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We can't provide you with more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place...without ever leaving your office. The Webinar Training Pass gives you year-round unrestricted access to dozens of on-demand training webinars, featuring top clinical trials experts and FDA officials. Need training on a topic? The Training Pass lets you train on your schedule—on the subjects you need most. Webinar Training Pass Gives You:

  1. Training from the best minds and thought leaders in the clinical trials industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to dozens of archived webinars.
  4. One automatic registration to more than 40 live webinars we'll host during the life of your subscription.

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Safety Reporting in Global Clinical Trials

61 minutes

Recorded on Thursday, September 27, 2018


Safety reporting experts Kendra Hayden and Steven Beales point out new efficiencies in safety reporting that can help cut trial costs. They discuss:

  • How to reduce a site’s reporting burden by 10 hours per week;
  • Global safety reporting regulations; and
  • How to maximize control over global safety reporting.

Speakers: Kendra Hayden, Business Transformation Program Lead for Safety Reporting, WIRB-Copernicus Group, and Steven Beales, senior VP-IT and Market Owner of Safety Solutions at ePharmaSolutions

Clinical Trials in the Precision Medicine Era

61 minutes

Recorded on Thursday, August 23, 2018


A panel of clinical trial experts discusses the implications and opportunities presented by the developing field of gene therapy. They talk about:

  • How genetic testing is being used in clinical trials;
  • How precision medicine is making trial protocols more complicated; and
  • Expertise and infrastructure needed to collect genetic information.

Speakers: Lindsay McNair, Chief Medical Officer, WIRB-Copernicus Group; Jill Johnston, President, Site Support & Management for Clinical Services, WCG; Karmen Trzupek, Director of Clinical Trial Services and Director of Ocular and Rare Disease Programs, InformedDNA

Getting Real About Real-World Evidence

60 minutes

Recorded on Wednesday, August 15, 2018


FDA specialist Sonali P. Gunawardhana and clinical research expert Mary Jo Lamberti discuss the evolution of real-world evidence (RWE) in clinical studies and the FDA’s policies and priorities. Topics include:

  • Ways drugmakers are using RWE to support promotional claims and premarket applications;
  • Impact of recent FDA statements on including RWE in approval and clearance applications and as a basis for drug and device promotional claims; and
  • How the agency may use RWE to support regulatory decisionmaking.

Speakers: Sonali P. Gunawardhana, Of Counsel, Shook, Hardy & Bacon LLP, and Mary Jo Lamberti, Professor and Associate Director of Sponsored Research, Tufts Center for the Study of Drug Development

The Real Impact of the Common Rule in 2018

77 minutes

Recorded on Thursday, June 21, 2018


Clinical research compliance experts Jennifer Mallory and Carrie Hanger provide an overview of changes in the Common Rule set to take effect in January 2019. They discuss:

  • Broad consent for secondary research;
  • Limited and continuing IRB review;
  • Exemptions;
  • Federalwide assurances; and 
  • Cooperative research.

Speakers: Jennifer Mallory and Carrie Hanger, partners, Nelson Mullins Riley & Scarborough