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Home » Webinars

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The FDA Work Plan for the 21st Century Cures Act
69 minutes

FDA regulatory expert Jim O’Reilly discusses how the FDA plans to implement the variety of provisions in the 21st Century Cures Act and how those plans will affect manufacturers. He covers:

  • How the FDA Science Board's new standards can lead to much faster product development approvals; 
  • How the FDA will allocate the $500 million authorized by Congress; and
  • The role of the agency’s new Office of Translational Sciences, which governs the bench-to-clinical process.

Speaker: Jim O’Reilly, Professor, University of Cincinnati College of Medicine

Presentation: Download the presentation

Transcript: Download the transcript

European Medical Device Regulations
82 minutes

European regulatory expert James Pink provides a deep dive into the new EU medical device regulations, including its 22 articles on clinical evaluation and investigation. He discusses:

  • New requirements for documentation confirmation and updating;
  • New separate software rules;
  • Stricter requirements for implantable devices; and
  • Possible sanctions for devicemakers who are not ready to comply with the new rules.

Speaker: James Pink, Vice President, NSF Health Sciences Medical Devices, Europe

Presentation: Download the presentation

Transcript: Download the transcript

Electronic Informed Consent for Biobanks
55 minutes

Informed consent expert Susan Brink discusses strategies for implementing an electronic informed consent system. Topics include:

  • Broad v. dynamic consent;
  • Integration with other systems; and
  • The process of setting up an eConsent system.

Speaker: Susan G. Brink, Executive Vice President, e-consent Products and Services, Enforme Interactive, Inc.

Presentation: Download the presentation

Transcript: Download the transcript

Addressing Acceptable Recruitment Methods for Sponsors and Sites
65 minutes

Patient recruitment experts David Borasky and Amanda Plucinak present strategies for expediting study recruitment. They discuss:

  • How to develop data to understand why studies are behind schedule and over-budget;
  • How to use proven strategies and tactics to improve your patient recruitment numbers;
  • How to foster awareness of the importance of implementing  appropriate effort into creating a recruitment plan for a study; and
  • How to comply with new GDPR requirements.  

Speakers: David Borasky, Vice President, IRB Compliance, WIRB-Copernicus Group; Amanda Plucinak, Quality Assurance Manager, ThreeWire

Presentation: Download the presentation

Transcript: Download the transcript

Managing Clinical Trial Materials
61 minutes

Supply chain analyst Hedley Rees advises on the most effective techniques for forecasting and managing clinical trial materials needs. Topics covered include:

  • Mapping the end-to-end physical flow of the supply chain;
  • Key information flows in the supply chain; and
  • Prerequisites for successful delivery of drug to site.

Speaker: Hedley Rees, Managing Consultant, Pharma Flow

Presentation: Download the presentation

Transcript: Download the transcript

The Real Impact of the Common Rule in 2018
77 minutes

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

Presentation: Download the presentation

Transcript: Download the transcript

Strategies that Inform Investigator Selection and Enhance Enrollment
60 minutes

Clinical trial contracting experts Suzanne Caruso and Brooke Millman discuss negotiating and finalizing site contracts to ensure that you begin your next study holding all the cards: quick startup, decreased costs, no unnecessary terms and conditions that cause hassles and delays. They cover:

  • Start-up dates, deadlines, and schedules;
  • Necessary and avoidable costs and expenses;
  • Air-tight provisions that avoid hassles and complications;
  • Enrolling patients to expedite trials and time to market; and
  • Payment terms and conditions that meet your budget.

Speakers: Suzanne Caruso, Vice President, Clinical Solutions, and Brooke Millman, Vice President, Consulting Solutions, WIRB Copernicus Group

Presentation: Download the presentation

Transcript: Download the transcript

Recruiting Patients & Time Management
52 minutes

Clinical trial specialists Kari Lotsberg and Fabian Sandoval discuss the value of having staff dedicated solely to patient recruitment. They cover:

  • The five stages of recruitment;
  • Recruitment problems that can stem from lack of time; and 
  • Benefits of a community recruitment strategy.

Speakers: Kari Lotsberg, Manager of Site Services, ThreeWire; Fabian Sandoval, CEO & Research Director at Emerson Clinical Research Institute.

Presentation: Download the presentation

Transcript: Download the transcript

Clinical Trials in the Precision Medicine Era
61 minutes

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

Presentation: Download the presentation

Transcript: Download the transcript

Clinical Trial Portals for Small and Mid-Size Biotech Firms
50 minutes

IT experts Brian Mundy and Steven Beales discuss the importance of using clinical trial portals. Topics include:

  • How clinical trial portals enable you to differentiate yourself from your competition with potential Big Pharma and VC partners;
  • How to demonstrate you’ve got the technology solutions in place to efficiently meet milestones, deadlines, and startup times for your clinical trials; and  
  • How to attract the top sites to participate in your clinical studies.

Speakers: Brian Mundy, Director of Product Strategy, and Steven Beales, Senior Vice President of IT, WCG ePharmaSolutions

Presentation: Download the presentation

Transcript: Download the transcript

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