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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:

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Developing Pharmaceutical Investigational Brochures & Annual Reports

54 minutes

Recorded on Tuesday, January 29, 2019

Description

Regulatory expert Tiffany Guckin explains the nature and content of investigator’s brochures (IB) and IND annual reports. She discusses:

  • The importance of annual reports to the FDA and sponsors; 
  • Structure and content of an IB per ICH E6 (R2);
  • How to ensure you are accurately representing your investigation to potential subjects; and 
  • Best practices that can be included in SOPs or other regulatory processes.

Speaker: Tiffany Guckin, Associate Director of Regulatory Affairs, Invicro

Returning Plain-Language Summaries to Research Participants

57 minutes

Recorded on Tuesday, November 27, 2018

Description

Patient communication and compliance experts Jill McNair, David Forster and Behtash Bahador discuss best practices in presenting research results to study participants. Topics include:

  • Working with IRBs that oversee the clinical trials for which patient summaries are provided;
  • Case study of one sponsor’s collaboration with IRBs during the plain-language summary creation and delivery process; and
  • Upcoming regulations that may affect how you provide trial results to participants.

Speakers: Jill McNair, Senior Director-Patient Engagement, The Center for Information and Study on Clinical Research Participation (CISCRP); Behtash Bahador, Senior Manager for the Communicating Trial Results Program, CISCRP; David Forster, Chief Compliance Officer, WIRB-Copernicus Group

Safety Reporting in Global Clinical Trials

61 minutes

Recorded on Thursday, September 27, 2018

Description

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

Description

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