Historically, medical device developers often opted to bring new products to market in the EU first, as obtaining a CE mark was perceived to be faster, less expensive, and more predictable than getting US FDA clearance or approval. With the introduction of the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the...
Meet Our Speakers: Matthew Nowland, Vice President, Regulatory Affairs, MedTech, Premier ConsultingMichael Edwards, Senior Director, Regulatory Affairs, MedTech, Premier Consulting
Meet Our Speakers: Dr. Olu AlobaVice President, CMC Services Dr. Marianthi KarakatsaniDirector, CMC Development Strategy
Pediatric rare disease trials combine rarity of disease with a restricted and geographically-dispersed population of vulnerable subjects for research, creating unique challenges for study design and execution. Recruitment is challenging, as patients, parents, and caregivers need to juggle school schedules, work responsibilities, and family obligations to accommodate study participation. Incorporating decentralized clinical trial (DCT) strategies...
Meet Our Speakers: Betsy ReidSenior Vice President, Pediatrics Adam Bloomfield, MD, FAAPExecutive Director, Medical Affairs, Rare Diseases and Pediatrics
November 3rd, 202311:00 a.m. EST Historically, medical device developers often opted to bring new products to market in the EU first, as obtaining a CE mark was perceived to be faster, less expensive, and more predictable than getting US FDA clearance or approval. With the introduction of the EU’s Medical Device Regulation (MDR) and In...
Sponsors can use the 505(b)(2) pathway to develop drugs with new indications, dosage forms or strengths, formulations, dosing regimens, routes of administration, or even active ingredients. In many cases, these changes create new, differentiated products that patients or healthcare providers prefer over previous versions, leading to both improved experiences for patients and tremendous commercial value...
With the positive aim of increasing patient safety, the In Vitro Diagnostic Regulation (IVDR) has fundamentally changed the way in vitro diagnostics (IVD) are regulated in the EU. The depth of expectations for review and documentation have increased substantially. As a result, IVD sponsors are having to adapt to a daunting set of regulatory updates.This...
Conducting rigorous assessments and obtaining the highest-quality data are essential to dermatology clinical research. Traditional clinical trial designs can pose obstacles for patients with busy work and personal lives, especially if they live far from a study site. Decentralized trials open opportunities for broader patient populations, increasingly important as competition for patients grows with the...
Real-world evidence is increasingly important in drug development as the medical and pharma communities recognize the data’s potential for predicting the benefits of treatment interventions. Accelerating this trend is the Food and Drug Administration’s growing understanding of how RWE has helped researchers better understand and use COVID-19 treatments. While placebo-controlled trials continue to have a...