of Medicines
Quality of medicine is a major challenge, especially in low- and middle-income countries. The factors contributing include weak regulatory capacity,...
-
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices
Nearly ubiquitous use of personal electronics, wearable sensors, and other types of digital health technologies, along with wireless connectivity,...