Results for 'FDA'
Compliance 101-Most common issues and MSL-related gray areas
compliance in medical affairs, MSL compliance, FDA standards, ethical collaboration, professional development conferences
In this episode, Jessica McLin and Melody Davis explore the intricacies of compliance and communication in medical affairs. Jessica shares her journey into entrepreneurship and discusses her work with Versant Learning Solutions. The conversation covers FDA standards, ethical collaboration with …
Nov 10th • 41 mins listen
How and Why Medical Affairs Can Support Diversity in Clinical Trials
diversity in clinical trials, role of MSLs, FDA guidance on diversity, patient-centric approaches, cultural awareness and allyship
In this episode, Tom Caravela is joined by Brad Atkinson, Brian Wilson, and Christina Wright to explore the critical role of diversity in clinical trials and the MSL’s part in fostering inclusivity. The discussion covers FDA guidance on diversity, challenges in therapeutic areas, and the …
Aug 24th • 42 mins listen
The Role of MSLs in Achieving Health Equity
health equity, healthcare inequity, pharmaceutical companies, patient advocacy, FDA regulations
In this episode, Ariel Katz, co-founder of H1, joins Tom Caravela to discuss the crucial topic of health equity. Ariel shares insights into his background and the mission of H1, defining health equity and exploring the causes of healthcare inequity. The conversation delves into the roles of MSL…
Jul 12th • 29 mins listen
Oncology Pharmacology 2023: Today’s Treatments and Tomorrow’s Breakthroughs
CDER, FDA, Nurses, biomarker, immunomodulatory
Highlights From Today’s Episode “Full approval through the Center for Drug Evaluation and Research (CDER) and FDA means that those drugs have gone through the laboratory testing, human clinical trial testing, and very extensive clinical trials to make sure that they are effective and th…
Mar 30th • 53 mins listen
Oncology Clinical Trials and Drug Development
ONS member Moe Schwartz, PharmD, BCOP, professor of pharmacy practice in the James L. Winkle College of Pharmacy at the University of Cincinnati in Ohio and member of the Cincinnati Tri-State ONS Chapter, joins Stephanie Jardine, BSN, RN, oncology clinical specialist at ONS, to discuss cancer drug…
Oct 16th • 38 mins listen