CTTI

Webinars

WebinarCTTI's webinars feature esteemed speakers discussing topics related to innovation and culture within the clinical trials enterprise. Below, you will find information about upcoming webinars, as well as recordings of previous webinars.

All webinars listed below are free and open to the public, and we encourage you to invite colleagues involved in the clinical trials enterprise.


Upcoming CTTI Webinars:

Thursday, June 16, 2016 
from 12:00 - 1:00 PM EST

  • TOPIC: DMC Project Recommendations
  • Webinar details can be found here.

Past CTTI Webinars:

 


 

CTTI Presents Recommendations for Recruitment: Moving Recruitment Planning Upstream to Reduce Barriers

Video coming soon.

DATE: May 19, 2016 from 12:00-1:00 p.m. EST

PRESENTERS:

  • Jonca Bull, MD, Director, Office of Minority Health, US Food and Drug Administration
  • Elizabeth Mahon, JD, Associate Director Global Clinical Operations – US, Janssen R&D

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Case Studies on Expedited IND Safety Reporting

Video coming soon.

DATE: April 21, 2016 from 12:00-1:00 p.m. EST

PRESENTERS:

  • Annemarie Forrest, Senior Clinical Project Manager, CTTI
  • Patrick Archdeacon, Senior Clinical Advisor, Office of Medical Policy, Food and Drug Administration, Center for Drug Evaluation and Research
  • Nina Stuccio, Head, Medical Safety Review, Global Clinical Safety & Pharmacovigilance, Merck, Inc

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Presenting CTTI Recommendations: Informed Consent

DATE: November 19, 2015 from 12:00-1:00 p.m. EST

OBJECTIVE: Team members from CTTI’s Informed Consent Project unveiled the official recommendations resulting from this project. These recommendations propose a new model for the informed consent process that places the focus back where it should be: on the participant.

PRESENTERS:

  • Jennifer Lentz, Global Informed Consent Process Owner, US CMS Coordinator, Global Clinical Operations, Eli Lilly and Company
  • Michele Kennett, Assistant Vice Chancellor for Research, Director of Human Research Protections, Director of MU Institutional Review Board, University of Missouri

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 

 

Presenting CTTI Recommendations: Effective Engagement with Patient Groups Around Clinical Trials

DATE: October 15, 2015 from 12:00-1:00 p.m. EST

OBJECTIVE: Team members from CTTI’s Patient Groups & Clinical Trials project presented the official recommendations on effective engagement with patient groups around clinical trials. Released on October 7, 2015, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools. 

PRESENTERS:

  • Sharon Hesterlee (Myotonic Dystrophy Foundation)
  • Patricia Cornet (Bristol-Myers Squibb)
  • Scott Weir (KUMC)

CLICK HERE to view the slides from this presentation.

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Medical Device Innovation Consortium’s (MDIC) Patient Centered Benefit-Risk (PCBR) Framework

DATE: August 20, 2015 from 12:00-1:00 p.m. EST

OBJECTIVE: This webinar features the Medical Device Innovation Consortium (MDIC) and their recently released Patient Centered Benefit-Risk Assessment (PCBR). CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake, participated in the development of the PCBR framework and we are pleased to share the recording of this event.

PRESENTERS:

  • Ross Jaffe, Managing Director, Versant Ventures; Director, National Venture Capital Association; Board Champion, MDIC
  • Kathryn O'Callaghan, Associate Center Director for Science & Strategic Partnerships, FDA CDRH

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Quality by Design Project: Recommendations and Toolkit

DATE: July 16, 2015 from 12:00-1:00 p.m. EST

OBJECTIVE: The Quality by Design (QbD) project team presented the QbD recommendations and an introduction to the QbD Toolkit, released June 15, 2015. This web-based Toolkit provides resources for facilitating adoption and real world application of QbD concepts.

PRESENTERS:

  • Ann Meeker-O'Connell, Head, Risk Management and External Engagement, Johnson & Johnson BioResearch Quality & Compliance
  • Coleen Glessner, MBA, Quality Expert 
  • Martin Landray, Clinical Trials Service Unit & Epidemiological Studies Unit, University of Oxford

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

MIT Collaborative Initiatives' Clinical Trials Systems Project: An Introduction

DATE: May 21, 2015 12:00–1:00 p.m. EST.

OBJECTIVE: Tenley Albright, Tak Igusa, and Enrique Martinez present on The MIT Collaborative Initiatives’ Clinical Trials Systems Project. 

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Translating Quality by Design Principles into Practice, Part 3

DATE: April 15, 2015 11 a.m.–12:00 p.m. EST.

AGENDA

  • Introduction to CTTI by Pamela Tenaerts, Executive Director, CTTI
  • Upcoming CTTI QbD Project Activities by Ann Meeker O’Connell
  • QbD Implementation by Louise Bowman
  • Implementation of QbD in Clinical Trials: Panel Discussion by:
    • Ann Meeker-O’Connell, Head, Risk Management and External Engagement, Janssen
    • Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer
    • Sabrina Comic-Savic, Senior Director, GCP Compliance, The Medicines Company
    • Louise Bowman, University of Oxford

OBJECTIVE: This webinar is the third in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. Click here for more information about CTTI's QbD Project.

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Translating Quality by Design Principles into Practice, Part 2

DATE: January 14, 2015 11 a.m.–12:00 p.m. EST.

AGENDA

OBJECTIVE: This webinar is the second in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. Click here for more information about CTTI's QbD Project.

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Translating Quality by Design Principles into Practice, Part 1

DATE: October 16, 2014 12–1:00 p.m. EST.

AGENDA

  • CTTI Quality by Design Project Overview by Ann Meeker-O’Connell, Senior Director, Clinical Quality Strategy Team Lead, Janssen
  • Pfizer Experience by Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer
  • Seattle Genetics Experience by Marta Fields, Senior Director, Compliance and Quality Systems, Seattle Genetics
  • Q&A

OBJECTIVE: This webinar is the first in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. Click here for more information about CTTI's QbD Project.

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Patient Advocacy/Industry Partnerships to Accelerate Therapy Development

DATE: July 17, 2014 12–1:00 p.m. EST.

PRESENTERS

  • Sharon Hesterlee, Ph.D., Vice President Research, Parent Project Muscular Dystrophy
  • Holly Peay, MS CGC, Vice President, Education and Outreach, Parent Project Muscular Dystrophy, and Director, DuchenneConnect Registry

OBJECTIVE: Sharon Hesterlee and Holly Peay discuss the ways in which Parent Project Muscular Dystrophy (PPMD) has partnered with industry to accelerate therapy development for Duchenne Muscular Dystrophy.

ADDITIONAL RESOURCES:

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Developing Approaches to Conducting Randomized Trials in the Mini-Sentinel Environment

DATE: May 15, 2014 12–1:00 p.m. EST.

PRESENTERS

  • Richard Platt, MD, MS, of Mini-Sentinel
  • Patrick Archdeacon, MD of the FDA

OBJECTIVE: Summarize the work generated by CTTI’s Uses of Electronic Data Project and the resulting, recently released report, Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Update of Harvard MRCT Programmatic Activities

DATE: March 20, 2014 12–1:00 p.m. EST.

PRESENTERS

  • Rebecca Li, Executive Director of the Multi-Regional Clinical Trials (MRCT) Center

OBJECTIVE: Rebecca Li presented an update on MRCT programmatic activities for CTTI members.

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Research Institution Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

DATE: February 6, 2014 12–1:00 p.m. EST.

PRESENTERS

  • Daniel Nelson, Director, Office of Human Research Ethics, University of North Carolina at Chapel Hill
  • Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System

OBJECTIVE: To share experiences from two research institutions about implementation of a central IRB model for multi-center clinical trials

AGENDA:

  1. Results from a randomized, controlled trial of central versus local IRB review
  2. The institutional policy resulting from study results and a summary of conclusions that can be applied more broadly
  3. The continuing role of the institution in research compliance
  4. Examples from a research institution that serves as a central IRB and relies on commercial, academic, and federal external IRBs for multi-center clinical trials
  5. Questions and Discussion

CLICK HERE to view the presentation slides.

*This webinar includes presenters from CTTI's Advancing the Use of Central IRBs for Multi-center Clinical Trials project team.

**The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Lung Cancer Master Protocol and I-SPY 2

DATE: January 16, 2014 12–1:00 p.m. EST.

PRESENTERS

  • Jeff Allen, PhD, Friends of Cancer Research
  • Jane Perlmutter, PhD, MBA, Gemini Group

AGENDA:

  1. Lung Cancer Master Protocol presented by Jeff Allen
  2. I-SPY 2 presented by Jane Perlmutter

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

Sponsors' Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

DATE: November 14, 2013 12–1:00 p.m. EST.

PRESENTERS

  • Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System
  • Soo Bang, Sr. Director, Business Development & Global Alliances, Celgene Corporation
  • Petra Kaufmann, M.D., M.Sc., Director, Office of Clinical Research, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

OBJECTIVE: To share experiences across different sponsor organizations in implementation of central IRB model for multi-centered clinical trials

AGENDA:

  1. Introduction: CTTI Use of Central IRBs for Multi-center Clinical Trials Project and Recommendations
  2. Sponsors’ role in choosing to use a central IRB for multi-center clinical trials
  3. One biopharmaceutical sponsor’s approach for adapting to new paradigm for IRB review in the U.S.
  4. A federal sponsor's experience of using a single central IRB for clinical trial networks
  5. Questions and Discussion

CLICK HERE to view the presentation slides.

*This webinar includes presenters from CTTI's Advancing the Use of Central IRBs for Multi-center Clinical Trials project team.

**The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 

 


 

Results of National Public Poll on Clinical Trials

DATE: October 17, 2013 12-1:00 p.m. EST

PRESENTER: Mary Woolley, President of Research!America

SUMMARY: A few months ago, CTTI assisted with questions to include in a national poll conducted by Research!America, the nation's largest not-for-profit, membership-supported, grassroots public education and advocacy organization. They are committed to making medical and health research a higher national priority, and Woolley's review of the survey includes trust factors for clinical trial participation, as well as attitudes towards and information sources for clinical trials.

*If you wish to share this webinar with your networks, visit the accompanying blog post. From the post, submitting this webinar to Facebook, Twitter, LinkedIn, and other social sites is just a click away. 

**The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 


 

TransCelerate BioPharma Presents Risk Based Monitoring Initiative to CTTI Members

DATE: August 20, 2013 12-1:00 p.m. EST

PRESENTER: Craig Wozniak

SUMMARY: CTTI and TransCelerate have been in an ongoing dialogue about their respective efforts, including, for example, how work related to risk based monitoring (RBM) may be integrated. This webinar features a presentation by TransCelerate highlighting their RBM initiative.

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

 

 

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CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. Read our Citation Policy here.