Webinars

Clinical Research: Phase 1 - Phase 4

The Expanding Role of RWE in Rare Studies

4 August 2022 10:00am EST 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...

Clinical Research: Phase 1 - Phase 4

Addressing Challenges In Bringing Male Contraceptives to Market

21 July 2022 10:00am EST There are currently more than a dozen categories of female birth control with proven efficacy on the market. Conversely, the only options available for men today are condoms and vasectomy, despite decades of research. No new male contraceptive products have entered the market since the condom was created in the...

Clinical Research: Phase 1 - Phase 4

India Webinar: Considerations to Improve Patient Outcomes in Early Drug Development

Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes. Topics in this...

Taking Device Clinical Development to the US & Europe

Thursday, April 28 2:00 p.m. AEST Medical devices play an increasingly critical role in the health and quality of life of millions of people worldwide. While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences...

IVDR Survival Guide: Know The 4 Main Challenges And How To Overcome Them

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...

The 505(b)(2) Pathway: Getting to the Clinic Faster

Wednesday, April 206:30 pm IST | 9:00 a.m. EDT | 1:00 p.m. GMT Use of the 505(b)(2) regulatory pathway has seen rapid growth as drug developers seek to avoid unnecessary duplication of research and get products to market faster. By making it possible to postpone or outright eliminate trial phases, the 505(b)(2) pathway offers a...

Designing and Conducting Decentralized Dermatology Trials

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...

New-Drug Development: Succeeding With the FDA (Australia)

March 31, 2022 | 2:00 PM AEDT / 11:00 PM EDT (March 30) 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...

Clinical Research: Phase 1 - Phase 4

IVDR Survival Guide: Know the 4 Main Challenges and How to Overcome Them

March 23, 2022 | 10:00 AM EST / 7:00 AM PST / 3:00 PM GMT 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...

New-Drug Development: Succeeding With the FDA (India)

March 17, 2022 | 6:30 PM IST / 8:00 AM EST / 5:00 AM PST 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...