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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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The Real Impact of the Common Rule in 2018

77 minutes

Recorded on Thursday, June 21, 2018

Description

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

Inside the FDA’s Oncology Center of Excellence

31 minutes

Recorded on Wednesday, June 13, 2018

Description

Acting Associate Director for Regulatory Affairs Tamy Kim explains the Oncology Center of Excellence mission to expedite the development of oncology and hematology medical products and support an integrated approach in the clinical evaluation of drugs, biologics, and devices for the treatment of cancer. She discusses:

  • The center’s structure, including where it sits within the agency and how it interacts with other centers;
  • Nuances of the regulatory role, such as the formation of clinical review teams for oncology products;
  • Elements of OCE research; and 
  • Examples of OCE outreach, including interactions with professional societies and patient or advocacy groups.

Speaker: Tamy Kim, Acting Associate Director for Regulatory Affairs in the Oncology Center of Excellence

Appendix M of the NIH Guidelines

47 minutes

Recorded on Tuesday, June 05, 2018

Description

Clinical research expert Daniel Kavanagh discusses registration and reporting requirements for gene therapy research under the recently revised NIH guidelines. He covers:

  • NIH reporting compliance;
  • The Office of Science Policy registration process; and
  • Progress and safety reporting requirements.

Speaker: Daniel Kavanagh, Senior Director of Biosafety and Gene Therapy, WCG Biosafety

Cutting the Costs of Clinical Trial Subject Recruitment

62 minutes

Recorded on Wednesday, May 30, 2018

Description

Patient recruitment expert Steven Pyffer discusses ways to reach potential research subjects through both tradition and digital avenues. He covers:

  • Insight on the factors that determine the actual outreach cost of a randomized patient;
  • Ways to reduce patient outreach cost; and
  • Improved expectations to patient outreach performance.

Speaker: Steven Pyffer, Senior Director of Patient Outreach, ThreeWire