Webinars

New-Drug Development: Succeeding With the FDA

November 24th, 20226:30 p.m. IST Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the steps — and how the agency works — can alleviate the stress and get your product on the path to approval. This webinar examines some key questions...

Regulatory Strategy Considerations for Working with the FDA vs. the EMA

November 24th, 20222:00 p.m. AEST This webinar will compare approval processes, types (and costs) of agency meetings, expedited programs, pediatric plans, and more. We’ll discuss: How the FDA and EMA approach the new the drug application process and meet with sponsorsOpportunities for expedited drug development through the breakthrough (U.S.) and PRIME (European) designationsSignificant differences in...

Accelerate Product Approval Using In Silico Modeling & Simulation

In clinical research and development, comparison to a control is highly recommended by regulatory agencies for the purpose of demonstrating evidence of clinical efficacy of a drug or device. The control could be a placebo, a known standard-of-care or an available market-approved drug or device. With some diseases or certain classes of devices, a viable...

Disease-Modifying Therapies in Alzheimer’s and Neurodegenerative Disorders

The landscape for Alzheimer’s disease diagnosis has changed significantly over the past decade, but there is still only one conditionally FDA-approved medication. Despite extensive research and many expensive clinical trials, more than 200 investigational programs have failed or been abandoned in the past 10 years alone. New treatments are needed to prevent Alzheimer’s, delay its...

Regulatory Strategy Considerations for Working with the FDA and EMA

October 4th, 20229:00 a.m. EDT | 6:30 p.m. IST This webinar will compare approval processes, types (and costs) of agency meetings, expedited programs, pediatric plans, and more. We’ll discuss: How the FDA and EMA approach the new the drug application process and meet with sponsorsOpportunities for expedited drug development through the breakthrough (U.S.) and PRIME...

Clinical Research: Phase 1 - Phase 4

The Expanding Role of RWE in Rare Studies

September 29th, 20222:00 p.m. AET / 1:00 p.m. KST / 12:00 p.m. SGT 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...

Consulting

Regulatory and Commercial Insights to Maximize the Development of Digital Health Solutions

October 6th, 202210:00 a.m. EST Digital health solutions, and more specifically digital medicines and digital therapeutics (DTx), are increasingly recognized as potential solutions for areas of high unmet medical need. Rising expectations for these innovative solutions have put significant pressure on developers of digital medicines to bring them to market faster and to generate substantial...

Real-World Science and Late Phase

The Expanding Role of RWE in Rare Studies

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...

Clinical Research: Phase 1 - Phase 4

Designing and Conducting Decentralized Dermatology Trials

August 25th, 20222:00 p.m. AET / 1:00 p.m. KST / 12:00 p.m. SGT 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...

Accelerate Product Approval Using In Silico Modeling & Simulation

September 22nd, 202210am EDT / 7am PDT / 4pm CEST In clinical research and development, comparison to a control is highly recommended by regulatory agencies for the purpose of demonstrating evidence of clinical efficacy of a drug or device. The control could be a placebo, a known standard-of-care or an available market-approved drug or device....